| Product Name | Dosage Form | Route | Strength | Package Description | Labeler Name | NDC Package | Product NDC | Monograph ID | Market Category | DEA |
|---|---|---|---|---|---|---|---|---|---|---|
| .Alpha.-Tocopherol Acetate, Dl-; .Beta.-Carotene; Ascorbic Acid; Calcium Carbonate; Calcium Pantothenate; Cholecalciferol; Cyanocobalamin; Docusate Sodium; Ferrous Fumarate; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine; Zinc Oxide | Tablet | Oral | 30mg/1, 1000 [iU]/1, 100 mg/1, 200 mg/1, 7 mg/1, 400 [iU]/1, 12 ug/1, 25 mg/1, 29 mg/1, 1 mg/1, 15 mg/1, 20 mg/1, 3 mg/1, 3 mg/1, 20 mg/1 | 100 Tablet In 1 Bottle (13925-116-01) | Seton Pharmaceuticals | 13925-116-01 | 13925-116 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; .Beta.-Carotene; Calcium Ascorbate; Calcium Carbonate; Calcium Pantothenate; Cholecalciferol; Cyanocobalamin; Ferrous Fumarate; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Zinc Oxide | Tablet, Chewable | Oral | 30[iU]/1, 1000 [iU]/1, 100 mg/1, 200 mg/1, 7 mg/1, 400 [iU]/1, 12 ug/1, 29 mg/1, 1 mg/1, 15 mg/1, 20 mg/1, 3 mg/1, 3 mg/1, 20 mg/1 | 100 Tablet, Chewable In 1 Bottle (13925-117-01) | Seton Pharmaceuticals | 13925-117-01 | 13925-117 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; Ascorbic Acid; Beta Carotene; Calcium Carbonate; Cholecalciferol; Cupric Oxide; Cyanocobalamin; Ferrous Fumarate; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Vitamin A Acetate; Zinc Oxide | Tablet | Oral | 10mg/1, 120 mg/1, 276 ug/1, 200 mg/1, 10 ug/1, 2 mg/1, 12 ug/1, 27 mg/1, 1667 ug/1, 20 mg/1, 10 mg/1, 3 mg/1, 1.84 mg/1, 924 ug/1, 25 mg/1 | 100 Tablet In 1 Bottle, Plastic (39328-106-10) | Patrin Pharma, Inc. | 39328-106-10 | 39328-106 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; Ascorbic Acid; Biotin; Calcium Carbonate; Calcium Pantothenate; Cholecalciferol; Cupric Oxide; Cyanocobalamin; Ferrous Fumarate; Folic Acid; Magnesium Oxide; Niacinamide; Potassium Iodide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Vitamin A Acetate; Zinc Oxide | Tablet, Film Coated | Oral | 10[iU]/1, 80 mg/1, 300 ug/1, 120 mg/1, 6 mg/1, 400 [iU]/1, 2 mg/1, 12 ug/1, 27 mg/1, 1 mg/1, 30 ug/1, 20 mg/1, 150 ug/1, 20 mg/1, 3.4 mg/1, 3 mg/1, 2500 [iU]/1, 15 ug/1 | 90 Tablet, Film Coated In 1 Bottle (42192-320-90) | Acella Pharmaceuticals, LLC | 42192-320-90 | 42192-320 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; Ascorbic Acid; Calcium; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Fumarate; Folic Acid; Magnesium; Pyridoxine | Capsule, Gelatin Coated | Oral | 10[iU]/1, 85 [iU]/1, 140 mg/1, 200 [iU]/1, 12 ug/1, 300 mg/1, 27 mg/1, 1 mg/1, 45 mg/1, 25 [iU]/1 | 30 Capsule, Gelatin Coated In 1 Bottle (42192-321-30) | Acella Pharmaceuticals, LLC | 42192-321-30 | 42192-321 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; Ascorbic Acid; Calcium; Cholecalciferol; Doconexent; Ferrous Fumarate; Folic Acid; Pyridoxine | Capsule, Gelatin Coated | Oral | 30[iU]/1, 28 mg/1, 160 mg/1, 400 [iU]/1, 300 mg/1, 27 mg/1, 1.25 mg/1, 25 mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (42192-323-30) | Acella Pharmaceuticals, LLC | 42192-323-30 | 42192-323 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate, Dl-; Calcium Citrate; Cholecalciferol; Doconexent; Docusate Sodium; Folic Acid; Iron Pentacarbonyl; Pyridoxine Hydrochloride | Capsule, Liquid Filled | Oral | 30[iU]/1, 100 mg/1, 400 [iU]/1, 250 mg/1, 50 mg/1, 1 mg/1, 28 mg/1, 25 mg/1 | 30 Capsule, Liquid Filled In 1 Capsule (42192-343-30) | Acella Pharmaceuticals, LLC | 42192-343-30 | 42192-343 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol Acetate; Niacinamide; Titanium Dioxide; Zinc Oxide | Lotion | Topical | .5g/88g, .1 g/88g, .1 g/88g, .1 g/88g | 88 G In 1 Bottle (83325-008-03) | Volans Epic LLC | 83325-008-03 | 83325-008 | M020 | OTC MONOGRAPH DRUG | N/A |
| .Alpha.-Tocopherol, D-; Ascorbic Acid; Cholecalciferol; Doconexent; Docusate Sodium; Ferrous Fumarate; Folic Acid; Pyridoxine Hydrochloride; Tricalcium Phosphate | Capsule, Liquid Filled | Oral | 30[iU]/1, 28 mg/1, 800 [iU]/1, 325 mg/1, 55 mg/1, 29 mg/1, 1.25 mg/1, 25 mg/1, 160 mg/1 | 30 Capsule, Liquid Filled In 1 Capsule (42192-341-30) | Acella Pharmaceuticals, LLC | 42192-341-30 | 42192-341 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Alpha.-Tocopherol; Ascorbic Acid; Biotin; Calcium Carbonate; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Fumarate; Folic Acid; Icosapent; Magnesium Oxide; Potassium Iodide; Pyridoxine | Capsule, Gelatin Coated | Oral | 10[iU]/1, 85 mg/1, 250 ug/1, 140 mg/1, 200 [iU]/1, 12 ug/1, 300 mg/1, 28 mg/1, 1 mg/1, 40 mg/1, 45 mg/1, 150 ug/1, 25 mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (42192-332-30) | Acella Pharmaceuticals, LLC | 42192-332-30 | 42192-332 | N/A | UNAPPROVED DRUG OTHER | N/A |
| .Beta.-Sitosterol; Cyanocobalamin; Doconexent; Folic Acid; Icosapent; Omega-3 Fatty Acids; Pyridoxine Hydrochloride | Capsule, Coated | Oral | 200mg/1, 500 ug/1, 350 mg/1, 1 mg/1, 35 mg/1, 500 mg/1, 12.5 mg/1 | 60 Capsule, Coated In 1 Bottle (42192-301-60) | Acella Pharmaceuticals, LLC | 42192-301-60 | 42192-301 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Abacavir | Tablet | Oral | 300mg/1 | 60 Tablet In 1 Bottle (31722-557-60) | Camber Pharmaceuticals, Inc. | 31722-557-60 | 31722-557 | ANDA091560 | ANDA | N/A |
| Abacavir | Tablet | Oral | 300mg/1 | 60 Tablet In 1 Bottle (72865-167-60) | XLCare Pharmaceuticals Inc. | 72865-167-60 | 72865-167 | ANDA091560 | ANDA | N/A |
| Abiraterone Acetate | Tablet | Oral | 250mg/1 | 120 Tablet In 1 Bottle (60505-4327-1) | Apotex Corp. | 60505-4327-1 | 60505-4327 | ANDA208453 | ANDA | N/A |
| Abiraterone Acetate | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-4764-6) | Apotex Corp. | 60505-4764-6 | 60505-4764 | ANDA212462 | ANDA | N/A |
| Abacavir Sulfate | Solution | Oral | 20mg/mL | 1 Bottle In 1 Carton (64980-405-24) / 240 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-405-24 | 64980-405 | ANDA077950 | ANDA | N/A |
| Abiraterone Acetate | Tablet | Oral | 250mg/1 | 120 Tablet In 1 Bottle (0143-9597-21) | Hikma Pharmaceuticals USA Inc. | 0143-9597-21 | 0143-9597 | ANDA208339 | ANDA | N/A |
| Abrocitinib | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0335-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0335-30 | 0069-0335 | NDA213871 | NDA | N/A |
| Abrocitinib | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0235-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0235-30 | 0069-0235 | NDA213871 | NDA | N/A |
| Abrocitinib | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0435-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0435-30 | 0069-0435 | NDA213871 | NDA | N/A |
| Acacia Longifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1006-2) | Jubilant HollisterStier LLC | 65044-1006-2 | 65044-1006 | BLA103888 | BLA | N/A |
| Acacia Longifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1006-3) | Jubilant HollisterStier LLC | 65044-1006-3 | 65044-1006 | BLA103888 | BLA | N/A |
| Acacia Longifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1006-4) | Jubilant HollisterStier LLC | 65044-1006-4 | 65044-1006 | BLA103888 | BLA | N/A |
| Acacia Longifolia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1007-1) | Jubilant HollisterStier LLC | 65044-1007-1 | 65044-1007 | BLA103888 | BLA | N/A |
| Acarbose | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (0054-0140-25) | Hikma Pharmaceuticals USA Inc. | 0054-0140-25 | 0054-0140 | ANDA078470 | ANDA | N/A |
| Acarbose | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (0054-0141-25) | Hikma Pharmaceuticals USA Inc. | 0054-0141-25 | 0054-0141 | ANDA078470 | ANDA | N/A |
| Acarbose | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (0054-0142-25) | Hikma Pharmaceuticals USA Inc. | 0054-0142-25 | 0054-0142 | ANDA078470 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (51407-666-01) | Golden State Medical Supply, Inc. | 51407-666-01 | 51407-666 | ANDA074007 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (51407-667-01) | Golden State Medical Supply, Inc. | 51407-667-01 | 51407-667 | ANDA074007 | ANDA | N/A |
| Abiraterone Acetate | Tablet | Oral | 250mg/1 | 120 Tablet In 1 Bottle (64980-418-12) | Rising Pharmaceuticals, Inc. | 64980-418-12 | 64980-418 | ANDA208371 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (65162-669-10) | Amneal Pharmaceuticals LLC | 65162-669-10 | 65162-669 | ANDA075047 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (65162-669-50) | Amneal Pharmaceuticals LLC | 65162-669-50 | 65162-669 | ANDA075047 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (65162-670-03) | Amneal Pharmaceuticals LLC | 65162-670-03 | 65162-670 | ANDA075047 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (65162-670-10) | Amneal Pharmaceuticals LLC | 65162-670-10 | 65162-670 | ANDA075047 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (65162-670-50) | Amneal Pharmaceuticals LLC | 65162-670-50 | 65162-670 | ANDA075047 | ANDA | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (62559-255-01) | ANI Pharmaceuticals, Inc. | 62559-255-01 | 62559-255 | ANDA074007 | ANDA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1213-2) | Jubilant HollisterStier LLC | 65044-1213-2 | 65044-1213 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1213-3) | Jubilant HollisterStier LLC | 65044-1213-3 | 65044-1213 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1213-4) | Jubilant HollisterStier LLC | 65044-1213-4 | 65044-1213 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1214-1) | Jubilant HollisterStier LLC | 65044-1214-1 | 65044-1214 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1216-2) | Jubilant HollisterStier LLC | 65044-1216-2 | 65044-1216 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1216-3) | Jubilant HollisterStier LLC | 65044-1216-3 | 65044-1216 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1216-4) | Jubilant HollisterStier LLC | 65044-1216-4 | 65044-1216 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 10 Ml In 1 Vial (65044-1217-2) | Jubilant HollisterStier LLC | 65044-1217-2 | 65044-1217 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 30 Ml In 1 Vial (65044-1217-3) | Jubilant HollisterStier LLC | 65044-1217-3 | 65044-1217 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 50 Ml In 1 Vial (65044-1217-4) | Jubilant HollisterStier LLC | 65044-1217-4 | 65044-1217 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .017 g/mL, .017 g/mL, .017 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2854-2) | Jubilant HollisterStier LLC | 65044-2854-2 | 65044-2854 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .017 g/mL, .017 g/mL, .017 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2854-3) | Jubilant HollisterStier LLC | 65044-2854-3 | 65044-2854 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .017 g/mL, .017 g/mL, .017 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2854-4) | Jubilant HollisterStier LLC | 65044-2854-4 | 65044-2854 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-2855-2) | Jubilant HollisterStier LLC | 65044-2855-2 | 65044-2855 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-2855-3) | Jubilant HollisterStier LLC | 65044-2855-3 | 65044-2855 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-2855-4) | Jubilant HollisterStier LLC | 65044-2855-4 | 65044-2855 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .033 g/mL, .033 g/mL, .033 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-2856-2) | Jubilant HollisterStier LLC | 65044-2856-2 | 65044-2856 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .033 g/mL, .033 g/mL, .033 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-2856-3) | Jubilant HollisterStier LLC | 65044-2856-3 | 65044-2856 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .033 g/mL, .033 g/mL, .033 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-2856-4) | Jubilant HollisterStier LLC | 65044-2856-4 | 65044-2856 | BLA103888 | BLA | N/A |
| Acer Negundo Pollen; Acer Rubrum Pollen; Acer Saccharum Pollen; Carya Illinoinensis Pollen; Platanus Occidentalis Pollen; Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen; Salix Nigra Pollen | Injection, Solution | Percutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .017 g/mL, .017 g/mL, .017 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2858-1) | Jubilant HollisterStier LLC | 65044-2858-1 | 65044-2858 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1831-2) | Jubilant HollisterStier LLC | 65044-1831-2 | 65044-1831 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1831-3) | Jubilant HollisterStier LLC | 65044-1831-3 | 65044-1831 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1831-4) | Jubilant HollisterStier LLC | 65044-1831-4 | 65044-1831 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1832-1) | Jubilant HollisterStier LLC | 65044-1832-1 | 65044-1832 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2620-1) | Jubilant HollisterStier LLC | 65044-2620-1 | 65044-2620 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-2622-2) | Jubilant HollisterStier LLC | 65044-2622-2 | 65044-2622 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-2622-3) | Jubilant HollisterStier LLC | 65044-2622-3 | 65044-2622 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-2622-4) | Jubilant HollisterStier LLC | 65044-2622-4 | 65044-2622 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 10 Ml In 1 Vial (65044-2623-2) | Jubilant HollisterStier LLC | 65044-2623-2 | 65044-2623 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 30 Ml In 1 Vial (65044-2623-3) | Jubilant HollisterStier LLC | 65044-2623-3 | 65044-2623 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 50 Ml In 1 Vial (65044-2623-4) | Jubilant HollisterStier LLC | 65044-2623-4 | 65044-2623 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-2624-2) | Jubilant HollisterStier LLC | 65044-2624-2 | 65044-2624 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-2624-3) | Jubilant HollisterStier LLC | 65044-2624-3 | 65044-2624 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-2624-4) | Jubilant HollisterStier LLC | 65044-2624-4 | 65044-2624 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2619-2) | Jubilant HollisterStier LLC | 65044-2619-2 | 65044-2619 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2619-3) | Jubilant HollisterStier LLC | 65044-2619-3 | 65044-2619 | BLA103888 | BLA | N/A |
| Acer Saccharum Pollen; Betula Nigra Pollen; Carya Ovata Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Platanus Occidentalis Pollen; Populus Deltoides Pollen; Quercus Rubra Pollen; Salix Nigra Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2619-4) | Jubilant HollisterStier LLC | 65044-2619-4 | 65044-2619 | BLA103888 | BLA | N/A |
| Acetaminophen | Suppository | Rectal | 650mg/1 | 1 Suppository In 1 Blister Pack (45802-730-00) | Padagis Israel Pharmaceuticals Ltd | 45802-730-00 | 45802-730 | ANDA070608 | ANDA | N/A |
| Acetaminophen | Suppository | Rectal | 650mg/1 | 12 Blister Pack In 1 Carton (45802-730-30) / 1 Suppository In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-730-30 | 45802-730 | ANDA070608 | ANDA | N/A |
| Acetaminophen | Suppository | Rectal | 650mg/1 | 50 Blister Pack In 1 Carton (45802-730-32) / 1 Suppository In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-730-32 | 45802-730 | ANDA070608 | ANDA | N/A |
| Acetaminophen | Suppository | Rectal | 650mg/1 | 100 Blister Pack In 1 Carton (45802-730-33) / 1 Suppository In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-730-33 | 45802-730 | ANDA070608 | ANDA | N/A |
| Acetaminophen | Suppository | Rectal | 120mg/1 | 12 Blister Pack In 1 Carton (45802-732-30) / 1 Suppository In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-732-30 | 45802-732 | ANDA070607 | ANDA | N/A |
| Acetaminophen | Suppository | Rectal | 120mg/1 | 100 Blister Pack In 1 Carton (45802-732-33) / 1 Suppository In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-732-33 | 45802-732 | ANDA070607 | ANDA | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (45802-203-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-203-26 | 45802-203 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (45802-201-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-201-26 | 45802-201 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 160mg/5mL | 5 Tray In 1 Case (39328-031-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (39328-031-05) | Patrin Pharma, Inc. | 39328-031-50 | 39328-031 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 160mg/5mL | 10 Tray In 1 Case (39328-031-99) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (39328-031-05) | Patrin Pharma, Inc. | 39328-031-99 | 39328-031 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 325mg/10.15mL | 5 Tray In 1 Case (39328-032-50) / 10 Cup, Unit-Dose In 1 Tray / 10.15 Ml In 1 Cup, Unit-Dose (39328-032-10) | Patrin Pharma, Inc. | 39328-032-50 | 39328-032 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 325mg/10.15mL | 10 Cup, Unit-Dose In 1 Case (39328-032-99) / 10.15 Ml In 1 Cup, Unit-Dose (39328-032-10) / 10 In 1 Tray | Patrin Pharma, Inc. | 39328-032-99 | 39328-032 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 650mg/20.3mL | 5 Tray In 1 Case (39328-034-50) / 10 Cup, Unit-Dose In 1 Tray / 20.3 Ml In 1 Cup, Unit-Dose (39328-034-20) | Patrin Pharma, Inc. | 39328-034-50 | 39328-034 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Liquid | Oral | 650mg/20.3mL | 10 Tray In 1 Case (39328-034-99) / 10 Cup, Unit-Dose In 1 Tray / 20.3 Ml In 1 Cup, Unit-Dose (39328-034-20) | Patrin Pharma, Inc. | 39328-034-99 | 39328-034 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Tablet | Oral | 500mg/1 | 40 Tablet In 1 Bottle, Plastic (60760-534-40) | St. Mary's Medical Park Pharmacy | 60760-534-40 | 60760-534 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Tablet | Oral | 325mg/1 | 50 Tablet In 1 Bottle, Plastic (60760-453-50) | St. Mary's Medical Park Pharmacy | 60760-453-50 | 60760-453 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Suppository | Rectal | 80mg/1 | 6 Blister Pack In 1 Carton (51672-2114-2) / 1 Suppository In 1 Blister Pack (51672-2114-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2114-2 | 51672-2114 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 80mg/1 | 50 Blister Pack In 1 Carton (51672-2114-4) / 1 Suppository In 1 Blister Pack (51672-2114-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2114-4 | 51672-2114 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 120mg/1 | 6 Blister Pack In 1 Carton (51672-2115-2) / 1 Suppository In 1 Blister Pack (51672-2115-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2115-2 | 51672-2115 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 120mg/1 | 50 Blister Pack In 1 Carton (51672-2115-4) / 1 Suppository In 1 Blister Pack (51672-2115-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2115-4 | 51672-2115 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 325mg/1 | 6 Blister Pack In 1 Carton (51672-2116-2) / 1 Suppository In 1 Blister Pack (51672-2116-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2116-2 | 51672-2116 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 325mg/1 | 50 Blister Pack In 1 Carton (51672-2116-4) / 1 Suppository In 1 Blister Pack (51672-2116-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2116-4 | 51672-2116 | NDA018337 | NDA | N/A |
| Acetaminophen | Suppository | Rectal | 650mg/1 | 50 Blister Pack In 1 Carton (51672-2117-4) / 1 Suppository In 1 Blister Pack (51672-2117-0) | Taro Pharmaceuticals U.S.A. Inc. | 51672-2117-4 | 51672-2117 | NDA018337 | NDA | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (51672-5319-8) / 118 Ml In 1 Bottle | TARO PHARMACEUTICALS U.S.A., INC. | 51672-5319-8 | 51672-5319 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (51672-5320-8) / 118 Ml In 1 Bottle | TARO PHARMACEUTICALS U.S.A., INC. | 51672-5320-8 | 51672-5320 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (69729-068-04) / 118 Ml In 1 Bottle | OPMX Chula Vista | 69729-068-04 | 69729-068 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (69729-118-04) / 118 Ml In 1 Bottle | OPMX Chula Vista | 69729-118-04 | 69729-118 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (69729-047-04) / 118 Ml In 1 Bottle | OPMX Chula Vista | 69729-047-04 | 69729-047 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen | Suspension | Oral | 160mg/5mL | 1 Bottle In 1 Carton (69729-006-02) / 60 Ml In 1 Bottle | OPMX Chula Vista | 69729-006-02 | 69729-006 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Acebutolol Hydrochloride | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (62559-256-01) | ANI Pharmaceuticals, Inc. | 62559-256-01 | 62559-256 | ANDA074007 | ANDA | N/A |
| Acetaminophen | Injection, Solution | Intravenous | 10mg/mL | 24 Vial, Single-Dose In 1 Carton (31722-205-24) / 100 Ml In 1 Vial, Single-Dose (31722-205-31) | Camber Pharmaceuticals, Inc. | 31722-205-24 | 31722-205 | ANDA216617 | ANDA | N/A |
| Acetaminophen | Injection, Solution | Intravenous | 10mg/mL | 24 Vial, Glass In 1 Carton (24201-100-24) / 100 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 24201-100-24 | 24201-100 | ANDA202605 | ANDA | N/A |
| Acetaminophen | Injection, Solution | Intravenous | 10mg/mL | 24 Vial, Glass In 1 Carton (24201-110-24) / 100 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 24201-110-24 | 24201-110 | ANDA202605 | ANDA | N/A |
| Acetaminophen | Injection | Intravenous | 1000mg/100mL | 10 Bag In 1 Carton (0143-9386-10) / 100 Ml In 1 Bag (0143-9386-01) | Hikma Pharmaceuticals USA Inc. | 0143-9386-10 | 0143-9386 | NDA206968 | NDA | N/A |
| Acetaminophen; Aspirin; Caffeine | Tablet, Film Coated | Oral | 250mg/1, 250 mg/1, 65 mg/1 | 1 Bottle, Plastic In 1 Carton (52389-237-28) / 28 Tablet, Film Coated In 1 Bottle, Plastic (52389-237-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-237-28 | 52389-237 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 100 Tablet In 1 Bottle (79739-7320-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7320-1 | 79739-7320 | ANDA209587 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 500 Tablet In 1 Bottle (79739-7320-5) | LGM PHARMA SOLUTIONS, LLC | 79739-7320-5 | 79739-7320 | ANDA209587 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 100 Tablet In 1 Bottle, Plastic (60429-589-01) | Golden State Medical Supply, Inc. | 60429-589-01 | 60429-589 | ANDA089175 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 500 Tablet In 1 Bottle, Plastic (60429-589-05) | Golden State Medical Supply, Inc. | 60429-589-05 | 60429-589 | ANDA089175 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Capsule | Oral | 300mg/1, 50 mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (51672-4222-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4222-1 | 51672-4222 | ANDA213046 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 100 Tablet In 1 Bottle (10702-253-01) | KVK-Tech, Inc. | 10702-253-01 | 10702-253 | ANDA211106 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Tablet | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 500 Tablet In 1 Bottle (10702-253-50) | KVK-Tech, Inc. | 10702-253-50 | 10702-253 | ANDA211106 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (13925-536-01) | Seton Pharmaceuticals LLC | 13925-536-01 | 13925-536 | ANDA214087 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine | Capsule | Oral | 300mg/1, 50 mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (13925-535-01) | Seton Pharmaceuticals LLC | 13925-535-01 | 13925-535 | ANDA214087 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1, 30 mg/1 | 100 Capsule In 1 Bottle, Plastic (79739-6670-1) | LGM PHARMA SOLUTIONS, LLC | 79739-6670-1 | 79739-6670 | ANDA076560 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1, 30 mg/1 | 500 Capsule In 1 Bottle, Plastic (79739-6670-5) | LGM PHARMA SOLUTIONS, LLC | 79739-6670-5 | 79739-6670 | ANDA076560 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule | Oral | 300mg/1, 50 mg/1, 40 mg/1, 30 mg/1 | 100 Capsule In 1 Bottle (0054-0650-25) | Hikma Pharmaceuticals USA Inc. | 0054-0650-25 | 0054-0650 | ANDA215138 | ANDA | CIII |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1, 30 mg/1 | 100 Capsule In 1 Bottle (0054-3000-01) | Hikma Pharmaceuticals USA Inc. | 0054-3000-01 | 0054-3000 | ANDA215138 | ANDA | CIII |
| Acetaminophen; Codeine Phosphate | Tablet | Oral | 300mg/1, 30 mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-581-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-581-30 | 60760-581 | ANDA040419 | ANDA | CIII |
| Acetaminophen; Codeine Phosphate | Tablet | Oral | 300mg/1, 30 mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-466-30) | St. Mary's Medical Park Pharmacy | 60760-466-30 | 60760-466 | ANDA202800 | ANDA | CIII |
| Acetaminophen | Solution | Oral | 160mg/5mL | 118 Ml In 1 Bottle, Plastic (57237-304-12) | Rising Pharma Holdings, Inc. | 57237-304-12 | 57237-304 | OTC MONOGRAPH NOT FINAL | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen | Solution | Oral | 160mg/5mL | 473 Ml In 1 Bottle, Plastic (57237-304-16) | Rising Pharma Holdings, Inc. | 57237-304-16 | 57237-304 | OTC MONOGRAPH NOT FINAL | OTC MONOGRAPH NOT FINAL | N/A |
| Acetaminophen; Codeine Phosphate | Tablet | Oral | 300mg/1, 30 mg/1 | 100 Tablet In 1 Bottle (65162-033-10) | Amneal Pharmaceuticals LLC | 65162-033-10 | 65162-033 | ANDA040779 | ANDA | CIII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (60429-590-01) | Golden State Medical Supply, Inc. | 60429-590-01 | 60429-590 | ANDA040409 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (60429-590-05) | Golden State Medical Supply, Inc. | 60429-590-05 | 60429-590 | ANDA040409 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (60429-591-01) | Golden State Medical Supply, Inc. | 60429-591-01 | 60429-591 | ANDA040405 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (60429-591-05) | Golden State Medical Supply, Inc. | 60429-591-05 | 60429-591 | ANDA040405 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (60429-592-01) | Golden State Medical Supply, Inc. | 60429-592-01 | 60429-592 | ANDA040400 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (60429-592-05) | Golden State Medical Supply, Inc. | 60429-592-05 | 60429-592 | ANDA040400 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-035-01) | Tris Pharma Inc | 27808-035-01 | 27808-035 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle, Plastic (27808-035-02) | Tris Pharma Inc | 27808-035-02 | 27808-035 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle, Plastic (27808-035-03) | Tris Pharma Inc | 27808-035-03 | 27808-035 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-036-01) | Tris Pharma Inc | 27808-036-01 | 27808-036 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle, Plastic (27808-036-02) | Tris Pharma Inc | 27808-036-02 | 27808-036 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 1000 Tablet In 1 Bottle, Plastic (27808-036-03) | Tris Pharma Inc | 27808-036-03 | 27808-036 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-037-01) | Tris Pharma Inc | 27808-037-01 | 27808-037 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle, Plastic (27808-037-02) | Tris Pharma Inc | 27808-037-02 | 27808-037 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle, Plastic (27808-037-03) | Tris Pharma Inc | 27808-037-03 | 27808-037 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 325mg/15mL, 7.5 mg/15mL | 473 Ml In 1 Bottle, Plastic (27808-049-01) | Tris Pharma Inc | 27808-049-01 | 27808-049 | ANDA201295 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-114-01) | Tris Pharma Inc | 27808-114-01 | 27808-114 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (27808-114-02) | Tris Pharma Inc | 27808-114-02 | 27808-114 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (27808-115-01) | Tris Pharma Inc | 27808-115-01 | 27808-115 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (27808-115-02) | Tris Pharma Inc | 27808-115-02 | 27808-115 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-116-01) | Tris Pharma Inc | 27808-116-01 | 27808-116 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (27808-116-02) | Tris Pharma Inc | 27808-116-02 | 27808-116 | ANDA202214 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 300mg/15mL, 10 mg/15mL | 473 Ml In 1 Bottle, Plastic (27808-130-01) | Tris Pharma Inc | 27808-130-01 | 27808-130 | ANDA201295 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 325mg/15mL, 7.5 mg/15mL | 120 Ml In 1 Bottle (66689-023-04) | VistaPharm, LLC | 66689-023-04 | 66689-023 | ANDA200343 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 325mg/15mL, 7.5 mg/15mL | 473 Ml In 1 Bottle (66689-023-16) | VistaPharm, LLC | 66689-023-16 | 66689-023 | ANDA200343 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 325mg/15mL, 7.5 mg/15mL | 50 Cup, Unit-Dose In 1 Case (66689-023-50) / 15 Ml In 1 Cup, Unit-Dose (66689-023-01) | VistaPharm, LLC | 66689-023-50 | 66689-023 | ANDA200343 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 108mg/5mL, 2.5 mg/5mL | 50 Cup, Unit-Dose In 1 Case (66689-004-50) / 5 Ml In 1 Cup, Unit-Dose (66689-004-01) | VistaPharm, LLC | 66689-004-50 | 66689-004 | ANDA200343 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Solution | Oral | 217mg/10mL, 5 mg/10mL | 50 Cup, Unit-Dose In 1 Case (66689-005-50) / 10 Ml In 1 Cup, Unit-Dose (66689-005-01) | VistaPharm, LLC | 66689-005-50 | 66689-005 | ANDA200343 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (10702-191-01) | KVK-Tech, Inc. | 10702-191-01 | 10702-191 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 30 Tablet In 1 Bottle (10702-191-03) | KVK-Tech, Inc. | 10702-191-03 | 10702-191 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle (10702-191-10) | KVK-Tech, Inc. | 10702-191-10 | 10702-191 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (10702-191-50) | KVK-Tech, Inc. | 10702-191-50 | 10702-191 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (10702-192-01) | KVK-Tech, Inc. | 10702-192-01 | 10702-192 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 30 Tablet In 1 Bottle (10702-192-03) | KVK-Tech, Inc. | 10702-192-03 | 10702-192 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle (10702-192-10) | KVK-Tech, Inc. | 10702-192-10 | 10702-192 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (10702-192-50) | KVK-Tech, Inc. | 10702-192-50 | 10702-192 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (10702-193-01) | KVK-Tech, Inc. | 10702-193-01 | 10702-193 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 30 Tablet In 1 Bottle (10702-193-03) | KVK-Tech, Inc. | 10702-193-03 | 10702-193 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 1000 Tablet In 1 Bottle (10702-193-10) | KVK-Tech, Inc. | 10702-193-10 | 10702-193 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (10702-193-50) | KVK-Tech, Inc. | 10702-193-50 | 10702-193 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (10702-194-01) | KVK-Tech, Inc. | 10702-194-01 | 10702-194 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 30 Tablet In 1 Bottle (10702-194-03) | KVK-Tech, Inc. | 10702-194-03 | 10702-194 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle (10702-194-10) | KVK-Tech, Inc. | 10702-194-10 | 10702-194 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (10702-194-50) | KVK-Tech, Inc. | 10702-194-50 | 10702-194 | ANDA209036 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (10702-189-01) | KVK-Tech, Inc. | 10702-189-01 | 10702-189 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 30 Tablet In 1 Bottle (10702-189-03) | KVK-Tech, Inc. | 10702-189-03 | 10702-189 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle (10702-189-10) | KVK-Tech, Inc. | 10702-189-10 | 10702-189 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (10702-189-50) | KVK-Tech, Inc. | 10702-189-50 | 10702-189 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (10702-190-01) | KVK-Tech, Inc. | 10702-190-01 | 10702-190 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 30 Tablet In 1 Bottle (10702-190-03) | KVK-Tech, Inc. | 10702-190-03 | 10702-190 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 1000 Tablet In 1 Bottle (10702-190-10) | KVK-Tech, Inc. | 10702-190-10 | 10702-190 | ANDA209037 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (10702-190-50) | KVK-Tech, Inc. | 10702-190-50 | 10702-190 | ANDA209037 | ANDA | CII |
| Acetaminophen; Codeine Phosphate | Tablet | Oral | 300mg/1, 30 mg/1 | 1000 Tablet In 1 Bottle (65162-033-11) | Amneal Pharmaceuticals LLC | 65162-033-11 | 65162-033 | ANDA040779 | ANDA | CIII |
| Acetaminophen; Codeine Phosphate | Tablet | Oral | 300mg/1, 30 mg/1 | 500 Tablet In 1 Bottle (65162-033-50) | Amneal Pharmaceuticals LLC | 65162-033-50 | 65162-033 | ANDA040779 | ANDA | CIII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (65162-696-10) | Amneal Pharmaceuticals LLC | 65162-696-10 | 65162-696 | ANDA207137 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle (65162-696-11) | Amneal Pharmaceuticals LLC | 65162-696-11 | 65162-696 | ANDA207137 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (65162-696-50) | Amneal Pharmaceuticals LLC | 65162-696-50 | 65162-696 | ANDA207137 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 30 Tablet In 1 Bottle (65162-115-03) | Amneal Pharmaceuticals LLC | 65162-115-03 | 65162-115 | ANDA040746 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (65162-115-10) | Amneal Pharmaceuticals LLC | 65162-115-10 | 65162-115 | ANDA040746 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 1000 Tablet In 1 Bottle (65162-115-11) | Amneal Pharmaceuticals LLC | 65162-115-11 | 65162-115 | ANDA040746 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (65162-115-50) | Amneal Pharmaceuticals LLC | 65162-115-50 | 65162-115 | ANDA040746 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (65162-675-10) | Amneal Pharmaceuticals LLC | 65162-675-10 | 65162-675 | ANDA206869 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle (65162-675-11) | Amneal Pharmaceuticals LLC | 65162-675-11 | 65162-675 | ANDA206869 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 300mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (65162-675-50) | Amneal Pharmaceuticals LLC | 65162-675-50 | 65162-675 | ANDA206869 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (42806-111-01) | Epic Pharma, LLC | 42806-111-01 | 42806-111 | ANDA203863 | ANDA | CII |
| Acetaminophen; Ibuprofen | Tablet, Film Coated | Oral | 250mg/1, 125 mg/1 | 216 Tablet, Film Coated In 1 Bottle (69452-394-64) | Bionpharma Inc. | 69452-394-64 | 69452-394 | ANDA216999 | ANDA | N/A |
| Acetaminophen; Ibuprofen | Tablet, Film Coated | Oral | 250mg/1, 125 mg/1 | 1 Bottle In 1 Carton (69452-446-23) / 144 Tablet, Film Coated In 1 Bottle | Bionpharma Inc. | 69452-446-23 | 69452-446 | ANDA216999 | ANDA | N/A |
| Acetaminophen; Ibuprofen | Tablet, Film Coated | Oral | 250mg/1, 125 mg/1 | 1 Bottle In 1 Carton (69452-447-22) / 120 Tablet, Film Coated In 1 Bottle | Bionpharma Inc. | 69452-447-22 | 69452-447 | ANDA216999 | ANDA | N/A |
| Acetaminophen; Ibuprofen | Injection | Intravenous | 1000mg/100mL, 300 mg/100mL | 10 Vial In 1 Carton (0143-9150-10) / 100 Ml In 1 Vial (0143-9150-01) | Hikma Pharmaceuticals USA Inc. | 0143-9150-10 | 0143-9150 | NDA215320 | NDA | N/A |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (10702-184-01) | KVK-Tech, Inc. | 10702-184-01 | 10702-184 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 2.5 mg/1 | 1000 Tablet In 1 Bottle (10702-184-10) | KVK-Tech, Inc. | 10702-184-10 | 10702-184 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (10702-184-50) | KVK-Tech, Inc. | 10702-184-50 | 10702-184 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (10702-185-01) | KVK-Tech, Inc. | 10702-185-01 | 10702-185 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle (10702-185-10) | KVK-Tech, Inc. | 10702-185-10 | 10702-185 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (10702-185-50) | KVK-Tech, Inc. | 10702-185-50 | 10702-185 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (10702-186-01) | KVK-Tech, Inc. | 10702-186-01 | 10702-186 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 7.5 mg/1 | 1000 Tablet In 1 Bottle (10702-186-10) | KVK-Tech, Inc. | 10702-186-10 | 10702-186 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (10702-186-50) | KVK-Tech, Inc. | 10702-186-50 | 10702-186 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (10702-187-01) | KVK-Tech, Inc. | 10702-187-01 | 10702-187 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle (10702-187-10) | KVK-Tech, Inc. | 10702-187-10 | 10702-187 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (10702-187-50) | KVK-Tech, Inc. | 10702-187-50 | 10702-187 | ANDA210644 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Solution | Oral | 325mg/5mL, 5 mg/5mL | 500 Ml In 1 Bottle (29033-405-35) | Nostrum Laboratories, Inc. | 29033-405-35 | 29033-405 | ANDA201448 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Solution | Oral | 325mg/5mL, 5 mg/5mL | 500 Ml In 1 Bottle (10702-238-50) | KVK-Tech, Inc. | 10702-238-50 | 10702-238 | ANDA211499 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (42806-112-01) | Epic Pharma, LLC | 42806-112-01 | 42806-112 | ANDA203863 | ANDA | CII |
| Acetaminophen; Hydrocodone Bitartrate | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (42806-113-01) | Epic Pharma, LLC | 42806-113-01 | 42806-113 | ANDA203863 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 30 Tablet In 1 Bottle (65162-207-03) | Amneal Pharmaceuticals LLC | 65162-207-03 | 65162-207 | ANDA040778 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (65162-207-10) | Amneal Pharmaceuticals LLC | 65162-207-10 | 65162-207 | ANDA040778 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (65162-207-50) | Amneal Pharmaceuticals LLC | 65162-207-50 | 65162-207 | ANDA040778 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (42806-114-01) | Epic Pharma, LLC | 42806-114-01 | 42806-114 | ANDA203864 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (47781-196-01) | Alvogen, Inc. | 47781-196-01 | 47781-196 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (47781-196-05) | Alvogen, Inc. | 47781-196-05 | 47781-196 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (47781-229-01) | Alvogen, Inc. | 47781-229-01 | 47781-229 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (47781-229-05) | Alvogen, Inc. | 47781-229-05 | 47781-229 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (47781-230-01) | Alvogen, Inc. | 47781-230-01 | 47781-230 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (47781-230-05) | Alvogen, Inc. | 47781-230-05 | 47781-230 | ANDA202677 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 10 mg/1 | 250 Tablet In 1 Bottle (47781-230-63) | Alvogen, Inc. | 47781-230-63 | 47781-230 | ANDA202677 | ANDA | CII |
| Acetaminophen; Pamabrom | Tablet, Film Coated | Oral | 500mg/1, 25 mg/1 | 1 Blister Pack In 1 Carton (52389-153-14) / 14 Tablet, Film Coated In 1 Blister Pack (52389-153-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-153-14 | 52389-153 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Pamabrom | Tablet, Film Coated | Oral | 500mg/1, 25 mg/1 | 2 Blister Pack In 1 Carton (52389-153-28) / 14 Tablet, Film Coated In 1 Blister Pack (52389-153-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-153-28 | 52389-153 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Pamabrom | Tablet, Film Coated | Oral | 500mg/1, 25 mg/1 | 5 Blister Pack In 1 Carton (52389-153-35) / 7 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-153-35 | 52389-153 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Pamabrom | Tablet, Film Coated | Oral | 500mg/1, 25 mg/1 | 1 Bottle, Plastic In 1 Carton (52389-153-38) / 38 Tablet, Film Coated In 1 Bottle, Plastic (52389-153-03) | Alva-Amco Pharmacal Companies, Inc. | 52389-153-38 | 52389-153 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Pamabrom | Tablet, Film Coated | Oral | 500mg/1, 25 mg/1 | 1 Bottle In 1 Carton (52389-153-46) / 46 Tablet, Film Coated In 1 Bottle | Alva-Amco Pharmacal Companies, Inc. | 52389-153-46 | 52389-153 | M013 | OTC MONOGRAPH DRUG | N/A |
| Acetaminophen; Tramadol Hydrochloride | Tablet, Film Coated | Oral | 325mg/1, 37.5 mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (60760-922-20) | St. Mary's Medical Park Pharmacy | 60760-922-20 | 60760-922 | ANDA207152 | ANDA | CIV |
| Acetazolamide | Capsule, Extended Release | Oral | 500mg/1 | 100 Capsule, Extended Release In 1 Bottle (29033-030-01) | Nostrum Laboratories, Inc. | 29033-030-01 | 29033-030 | ANDA204691 | ANDA | N/A |
| Acetazolamide | Tablet | Oral | 125mg/1 | 100 Tablet In 1 Bottle (51672-4022-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4022-1 | 51672-4022 | ANDA040195 | ANDA | N/A |
| Acetazolamide | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (51672-4023-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4023-1 | 51672-4023 | ANDA040195 | ANDA | N/A |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (42806-115-01) | Epic Pharma, LLC | 42806-115-01 | 42806-115 | ANDA203864 | ANDA | CII |
| Acetaminophen; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (42806-116-01) | Epic Pharma, LLC | 42806-116-01 | 42806-116 | ANDA203864 | ANDA | CII |
| Acetazolamide | Tablet | Oral | 125mg/1 | 1000 Tablet In 1 Bottle (70954-033-20) | ANI Pharmaceuticals, Inc. | 70954-033-20 | 70954-033 | ANDA210588 | ANDA | N/A |
| Acetazolamide | Tablet | Oral | 125mg/1 | 100 Tablet In 1 Bottle (70954-033-30) | ANI Pharmaceuticals, Inc. | 70954-033-30 | 70954-033 | ANDA210588 | ANDA | N/A |
| Acetazolamide | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle (70954-034-20) | ANI Pharmaceuticals, Inc. | 70954-034-20 | 70954-034 | ANDA210588 | ANDA | N/A |
| Acetazolamide Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 1 Vial In 1 Box, Unit-Dose (0143-9503-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9503-01 | 0143-9503 | ANDA040089 | ANDA | N/A |
| Acetazolamide Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 1 Vial In 1 Carton (0143-9006-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9006-01 | 0143-9006 | ANDA040089 | ANDA | N/A |
| Acetic Acid; Hydrocortisone | Solution | Auricular (Otic) | 20.8mg/mL, 10.4 mg/mL | 1 Bottle In 1 Carton (51672-3007-1) / 10 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-3007-1 | 51672-3007 | ANDA088759 | ANDA | N/A |
| Acetic Acid; Hydrocortisone | Solution | Auricular (Otic) | 20mg/mL, 10 mg/mL | 1 Bottle In 1 Carton (0713-0849-09) / 10 Ml In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0849-09 | 0713-0849 | ANDA040609 | ANDA | N/A |
| Acetylcysteine | Injection | Intravenous | 200mg/mL | 4 Vial In 1 Carton (0574-0805-30) / 30 Ml In 1 Vial | Padagis US LLC | 0574-0805-30 | 0574-0805 | NDA021539 | NDA AUTHORIZED GENERIC | N/A |
| Acetylcysteine | Injection, Solution | Intravenous | 200mg/mL | 4 Vial In 1 Carton (25021-812-66) / 30 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-812-66 | 25021-812 | ANDA091684 | ANDA | N/A |
| Acetylcysteine | Injection, Solution | Intravenous | 200mg/mL | 4 Vial In 1 Carton (25021-812-30) / 30 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-812-30 | 25021-812 | ANDA091684 | ANDA | N/A |
| Acetylcysteine | Injection, Solution | Intravenous | 200mg/mL | 4 Vial In 1 Carton (70069-788-04) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-788-04 | 70069-788 | ANDA218397 | ANDA | N/A |
| Acetazolamide | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (70954-034-30) | ANI Pharmaceuticals, Inc. | 70954-034-30 | 70954-034 | ANDA210588 | ANDA | N/A |
| Acetylcysteine | Inhalant | Respiratory (Inhalation) | 100mg/mL | 25 Vial, Glass In 1 Tray (0517-7504-25) / 4 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-7504-25 | 0517-7504 | ANDA072489 | ANDA | N/A |
| Acetylcysteine | Inhalant | Respiratory (Inhalation) | 100mg/mL | 3 Vial, Glass In 1 Box (0517-7510-03) / 10 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-7510-03 | 0517-7510 | ANDA072489 | ANDA | N/A |
| Acetylcysteine | Inhalant | Respiratory (Inhalation) | 200mg/mL | 25 Vial, Glass In 1 Tray (0517-7604-25) / 4 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-7604-25 | 0517-7604 | ANDA072547 | ANDA | N/A |
| Acetylcysteine | Inhalant | Respiratory (Inhalation) | 200mg/mL | 3 Vial, Glass In 1 Box (0517-7610-03) / 10 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-7610-03 | 0517-7610 | ANDA072547 | ANDA | N/A |
| Acetylcysteine | Inhalant | Respiratory (Inhalation) | 200mg/mL | 3 Vial, Glass In 1 Box (0517-7630-03) / 30 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-7630-03 | 0517-7630 | ANDA072547 | ANDA | N/A |
| Acetylcysteine | Solution | Oral; Respiratory (Inhalation) | 100mg/mL | 3 Vial In 1 Carton (0409-3307-03) / 30 Ml In 1 Vial (0409-3307-11) | Hospira, Inc. | 0409-3307-03 | 0409-3307 | ANDA073664 | ANDA | N/A |
| Acetylcysteine | Solution | Oral; Respiratory (Inhalation) | 200mg/mL | 3 Vial In 1 Carton (0409-3308-03) / 30 Ml In 1 Vial (0409-3308-11) | Hospira, Inc. | 0409-3308-03 | 0409-3308 | ANDA074037 | ANDA | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 120 Ml In 1 Bottle (0574-0520-04) | Padagis US LLC | 0574-0520-04 | 0574-0520 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 240 Ml In 1 Bottle (0574-0520-08) | Padagis US LLC | 0574-0520-08 | 0574-0520 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 120 Ml In 1 Tube (0574-0520-74) | Padagis US LLC | 0574-0520-74 | 0574-0520 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 240 Ml In 1 Tube (0574-0520-76) | Padagis US LLC | 0574-0520-76 | 0574-0520 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 120 Ml In 1 Bottle (0574-0521-04) | Padagis US LLC | 0574-0521-04 | 0574-0521 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 240 Ml In 1 Bottle (0574-0521-08) | Padagis US LLC | 0574-0521-08 | 0574-0521 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 72 Ml In 1 Tube (0574-0521-25) | Padagis US LLC | 0574-0521-25 | 0574-0521 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 120 Ml In 1 Tube (0574-0521-74) | Padagis US LLC | 0574-0521-74 | 0574-0521 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 208mg/mL | 240 Ml In 1 Tube (0574-0521-76) | Padagis US LLC | 0574-0521-76 | 0574-0521 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Pellet | Oral | 25g/25g | 25 G In 1 Bottle (0574-0122-25) | Padagis US LLC | 0574-0122-25 | 0574-0122 | part357 | OTC MONOGRAPH NOT FINAL | N/A |
| Activated Charcoal | Suspension | Oral | 50g/240mL | 240 Ml In 1 Bottle, Plastic (66689-201-08) | VistaPharm, LLC | 66689-201-08 | 66689-201 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Activated Charcoal | Suspension | Oral | 50g/240mL | 120 Ml In 1 Bottle, Plastic (66689-202-04) | VistaPharm, LLC | 66689-202-04 | 66689-202 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Activated Charcoal | Suspension | Oral | 50g/240mL | 240 Ml In 1 Bottle, Plastic (66689-202-08) | VistaPharm, LLC | 66689-202-08 | 66689-202 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Activated Charcoal | Suspension | Oral | 50g/240mL | 120 Ml In 1 Bottle, Plastic (66689-203-04) | VistaPharm, LLC | 66689-203-04 | 66689-203 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Activated Charcoal | Suspension | Oral | 50g/240mL | 240 Ml In 1 Bottle, Plastic (66689-203-08) | VistaPharm, LLC | 66689-203-08 | 66689-203 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (75834-122-01) | Nivagen Pharmaceuticals, Inc. | 75834-122-01 | 75834-122 | ANDA202168 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle (75834-122-05) | Nivagen Pharmaceuticals, Inc. | 75834-122-05 | 75834-122 | ANDA202168 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (75834-123-01) | Nivagen Pharmaceuticals, Inc. | 75834-123-01 | 75834-123 | ANDA202168 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (75834-123-05) | Nivagen Pharmaceuticals, Inc. | 75834-123-05 | 75834-123 | ANDA202168 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (75834-124-01) | Nivagen Pharmaceuticals, Inc. | 75834-124-01 | 75834-124 | ANDA201445 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (75834-124-05) | Nivagen Pharmaceuticals, Inc. | 75834-124-05 | 75834-124 | ANDA201445 | ANDA | N/A |
| Acyclovir | Suspension | Oral | 200mg/5mL | 473 Ml In 1 Bottle (70954-188-10) | Novitium Pharma LLC | 70954-188-10 | 70954-188 | ANDA212252 | ANDA | N/A |
| Acyclovir | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (45802-044-75) / 5 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-044-75 | 45802-044 | ANDA208702 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-652-60) | St. Mary's Medical Park Pharmacy | 60760-652-60 | 60760-652 | ANDA075677 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-145-01) | Golden State Medical Supply, Inc. | 51407-145-01 | 51407-145 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-145-05) | Golden State Medical Supply, Inc. | 51407-145-05 | 51407-145 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-146-01) | Golden State Medical Supply, Inc. | 51407-146-01 | 51407-146 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-146-05) | Golden State Medical Supply, Inc. | 51407-146-05 | 51407-146 | ANDA075382 | ANDA | N/A |
| Acyclovir | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1360-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1360-1 | 51672-1360 | ANDA205469 | ANDA | N/A |
| Acyclovir | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1360-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1360-2 | 51672-1360 | ANDA205469 | ANDA | N/A |
| Acyclovir | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1361-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1361-5 | 51672-1361 | ANDA205470 | ANDA | N/A |
| Acyclovir | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1361-9) / 2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1361-9 | 51672-1361 | ANDA205470 | ANDA | N/A |
| Acyclovir | Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (66689-342-16) / 473 Ml In 1 Bottle | VistaPharm, LLC | 66689-342-16 | 66689-342 | ANDA213951 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (60505-5306-1) | Apotex Corp. | 60505-5306-1 | 60505-5306 | ANDA077309 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 1000 Tablet In 1 Bottle (60505-5306-8) | Apotex Corp. | 60505-5306-8 | 60505-5306 | ANDA077309 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (60505-5307-1) | Apotex Corp. | 60505-5307-1 | 60505-5307 | ANDA077309 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (60505-5307-5) | Apotex Corp. | 60505-5307-5 | 60505-5307 | ANDA077309 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (60505-0042-6) | Apotex Corp. | 60505-0042-6 | 60505-0042 | ANDA075677 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (69452-290-20) | Bionpharma Inc. | 69452-290-20 | 69452-290 | ANDA209366 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle (69452-290-30) | Bionpharma Inc. | 69452-290-30 | 69452-290 | ANDA209366 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (69452-291-20) | Bionpharma Inc. | 69452-291-20 | 69452-291 | ANDA209366 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (69452-291-30) | Bionpharma Inc. | 69452-291-30 | 69452-291 | ANDA209366 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 24 Bottle, Plastic In 1 Box (61442-112-01) / 100 Tablet In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-112-01 | 61442-112 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 400mg/1 | 12 Bottle, Plastic In 1 Box (61442-112-05) / 500 Tablet In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-112-05 | 61442-112 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 24 Bottle, Plastic In 1 Box (61442-113-01) / 100 Tablet In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-113-01 | 61442-113 | ANDA075382 | ANDA | N/A |
| Acyclovir | Tablet | Oral | 800mg/1 | 12 Bottle, Plastic In 1 Box (61442-113-05) / 500 Tablet In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-113-05 | 61442-113 | ANDA075382 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 12 Bottle, Plastic In 1 Box (61442-114-01) / 100 Capsule In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-114-01 | 61442-114 | ANDA206261 | ANDA | N/A |
| Acyclovir | Capsule | Oral | 200mg/1 | 12 Bottle, Plastic In 1 Box (61442-114-05) / 500 Capsule In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-114-05 | 61442-114 | ANDA206261 | ANDA | N/A |
| Acetazolamide | Capsule, Extended Release | Oral | 500mg/1 | 100 Capsule, Extended Release In 1 Bottle (50742-233-01) | Ingenus Pharmaceuticals, LLC | 50742-233-01 | 50742-233 | ANDA203434 | ANDA | N/A |
| Acetylcysteine | Injection, Solution | Intravenous | 200mg/mL | 4 Vial In 1 Carton (66220-207-30) / 30 Ml In 1 Vial | Cumberland Pharmaceuticals Inc. | 66220-207-30 | 66220-207 | NDA021539 | NDA | N/A |
| Acyclovir | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (65162-835-94) / 15 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-835-94 | 65162-835 | ANDA204605 | ANDA | N/A |
| Acyclovir Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 10 Vial, Single-Dose In 1 Box (0143-9657-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0143-9657-01) | Hikma Pharmaceuticals USA Inc. | 0143-9657-10 | 0143-9657 | ANDA205771 | ANDA | N/A |
| Acyclovir Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Box (0143-9658-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0143-9658-01) | Hikma Pharmaceuticals USA Inc. | 0143-9658-10 | 0143-9658 | ANDA205771 | ANDA | N/A |
| Adapalene | Cream | Topical | .1g/100g | 1 Tube In 1 Carton (45802-453-84) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-453-84 | 45802-453 | NDA020748 | NDA AUTHORIZED GENERIC | N/A |
| Adapalene | Gel | Topical | 3mg/g | 1 Tube In 1 Carton (51672-1377-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1377-6 | 51672-1377 | ANDA208322 | ANDA | N/A |
| Adapalene | Gel | Topical | 3mg/g | 1 Bottle, Pump In 1 Carton (51672-1377-9) / 45 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1377-9 | 51672-1377 | ANDA208322 | ANDA | N/A |
| Adapalene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (51672-2150-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2150-1 | 51672-2150 | ANDA215940 | ANDA | N/A |
| Adapalene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (51672-2150-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2150-6 | 51672-2150 | ANDA215940 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 3mg/g, 25 mg/g | 45 G In 1 Bottle, Pump (45802-853-45) | Padagis Israel Pharmaceuticals Ltd | 45802-853-45 | 45802-853 | ANDA212464 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | .1g/100g, 2.5 g/100g | 45 G In 1 Bottle, Pump (45802-846-01) | Padagis Israel Pharmaceuticals Ltd | 45802-846-01 | 45802-846 | ANDA205033 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 1mg/g, 25 mg/g | 45 G In 1 Bottle, Pump (66993-869-48) | Prasco Laboratories | 66993-869-48 | 66993-869 | NDA022320 | NDA AUTHORIZED GENERIC | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 1mg/g, 25 mg/g | 1 Bottle, Pump In 1 Carton (51672-1364-3) / 45 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1364-3 | 51672-1364 | ANDA206959 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 1mg/g, 25 mg/g | 1 Tube In 1 Carton (51672-1364-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1364-6 | 51672-1364 | ANDA206959 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 3mg/g, 25 mg/g | 1 Bottle, Pump In 1 Carton (51672-1384-4) / 60 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1384-4 | 51672-1384 | ANDA209148 | ANDA | N/A |
| Adapalene; Benzoyl Peroxide | Gel | Topical | 3mg/g, 25 mg/g | 1 Bottle, Pump In 1 Carton (51672-1384-9) / 45 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1384-9 | 51672-1384 | ANDA209148 | ANDA | N/A |
| Adefovir Dipivoxil | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (60505-3947-3) / 30 Tablet In 1 Bottle | Apotex Corp. | 60505-3947-3 | 60505-3947 | ANDA205459 | ANDA | N/A |
| Adenosine | Injection | Intravenous | 3mg/mL | 10 Vial In 1 Carton (25021-318-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-318-02 | 25021-318 | ANDA206778 | ANDA | N/A |
| Adenosine | Injection | Intravenous | 3mg/mL | 10 Vial In 1 Carton (25021-318-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-318-04 | 25021-318 | ANDA206778 | ANDA | N/A |
| Adenosine | Injection | Intravenous | 3mg/mL | 10 Syringe In 1 Carton (25021-301-67) / 2 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-301-67 | 25021-301 | ANDA077283 | ANDA | N/A |
| Adenosine | Injection | Intravenous | 3mg/mL | 10 Syringe In 1 Carton (25021-301-68) / 4 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-301-68 | 25021-301 | ANDA077283 | ANDA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0777-1) | Jubilant HollisterStier LLC | 65044-0777-1 | 65044-0777 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0777-2) | Jubilant HollisterStier LLC | 65044-0777-2 | 65044-0777 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0777-3) | Jubilant HollisterStier LLC | 65044-0777-3 | 65044-0777 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0777-4) | Jubilant HollisterStier LLC | 65044-0777-4 | 65044-0777 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0778-1) | Jubilant HollisterStier LLC | 65044-0778-1 | 65044-0778 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0778-2) | Jubilant HollisterStier LLC | 65044-0778-2 | 65044-0778 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0778-3) | Jubilant HollisterStier LLC | 65044-0778-3 | 65044-0778 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0778-4) | Jubilant HollisterStier LLC | 65044-0778-4 | 65044-0778 | BLA103876 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL, 100000 [BAU]/mL, 10000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, .05 g/mL | 10 Ml In 1 Vial (65044-0854-2) | Jubilant HollisterStier LLC | 65044-0854-2 | 65044-0854 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL, 100000 [BAU]/mL, 10000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, .05 g/mL | 30 Ml In 1 Vial (65044-0854-3) | Jubilant HollisterStier LLC | 65044-0854-3 | 65044-0854 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL, 100000 [BAU]/mL, 10000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, .05 g/mL | 50 Ml In 1 Vial (65044-0854-4) | Jubilant HollisterStier LLC | 65044-0854-4 | 65044-0854 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous | 100000[BAU]/mL, 100000 [BAU]/mL, 10000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, .05 g/mL | 5 Ml In 1 Vial (65044-0855-1) | Jubilant HollisterStier LLC | 65044-0855-1 | 65044-0855 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL, 10000 [BAU]/mL, 1000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, .005 g/mL | 10 Ml In 1 Vial (65044-0856-2) | Jubilant HollisterStier LLC | 65044-0856-2 | 65044-0856 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL, 10000 [BAU]/mL, 1000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, .005 g/mL | 30 Ml In 1 Vial (65044-0856-3) | Jubilant HollisterStier LLC | 65044-0856-3 | 65044-0856 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL, 10000 [BAU]/mL, 1000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, .005 g/mL | 50 Ml In 1 Vial (65044-0856-4) | Jubilant HollisterStier LLC | 65044-0856-4 | 65044-0856 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Cynodon Dactylon Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous | 10000[BAU]/mL, 10000 [BAU]/mL, 1000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, 10000 [BAU]/mL, .005 g/mL | 5 Ml In 1 Vial (65044-0857-1) | Jubilant HollisterStier LLC | 65044-0857-1 | 65044-0857 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Cynodon Dactylon Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen; Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL, 10000 [BAU]/mL, 100000 [BAU]/mL, 100000 [BAU]/mL, .05 g/mL | 50 Ml In 1 Vial (65044-0879-4) | Jubilant HollisterStier LLC | 65044-0879-4 | 65044-0879 | BLA103888 | BLA | N/A |
| Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 25000[BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL | 5 Ml In 1 Vial (65044-0842-1) | Jubilant HollisterStier LLC | 65044-0842-1 | 65044-0842 | BLA103873 | BLA | N/A |
| Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 25000[BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL | 10 Ml In 1 Vial (65044-0842-2) | Jubilant HollisterStier LLC | 65044-0842-2 | 65044-0842 | BLA103873 | BLA | N/A |
| Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 25000[BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL | 30 Ml In 1 Vial (65044-0842-3) | Jubilant HollisterStier LLC | 65044-0842-3 | 65044-0842 | BLA103873 | BLA | N/A |
| Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 25000[BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL, 25000 [BAU]/mL | 50 Ml In 1 Vial (65044-0842-4) | Jubilant HollisterStier LLC | 65044-0842-4 | 65044-0842 | BLA103873 | BLA | N/A |
| Ailanthus Altissima Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2599-2) | Jubilant HollisterStier LLC | 65044-2599-2 | 65044-2599 | BLA103888 | BLA | N/A |
| Ailanthus Altissima Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2599-3) | Jubilant HollisterStier LLC | 65044-2599-3 | 65044-2599 | BLA103888 | BLA | N/A |
| Ailanthus Altissima Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2599-4) | Jubilant HollisterStier LLC | 65044-2599-4 | 65044-2599 | BLA103888 | BLA | N/A |
| Ailanthus Altissima Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2600-1) | Jubilant HollisterStier LLC | 65044-2600-1 | 65044-2600 | BLA103888 | BLA | N/A |
| Albendazole | Tablet | Oral | 200mg/1 | 2 Tablet In 1 Bottle (51407-258-02) | Golden State Medical Supply | 51407-258-02 | 51407-258 | ANDA211117 | ANDA | N/A |
| Acyclovir | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (65162-835-96) / 30 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-835-96 | 65162-835 | ANDA204605 | ANDA | N/A |
| Albumin Aggregated | Injection, Powder, For Solution | Intravenous | 2.5mg/1 | 30 Injection, Powder, For Solution In 1 Kit (65174-270-30) | Jubilant DraxImage Inc | 65174-270-30 | 65174-270 | BLA017881 | BLA | N/A |
| Acyclovir | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (65162-836-14) / 5 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-836-14 | 65162-836 | ANDA208766 | ANDA | N/A |
| Albendazole | Tablet, Film Coated | Oral | 200mg/1 | 2 Tablet, Film Coated In 1 Bottle (64896-693-49) | Amneal Pharmaceuticals LLC | 64896-693-49 | 64896-693 | NDA020666 | NDA | N/A |
| Albendazole | Tablet, Film Coated | Oral | 200mg/1 | 2 Tablet, Film Coated In 1 Bottle (31722-935-02) | Camber Pharmaceuticals | 31722-935-02 | 31722-935 | ANDA210011 | ANDA | N/A |
| Albendazole | Tablet, Film Coated | Oral | 200mg/1 | 28 Tablet, Film Coated In 1 Bottle (31722-935-28) | Camber Pharmaceuticals | 31722-935-28 | 31722-935 | ANDA210011 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | .63mg/3mL | 30 Pouch In 1 Carton (0487-0301-01) / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-0301-01 | 0487-0301 | ANDA076355 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | .63mg/3mL | 30 Bag In 1 Box (0487-0301-02) / 1 Pouch In 1 Bag / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-0301-02 | 0487-0301 | ANDA076355 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/3mL | 30 Pouch In 1 Carton (0487-9501-01) / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9501-01 | 0487-9501 | ANDA074880 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/3mL | 1 Pouch In 1 Carton (0487-9501-03) / 30 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9501-03 | 0487-9501 | ANDA074880 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/3mL | 1 Pouch In 1 Carton (0487-9501-25) / 25 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9501-25 | 0487-9501 | ANDA074880 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/3mL | 2 Pouch In 1 Carton (0487-9501-60) / 30 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9501-60 | 0487-9501 | ANDA074880 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/.5mL | 30 Bag In 1 Box (0487-9901-02) / 1 Pouch In 1 Bag / 1 Vial, Single-Dose In 1 Pouch / .5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9901-02 | 0487-9901 | ANDA075664 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle, Plastic (75834-273-01) | Nivagen Pharmaceuticals Inc | 75834-273-01 | 75834-273 | ANDA210948 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle, Plastic (75834-274-01) | Nivagen Pharmaceuticals Inc | 75834-274-01 | 75834-274 | ANDA210948 | ANDA | N/A |
| Albuterol Sulfate | Aerosol, Metered | Respiratory (Inhalation) | 90ug/1 | 1 Inhaler In 1 Carton (45802-088-01) / 200 Aerosol, Metered In 1 Inhaler | Padagis Israel Pharmaceuticals Ltd | 45802-088-01 | 45802-088 | ANDA203760 | ANDA | N/A |
| Albuterol Sulfate | Aerosol, Metered | Respiratory (Inhalation) | 90ug/1 | 1 Inhaler In 1 Carton (66993-019-68) / 200 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-019-68 | 66993-019 | NDA020983 | NDA AUTHORIZED GENERIC | N/A |
| Albuterol Sulfate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51407-367-01) | Golden State Medical Supply | 51407-367-01 | 51407-367 | ANDA072637 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (51407-368-01) | Golden State Medical Supply | 51407-368-01 | 51407-368 | ANDA072637 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 2.5mg/.5mL | 30 Pouch In 1 Carton (0487-9901-30) / 1 Vial, Single-Dose In 1 Pouch / .5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9901-30 | 0487-9901 | ANDA075664 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 1.25mg/3mL | 30 Pouch In 1 Carton (0487-9904-01) / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9904-01 | 0487-9904 | ANDA076355 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 1.25mg/3mL | 30 Bag In 1 Box (0487-9904-02) / 1 Pouch In 1 Bag / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9904-02 | 0487-9904 | ANDA076355 | ANDA | N/A |
| Albuterol Sulfate | Solution | Respiratory (Inhalation) | 1.25mg/3mL | 25 Pouch In 1 Carton (0487-9904-25) / 1 Vial, Single-Dose In 1 Pouch / 3 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9904-25 | 0487-9904 | ANDA076355 | ANDA | N/A |
| Albuterol Sulfate | Aerosol, Metered | Respiratory (Inhalation) | 90ug/1 | 1 Canister In 1 Carton (0054-0742-87) / 200 Aerosol, Metered In 1 Canister | Hikma Pharmaceuticals USA Inc. | 0054-0742-87 | 0054-0742 | ANDA207085 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (64980-442-01) | Rising Pharmaceuticals, Inc. | 64980-442-01 | 64980-442 | ANDA207046 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (64980-442-50) | Rising Pharmaceuticals, Inc. | 64980-442-50 | 64980-442 | ANDA207046 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (64980-443-01) | Rising Pharmaceuticals, Inc. | 64980-443-01 | 64980-443 | ANDA207046 | ANDA | N/A |
| Albuterol Sulfate | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (64980-443-50) | Rising Pharmaceuticals, Inc. | 64980-443-50 | 64980-443 | ANDA207046 | ANDA | N/A |
| Alclometasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1306-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1306-1 | 51672-1306 | ANDA076587 | ANDA | N/A |
| Alclometasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1306-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1306-3 | 51672-1306 | ANDA076587 | ANDA | N/A |
| Alclometasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1306-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1306-6 | 51672-1306 | ANDA076587 | ANDA | N/A |
| Alclometasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1316-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1316-1 | 51672-1316 | ANDA076730 | ANDA | N/A |
| Alclometasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1316-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1316-3 | 51672-1316 | ANDA076730 | ANDA | N/A |
| Alclometasone Dipropionate | Ointment | Topical | .5mg/g | 5 G In 1 Tube (51672-1316-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1316-5 | 51672-1316 | ANDA076730 | ANDA | N/A |
| Alclometasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1316-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1316-6 | 51672-1316 | ANDA076730 | ANDA | N/A |
| Alcohol | Liquid | Topical | .6kg/kg | .213 Kg In 1 Bottle, Pump (82140-432-01) | eHealth Nexus LLC | 82140-432-01 | 82140-432 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | .6kg/kg | .053 Kg In 1 Bottle, Pump (82140-432-02) | eHealth Nexus LLC | 82140-432-02 | 82140-432 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | .6kg/kg | .09 Kg In 1 Bottle, Plastic (82140-432-03) | eHealth Nexus LLC | 82140-432-03 | 82140-432 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-034-01) | FOURSTAR GROUP USA, INC. | 80684-034-01 | 80684-034 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 89 Ml In 1 Bottle (80684-120-00) | FOURSTAR GROUP USA, INC. | 80684-120-00 | 80684-120 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-081-00) | Fourstar Group USA, Inc. | 80684-081-00 | 80684-081 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-114-00) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC. | 80684-114-00 | 80684-114 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-115-00) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC | 80684-115-00 | 80684-115 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-119-00) | Fourstar Group USA, Inc. | 80684-119-00 | 80684-119 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-117-00) | FOURSTAR GROUP USA, INC. | 80684-117-00 | 80684-117 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-116-00) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC. | 80684-116-00 | 80684-116 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-118-00) | Fourstar Group USA, Inc. | 80684-118-00 | 80684-118 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 30 Ml In 1 Bottle (80684-107-00) | FOURSTAR GROUP USA, INC. | 80684-107-00 | 80684-107 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 30 Ml In 1 Bottle (80684-106-00) | FOURSTAR GROUP USA, INC. | 80684-106-00 | 80684-106 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-096-00) | Fourstar Group USA, Inc. | 80684-096-00 | 80684-096 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-102-00) | Fourstar Group USA, Inc. | 80684-102-00 | 80684-102 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-103-00) | Fourstar Group USA, Inc. | 80684-103-00 | 80684-103 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 30 Ml In 1 Bottle (80684-099-00) | Fourstar Group USA, Inc. | 80684-099-00 | 80684-099 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 30 Ml In 1 Bottle (80684-100-00) | Fourstar Group USA, Inc. | 80684-100-00 | 80684-100 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-095-00) | Fourstar Group USA, Inc. | 80684-095-00 | 80684-095 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-104-00) | Fourstar Group USA, Inc. | 80684-104-00 | 80684-104 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-125-00) | FOURSTAR GROUP USA, INC. | 80684-125-00 | 80684-125 | M505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-123-00) | FOURSTAR GROUP USA, INC. | 80684-123-00 | 80684-123 | M505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle (80684-124-00) | FOURSTAR GROUP USA, INC. | 80684-124-00 | 80684-124 | M505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-060-02) | Fourstar Group USA, Inc. | 80684-060-02 | 80684-060 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-062-02) | Fourstar Group USA, Inc. | 80684-062-02 | 80684-062 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-063-02) | Fourstar Group USA, Inc. | 80684-063-02 | 80684-063 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 710g/L | 189.27 L In 1 Drum (71212-100-00) | Chemstation | 71212-100-00 | 71212-100 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | 710g/L | 4 Bottle In 1 Box (71212-100-01) / 3.79 L In 1 Bottle | Chemstation | 71212-100-01 | 71212-100 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | 710g/L | 6 Cartridge In 1 Box (71212-100-02) / 1.25 L In 1 Cartridge | Chemstation | 71212-100-02 | 71212-100 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 236 Ml In 1 Bottle (80684-061-08) | Fourstar Group USA, Inc. | 80684-061-08 | 80684-061 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle, Spray (80684-091-00) | Fourstar Group USA, Inc | 80684-091-00 | 80684-091 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-030-01) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC. | 80684-030-01 | 80684-030 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-105-00) | FOURSTAR GROUP USA, INC. | 80684-105-00 | 80684-105 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle, Spray (80684-092-00) | Fourstar Group USA, Inc. | 80684-092-00 | 80684-092 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-031-01) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC. | 80684-031-01 | 80684-031 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .7mL/mL | 29 Ml In 1 Bottle (80684-003-01) | Fourstar Group USA, Inc. | 80684-003-01 | 80684-003 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 89 Ml In 1 Bottle (80684-121-00) | FOURSTAR GROUP USA, INC. | 80684-121-00 | 80684-121 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Topical | .7mL/mL | 29 Ml In 1 Bottle (80684-004-01) | Fourstar Group USA, Inc. | 80684-004-01 | 80684-004 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-036-01) | FOURSTAR GROUP USA, INC. | 80684-036-01 | 80684-036 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-083-00) | Fourstar Group USA, Inc. | 80684-083-00 | 80684-083 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-033-01) | FOURSTAR GROUP USA, INC. | 80684-033-01 | 80684-033 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-080-00) | Fourstar Group USA, Inc. | 80684-080-00 | 80684-080 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 10 Ml In 1 Bottle, Spray (80684-090-00) | Fourstar Group USA, Inc. | 80684-090-00 | 80684-090 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .7mL/mL | 29 Ml In 1 Bottle (80684-005-01) | Fourstar Group USA, Inc. | 80684-005-01 | 80684-005 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .65mL/mL | 29 Ml In 1 Bottle (80684-000-01) | FOURSTAR GROUP USA, INC. | 80684-000-01 | 80684-000 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .65mL/mL | 29 Ml In 1 Bottle (80684-001-01) | FOURSTAR GROUP USA, INC. | 80684-001-01 | 80684-001 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .65mL/mL | 29 Ml In 1 Bottle (80684-002-01) | FOURSTAR GROUP USA, INC. | 80684-002-01 | 80684-002 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 1 Bottle In 1 Box (80684-032-01) / 89 Ml In 1 Bottle | FOURSTAR GROUP USA, INC. | 80684-032-01 | 80684-032 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-064-02) | Fourstar Group USA, Inc. | 80684-064-02 | 80684-064 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-065-02) | Fourstar Group USA, Inc. | 80684-065-02 | 80684-065 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 236 Ml In 1 Bottle (80684-065-08) | Fourstar Group USA, Inc. | 80684-065-08 | 80684-065 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-035-01) | FOURSTAR GROUP USA, INC. | 80684-035-01 | 80684-035 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 59 Ml In 1 Bottle (80684-082-00) | Fourstar Group USA, Inc. | 80684-082-00 | 80684-082 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Liquid | Topical | 70mL/100mL | 89 Ml In 1 Bottle (80684-122-00) | FOURSTAR GROUP USA, INC. | 80684-122-00 | 80684-122 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Topical | .7mL/mL | 29 Ml In 1 Bottle (80684-006-01) | Fourstar Group USA, Inc. | 80684-006-01 | 80684-006 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Swab | Topical | 75g/100g | 100 Pouch In 1 Canister (77435-012-01) / 3.2 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-012-01 | 77435-012 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 280 Pouch In 1 Canister (77435-103-01) / 4.32 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-103-01 | 77435-103 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Topical | 377.5mL/500mL | 12 Bottle, Plastic In 1 Package (62169-203-12) / 500 Ml In 1 Bottle, Plastic (62169-203-17) | Laboratoires Anios | 62169-203-12 | 62169-203 | M003 | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 562 Ml In 1 Bottle, Spray (52915-074-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-074-19 | 52915-074 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 59 Ml In 1 Bottle, Spray (52915-074-20) | ORGANIC & SUSTAINABLE BEAUTY | 52915-074-20 | 52915-074 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 72 Pouch In 1 Canister (77435-010-01) / 2.7 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-010-01 | 77435-010 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 72 Pouch In 1 Canister (77435-114-01) / 3.5 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-114-01 | 77435-114 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 562 Ml In 1 Bottle, Spray (52915-075-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-075-19 | 52915-075 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 59 Ml In 1 Bottle, Spray (52915-075-20) | ORGANIC & SUSTAINABLE BEAUTY | 52915-075-20 | 52915-075 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 50 Pouch In 1 Bag (77435-109-01) / 4 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-109-01 | 77435-109 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Topical | .65mL/mL | 30 Ml In 1 Bottle (15751-3050-1) | Eminence Organic Skin Care Ltd. | 15751-3050-1 | 15751-3050 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | .7mL/mL | 236 Ml In 1 Bottle (76924-000-00) | General Organics Inc. | 76924-000-00 | 76924-000 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 50 Ml In 1 Bottle (75360-1125-1) | Hemani International | 75360-1125-1 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 65 Ml In 1 Bottle (75360-1125-2) | Hemani International | 75360-1125-2 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 100 Ml In 1 Bottle (75360-1125-3) | Hemani International | 75360-1125-3 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 250 Ml In 1 Bottle (75360-1125-4) | Hemani International | 75360-1125-4 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 1000 Ml In 1 Bottle (75360-1125-5) | Hemani International | 75360-1125-5 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 500 Ml In 1 Bottle (75360-1125-6) | Hemani International | 75360-1125-6 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 80mL/100mL | 400 Ml In 1 Bag (75360-1125-7) | Hemani International | 75360-1125-7 | 75360-1125 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Cloth | Topical | 75g/100g | 10 Pouch In 1 Package (77435-023-01) / 3.6 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-023-01 | 77435-023 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Cloth | Topical | 75g/100g | 150 Package In 1 Canister (77435-101-03) / 9.12 G In 1 Package | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-101-03 | 77435-101 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Cloth | Topical | 75g/100g | 10 Pouch In 1 Bag (77435-016-01) / 4.05 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-016-01 | 77435-016 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Cloth | Topical | 75g/100g | 50 Pouch In 1 Bag (77435-018-01) / 4.05 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-018-01 | 77435-018 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | .62mL/mL | 1000 Ml In 1 Cartridge (43097-658-10) | People's JanitorialSupply | 43097-658-10 | 43097-658 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | .62mL/mL | 1000 Ml In 1 Bottle, Plastic (43097-658-11) | People's JanitorialSupply | 43097-658-11 | 43097-658 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | .62mL/mL | 1000 Ml In 1 Bag (43097-658-12) | People's JanitorialSupply | 43097-658-12 | 43097-658 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Liquid | Topical | .62mL/mL | 800 Ml In 1 Bag (43097-658-13) | People's JanitorialSupply | 43097-658-13 | 43097-658 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 562 Ml In 1 Bottle, Spray (52915-066-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-066-19 | 52915-066 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/100mL | 59 Ml In 1 Bottle, Spray (52915-066-20) | ORGANIC & SUSTAINABLE BEAUTY | 52915-066-20 | 52915-066 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Cutaneous | 2649.787mL/3785.41mL | 1 Ml In 1 Bottle, Pump (71824-1700-1) | Prima Fleur Botanicals, Inc. | 71824-1700-1 | 71824-1700 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 41.40297mL/59.15mL | 1 Ml In 1 Bottle, Pump (71824-1702-1) | Prima Fleur Botanicals, Inc. | 71824-1702-1 | 71824-1702 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 165.6116mL/236.588mL | 1 Ml In 1 Bottle, Pump (71824-1708-1) | Prima Fleur Botanicals, Inc. | 71824-1708-1 | 71824-1708 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 331.2232mL/473.176mL | 1 Ml In 1 Bottle, Pump (71824-1716-1) | Prima Fleur Botanicals, Inc. | 71824-1716-1 | 71824-1716 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 2649.787mL/3785.41mL | 1 Ml In 1 Bottle, Plastic (71824-1800-1) | Prima Fleur Botanicals, Inc. | 71824-1800-1 | 71824-1800 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 41.40297mL/59.51mL | 1 Ml In 1 Bottle, Dispensing (71824-1802-1) | Prima Fleur Botanicals, Inc. | 71824-1802-1 | 71824-1802 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 165.6116mL/236.588mL | 1 Ml In 1 Bottle, Pump (71824-1808-1) | Prima Fleur Botanicals, Inc. | 71824-1808-1 | 71824-1808 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 331.2232mL/473.176mL | 1 Ml In 1 Bottle, Pump (71824-1816-1) | Prima Fleur Botanicals, Inc. | 71824-1816-1 | 71824-1816 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 2649.787mL/3785.41mL | 1 Ml In 1 Bottle, Plastic (71824-1900-1) | Prima Fleur Botanicals, Inc. | 71824-1900-1 | 71824-1900 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 41.40297mL/59.51mL | 1 Ml In 1 Bottle, Plastic (71824-1902-1) | Prima Fleur Botanicals, Inc. | 71824-1902-1 | 71824-1902 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 165.6116mL/236.588mL | 1 Ml In 1 Bottle, Pump (71824-1908-1) | Prima Fleur Botanicals, Inc. | 71824-1908-1 | 71824-1908 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 331.2232mL/473.176mL | 1 Ml In 1 Bottle, Pump (71824-1916-1) | Prima Fleur Botanicals, Inc. | 71824-1916-1 | 71824-1916 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Swab | Topical | 75g/100g | 160 Pouch In 1 Canister (77435-106-01) / 3.8 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-106-01 | 77435-106 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 100 Pouch In 1 Canister (77435-106-02) / 4.2 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-106-02 | 77435-106 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 70mL/100mL | 118 Ml In 1 Bottle, Spray (81751-001-04) | Anita Saluja, Md, LLC | 81751-001-04 | 81751-001 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 75g/100g | 80 Pouch In 1 Bag (77435-104-01) / 3.6 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-104-01 | 77435-104 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/mL | 562 Ml In 1 Bottle, Spray (52915-076-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-076-19 | 52915-076 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Spray | Topical | 62mL/mL | 59 Ml In 1 Bottle, Spray (52915-076-20) | ORGANIC & SUSTAINABLE BEAUTY | 52915-076-20 | 52915-076 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Cloth | Topical | 62g/100g | 1 Pouch In 1 Package (77435-022-01) / 3.75 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-022-01 | 77435-022 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Swab | Topical | 70g/100g | 10 Pouch In 1 Bag (77435-111-01) / 4 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-111-01 | 77435-111 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Alcohol | Gel | Cutaneous | 2649.787mL/3785.41mL | 1 Ml In 1 Bottle, Plastic (71824-7900-1) | Prima Fleur Botanicals, Inc. | 71824-7900-1 | 71824-7900 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 41.40297mL/59.1471mL | 1 Ml In 1 Bottle, Plastic (71824-7902-1) | Prima Fleur Botanicals, Inc. | 71824-7902-1 | 71824-7902 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 165.6116mL/236.588mL | 1 Ml In 1 Bottle, Plastic (71824-7908-1) | Prima Fleur Botanicals, Inc. | 71824-7908-1 | 71824-7908 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 331.2232mL/473.176mL | 1 Ml In 1 Bottle, Plastic (71824-7916-1) | Prima Fleur Botanicals, Inc. | 71824-7916-1 | 71824-7916 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 2649.787mL/3785.41mL | 1 Ml In 1 Bottle, Pump (71824-7700-1) | Prima Fleur Botanicals, Inc. | 71824-7700-1 | 71824-7700 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 41.40297mL/59.1471mL | 1 Ml In 1 Bottle, Pump (71824-7702-1) | Prima Fleur Botanicals, Inc. | 71824-7702-1 | 71824-7702 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Cutaneous | 165.6116mL/236.588mL | 1 Ml In 1 Bottle, Pump (71824-7708-1) | Prima Fleur Botanicals, Inc. | 71824-7708-1 | 71824-7708 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Alcohol | Gel | Topical | 70mL/100mL | 2000 Ml In 1 Bottle, Pump (71569-370-88) | Jubilant, LLC | 71569-370-88 | 71569-370 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Albuterol Sulfate; Ipratropium Bromide | Solution | Respiratory (Inhalation) | 3mg/3mL, .5 mg/3mL | 30 Pouch In 1 Carton (0487-0201-01) / 1 Vial, Single-Use In 1 Pouch / 3 Ml In 1 Vial, Single-Use | Nephron Pharmaceuticals Corporation | 0487-0201-01 | 0487-0201 | ANDA076749 | ANDA | N/A |
| Albuterol Sulfate; Ipratropium Bromide | Solution | Respiratory (Inhalation) | 3mg/3mL, .5 mg/3mL | 30 Pouch In 1 Carton (0487-0201-02) / 1 Vial, Single-Use In 1 Pouch / 3 Ml In 1 Vial, Single-Use | Nephron Pharmaceuticals Corporation | 0487-0201-02 | 0487-0201 | ANDA076749 | ANDA | N/A |
| Albuterol Sulfate; Ipratropium Bromide | Solution | Respiratory (Inhalation) | 3mg/3mL, .5 mg/3mL | 6 Pouch In 1 Carton (0487-0201-03) / 5 Vial, Single-Use In 1 Pouch / 3 Ml In 1 Vial, Single-Use | Nephron Pharmaceuticals Corporation | 0487-0201-03 | 0487-0201 | ANDA076749 | ANDA | N/A |
| Albuterol Sulfate; Ipratropium Bromide | Solution | Respiratory (Inhalation) | 3mg/3mL, .5 mg/3mL | 12 Pouch In 1 Carton (0487-0201-60) / 5 Vial, Single-Use In 1 Pouch / 3 Ml In 1 Vial, Single-Use | Nephron Pharmaceuticals Corporation | 0487-0201-60 | 0487-0201 | ANDA076749 | ANDA | N/A |
| Alendronate Sodium | Solution | Oral | 70mg/75mL | 4 Bottle In 1 Carton (70954-264-10) / 75 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 70954-264-10 | 70954-264 | ANDA214512 | ANDA | N/A |
| Alendronate Sodium | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (64980-340-01) | Rising Pharma Holdings, Inc. | 64980-340-01 | 64980-340 | ANDA090124 | ANDA | N/A |
| Alendronate Sodium | Solution | Oral | 70mg/75mL | 4 Bottle, Unit-Dose In 1 Carton (0054-0282-59) / 75 Ml In 1 Bottle, Unit-Dose | Hikma Pharmaceuticals USA Inc. | 0054-0282-59 | 0054-0282 | ANDA090520 | ANDA | N/A |
| Alfuzosin Hydrochloride | Tablet, Extended Release | Oral | 10mg/1 | 90 Tablet, Extended Release In 1 Bottle (51407-829-90) | Golden State Medical Supply, Inc. | 51407-829-90 | 51407-829 | ANDA079013 | ANDA | N/A |
| Alfuzosin Hydrochloride | Tablet, Extended Release | Oral | 10mg/1 | 90 Tablet, Extended Release In 1 Bottle (60505-2850-9) | Apotex Corp. | 60505-2850-9 | 60505-2850 | ANDA079013 | ANDA | N/A |
| Alendronate Sodium | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (64980-340-03) | Rising Pharma Holdings, Inc. | 64980-340-03 | 64980-340 | ANDA090124 | ANDA | N/A |
| Alendronate Sodium | Tablet | Oral | 35mg/1 | 3 Blister Pack In 1 Carton (64980-341-12) / 4 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-341-12 | 64980-341 | ANDA090124 | ANDA | N/A |
| Alendronate Sodium | Tablet | Oral | 35mg/1 | 1 Blister Pack In 1 Carton (64980-341-14) / 4 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-341-14 | 64980-341 | ANDA090124 | ANDA | N/A |
| Aliskiren Hemifumarate | Tablet, Film Coated | Oral | 150mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-141-30) | Prasco Laboratories | 66993-141-30 | 66993-141 | NDA021985 | NDA AUTHORIZED GENERIC | N/A |
| Aliskiren Hemifumarate | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-142-30) | Prasco Laboratories | 66993-142-30 | 66993-142 | NDA021985 | NDA AUTHORIZED GENERIC | N/A |
| Allantoin; Zinc Oxide | Ointment | Topical | 10mg/g, 250 mg/g | 1 Tube In 1 Package (54312-525-16) / 50 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-525-16 | 54312-525 | M016 | OTC MONOGRAPH DRUG | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-134-90) | St. Mary's Medical Park Pharmacy | 60760-134-90 | 60760-134 | ANDA203154 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-139-90) | St. Mary's Medical Park Pharmacy | 60760-139-90 | 60760-139 | ANDA203154 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-656-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-656-90 | 60760-656 | ANDA211820 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 200mg/1 | 90 Tablet In 1 Bottle (69315-409-09) | Leading Pharma, LLC | 69315-409-09 | 69315-409 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (69315-291-01) | Leading Pharma, LLC | 69315-291-01 | 69315-291 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (69315-291-05) | Leading Pharma, LLC | 69315-291-05 | 69315-291 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (69315-291-10) | Leading Pharma, LLC | 69315-291-10 | 69315-291 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (69315-292-01) | Leading Pharma, LLC | 69315-292-01 | 69315-292 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (69315-292-05) | Leading Pharma, LLC | 69315-292-05 | 69315-292 | ANDA214443 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (69315-292-10) | Leading Pharma, LLC | 69315-292-10 | 69315-292 | ANDA214443 | ANDA | N/A |
| Alendronate Sodium | Tablet | Oral | 70mg/1 | 1 Blister Pack In 1 Carton (64980-342-14) / 4 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-342-14 | 64980-342 | ANDA090124 | ANDA | N/A |
| Alfuzosin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (57237-114-01) | Rising Pharma Holdings, Inc. | 57237-114-01 | 57237-114 | ANDA079060 | ANDA | N/A |
| Alfuzosin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (57237-114-05) | Rising Pharma Holdings, Inc. | 57237-114-05 | 57237-114 | ANDA079060 | ANDA | N/A |
| Alfuzosin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (57237-114-90) | Rising Pharma Holdings, Inc. | 57237-114-90 | 57237-114 | ANDA079060 | ANDA | N/A |
| Allergy Relief | Tablet | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-317-01) / 100 Tablet In 1 Bottle, Plastic | Camber Consumer Care | 69230-317-01 | 69230-317 | ANDA075209 | ANDA | N/A |
| Allergy Relief | Tablet | Oral | 10mg/1 | 300 Tablet In 1 Bottle, Plastic (69230-317-03) | Camber Consumer Care | 69230-317-03 | 69230-317 | ANDA075209 | ANDA | N/A |
| Allergy Relief | Tablet | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-317-30) / 30 Tablet In 1 Bottle, Plastic | Camber Consumer Care | 69230-317-30 | 69230-317 | ANDA075209 | ANDA | N/A |
| Allergy Relief | Capsule | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-303-24) / 25 Capsule In 1 Bottle, Plastic | Camber Consumer Care | 69230-303-24 | 69230-303 | ANDA207235 | ANDA | N/A |
| Allergy Relief | Capsule | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-303-40) / 40 Capsule In 1 Bottle, Plastic | Camber Consumer Care | 69230-303-40 | 69230-303 | ANDA207235 | ANDA | N/A |
| Allergy Relief | Tablet | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-304-01) / 100 Tablet In 1 Bottle, Plastic | Camber Consumer Care | 69230-304-01 | 69230-304 | ANDA209274 | ANDA | N/A |
| Allergy Relief | Tablet | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Box (69230-304-30) / 30 Tablet In 1 Bottle, Plastic | Camber Consumer Care | 69230-304-30 | 69230-304 | ANDA209274 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (31722-252-01) | Camber Pharmaceuticals, Inc. | 31722-252-01 | 31722-252 | ANDA217748 | ANDA | N/A |
| Allopurinol Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/25mL | 1 Vial In 1 Box, Unit-Dose (0143-9533-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9533-01 | 0143-9533 | ANDA076870 | ANDA | N/A |
| Allylthiourea; Arnica Montana; Calendula Officinalis Flowering Top; Echinacea Angustifolia; Silver; St. John'S Wort; Sulfur; Urtica Urens | Spray | Topical | 30[kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL | 1 Bottle, Spray In 1 Carton (52793-700-02) / 60 Ml In 1 Bottle, Spray | PRINCETON BIOTECHNOLOGY CORPORATION | 52793-700-02 | 52793-700 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Allylthiourea; Arnica Montana; Calendula Officinalis Flowering Top; Echinacea Angustifolia; Silver; St. John'S Wort; Sulfur; Urtica Urens | Spray | Topical | 30[kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL | 1 Bottle, Spray In 1 Carton (52793-700-06) / 6 Ml In 1 Bottle, Spray | PRINCETON BIOTECHNOLOGY CORPORATION | 52793-700-06 | 52793-700 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Allylthiourea; Arnica Montana; Calendula Officinalis Flowering Top; Echinacea Angustifolia; Silver; St. John'S Wort; Sulfur; Urtica Urens | Spray | Topical | 30[kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL, 30 [kp_C]/60mL | 1 Bottle, Spray In 1 Carton (52793-700-10) / 10 Ml In 1 Bottle, Spray | PRINCETON BIOTECHNOLOGY CORPORATION | 52793-700-10 | 52793-700 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Almond | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3014-2) | Jubilant HollisterStier LLC | 65044-3014-2 | 65044-3014 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1018-2) | Jubilant HollisterStier LLC | 65044-1018-2 | 65044-1018 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1018-3) | Jubilant HollisterStier LLC | 65044-1018-3 | 65044-1018 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1018-4) | Jubilant HollisterStier LLC | 65044-1018-4 | 65044-1018 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1019-1) | Jubilant HollisterStier LLC | 65044-1019-1 | 65044-1019 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1021-2) | Jubilant HollisterStier LLC | 65044-1021-2 | 65044-1021 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1021-3) | Jubilant HollisterStier LLC | 65044-1021-3 | 65044-1021 | BLA103888 | BLA | N/A |
| Alnus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1021-4) | Jubilant HollisterStier LLC | 65044-1021-4 | 65044-1021 | BLA103888 | BLA | N/A |
| Alogliptin Benzoate | Tablet, Film Coated | Oral | 12.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-103-65) | Padagis Israel Pharmaceuticals Ltd | 45802-103-65 | 45802-103 | NDA022271 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-150-65) | Padagis Israel Pharmaceuticals Ltd | 45802-150-65 | 45802-150 | NDA022271 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate | Tablet, Film Coated | Oral | 6.25mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-087-65) | Padagis Israel Pharmaceuticals Ltd | 45802-087-65 | 45802-087 | NDA022271 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Metformin Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 1000 mg/1 | 60 Tablet, Film Coated In 1 Bottle (45802-211-72) | Padagis Israel Pharmaceuticals Ltd | 45802-211-72 | 45802-211 | NDA203414 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Metformin Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 500 mg/1 | 60 Tablet, Film Coated In 1 Bottle (45802-169-72) | Padagis Israel Pharmaceuticals Ltd | 45802-169-72 | 45802-169 | NDA203414 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 25mg/1, 30 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-402-65) | Padagis Israel Pharmaceuticals Ltd | 45802-402-65 | 45802-402 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 15 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-238-65) | Padagis Israel Pharmaceuticals Ltd | 45802-238-65 | 45802-238 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 30 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-260-65) | Padagis Israel Pharmaceuticals Ltd | 45802-260-65 | 45802-260 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 45 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-304-65) | Padagis Israel Pharmaceuticals Ltd | 45802-304-65 | 45802-304 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 25mg/1, 15 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-351-65) | Padagis Israel Pharmaceuticals Ltd | 45802-351-65 | 45802-351 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 25mg/1, 45 mg/1 | 30 Tablet, Film Coated In 1 Bottle (45802-499-65) | Padagis Israel Pharmaceuticals Ltd | 45802-499-65 | 45802-499 | NDA022426 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (31722-252-05) | Camber Pharmaceuticals, Inc. | 31722-252-05 | 31722-252 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (31722-252-10) | Camber Pharmaceuticals, Inc. | 31722-252-10 | 31722-252 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (31722-252-90) | Camber Pharmaceuticals, Inc. | 31722-252-90 | 31722-252 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (31722-253-01) | Camber Pharmaceuticals, Inc. | 31722-253-01 | 31722-253 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (31722-253-05) | Camber Pharmaceuticals, Inc. | 31722-253-05 | 31722-253 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (31722-253-10) | Camber Pharmaceuticals, Inc. | 31722-253-10 | 31722-253 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (31722-253-90) | Camber Pharmaceuticals, Inc. | 31722-253-90 | 31722-253 | ANDA217748 | ANDA | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (16571-883-01) | Rising Pharma Holdings, Inc. | 16571-883-01 | 16571-883 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Alprazolam | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-550-30) | St. Mary's Medical Park Pharmacy | 60760-550-30 | 60760-550 | ANDA207507 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | .5mg/1 | 60 Tablet, Extended Release In 1 Bottle (58151-503-91) | Viatris Specialty LLC | 58151-503-91 | 58151-503 | NDA021434 | NDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 1mg/1 | 60 Tablet, Extended Release In 1 Bottle (58151-504-91) | Viatris Specialty LLC | 58151-504-91 | 58151-504 | NDA021434 | NDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 2mg/1 | 60 Tablet, Extended Release In 1 Bottle (58151-505-91) | Viatris Specialty LLC | 58151-505-91 | 58151-505 | NDA021434 | NDA | CIV |
| Allopurinol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (16571-883-09) | Rising Pharma Holdings, Inc. | 16571-883-09 | 16571-883 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (16571-883-10) | Rising Pharma Holdings, Inc. | 16571-883-10 | 16571-883 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (16571-883-50) | Rising Pharma Holdings, Inc. | 16571-883-50 | 16571-883 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (16571-884-01) | Rising Pharma Holdings, Inc. | 16571-884-01 | 16571-884 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 200mg/1 | 90 Tablet In 1 Bottle (16571-884-09) | Rising Pharma Holdings, Inc. | 16571-884-09 | 16571-884 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (16571-884-10) | Rising Pharma Holdings, Inc. | 16571-884-10 | 16571-884 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (16571-884-50) | Rising Pharma Holdings, Inc. | 16571-884-50 | 16571-884 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (16571-885-01) | Rising Pharma Holdings, Inc. | 16571-885-01 | 16571-885 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (16571-885-09) | Rising Pharma Holdings, Inc. | 16571-885-09 | 16571-885 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (16571-885-10) | Rising Pharma Holdings, Inc. | 16571-885-10 | 16571-885 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Allopurinol | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (16571-885-50) | Rising Pharma Holdings, Inc. | 16571-885-50 | 16571-885 | NDA016084 | NDA AUTHORIZED GENERIC | N/A |
| Alosetron Hydrochloride | Tablet, Film Coated | Oral | .5mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-248-03) | Amneal Pharmaceuticals LLC | 65162-248-03 | 65162-248 | ANDA206647 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet, Film Coated | Oral | .5mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-248-50) | Amneal Pharmaceuticals LLC | 65162-248-50 | 65162-248 | ANDA206647 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-249-03) | Amneal Pharmaceuticals LLC | 65162-249-03 | 65162-249 | ANDA206647 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-249-50) | Amneal Pharmaceuticals LLC | 65162-249-50 | 65162-249 | ANDA206647 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle (64980-453-03) | Rising Pharmaceuticals, Inc. | 64980-453-03 | 64980-453 | ANDA209180 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (64980-453-50) | Rising Pharmaceuticals, Inc. | 64980-453-50 | 64980-453 | ANDA209180 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle (64980-454-03) | Rising Pharmaceuticals, Inc. | 64980-454-03 | 64980-454 | ANDA209180 | ANDA | N/A |
| Alosetron Hydrochloride | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (64980-454-50) | Rising Pharmaceuticals, Inc. | 64980-454-50 | 64980-454 | ANDA209180 | ANDA | N/A |
| Alprazolam | Tablet, Extended Release | Oral | .5mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-809-03) | Amneal Pharmaceuticals LLC | 65162-809-03 | 65162-809 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | .5mg/1 | 60 Tablet, Extended Release In 1 Bottle (65162-809-06) | Amneal Pharmaceuticals LLC | 65162-809-06 | 65162-809 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | .5mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-809-50) | Amneal Pharmaceuticals LLC | 65162-809-50 | 65162-809 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 1mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-810-03) | Amneal Pharmaceuticals LLC | 65162-810-03 | 65162-810 | ANDA078387 | ANDA | CIV |
| Alprazolam | Solution, Concentrate | Oral | 1mg/mL | 1 Bottle In 1 Container (0054-3068-44) / 30 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-3068-44 | 0054-3068 | ANDA074312 | ANDA | CIV |
| Alternaria Alternata | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5008-2) | Jubilant HollisterStier LLC | 65044-5008-2 | 65044-5008 | BLA103888 | BLA | N/A |
| Alternaria Alternata | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5008-3) | Jubilant HollisterStier LLC | 65044-5008-3 | 65044-5008 | BLA103888 | BLA | N/A |
| Alternaria Alternata | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5008-4) | Jubilant HollisterStier LLC | 65044-5008-4 | 65044-5008 | BLA103888 | BLA | N/A |
| Alternaria Alternata | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5009-1) | Jubilant HollisterStier LLC | 65044-5009-1 | 65044-5009 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Aureobasidium Pullulans Var. Pullutans; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Dendryphiella Vinosa; Fusarium Oxysporum Vasinfectum; Mucor Racemosus; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum; Phoma Exigua Var. Exigua; Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .02 g/mL, .02 g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-5136-2) | Jubilant HollisterStier LLC | 65044-5136-2 | 65044-5136 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Aureobasidium Pullulans Var. Pullutans; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Dendryphiella Vinosa; Fusarium Oxysporum Vasinfectum; Mucor Racemosus; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum; Phoma Exigua Var. Exigua; Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .02 g/mL, .02 g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-5136-3) | Jubilant HollisterStier LLC | 65044-5136-3 | 65044-5136 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Aureobasidium Pullulans Var. Pullutans; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Dendryphiella Vinosa; Fusarium Oxysporum Vasinfectum; Mucor Racemosus; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum; Phoma Exigua Var. Exigua; Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .02 g/mL, .02 g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-5136-4) | Jubilant HollisterStier LLC | 65044-5136-4 | 65044-5136 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Aureobasidium Pullulans Var. Pullutans; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Dendryphiella Vinosa; Fusarium Oxysporum Vasinfectum; Mucor Racemosus; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum; Phoma Exigua Var. Exigua; Rhizopus Stolonifer | Injection, Solution | Percutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .02 g/mL, .02 g/mL, .04 g/mL, .1 g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-5137-1) | Jubilant HollisterStier LLC | 65044-5137-1 | 65044-5137 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL | 10 Ml In 1 Vial (65044-5000-2) | Jubilant HollisterStier LLC | 65044-5000-2 | 65044-5000 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL | 30 Ml In 1 Vial (65044-5000-3) | Jubilant HollisterStier LLC | 65044-5000-3 | 65044-5000 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL | 50 Ml In 1 Vial (65044-5000-4) | Jubilant HollisterStier LLC | 65044-5000-4 | 65044-5000 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Aspergillus Fumigatus; Aspergillus Nidulans; Aspergillus Niger Var. Niger; Aspergillus Terreus; Cladosporium Cladosporioides; Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous | .1g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .1 g/mL, .025 g/mL, .025 g/mL, .025 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-5002-1) | Jubilant HollisterStier LLC | 65044-5002-1 | 65044-5002 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Cladosporium Cladosporioides | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-5003-1) | Jubilant HollisterStier LLC | 65044-5003-1 | 65044-5003 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-5004-2) | Jubilant HollisterStier LLC | 65044-5004-2 | 65044-5004 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-5004-3) | Jubilant HollisterStier LLC | 65044-5004-3 | 65044-5004 | BLA103888 | BLA | N/A |
| Alternaria Alternata; Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-5004-4) | Jubilant HollisterStier LLC | 65044-5004-4 | 65044-5004 | BLA103888 | BLA | N/A |
| Alprazolam | Tablet, Extended Release | Oral | 1mg/1 | 60 Tablet, Extended Release In 1 Bottle (65162-810-06) | Amneal Pharmaceuticals LLC | 65162-810-06 | 65162-810 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 1mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-810-50) | Amneal Pharmaceuticals LLC | 65162-810-50 | 65162-810 | ANDA078387 | ANDA | CIV |
| Aluminum Sesquichlorohydrate | Emulsion | Topical | 15g/100mL | 50 Ml In 1 Bottle (14141-961-01) | BEL STAR S A | 14141-961-01 | 14141-961 | part350 | OTC MONOGRAPH FINAL | N/A |
| Aluminum Sesquichlorohydrate | Emulsion | Topical | 15g/100mL | 50 Ml In 1 Bottle (14141-962-01) | BEL STAR S A | 14141-962-01 | 14141-962 | part350 | OTC MONOGRAPH FINAL | N/A |
| Aluminum Sesquichlorohydrate | Emulsion | Topical | 13.6g/100mL | 50 Ml In 1 Bottle, Plastic (14141-200-01) | Bel Star S.A. (Colombia) | 14141-200-01 | 14141-200 | M019 | OTC MONOGRAPH FINAL | N/A |
| Aluminum Sesquichlorohydrate | Emulsion | Topical | 13.6g/100mL | 50 Ml In 1 Jar (14141-213-01) | BEL STAR S A | 14141-213-01 | 14141-213 | M019 | OTC MONOGRAPH FINAL | N/A |
| Aluminum Sesquichlorohydrate | Emulsion | Topical | 13.6g/100mL | 50 Ml In 1 Jar (14141-214-01) | Bel Star S.A. (Colombia) | 14141-214-01 | 14141-214 | part350 | OTC MONOGRAPH FINAL | N/A |
| Alvimopan | Capsule | Oral | 12mg/1 | 5 Blister Pack In 1 Carton (51407-870-33) / 6 Capsule In 1 Blister Pack | Golden State Medical Supply, Inc. | 51407-870-33 | 51407-870 | ANDA217753 | ANDA | N/A |
| Alvimopan | Capsule | Oral | 12mg/1 | 6 Blister Pack In 1 Carton (0054-0668-82) / 5 Capsule In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0668-82 | 0054-0668 | ANDA217753 | ANDA | N/A |
| Amantadine Hydrochloride | Solution | Oral | 50mg/5mL | 473 Ml In 1 Bottle, Plastic (39328-530-16) | Patrin Pharma, Inc. | 39328-530-16 | 39328-530 | ANDA214178 | ANDA | N/A |
| Amantadine Hydrochloride | Solution | Oral | 50mg/5mL | 10 Tray In 1 Case (39328-530-99) / 10 Cup, Unit-Dose In 1 Tray / 10 Ml In 1 Cup, Unit-Dose (39328-530-10) | Patrin Pharma, Inc. | 39328-530-99 | 39328-530 | ANDA214178 | ANDA | N/A |
| Amantadine Hydrochloride | Capsule, Liquid Filled | Oral | 100mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (69452-142-20) | Bionpharma Inc. | 69452-142-20 | 69452-142 | ANDA078720 | ANDA | N/A |
| Amantadine Hydrochloride | Capsule, Liquid Filled | Oral | 100mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (69452-142-30) | Bionpharma Inc. | 69452-142-30 | 69452-142 | ANDA078720 | ANDA | N/A |
| Alprazolam | Tablet, Extended Release | Oral | 2mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-812-03) | Amneal Pharmaceuticals LLC | 65162-812-03 | 65162-812 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 2mg/1 | 60 Tablet, Extended Release In 1 Bottle (65162-812-06) | Amneal Pharmaceuticals LLC | 65162-812-06 | 65162-812 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 2mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-812-50) | Amneal Pharmaceuticals LLC | 65162-812-50 | 65162-812 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-813-03) | Amneal Pharmaceuticals LLC | 65162-813-03 | 65162-813 | ANDA078387 | ANDA | CIV |
| Amaranthus Palmeri Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1297-2) | Jubilant HollisterStier LLC | 65044-1297-2 | 65044-1297 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1297-3) | Jubilant HollisterStier LLC | 65044-1297-3 | 65044-1297 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1297-4) | Jubilant HollisterStier LLC | 65044-1297-4 | 65044-1297 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1298-1) | Jubilant HollisterStier LLC | 65044-1298-1 | 65044-1298 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1300-2) | Jubilant HollisterStier LLC | 65044-1300-2 | 65044-1300 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1300-3) | Jubilant HollisterStier LLC | 65044-1300-3 | 65044-1300 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1300-4) | Jubilant HollisterStier LLC | 65044-1300-4 | 65044-1300 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1301-1) | Jubilant HollisterStier LLC | 65044-1301-1 | 65044-1301 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1303-2) | Jubilant HollisterStier LLC | 65044-1303-2 | 65044-1303 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1303-3) | Jubilant HollisterStier LLC | 65044-1303-3 | 65044-1303 | BLA103888 | BLA | N/A |
| Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1303-4) | Jubilant HollisterStier LLC | 65044-1303-4 | 65044-1303 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2125-2) | Jubilant HollisterStier LLC | 65044-2125-2 | 65044-2125 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2125-3) | Jubilant HollisterStier LLC | 65044-2125-3 | 65044-2125 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2125-4) | Jubilant HollisterStier LLC | 65044-2125-4 | 65044-2125 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2126-1) | Jubilant HollisterStier LLC | 65044-2126-1 | 65044-2126 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .025 g/mL, .025 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2630-1) | Jubilant HollisterStier LLC | 65044-2630-1 | 65044-2630 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .05 g/mL, .05 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-2632-2) | Jubilant HollisterStier LLC | 65044-2632-2 | 65044-2632 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .05 g/mL, .05 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-2632-3) | Jubilant HollisterStier LLC | 65044-2632-3 | 65044-2632 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .05 g/mL, .05 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-2632-4) | Jubilant HollisterStier LLC | 65044-2632-4 | 65044-2632 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 10 Ml In 1 Vial (65044-2633-2) | Jubilant HollisterStier LLC | 65044-2633-2 | 65044-2633 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 30 Ml In 1 Vial (65044-2633-3) | Jubilant HollisterStier LLC | 65044-2633-3 | 65044-2633 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL, 40000 [PNU]/mL | 50 Ml In 1 Vial (65044-2633-4) | Jubilant HollisterStier LLC | 65044-2633-4 | 65044-2633 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .025 g/mL, .025 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2634-2) | Jubilant HollisterStier LLC | 65044-2634-2 | 65044-2634 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .025 g/mL, .025 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2634-3) | Jubilant HollisterStier LLC | 65044-2634-3 | 65044-2634 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .025 g/mL, .025 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2634-4) | Jubilant HollisterStier LLC | 65044-2634-4 | 65044-2634 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-2635-2) | Jubilant HollisterStier LLC | 65044-2635-2 | 65044-2635 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-2635-3) | Jubilant HollisterStier LLC | 65044-2635-3 | 65044-2635 | BLA103888 | BLA | N/A |
| Amaranthus Retroflexus Pollen; Chenopodium Album Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-2635-4) | Jubilant HollisterStier LLC | 65044-2635-4 | 65044-2635 | BLA103888 | BLA | N/A |
| Ambrisentan | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4553-3) | Apotex Corp. | 60505-4553-3 | 60505-4553 | ANDA210701 | ANDA | N/A |
| Ambrisentan | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4552-3) | Apotex Corp. | 60505-4552-3 | 60505-4552 | ANDA210701 | ANDA | N/A |
| Ambrosia Artemisiifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2297-1) | Jubilant HollisterStier LLC | 65044-2297-1 | 65044-2297 | BLA103880 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2297-2) | Jubilant HollisterStier LLC | 65044-2297-2 | 65044-2297 | BLA103880 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2297-4) | Jubilant HollisterStier LLC | 65044-2297-4 | 65044-2297 | BLA103880 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2318-1) | Jubilant HollisterStier LLC | 65044-2318-1 | 65044-2318 | BLA103888 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2320-2) | Jubilant HollisterStier LLC | 65044-2320-2 | 65044-2320 | BLA103888 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2320-3) | Jubilant HollisterStier LLC | 65044-2320-3 | 65044-2320 | BLA103888 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2320-4) | Jubilant HollisterStier LLC | 65044-2320-4 | 65044-2320 | BLA103888 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2315-1) | Jubilant HollisterStier LLC | 65044-2315-1 | 65044-2315 | BLA103880 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2315-2) | Jubilant HollisterStier LLC | 65044-2315-2 | 65044-2315 | BLA103880 | BLA | N/A |
| Ambrosia Artemisiifolia Pollen; Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2315-4) | Jubilant HollisterStier LLC | 65044-2315-4 | 65044-2315 | BLA103880 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2308-2) | Jubilant HollisterStier LLC | 65044-2308-2 | 65044-2308 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2308-3) | Jubilant HollisterStier LLC | 65044-2308-3 | 65044-2308 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2308-4) | Jubilant HollisterStier LLC | 65044-2308-4 | 65044-2308 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2309-1) | Jubilant HollisterStier LLC | 65044-2309-1 | 65044-2309 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2311-2) | Jubilant HollisterStier LLC | 65044-2311-2 | 65044-2311 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2311-3) | Jubilant HollisterStier LLC | 65044-2311-3 | 65044-2311 | BLA103888 | BLA | N/A |
| Ambrosia Psilostachya Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2311-4) | Jubilant HollisterStier LLC | 65044-2311-4 | 65044-2311 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2293-2) | Jubilant HollisterStier LLC | 65044-2293-2 | 65044-2293 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2293-3) | Jubilant HollisterStier LLC | 65044-2293-3 | 65044-2293 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2293-4) | Jubilant HollisterStier LLC | 65044-2293-4 | 65044-2293 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2294-1) | Jubilant HollisterStier LLC | 65044-2294-1 | 65044-2294 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2296-2) | Jubilant HollisterStier LLC | 65044-2296-2 | 65044-2296 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2296-3) | Jubilant HollisterStier LLC | 65044-2296-3 | 65044-2296 | BLA103888 | BLA | N/A |
| Ambrosia Trifida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2296-4) | Jubilant HollisterStier LLC | 65044-2296-4 | 65044-2296 | BLA103888 | BLA | N/A |
| Amcinonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4060-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4060-1 | 51672-4060 | ANDA076367 | ANDA | N/A |
| Amcinonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4060-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4060-2 | 51672-4060 | ANDA076367 | ANDA | N/A |
| Amcinonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4060-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4060-3 | 51672-4060 | ANDA076367 | ANDA | N/A |
| Amikacin Sulfate | Injection, Solution | Intramuscular; Intravenous | 250mg/mL | 10 Vial In 1 Carton (25021-173-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-173-02 | 25021-173 | ANDA203323 | ANDA | N/A |
| Amikacin Sulfate | Injection, Solution | Intramuscular; Intravenous | 250mg/mL | 10 Vial In 1 Carton (25021-173-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-173-04 | 25021-173 | ANDA203323 | ANDA | N/A |
| Amikacin Sulfate | Injection | Intramuscular; Intravenous | 250mg/mL | 10 Vial In 1 Carton (0641-6166-10) / 4 Ml In 1 Vial (0641-6166-01) | Hikma Pharmaceuticals USA Inc. | 0641-6166-10 | 0641-6166 | ANDA063315 | ANDA | N/A |
| Amikacin Sulfate | Injection | Intramuscular; Intravenous | 250mg/mL | 10 Vial, Single-Dose In 1 Carton (0641-6167-10) / 2 Ml In 1 Vial, Single-Dose (0641-6167-01) | Hikma Pharmaceuticals USA Inc. | 0641-6167-10 | 0641-6167 | ANDA063315 | ANDA | N/A |
| Amiloride Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0574-0292-01) | Padagis US LLC | 0574-0292-01 | 0574-0292 | NDA018200 | NDA AUTHORIZED GENERIC | N/A |
| Aminocaproic Acid | Solution | Oral | .25g/mL | 236.5 Ml In 1 Bottle, Plastic (51672-4226-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4226-1 | 51672-4226 | ANDA214458 | ANDA | N/A |
| Alprazolam | Tablet, Extended Release | Oral | 3mg/1 | 60 Tablet, Extended Release In 1 Bottle (65162-813-06) | Amneal Pharmaceuticals LLC | 65162-813-06 | 65162-813 | ANDA078387 | ANDA | CIV |
| Aminocaproic Acid | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (80005-128-08) | Carnegie Pharmaceuticals, LLC | 80005-128-08 | 80005-128 | ANDA213928 | ANDA | N/A |
| Aminocaproic Acid | Tablet | Oral | 1000mg/1 | 30 Tablet In 1 Bottle (80005-129-08) | Carnegie Pharmaceuticals, LLC | 80005-129-08 | 80005-129 | ANDA213928 | ANDA | N/A |
| Aminocaproic Acid | Solution | Oral | .25g/mL | 236.5 Ml In 1 Bottle (80005-130-22) | Carnegie Pharmaceuticals, LLC | 80005-130-22 | 80005-130 | ANDA214140 | ANDA | N/A |
| Aminocaproic Acid | Injection, Solution | Intravenous | 250mg/mL | 25 Vial, Multi-Dose In 1 Tray (0517-9120-25) / 20 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-9120-25 | 0517-9120 | ANDA071192 | ANDA | N/A |
| Aminocaproic Acid | Injection, Solution | Intravenous | 250mg/mL | 25 Vial, Multi-Dose In 1 Tray (0517-9191-25) / 20 Ml In 1 Vial, Multi-Dose (0517-9191-01) | American Regent, Inc. | 0517-9191-25 | 0517-9191 | ANDA071192 | ANDA | N/A |
| Aminocaproic Acid | Injection, Solution | Intravenous | 250mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4346-73) / 20 Ml In 1 Vial, Single-Dose (0409-4346-16) | Hospira, Inc. | 0409-4346-73 | 0409-4346 | ANDA070010 | ANDA | N/A |
| Aminophylline Dihydrate | Injection, Solution | Intravenous | 25mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-5921-01) / 10 Ml In 1 Vial, Single-Dose (0409-5921-16) | Hospira, Inc. | 0409-5921-01 | 0409-5921 | ANDA087242 | ANDA | N/A |
| Aminophylline Dihydrate | Injection, Solution | Intravenous | 25mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-5922-01) / 20 Ml In 1 Vial, Single-Dose (0409-5922-16) | Hospira, Inc. | 0409-5922-01 | 0409-5922 | ANDA087242 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51407-873-30) | Golden State Medical Supply, Inc. | 51407-873-30 | 51407-873 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51407-874-05) | Golden State Medical Supply, Inc. | 51407-874-05 | 51407-874 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 200mg/1 | 90 Tablet In 1 Bottle (51407-874-90) | Golden State Medical Supply, Inc. | 51407-874-90 | 51407-874 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (51407-875-30) | Golden State Medical Supply, Inc. | 51407-875-30 | 51407-875 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51672-4055-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4055-6 | 51672-4055 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 300mg/1 | 10 Blister Pack In 1 Carton (51672-4056-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4056-0 | 51672-4056 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (51672-4056-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4056-1 | 51672-4056 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (51672-4056-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4056-3 | 51672-4056 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (51672-4056-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4056-6 | 51672-4056 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 400mg/1 | 10 Blister Pack In 1 Carton (51672-4057-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4057-0 | 51672-4057 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (51672-4057-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4057-6 | 51672-4057 | ANDA076362 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51672-4025-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4025-2 | 51672-4025 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51672-4025-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4025-3 | 51672-4025 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (51672-4025-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4025-4 | 51672-4025 | ANDA075424 | ANDA | N/A |
| Amiodarone Hydrochloride | Injection, Solution | Intravenous | 50mg/mL | 10 Vial In 1 Box (0143-9875-10) / 3 Ml In 1 Vial (0143-9875-01) | Hikma Pharmaceuticals USA Inc. | 0143-9875-10 | 0143-9875 | ANDA077234 | ANDA | N/A |
| Amiodarone Hydrochloride | Injection, Solution | Intravenous | 50mg/mL | 25 Vial In 1 Box (0143-9875-25) / 3 Ml In 1 Vial (0143-9875-01) | Hikma Pharmaceuticals USA Inc. | 0143-9875-25 | 0143-9875 | ANDA077234 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-907-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-907-90 | 60760-907 | ANDA214548 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-367-30) | St. Mary's Medical Park Pharmacy | 60760-367-30 | 60760-367 | ANDA202446 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 15 Tablet, Film Coated In 1 Bottle, Plastic (60760-556-15) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-556-15 | 60760-556 | ANDA214548 | ANDA | N/A |
| Alprazolam | Tablet, Extended Release | Oral | 3mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-813-50) | Amneal Pharmaceuticals LLC | 65162-813-50 | 65162-813 | ANDA078387 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .25mg/1 | 100 Tablet In 1 Bottle (70954-508-10) | ANI Pharmaceuticals, Inc. | 70954-508-10 | 70954-508 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .25mg/1 | 500 Tablet In 1 Bottle (70954-508-20) | ANI Pharmaceuticals, Inc. | 70954-508-20 | 70954-508 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (70954-508-30) | ANI Pharmaceuticals, Inc. | 70954-508-30 | 70954-508 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (70954-509-10) | ANI Pharmaceuticals, Inc. | 70954-509-10 | 70954-509 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (70954-509-20) | ANI Pharmaceuticals, Inc. | 70954-509-20 | 70954-509 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (70954-509-30) | ANI Pharmaceuticals, Inc. | 70954-509-30 | 70954-509 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (70954-510-10) | ANI Pharmaceuticals, Inc. | 70954-510-10 | 70954-510 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (70954-510-20) | ANI Pharmaceuticals, Inc. | 70954-510-20 | 70954-510 | ANDA074174 | ANDA | CIV |
| Amlodipine Benzoate | Suspension | Oral | 1mg/mL | 1 Bottle In 1 Carton (52652-5001-1) / 150 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc. | 52652-5001-1 | 52652-5001 | NDA211340 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (52605-043-10) | POLYGEN PHARMACEUTICALS INC. | 52605-043-10 | 52605-043 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (52605-043-19) | POLYGEN PHARMACEUTICALS INC. | 52605-043-19 | 52605-043 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (52605-041-10) | POLYGEN PHARMACEUTICALS INC. | 52605-041-10 | 52605-041 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle (52605-041-19) | POLYGEN PHARMACEUTICALS INC. | 52605-041-19 | 52605-041 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (52605-042-10) | POLYGEN PHARMACEUTICALS INC. | 52605-042-10 | 52605-042 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (52605-042-19) | POLYGEN PHARMACEUTICALS INC. | 52605-042-19 | 52605-042 | ANDA207821 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-459-30) | St. Mary's Medical Park Pharmacy | 60760-459-30 | 60760-459 | ANDA203245 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-459-90) | St. Mary's Medical Park Pharmacy | 60760-459-90 | 60760-459 | ANDA203245 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (58151-355-77) | Viatris Specialty LLC | 58151-355-77 | 58151-355 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 100 Blister Pack In 1 Box, Unit-Dose (58151-355-88) / 1 Tablet In 1 Blister Pack | Viatris Specialty LLC | 58151-355-88 | 58151-355 | NDA019787 | NDA | N/A |
| Alprazolam | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (70954-510-30) | ANI Pharmaceuticals, Inc. | 70954-510-30 | 70954-510 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (70954-511-10) | ANI Pharmaceuticals, Inc. | 70954-511-10 | 70954-511 | ANDA074174 | ANDA | CIV |
| Alprazolam | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (70954-511-20) | ANI Pharmaceuticals, Inc. | 70954-511-20 | 70954-511 | ANDA074174 | ANDA | CIV |
| Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide | Suspension | Oral | 1200mg/30mL, 120 mg/30mL, 1200 mg/30mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-316-31) / 30 Ml In 1 Cup, Unit-Dose (57237-316-03) | Rising Pharma Holdings, Inc. | 57237-316-31 | 57237-316 | part331 | OTC MONOGRAPH FINAL | N/A |
| Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide | Suspension | Oral | 2400mg/30mL, 240 mg/30mL, 2400 mg/30mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-324-31) / 30 Ml In 1 Cup, Unit-Dose (57237-324-03) | Rising Pharma Holdings, Inc. | 57237-324-31 | 57237-324 | part331 | OTC MONOGRAPH FINAL | N/A |
| Amantadine Hydrochloride | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (42806-716-05) | EPIC PHARMA LLC | 42806-716-05 | 42806-716 | ANDA214580 | ANDA | N/A |
| Amantadine Hydrochloride | Capsule | Oral | 100mg/1 | 10 Capsule In 1 Bottle (42806-716-11) | EPIC PHARMA LLC | 42806-716-11 | 42806-716 | ANDA214580 | ANDA | N/A |
| Amantadine Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (16571-834-01) | Rising Pharma Holdings, Inc. | 16571-834-01 | 16571-834 | ANDA210129 | ANDA | N/A |
| Amantadine Hydrochloride | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (16571-834-50) | Rising Pharma Holdings, Inc. | 16571-834-50 | 16571-834 | ANDA210129 | ANDA | N/A |
| Aminocaproic Acid | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (62559-225-30) | ANI Pharmaceuticals, Inc. | 62559-225-30 | 62559-225 | ANDA211629 | ANDA | N/A |
| AMINOCAPROIC ACID | Solution | Oral | .25g/mL | 236.5 Ml In 1 Bottle, Plastic (31722-035-23) | Camber Pharmaceuticals, Inc. | 31722-035-23 | 31722-035 | ANDA216464 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (16571-105-01) | Rising Pharma Holdings, Inc. | 16571-105-01 | 16571-105 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (16571-105-10) | Rising Pharma Holdings, Inc. | 16571-105-10 | 16571-105 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (16571-106-01) | Rising Pharma Holdings, Inc. | 16571-106-01 | 16571-106 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (16571-106-10) | Rising Pharma Holdings, Inc. | 16571-106-10 | 16571-106 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (16571-107-01) | Rising Pharma Holdings, Inc. | 16571-107-01 | 16571-107 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (16571-107-10) | Rising Pharma Holdings, Inc. | 16571-107-10 | 16571-107 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 75mg/1 | 100 Tablet In 1 Bottle (16571-108-01) | Rising Pharma Holdings, Inc. | 16571-108-01 | 16571-108 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (16571-109-01) | Rising Pharma Holdings, Inc. | 16571-109-01 | 16571-109 | ANDA217411 | ANDA | N/A |
| Amitriptyline Hydrochloride | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (16571-110-01) | Rising Pharma Holdings, Inc. | 16571-110-01 | 16571-110 | ANDA217411 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (65162-006-03) | Amneal Pharmaceuticals LLC | 65162-006-03 | 65162-006 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle (65162-006-09) | Amneal Pharmaceuticals LLC | 65162-006-09 | 65162-006 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (65162-006-10) | Amneal Pharmaceuticals LLC | 65162-006-10 | 65162-006 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (65162-006-11) | Amneal Pharmaceuticals LLC | 65162-006-11 | 65162-006 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle (0069-1520-68) | PFIZER LABORATORIES DIV PFIZER INC | 0069-1520-68 | 0069-1520 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 100 Blister Pack In 1 Box, Unit-Dose (0069-1530-41) / 1 Tablet In 1 Blister Pack | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530-41 | 0069-1530 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (0069-1530-68) | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530-68 | 0069-1530 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 300 Tablet In 1 Bottle (0069-1530-72) | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530-72 | 0069-1530 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 100 Blister Pack In 1 Box, Unit-Dose (0069-1540-41) / 1 Tablet In 1 Blister Pack | PFIZER LABORATORIES DIV PFIZER INC | 0069-1540-41 | 0069-1540 | NDA019787 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (0069-1540-68) | PFIZER LABORATORIES DIV PFIZER INC | 0069-1540-68 | 0069-1540 | NDA019787 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 2.5mg/1, 10 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-263-30) | Prasco Laboratories | 66993-263-30 | 66993-263 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 2.5mg/1, 20 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-264-30) | Prasco Laboratories | 66993-264-30 | 66993-264 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 2.5mg/1, 40 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-265-30) | Prasco Laboratories | 66993-265-30 | 66993-265 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 5mg/1, 10 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-266-30) | Prasco Laboratories | 66993-266-30 | 66993-266 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-267-30) | Prasco Laboratories | 66993-267-30 | 66993-267 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-268-30) | Prasco Laboratories | 66993-268-30 | 66993-268 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 5mg/1, 80 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-269-30) | Prasco Laboratories | 66993-269-30 | 66993-269 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 10mg/1, 10 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-270-30) | Prasco Laboratories | 66993-270-30 | 66993-270 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-271-30) | Prasco Laboratories | 66993-271-30 | 66993-271 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-272-30) | Prasco Laboratories | 66993-272-30 | 66993-272 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Coated | Oral | 10mg/1, 80 mg/1 | 30 Tablet, Coated In 1 Bottle (66993-273-30) | Prasco Laboratories | 66993-273-30 | 66993-273 | NDA021540 | NDA AUTHORIZED GENERIC | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 10 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3478-3) | Apotex Corp. | 60505-3478-3 | 60505-3478 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 10 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3479-3) | Apotex Corp. | 60505-3479-3 | 60505-3479 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3483-3) | Apotex Corp. | 60505-3483-3 | 60505-3483 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3484-3) | Apotex Corp. | 60505-3484-3 | 60505-3484 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3488-3) | Apotex Corp. | 60505-3488-3 | 60505-3488 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3489-3) | Apotex Corp. | 60505-3489-3 | 60505-3489 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3492-3) | Apotex Corp. | 60505-3492-3 | 60505-3492 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3493-3) | Apotex Corp. | 60505-3493-3 | 60505-3493 | ANDA205199 | ANDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-6323-30) | Pfizer Laboratories Div Pfizer Inc | 0069-6323-30 | 0069-6323 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-6565-30) | Pfizer Laboratories Div Pfizer Inc | 0069-6565-30 | 0069-6565 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-6747-30) | Pfizer Laboratories Div Pfizer Inc | 0069-6747-30 | 0069-6747 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-7232-30) | Pfizer Laboratories Div Pfizer Inc | 0069-7232-30 | 0069-7232 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-7476-30) | Pfizer Laboratories Div Pfizer Inc | 0069-7476-30 | 0069-7476 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-7654-30) | Pfizer Laboratories Div Pfizer Inc | 0069-7654-30 | 0069-7654 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1, 10 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-7810-30) | Pfizer Laboratories Div Pfizer Inc | 0069-7810-30 | 0069-7810 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-2260-30) | Pfizer Laboratories Div Pfizer Inc | 0069-2260-30 | 0069-2260 | NDA021540 | NDA | N/A |
| Amlodipine Besylate; Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 5mg/1, 10 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-6180-30) | Pfizer Laboratories Div Pfizer Inc | 0069-6180-30 | 0069-6180 | NDA021540 | NDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (65162-006-50) | Amneal Pharmaceuticals LLC | 65162-006-50 | 65162-006 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (65162-007-03) | Amneal Pharmaceuticals LLC | 65162-007-03 | 65162-007 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (65162-007-09) | Amneal Pharmaceuticals LLC | 65162-007-09 | 65162-007 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (65162-007-10) | Amneal Pharmaceuticals LLC | 65162-007-10 | 65162-007 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (65162-007-11) | Amneal Pharmaceuticals LLC | 65162-007-11 | 65162-007 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-007-50) | Amneal Pharmaceuticals LLC | 65162-007-50 | 65162-007 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (65162-008-03) | Amneal Pharmaceuticals LLC | 65162-008-03 | 65162-008 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (65162-008-09) | Amneal Pharmaceuticals LLC | 65162-008-09 | 65162-008 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (65162-008-10) | Amneal Pharmaceuticals LLC | 65162-008-10 | 65162-008 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-008-11) | Amneal Pharmaceuticals LLC | 65162-008-11 | 65162-008 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-008-50) | Amneal Pharmaceuticals LLC | 65162-008-50 | 65162-008 | ANDA078477 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (42806-055-05) | Epic Pharma, LLC | 42806-055-05 | 42806-055 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 12.5 mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0713-0874-30) | Cosette Pharmaceuticals, Inc. | 0713-0874-30 | 0713-0874 | NDA200175 | NDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 12.5 mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0713-0875-30) | Cosette Pharmaceuticals, Inc. | 0713-0875-30 | 0713-0875 | NDA200175 | NDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 25 mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0713-0876-30) | Cosette Pharmaceuticals, Inc. | 0713-0876-30 | 0713-0876 | NDA200175 | NDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 12.5 mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0713-0877-30) | Cosette Pharmaceuticals, Inc. | 0713-0877-30 | 0713-0877 | NDA200175 | NDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 25 mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (0713-0878-30) | Cosette Pharmaceuticals, Inc. | 0713-0878-30 | 0713-0878 | NDA200175 | NDA | N/A |
| Amlodipine Besylate; Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 5mg/1, 12.5 mg/1, 160 mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-668-30) | Golden State Medical Supply, Inc. | 51407-668-30 | 51407-668 | ANDA201087 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle (42806-055-09) | Epic Pharma, LLC | 42806-055-09 | 42806-055 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (42806-055-10) | Epic Pharma, LLC | 42806-055-10 | 42806-055 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (42806-056-05) | Epic Pharma, LLC | 42806-056-05 | 42806-056 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (42806-056-09) | Epic Pharma, LLC | 42806-056-09 | 42806-056 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (42806-056-10) | Epic Pharma, LLC | 42806-056-10 | 42806-056 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (42806-057-05) | Epic Pharma, LLC | 42806-057-05 | 42806-057 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (42806-057-09) | Epic Pharma, LLC | 42806-057-09 | 42806-057 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (42806-057-10) | Epic Pharma, LLC | 42806-057-10 | 42806-057 | ANDA078552 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 2.5mg/1, 10 mg/1 | 100 Capsule In 1 Bottle (57237-142-01) | Rising Pharma Holdings, Inc. | 57237-142-01 | 57237-142 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 2.5mg/1, 10 mg/1 | 500 Capsule In 1 Bottle (57237-142-05) | Rising Pharma Holdings, Inc. | 57237-142-05 | 57237-142 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 10 mg/1 | 100 Capsule In 1 Bottle (57237-143-01) | Rising Pharma Holdings, Inc. | 57237-143-01 | 57237-143 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 10 mg/1 | 500 Capsule In 1 Bottle (57237-143-05) | Rising Pharma Holdings, Inc. | 57237-143-05 | 57237-143 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-857-30) | Golden State Medical Supply, Inc. | 51407-857-30 | 51407-857 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-858-30) | Golden State Medical Supply, Inc. | 51407-858-30 | 51407-858 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-859-30) | Golden State Medical Supply, Inc. | 51407-859-30 | 51407-859 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-860-30) | Golden State Medical Supply, Inc. | 51407-860-30 | 51407-860 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0873-30) | Cosette Pharmaceuticals, Inc. | 0713-0873-30 | 0713-0873 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0870-30) | Cosette Pharmaceuticals, Inc. | 0713-0870-30 | 0713-0870 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0871-30) | Cosette Pharmaceuticals, Inc. | 0713-0871-30 | 0713-0871 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0872-30) | Cosette Pharmaceuticals, Inc. | 0713-0872-30 | 0713-0872 | NDA022100 | NDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 20 mg/1 | 100 Capsule In 1 Bottle (57237-144-01) | Rising Pharma Holdings, Inc. | 57237-144-01 | 57237-144 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 20 mg/1 | 500 Capsule In 1 Bottle (57237-144-05) | Rising Pharma Holdings, Inc. | 57237-144-05 | 57237-144 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (57237-145-01) | Rising Pharma Holdings, Inc. | 57237-145-01 | 57237-145 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 5mg/1, 40 mg/1 | 500 Capsule In 1 Bottle (57237-145-05) | Rising Pharma Holdings, Inc. | 57237-145-05 | 57237-145 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 10mg/1, 20 mg/1 | 100 Capsule In 1 Bottle (57237-146-01) | Rising Pharma Holdings, Inc. | 57237-146-01 | 57237-146 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 10mg/1, 20 mg/1 | 500 Capsule In 1 Bottle (57237-146-05) | Rising Pharma Holdings, Inc. | 57237-146-05 | 57237-146 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 10mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (57237-147-01) | Rising Pharma Holdings, Inc. | 57237-147-01 | 57237-147 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Benazepril Hydrochloride | Capsule | Oral | 10mg/1, 40 mg/1 | 500 Capsule In 1 Bottle (57237-147-05) | Rising Pharma Holdings, Inc. | 57237-147-05 | 57237-147 | ANDA202239 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-365-10) | ScieGen Pharmaceuticals, Inc | 50228-365-10 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-365-30) | ScieGen Pharmaceuticals, Inc | 50228-365-30 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-365-90) | ScieGen Pharmaceuticals, Inc | 50228-365-90 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-366-10) | ScieGen Pharmaceuticals, Inc | 50228-366-10 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amlodipine; Valsartan | Tablet | Oral | 5mg/1, 160 mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-771-30) | Golden State Medical Supply, Inc. | 51407-771-30 | 51407-771 | ANDA090011 | ANDA | N/A |
| Amlodipine; Valsartan | Tablet | Oral | 5mg/1, 320 mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-772-30) | Golden State Medical Supply, Inc. | 51407-772-30 | 51407-772 | ANDA090011 | ANDA | N/A |
| Amlodipine; Valsartan | Tablet | Oral | 10mg/1, 160 mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-773-30) | Golden State Medical Supply, Inc. | 51407-773-30 | 51407-773 | ANDA090011 | ANDA | N/A |
| Amlodipine; Valsartan | Tablet | Oral | 10mg/1, 320 mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-774-30) | Golden State Medical Supply, Inc. | 51407-774-30 | 51407-774 | ANDA090011 | ANDA | N/A |
| Ammonia | Inhalant | Respiratory (Inhalation) | .045g/.3mL | 100 Ampule In 1 Box (82749-150-02) / .3 Ml In 1 Ampule (82749-150-01) | Epic Medical Supply Corp | 82749-150-02 | 82749-150 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Ammonium Lactate | Lotion | Topical | 12g/100g | 400 G In 1 Bottle, Plastic (45802-419-26) | Padagis Israel Pharmaceuticals Ltd | 45802-419-26 | 45802-419 | ANDA075570 | ANDA | N/A |
| Ammonium Lactate | Lotion | Topical | 12g/100g | 225 G In 1 Bottle, Plastic (45802-419-54) | Padagis Israel Pharmaceuticals Ltd | 45802-419-54 | 45802-419 | ANDA075570 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 12g/100g | 385 G In 1 Bottle, Pump (45802-493-26) | Padagis Israel Pharmaceuticals Ltd | 45802-493-26 | 45802-493 | ANDA075774 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 12g/100g | 2 Tube In 1 Carton (45802-493-83) / 140 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-493-83 | 45802-493 | ANDA075774 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 12g/100g | 140 G In 1 Tube (45802-493-98) | Padagis Israel Pharmaceuticals Ltd | 45802-493-98 | 45802-493 | ANDA075774 | ANDA | N/A |
| Ammonium Lactate | Lotion | Topical | 120mg/g | 225 G In 1 Bottle, Plastic (51672-1300-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1300-5 | 51672-1300 | ANDA076216 | ANDA | N/A |
| Ammonium Lactate | Lotion | Topical | 120mg/g | 400 G In 1 Bottle, Plastic (51672-1300-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1300-9 | 51672-1300 | ANDA076216 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 120mg/g | 385 G In 1 Bottle, Plastic (51672-1301-0) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1301-0 | 51672-1301 | ANDA075883 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 120mg/g | 1 Tube In 1 Carton (51672-1301-2) / 140 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1301-2 | 51672-1301 | ANDA075883 | ANDA | N/A |
| Ammonium Lactate | Cream | Topical | 120mg/g | 2 Tube In 1 Carton (51672-1301-4) / 140 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1301-4 | 51672-1301 | ANDA075883 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-366-30) | ScieGen Pharmaceuticals, Inc | 50228-366-30 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-366-90) | ScieGen Pharmaceuticals, Inc | 50228-366-90 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-367-10) | ScieGen Pharmaceuticals, Inc | 50228-367-10 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-367-30) | ScieGen Pharmaceuticals, Inc | 50228-367-30 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-367-90) | ScieGen Pharmaceuticals, Inc | 50228-367-90 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-368-10) | ScieGen Pharmaceuticals, Inc | 50228-368-10 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-368-30) | ScieGen Pharmaceuticals, Inc | 50228-368-30 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-368-90) | ScieGen Pharmaceuticals, Inc | 50228-368-90 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-365-10) | ScieGen Pharmaceuticals, Inc | 50228-365-10 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-365-30) | ScieGen Pharmaceuticals, Inc | 50228-365-30 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-365-90) | ScieGen Pharmaceuticals, Inc | 50228-365-90 | 50228-365 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-366-10) | ScieGen Pharmaceuticals, Inc | 50228-366-10 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-366-30) | ScieGen Pharmaceuticals, Inc | 50228-366-30 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1, 40 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-366-90) | ScieGen Pharmaceuticals, Inc | 50228-366-90 | 50228-366 | ANDA209010 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (0143-9886-01) | Hikma Pharmaceuticals USA Inc. | 0143-9886-01 | 0143-9886 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 50 Ml In 1 Bottle (0143-9886-50) | Hikma Pharmaceuticals USA Inc. | 0143-9886-50 | 0143-9886 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 75 Ml In 1 Bottle (0143-9886-75) | Hikma Pharmaceuticals USA Inc. | 0143-9886-75 | 0143-9886 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (0143-9887-01) | Hikma Pharmaceuticals USA Inc. | 0143-9887-01 | 0143-9887 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 50 Ml In 1 Bottle (0143-9887-50) | Hikma Pharmaceuticals USA Inc. | 0143-9887-50 | 0143-9887 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 75 Ml In 1 Bottle (0143-9887-75) | Hikma Pharmaceuticals USA Inc. | 0143-9887-75 | 0143-9887 | ANDA065325 | ANDA | N/A |
| Amoxicillin | Capsule | Oral | 500mg/1 | 500 Capsule In 1 Bottle, Plastic (0143-9939-05) | Hikma Pharmaceuticals USA Inc. | 0143-9939-05 | 0143-9939 | ANDA065291 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 125mg/5mL | 100 Ml In 1 Bottle (0143-9888-01) | Hikma Pharmaceuticals USA Inc. | 0143-9888-01 | 0143-9888 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 125mg/5mL | 150 Ml In 1 Bottle (0143-9888-15) | Hikma Pharmaceuticals USA Inc. | 0143-9888-15 | 0143-9888 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 125mg/5mL | 80 Ml In 1 Bottle (0143-9888-80) | Hikma Pharmaceuticals USA Inc. | 0143-9888-80 | 0143-9888 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 250mg/5mL | 100 Ml In 1 Bottle (0143-9889-01) | Hikma Pharmaceuticals USA Inc. | 0143-9889-01 | 0143-9889 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 250mg/5mL | 150 Ml In 1 Bottle (0143-9889-15) | Hikma Pharmaceuticals USA Inc. | 0143-9889-15 | 0143-9889 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 250mg/5mL | 80 Ml In 1 Bottle (0143-9889-80) | Hikma Pharmaceuticals USA Inc. | 0143-9889-80 | 0143-9889 | ANDA065322 | ANDA | N/A |
| Amoxicillin | Tablet, Coated | Oral | 875mg/1 | 100 Tablet, Coated In 1 Bottle (0143-9285-01) | Hikma Pharmaceuticals USA Inc. | 0143-9285-01 | 0143-9285 | ANDA065255 | ANDA | N/A |
| Amoxicillin | Tablet, Coated | Oral | 875mg/1 | 20 Tablet, Coated In 1 Bottle (0143-9285-20) | Hikma Pharmaceuticals USA Inc. | 0143-9285-20 | 0143-9285 | ANDA065255 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Powder, For Suspension | Oral | 200mg/5mL, 28.5 mg/5mL | 100 Ml In 1 Bottle (69452-334-43) | Bionpharma Inc. | 69452-334-43 | 69452-334 | ANDA065066 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Powder, For Suspension | Oral | 400mg/5mL, 57 mg/5mL | 100 Ml In 1 Bottle (69452-335-43) | Bionpharma Inc. | 69452-335-43 | 69452-335 | ANDA065066 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Tablet, Film Coated | Oral | 500mg/1, 125 mg/1 | 20 Tablet, Film Coated In 1 Bottle (69452-336-11) | Bionpharma Inc. | 69452-336-11 | 69452-336 | ANDA065064 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Tablet, Film Coated | Oral | 875mg/1, 125 mg/1 | 20 Tablet, Film Coated In 1 Bottle (69452-337-11) | Bionpharma Inc. | 69452-337-11 | 69452-337 | ANDA065063 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Suspension | Oral | 600mg/5mL, 42.9 mg/5mL | 125 Ml In 1 Bottle (0143-9853-16) | Hikma Pharmaceuticals USA Inc. | 0143-9853-16 | 0143-9853 | ANDA065373 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Suspension | Oral | 600mg/5mL, 42.9 mg/5mL | 200 Ml In 1 Bottle (0143-9853-24) | Hikma Pharmaceuticals USA Inc. | 0143-9853-24 | 0143-9853 | ANDA065373 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Suspension | Oral | 600mg/5mL, 42.9 mg/5mL | 75 Ml In 1 Bottle (0143-9853-75) | Hikma Pharmaceuticals USA Inc. | 0143-9853-75 | 0143-9853 | ANDA065373 | ANDA | N/A |
| Amoxicillin; Clavulanate Potassium | Tablet | Oral | 875mg/1, 125 mg/1 | 20 Tablet In 1 Bottle (0143-9249-20) | Hikma Pharmaceuticals USA Inc. | 0143-9249-20 | 0143-9249 | ANDA203824 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 200mg/5mL, 28.5 mg/5mL | 100 Ml In 1 Bottle (0143-9981-01) | Hikma Pharmaceuticals USA Inc. | 0143-9981-01 | 0143-9981 | ANDA065191 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 200mg/5mL, 28.5 mg/5mL | 50 Ml In 1 Bottle (0143-9981-50) | Hikma Pharmaceuticals USA Inc. | 0143-9981-50 | 0143-9981 | ANDA065191 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 200mg/5mL, 28.5 mg/5mL | 75 Ml In 1 Bottle (0143-9981-75) | Hikma Pharmaceuticals USA Inc. | 0143-9981-75 | 0143-9981 | ANDA065191 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 400mg/5mL, 57 mg/5mL | 100 Ml In 1 Bottle (0143-9982-01) | Hikma Pharmaceuticals USA Inc. | 0143-9982-01 | 0143-9982 | ANDA065191 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 400mg/5mL, 57 mg/5mL | 50 Ml In 1 Bottle (0143-9982-50) | Hikma Pharmaceuticals USA Inc. | 0143-9982-50 | 0143-9982 | ANDA065191 | ANDA | N/A |
| Amoxicillin; Clavulanic Acid | Powder, For Suspension | Oral | 400mg/5mL, 57 mg/5mL | 75 Ml In 1 Bottle (0143-9982-75) | Hikma Pharmaceuticals USA Inc. | 0143-9982-75 | 0143-9982 | ANDA065191 | ANDA | N/A |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-598-02) | Prasco Laboratories | 66993-598-02 | 66993-598 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-599-02) | Prasco Laboratories | 66993-599-02 | 66993-599 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-594-02) | Prasco Laboratories | 66993-594-02 | 66993-594 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-595-02) | Prasco Laboratories | 66993-595-02 | 66993-595 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-596-02) | Prasco Laboratories | 66993-596-02 | 66993-596 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (66993-597-02) | Prasco Laboratories | 66993-597-02 | 66993-597 | NDA021303 | NDA AUTHORIZED GENERIC | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Capsule, Extended Release In 1 Bottle (51407-559-01) | Golden State Medical Supply, Inc. | 51407-559-01 | 51407-559 | ANDA214403 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (51407-560-01) | Golden State Medical Supply, Inc. | 51407-560-01 | 51407-560 | ANDA214403 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (51407-561-01) | Golden State Medical Supply, Inc. | 51407-561-01 | 51407-561 | ANDA214403 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (51407-562-01) | Golden State Medical Supply, Inc. | 51407-562-01 | 51407-562 | ANDA214403 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (51407-548-01) | Golden State Medical Supply, Inc. | 51407-548-01 | 51407-548 | ANDA212037 | ANDA | CII |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-367-10) | ScieGen Pharmaceuticals, Inc | 50228-367-10 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-367-30) | ScieGen Pharmaceuticals, Inc | 50228-367-30 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-367-90) | ScieGen Pharmaceuticals, Inc | 50228-367-90 | 50228-367 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-368-10) | ScieGen Pharmaceuticals, Inc | 50228-368-10 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-368-30) | ScieGen Pharmaceuticals, Inc | 50228-368-30 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amlodipine Besylate; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 10mg/1, 40 mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-368-90) | ScieGen Pharmaceuticals, Inc | 50228-368-90 | 50228-368 | ANDA209010 | ANDA | N/A |
| Amoxicillin | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-028-01) | Rising Pharma Holdings, Inc. | 57237-028-01 | 57237-028 | ANDA065256 | ANDA | N/A |
| Amoxicillin | Tablet, Film Coated | Oral | 500mg/1 | 20 Tablet, Film Coated In 1 Bottle (57237-028-20) | Rising Pharma Holdings, Inc. | 57237-028-20 | 57237-028 | ANDA065256 | ANDA | N/A |
| Amoxicillin | Tablet, Film Coated | Oral | 875mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-029-01) | Rising Pharma Holdings, Inc. | 57237-029-01 | 57237-029 | ANDA065256 | ANDA | N/A |
| Amoxicillin | Tablet, Film Coated | Oral | 875mg/1 | 20 Tablet, Film Coated In 1 Bottle (57237-029-20) | Rising Pharma Holdings, Inc. | 57237-029-20 | 57237-029 | ANDA065256 | ANDA | N/A |
| Amoxicillin | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (57237-030-01) | Rising Pharma Holdings, Inc. | 57237-030-01 | 57237-030 | ANDA065271 | ANDA | N/A |
| Amoxicillin | Capsule | Oral | 250mg/1 | 500 Capsule In 1 Bottle (57237-030-05) | Rising Pharma Holdings, Inc. | 57237-030-05 | 57237-030 | ANDA065271 | ANDA | N/A |
| Amoxicillin | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle (57237-031-01) | Rising Pharma Holdings, Inc. | 57237-031-01 | 57237-031 | ANDA065271 | ANDA | N/A |
| Amoxicillin | Capsule | Oral | 500mg/1 | 500 Capsule In 1 Bottle (57237-031-05) | Rising Pharma Holdings, Inc. | 57237-031-05 | 57237-031 | ANDA065271 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (57237-032-01) | Rising Pharma Holdings, Inc. | 57237-032-01 | 57237-032 | ANDA065334 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 50 Ml In 1 Bottle (57237-032-50) | Rising Pharma Holdings, Inc. | 57237-032-50 | 57237-032 | ANDA065334 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 200mg/5mL | 75 Ml In 1 Bottle (57237-032-75) | Rising Pharma Holdings, Inc. | 57237-032-75 | 57237-032 | ANDA065334 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (57237-033-01) | Rising Pharma Holdings, Inc. | 57237-033-01 | 57237-033 | ANDA065334 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 50 Ml In 1 Bottle (57237-033-50) | Rising Pharma Holdings, Inc. | 57237-033-50 | 57237-033 | ANDA065334 | ANDA | N/A |
| Amoxicillin | Powder, For Suspension | Oral | 400mg/5mL | 75 Ml In 1 Bottle (57237-033-75) | Rising Pharma Holdings, Inc. | 57237-033-75 | 57237-033 | ANDA065334 | ANDA | N/A |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-277-10) | ANI Pharmaceuticals, Inc. | 43975-277-10 | 43975-277 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-278-10) | ANI Pharmaceuticals, Inc. | 43975-278-10 | 43975-278 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-279-10) | ANI Pharmaceuticals, Inc. | 43975-279-10 | 43975-279 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-280-10) | ANI Pharmaceuticals, Inc. | 43975-280-10 | 43975-280 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-281-10) | ANI Pharmaceuticals, Inc. | 43975-281-10 | 43975-281 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (43975-282-10) | ANI Pharmaceuticals, Inc. | 43975-282-10 | 43975-282 | ANDA205401 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-316-05) | Ascent Pharmaceuticals, Inc | 43602-316-05 | 43602-316 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-316-30) | Ascent Pharmaceuticals, Inc | 43602-316-30 | 43602-316 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-317-05) | Ascent Pharmaceuticals, Inc | 43602-317-05 | 43602-317 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-317-30) | Ascent Pharmaceuticals, Inc | 43602-317-30 | 43602-317 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-318-05) | Ascent Pharmaceuticals, Inc | 43602-318-05 | 43602-318 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-318-30) | Ascent Pharmaceuticals, Inc | 43602-318-30 | 43602-318 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-319-05) | Ascent Pharmaceuticals, Inc | 43602-319-05 | 43602-319 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-319-30) | Ascent Pharmaceuticals, Inc | 43602-319-30 | 43602-319 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-320-05) | Ascent Pharmaceuticals, Inc | 43602-320-05 | 43602-320 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-320-30) | Ascent Pharmaceuticals, Inc | 43602-320-30 | 43602-320 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-321-05) | Ascent Pharmaceuticals, Inc | 43602-321-05 | 43602-321 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-321-30) | Ascent Pharmaceuticals, Inc | 43602-321-30 | 43602-321 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (43602-370-01) | Ascent Pharmaceuticals, Inc | 43602-370-01 | 43602-370 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (43602-370-05) | Ascent Pharmaceuticals, Inc | 43602-370-05 | 43602-370 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (43602-371-01) | Ascent Pharmaceuticals, Inc | 43602-371-01 | 43602-371 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (43602-371-05) | Ascent Pharmaceuticals, Inc | 43602-371-05 | 43602-371 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1, 10 mg/1, 10 mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (43602-372-01) | Ascent Pharmaceuticals, Inc | 43602-372-01 | 43602-372 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1, 10 mg/1, 10 mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (43602-372-05) | Ascent Pharmaceuticals, Inc | 43602-372-05 | 43602-372 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 12.5mg/1, 12.5 mg/1, 12.5 mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (43602-373-01) | Ascent Pharmaceuticals, Inc | 43602-373-01 | 43602-373 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 12.5mg/1, 12.5 mg/1, 12.5 mg/1, 12.5 mg/1 | 500 Tablet In 1 Bottle (43602-373-05) | Ascent Pharmaceuticals, Inc | 43602-373-05 | 43602-373 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1, 15 mg/1, 15 mg/1, 15 mg/1 | 100 Tablet In 1 Bottle (43602-374-01) | Ascent Pharmaceuticals, Inc | 43602-374-01 | 43602-374 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1, 15 mg/1, 15 mg/1, 15 mg/1 | 500 Tablet In 1 Bottle (43602-374-05) | Ascent Pharmaceuticals, Inc | 43602-374-05 | 43602-374 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1, 20 mg/1, 20 mg/1, 20 mg/1 | 100 Tablet In 1 Bottle (43602-375-01) | Ascent Pharmaceuticals, Inc | 43602-375-01 | 43602-375 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1, 20 mg/1, 20 mg/1, 20 mg/1 | 500 Tablet In 1 Bottle (43602-375-05) | Ascent Pharmaceuticals, Inc | 43602-375-05 | 43602-375 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1, 30 mg/1, 30 mg/1, 30 mg/1 | 100 Tablet In 1 Bottle (43602-376-01) | Ascent Pharmaceuticals, Inc | 43602-376-01 | 43602-376 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle (47781-174-01) | Alvogen Inc. | 47781-174-01 | 47781-174 | ANDA207388 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (47781-176-01) | Alvogen Inc. | 47781-176-01 | 47781-176 | ANDA207388 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Tablet In 1 Bottle (47781-178-01) | Alvogen Inc. | 47781-178-01 | 47781-178 | ANDA207388 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (47781-179-01) | Alvogen Inc. | 47781-179-01 | 47781-179 | ANDA207388 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (47781-180-01) | Alvogen Inc. | 47781-180-01 | 47781-180 | ANDA207388 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1, 30 mg/1, 30 mg/1, 30 mg/1 | 500 Tablet In 1 Bottle (43602-376-05) | Ascent Pharmaceuticals, Inc | 43602-376-05 | 43602-376 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-316-05) | Ascent Pharmaceuticals, Inc | 43602-316-05 | 43602-316 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-316-30) | Ascent Pharmaceuticals, Inc | 43602-316-30 | 43602-316 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-317-05) | Ascent Pharmaceuticals, Inc | 43602-317-05 | 43602-317 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-317-30) | Ascent Pharmaceuticals, Inc | 43602-317-30 | 43602-317 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-318-05) | Ascent Pharmaceuticals, Inc | 43602-318-05 | 43602-318 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-318-30) | Ascent Pharmaceuticals, Inc | 43602-318-30 | 43602-318 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-319-05) | Ascent Pharmaceuticals, Inc | 43602-319-05 | 43602-319 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-319-30) | Ascent Pharmaceuticals, Inc | 43602-319-30 | 43602-319 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-320-05) | Ascent Pharmaceuticals, Inc | 43602-320-05 | 43602-320 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-320-30) | Ascent Pharmaceuticals, Inc | 43602-320-30 | 43602-320 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-321-05) | Ascent Pharmaceuticals, Inc | 43602-321-05 | 43602-321 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-321-30) | Ascent Pharmaceuticals, Inc | 43602-321-30 | 43602-321 | ANDA214959 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (43602-370-01) | Ascent Pharmaceuticals, Inc | 43602-370-01 | 43602-370 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (43602-370-05) | Ascent Pharmaceuticals, Inc | 43602-370-05 | 43602-370 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (43602-371-01) | Ascent Pharmaceuticals, Inc | 43602-371-01 | 43602-371 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (43602-371-05) | Ascent Pharmaceuticals, Inc | 43602-371-05 | 43602-371 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1, 10 mg/1, 10 mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (43602-372-01) | Ascent Pharmaceuticals, Inc | 43602-372-01 | 43602-372 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1, 10 mg/1, 10 mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (43602-372-05) | Ascent Pharmaceuticals, Inc | 43602-372-05 | 43602-372 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 12.5mg/1, 12.5 mg/1, 12.5 mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (43602-373-01) | Ascent Pharmaceuticals, Inc | 43602-373-01 | 43602-373 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 12.5mg/1, 12.5 mg/1, 12.5 mg/1, 12.5 mg/1 | 500 Tablet In 1 Bottle (43602-373-05) | Ascent Pharmaceuticals, Inc | 43602-373-05 | 43602-373 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1, 15 mg/1, 15 mg/1, 15 mg/1 | 100 Tablet In 1 Bottle (43602-374-01) | Ascent Pharmaceuticals, Inc | 43602-374-01 | 43602-374 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1, 15 mg/1, 15 mg/1, 15 mg/1 | 500 Tablet In 1 Bottle (43602-374-05) | Ascent Pharmaceuticals, Inc | 43602-374-05 | 43602-374 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1, 20 mg/1, 20 mg/1, 20 mg/1 | 100 Tablet In 1 Bottle (43602-375-01) | Ascent Pharmaceuticals, Inc | 43602-375-01 | 43602-375 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1, 20 mg/1, 20 mg/1, 20 mg/1 | 500 Tablet In 1 Bottle (43602-375-05) | Ascent Pharmaceuticals, Inc | 43602-375-05 | 43602-375 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1, 30 mg/1, 30 mg/1, 30 mg/1 | 100 Tablet In 1 Bottle (43602-376-01) | Ascent Pharmaceuticals, Inc | 43602-376-01 | 43602-376 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1, 30 mg/1, 30 mg/1, 30 mg/1 | 500 Tablet In 1 Bottle (43602-376-05) | Ascent Pharmaceuticals, Inc | 43602-376-05 | 43602-376 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle (43602-982-15) | Ascent Pharmaceuticals, Inc. | 43602-982-15 | 43602-982 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 500 Tablet In 1 Bottle (43602-982-16) | Ascent Pharmaceuticals, Inc. | 43602-982-16 | 43602-982 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.875mg/1, 1.875 mg/1, 1.875 mg/1, 1.875 mg/1 | 100 Tablet In 1 Bottle (43602-983-15) | Ascent Pharmaceuticals, Inc. | 43602-983-15 | 43602-983 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.875mg/1, 1.875 mg/1, 1.875 mg/1, 1.875 mg/1 | 500 Tablet In 1 Bottle (43602-983-16) | Ascent Pharmaceuticals, Inc. | 43602-983-16 | 43602-983 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (43602-984-15) | Ascent Pharmaceuticals, Inc. | 43602-984-15 | 43602-984 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (43602-984-16) | Ascent Pharmaceuticals, Inc. | 43602-984-16 | 43602-984 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.125mg/1, 3.125 mg/1, 3.125 mg/1, 3.125 mg/1 | 100 Tablet In 1 Bottle (43602-985-15) | Ascent Pharmaceuticals, Inc. | 43602-985-15 | 43602-985 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.125mg/1, 3.125 mg/1, 3.125 mg/1, 3.125 mg/1 | 500 Tablet In 1 Bottle (43602-985-16) | Ascent Pharmaceuticals, Inc. | 43602-985-16 | 43602-985 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Tablet In 1 Bottle (43602-986-15) | Ascent Pharmaceuticals, Inc. | 43602-986-15 | 43602-986 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 500 Tablet In 1 Bottle (43602-986-16) | Ascent Pharmaceuticals, Inc. | 43602-986-16 | 43602-986 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (43602-987-15) | Ascent Pharmaceuticals, Inc. | 43602-987-15 | 43602-987 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (43602-987-16) | Ascent Pharmaceuticals, Inc. | 43602-987-16 | 43602-987 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (43602-988-15) | Ascent Pharmaceuticals, Inc. | 43602-988-15 | 43602-988 | ANDA213709 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (52536-057-03) | Wilshire Pharmaceuticals | 52536-057-03 | 52536-057 | ANDA200166 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (52536-059-03) | Wilshire Pharmaceuticals | 52536-059-03 | 52536-059 | ANDA200166 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (24338-022-03) | AZURITY PHARMACEUTICALS, INC. | 24338-022-03 | 24338-022 | ANDA200166 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (24338-026-03) | AZURITY PHARMACEUTICALS, INC. | 24338-026-03 | 24338-026 | ANDA200166 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (69452-227-20) | Bionpharma Inc. | 69452-227-20 | 69452-227 | ANDA212919 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (69452-228-20) | Bionpharma Inc. | 69452-228-20 | 69452-228 | ANDA212919 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (43602-988-16) | Ascent Pharmaceuticals, Inc. | 43602-988-16 | 43602-988 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (43602-988-15) | Ascent Pharmaceuticals, Inc. | 43602-988-15 | 43602-988 | ANDA213709 | ANDA | CII |
| Ampicillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial In 1 Carton (25021-136-10) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-136-10 | 25021-136 | ANDA090354 | ANDA | N/A |
| Ampicillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-137-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-137-20 | 25021-137 | ANDA090354 | ANDA | N/A |
| Ampicillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 10 Vial, Glass In 1 Package (0409-3718-01) / 1 Injection, Powder, For Solution In 1 Vial, Glass (0409-3718-10) | Hospira, Inc | 0409-3718-01 | 0409-3718 | ANDA061395 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1, .5 g/1 | 10 Vial, Single-Dose In 1 Carton (71288-031-92) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (71288-031-91) | Meitheal Pharmaceuticals Inc. | 71288-031-92 | 71288-031 | ANDA065222 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1, .5 g/1 | 10 Vial, Single-Dose In 1 Carton (71288-031-21) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (71288-031-20) | Meitheal Pharmaceuticals Inc. | 71288-031-21 | 71288-031 | ANDA065222 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1, 1 g/1 | 10 Vial, Single-Dose In 1 Carton (71288-032-92) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (71288-032-91) | Meitheal Pharmaceuticals Inc. | 71288-032-92 | 71288-032 | ANDA065222 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1, 1 g/1 | 10 Vial, Single-Dose In 1 Carton (71288-032-21) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (71288-032-20) | Meitheal Pharmaceuticals Inc. | 71288-032-21 | 71288-032 | ANDA065222 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 10g/1, 5 g/1 | 1 Bottle In 1 Carton (71288-033-75) / 1 Injection, Powder, For Solution In 1 Bottle | Meitheal Pharmaceuticals Inc. | 71288-033-75 | 71288-033 | ANDA065314 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 10g/1, 5 g/1 | 1 Bottle In 1 Carton (71288-033-91) / 1 Injection, Powder, For Solution In 1 Bottle | Meitheal Pharmaceuticals Inc. | 71288-033-91 | 71288-033 | ANDA065314 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1, 1 g/1 | 10 Vial, Single-Dose In 1 Carton (71288-006-30) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (71288-006-31) | Meitheal Pharmaceuticals Inc. | 71288-006-30 | 71288-006 | ANDA090579 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1, .5 g/1 | 10 Vial In 1 Carton (25021-142-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-142-20 | 25021-142 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1, 1 g/1 | 10 Vial In 1 Carton (25021-143-30) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-143-30 | 25021-143 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 100mg/mL, 50 mg/mL | 1 Bottle In 1 Carton (25021-144-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-144-99 | 25021-144 | ANDA065403 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 1g/1.5g, .5 g/1.5g | 10 Vial In 1 Carton (0641-6116-10) / 1.5 G In 1 Vial (0641-6116-01) | Hikma Pharmaceuticals USA Inc. | 0641-6116-10 | 0641-6116 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 2g/3g, 1 g/3g | 10 Vial In 1 Carton (0641-6117-10) / 3 G In 1 Vial (0641-6117-01) | Hikma Pharmaceuticals USA Inc. | 0641-6117-10 | 0641-6117 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 100mg/mL, 50 mg/mL | 100 Ml In 1 Vial, Pharmacy Bulk Package (0641-6118-01) | Hikma Pharmaceuticals USA Inc. | 0641-6118-01 | 0641-6118 | ANDA065403 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 1g/1.5g, .5 g/1.5g | 10 Vial In 1 Carton (0641-6119-10) / 1.5 G In 1 Vial (0641-6119-01) | Hikma Pharmaceuticals USA Inc. | 0641-6119-10 | 0641-6119 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 2g/3g, 1 g/3g | 10 Vial In 1 Carton (0641-6120-10) / 3 G In 1 Vial (0641-6120-01) | Hikma Pharmaceuticals USA Inc. | 0641-6120-10 | 0641-6120 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 250mg/mL, 125 mg/mL | 10 Vial In 1 Carton (0641-6122-10) / 4 Ml In 1 Vial (0641-6122-01) | Hikma Pharmaceuticals USA Inc. | 0641-6122-10 | 0641-6122 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 250mg/mL, 125 mg/mL | 10 Vial In 1 Carton (0641-6123-10) / 8 Ml In 1 Vial (0641-6123-01) | Hikma Pharmaceuticals USA Inc. | 0641-6123-10 | 0641-6123 | ANDA065406 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 1g/1, .5 g/1 | 10 Vial In 1 Tray (0409-2689-01) / 1 Injection, Powder, For Solution In 1 Vial (0409-2689-21) | Hospira, Inc | 0409-2689-01 | 0409-2689 | ANDA065310 | ANDA | N/A |
| Ampicillin Sodium; Sulbactam Sodium | Injection, Powder, For Solution | Intravenous | 2g/1, 1 g/1 | 10 Vial In 1 Tray (0409-2987-03) / 1 Injection, Powder, For Solution In 1 Vial (0409-2987-23) | Hospira, Inc | 0409-2987-03 | 0409-2987 | ANDA065310 | ANDA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-4349-2) | Jubilant HollisterStier LLC | 65044-4349-2 | 65044-4349 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-4349-3) | Jubilant HollisterStier LLC | 65044-4349-3 | 65044-4349 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-4349-4) | Jubilant HollisterStier LLC | 65044-4349-4 | 65044-4349 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-4350-1) | Jubilant HollisterStier LLC | 65044-4350-1 | 65044-4350 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-4352-2) | Jubilant HollisterStier LLC | 65044-4352-2 | 65044-4352 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-4352-3) | Jubilant HollisterStier LLC | 65044-4352-3 | 65044-4352 | BLA103888 | BLA | N/A |
| Anas Platyrhynchos Feather; Anser Anser Feather; Gallus Gallus Feather | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-4352-4) | Jubilant HollisterStier LLC | 65044-4352-4 | 65044-4352 | BLA103888 | BLA | N/A |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (43602-988-16) | Ascent Pharmaceuticals, Inc. | 43602-988-16 | 43602-988 | ANDA213709 | ANDA | CII |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0825-1) | Jubilant HollisterStier LLC | 65044-0825-1 | 65044-0825 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0825-2) | Jubilant HollisterStier LLC | 65044-0825-2 | 65044-0825 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0825-3) | Jubilant HollisterStier LLC | 65044-0825-3 | 65044-0825 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0825-4) | Jubilant HollisterStier LLC | 65044-0825-4 | 65044-0825 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0826-1) | Jubilant HollisterStier LLC | 65044-0826-1 | 65044-0826 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0826-2) | Jubilant HollisterStier LLC | 65044-0826-2 | 65044-0826 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0826-3) | Jubilant HollisterStier LLC | 65044-0826-3 | 65044-0826 | BLA103878 | BLA | N/A |
| Anthoxanthum Odoratum Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0826-4) | Jubilant HollisterStier LLC | 65044-0826-4 | 65044-0826 | BLA103878 | BLA | N/A |
| Apis Mellifera Venom | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 13 Ml In 1 Vial (65044-9950-6) | Jubilant HollisterStier LLC | 65044-9950-6 | 65044-9950 | BLA103882 | BLA | N/A |
| Apis Mellifera Venom | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 5.5 Ml In 1 Vial (65044-9940-5) | Jubilant HollisterStier LLC | 65044-9940-5 | 65044-9940 | BLA103882 | BLA | N/A |
| Apple | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3020-2) | Jubilant HollisterStier LLC | 65044-3020-2 | 65044-3020 | BLA103888 | BLA | N/A |
| Argatroban | Injection, Solution | Intravenous | 1mg/mL | 1 Vial In 1 Carton (25021-414-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-414-50 | 25021-414 | ANDA214235 | ANDA | N/A |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle (43602-982-15) | Ascent Pharmaceuticals, Inc. | 43602-982-15 | 43602-982 | ANDA213709 | ANDA | CII |
| Argatroban | Injection | Intravenous | 50mg/50mL | 1 Vial In 1 Carton (0143-9559-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9559-01 | 0143-9559 | NDA203049 | NDA | N/A |
| Argatroban | Injection | Intravenous | 50mg/50mL | 1 Vial In 1 Carton (0143-9377-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9377-01 | 0143-9377 | NDA203049 | NDA | N/A |
| Argatroban | Injection | Intravenous | 250mg/2.5mL | 2.5 Ml In 1 Vial (0143-9674-01) | Hikma Pharmaceuticals USA Inc. | 0143-9674-01 | 0143-9674 | NDA203049 | NDA | N/A |
| Argatroban | Injection | Intravenous | 250mg/2.5mL | 1 Vial In 1 Carton (0143-9288-01) / 2.5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9288-01 | 0143-9288 | NDA203049 | NDA | N/A |
| Argatroban | Injection, Solution | Intravenous | 100mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1140-01) / 2.5 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1140-01 | 0409-1140 | ANDA204120 | ANDA | N/A |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 500 Tablet In 1 Bottle (43602-982-16) | Ascent Pharmaceuticals, Inc. | 43602-982-16 | 43602-982 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.875mg/1, 1.875 mg/1, 1.875 mg/1, 1.875 mg/1 | 100 Tablet In 1 Bottle (43602-983-15) | Ascent Pharmaceuticals, Inc. | 43602-983-15 | 43602-983 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.875mg/1, 1.875 mg/1, 1.875 mg/1, 1.875 mg/1 | 500 Tablet In 1 Bottle (43602-983-16) | Ascent Pharmaceuticals, Inc. | 43602-983-16 | 43602-983 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (43602-984-15) | Ascent Pharmaceuticals, Inc. | 43602-984-15 | 43602-984 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (43602-984-16) | Ascent Pharmaceuticals, Inc. | 43602-984-16 | 43602-984 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.125mg/1, 3.125 mg/1, 3.125 mg/1, 3.125 mg/1 | 100 Tablet In 1 Bottle (43602-985-15) | Ascent Pharmaceuticals, Inc. | 43602-985-15 | 43602-985 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.125mg/1, 3.125 mg/1, 3.125 mg/1, 3.125 mg/1 | 500 Tablet In 1 Bottle (43602-985-16) | Ascent Pharmaceuticals, Inc. | 43602-985-16 | 43602-985 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Tablet In 1 Bottle (43602-986-15) | Ascent Pharmaceuticals, Inc. | 43602-986-15 | 43602-986 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 500 Tablet In 1 Bottle (43602-986-16) | Ascent Pharmaceuticals, Inc. | 43602-986-16 | 43602-986 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (43602-987-15) | Ascent Pharmaceuticals, Inc. | 43602-987-15 | 43602-987 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (43602-987-16) | Ascent Pharmaceuticals, Inc. | 43602-987-16 | 43602-987 | ANDA213709 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 1.25mg/1, 1.25 mg/1, 1.25 mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle, Plastic (42806-339-01) | Epic Pharma, LLC | 42806-339-01 | 42806-339 | ANDA040444 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1, 2.5 mg/1, 2.5 mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle, Plastic (42806-341-01) | Epic Pharma, LLC | 42806-341-01 | 42806-341 | ANDA040444 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Tablet In 1 Bottle, Plastic (42806-343-01) | Epic Pharma, LLC | 42806-343-01 | 42806-343 | ANDA040444 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle, Plastic (42806-344-01) | Epic Pharma, LLC | 42806-344-01 | 42806-344 | ANDA040444 | ANDA | CII |
| Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle, Plastic (42806-345-01) | Epic Pharma, LLC | 42806-345-01 | 42806-345 | ANDA040444 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-029-01) | Epic Pharma LLC | 42806-029-01 | 42806-029 | ANDA213980 | ANDA | CII |
| Amphetamine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-030-01) | Epic Pharma LLC | 42806-030-01 | 42806-030 | ANDA213980 | ANDA | CII |
| Anastrozole | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle (62559-670-30) | ANI Pharmaceuticals, Inc. | 62559-670-30 | 62559-670 | NDA020541 | NDA | N/A |
| Argatroban | Injection, Solution | Intravenous | 100mg/mL | 1 Vial, Glass In 1 Carton (70121-1037-1) / 2.5 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1037-1 | 70121-1037 | ANDA206698 | ANDA | N/A |
| Aripiprazole | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (65162-893-74) / 150 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-893-74 | 65162-893 | ANDA203906 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (65162-896-03) | Amneal Pharmaceuticals LLC | 65162-896-03 | 65162-896 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 90 Tablet In 1 Bottle (65162-896-09) | Amneal Pharmaceuticals LLC | 65162-896-09 | 65162-896 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (65162-896-11) | Amneal Pharmaceuticals LLC | 65162-896-11 | 65162-896 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (65162-896-50) | Amneal Pharmaceuticals LLC | 65162-896-50 | 65162-896 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (65162-897-03) | Amneal Pharmaceuticals LLC | 65162-897-03 | 65162-897 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (65162-897-09) | Amneal Pharmaceuticals LLC | 65162-897-09 | 65162-897 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (65162-897-11) | Amneal Pharmaceuticals LLC | 65162-897-11 | 65162-897 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (66689-735-05) / 150 Ml In 1 Bottle | VistaPharm, LLC | 66689-735-05 | 66689-735 | ANDA212870 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (60505-2673-3) | Apotex Corp | 60505-2673-3 | 60505-2673 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (60505-2673-8) | Apotex Corp | 60505-2673-8 | 60505-2673 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (60505-2674-3) | Apotex Corp | 60505-2674-3 | 60505-2674 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-2674-8) | Apotex Corp | 60505-2674-8 | 60505-2674 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (60505-2675-3) | Apotex Corp | 60505-2675-3 | 60505-2675 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (60505-2675-8) | Apotex Corp | 60505-2675-8 | 60505-2675 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (60505-2676-3) | Apotex Corp | 60505-2676-3 | 60505-2676 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (60505-2676-8) | Apotex Corp | 60505-2676-8 | 60505-2676 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (60505-3075-3) | Apotex Corp | 60505-3075-3 | 60505-3075 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (60505-3075-8) | Apotex Corp | 60505-3075-8 | 60505-3075 | ANDA078583 | ANDA | N/A |
| Aripiprazole | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (60505-0404-5) / 150 Ml In 1 Bottle | Apotex Corp. | 60505-0404-5 | 60505-0404 | ANDA204094 | ANDA | N/A |
| Aripiprazole | Tablet, Orally Disintegrating | Oral | 10mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle, Plastic (69452-338-13) | Bionpharma Inc. | 69452-338-13 | 69452-338 | ANDA202547 | ANDA | N/A |
| Aripiprazole | Tablet, Orally Disintegrating | Oral | 15mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle, Plastic (69452-339-13) | Bionpharma Inc. | 69452-339-13 | 69452-339 | ANDA202547 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-897-50) | Amneal Pharmaceuticals LLC | 65162-897-50 | 65162-897 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (65162-898-03) | Amneal Pharmaceuticals LLC | 65162-898-03 | 65162-898 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (65162-898-09) | Amneal Pharmaceuticals LLC | 65162-898-09 | 65162-898 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-898-11) | Amneal Pharmaceuticals LLC | 65162-898-11 | 65162-898 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-898-50) | Amneal Pharmaceuticals LLC | 65162-898-50 | 65162-898 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (65162-899-03) | Amneal Pharmaceuticals LLC | 65162-899-03 | 65162-899 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 90 Tablet In 1 Bottle (65162-899-09) | Amneal Pharmaceuticals LLC | 65162-899-09 | 65162-899 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (65162-899-11) | Amneal Pharmaceuticals LLC | 65162-899-11 | 65162-899 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (65162-899-50) | Amneal Pharmaceuticals LLC | 65162-899-50 | 65162-899 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (65162-901-03) | Amneal Pharmaceuticals LLC | 65162-901-03 | 65162-901 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (65162-901-09) | Amneal Pharmaceuticals LLC | 65162-901-09 | 65162-901 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (65162-901-11) | Amneal Pharmaceuticals LLC | 65162-901-11 | 65162-901 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (65162-901-50) | Amneal Pharmaceuticals LLC | 65162-901-50 | 65162-901 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (65162-902-03) | Amneal Pharmaceuticals LLC | 65162-902-03 | 65162-902 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 90 Tablet In 1 Bottle (65162-902-09) | Amneal Pharmaceuticals LLC | 65162-902-09 | 65162-902 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (65162-902-11) | Amneal Pharmaceuticals LLC | 65162-902-11 | 65162-902 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (65162-902-50) | Amneal Pharmaceuticals LLC | 65162-902-50 | 65162-902 | ANDA204838 | ANDA | N/A |
| Aripiprazole | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (31722-684-15) / 150 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-684-15 | 31722-684 | ANDA216150 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (31722-819-01) | Camber Pharmaceuticals, Inc. | 31722-819-01 | 31722-819 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (31722-819-05) | Camber Pharmaceuticals, Inc. | 31722-819-05 | 31722-819 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (31722-819-30) | Camber Pharmaceuticals, Inc. | 31722-819-30 | 31722-819 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 10 Tablet In 1 Blister Pack (31722-819-31) | Camber Pharmaceuticals, Inc. | 31722-819-31 | 31722-819 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 250 Tablet In 1 Carton (31722-819-32) | Camber Pharmaceuticals, Inc. | 31722-819-32 | 31722-819 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-820-01) | Camber Pharmaceuticals, Inc. | 31722-820-01 | 31722-820 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (31722-820-05) | Camber Pharmaceuticals, Inc. | 31722-820-05 | 31722-820 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (31722-820-30) | Camber Pharmaceuticals, Inc. | 31722-820-30 | 31722-820 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 10 Tablet In 1 Blister Pack (31722-820-31) | Camber Pharmaceuticals, Inc. | 31722-820-31 | 31722-820 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 250 Tablet In 1 Carton (31722-820-32) | Camber Pharmaceuticals, Inc. | 31722-820-32 | 31722-820 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-827-01) | Camber Pharmaceuticals, Inc. | 31722-827-01 | 31722-827 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (31722-827-05) | Camber Pharmaceuticals, Inc. | 31722-827-05 | 31722-827 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (31722-827-30) | Camber Pharmaceuticals, Inc. | 31722-827-30 | 31722-827 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 10 Tablet In 1 Blister Pack (31722-827-31) | Camber Pharmaceuticals, Inc. | 31722-827-31 | 31722-827 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 250 Tablet In 1 Carton (31722-827-32) | Camber Pharmaceuticals, Inc. | 31722-827-32 | 31722-827 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (31722-828-01) | Camber Pharmaceuticals, Inc. | 31722-828-01 | 31722-828 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (31722-828-05) | Camber Pharmaceuticals, Inc. | 31722-828-05 | 31722-828 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (31722-828-30) | Camber Pharmaceuticals, Inc. | 31722-828-30 | 31722-828 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 10 Tablet In 1 Blister Pack (31722-828-31) | Camber Pharmaceuticals, Inc. | 31722-828-31 | 31722-828 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 250 Tablet In 1 Carton (31722-828-32) | Camber Pharmaceuticals, Inc. | 31722-828-32 | 31722-828 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-829-01) | Camber Pharmaceuticals, Inc. | 31722-829-01 | 31722-829 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (31722-829-05) | Camber Pharmaceuticals, Inc. | 31722-829-05 | 31722-829 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (31722-829-30) | Camber Pharmaceuticals, Inc. | 31722-829-30 | 31722-829 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 10 Tablet In 1 Blister Pack (31722-829-31) | Camber Pharmaceuticals, Inc. | 31722-829-31 | 31722-829 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 250 Tablet In 1 Carton (31722-829-32) | Camber Pharmaceuticals, Inc. | 31722-829-32 | 31722-829 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (31722-830-01) | Camber Pharmaceuticals, Inc. | 31722-830-01 | 31722-830 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (31722-830-05) | Camber Pharmaceuticals, Inc. | 31722-830-05 | 31722-830 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (31722-830-30) | Camber Pharmaceuticals, Inc. | 31722-830-30 | 31722-830 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 10 Tablet In 1 Blister Pack (31722-830-31) | Camber Pharmaceuticals, Inc. | 31722-830-31 | 31722-830 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 250 Tablet In 1 Carton (31722-830-32) | Camber Pharmaceuticals, Inc. | 31722-830-32 | 31722-830 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (31722-919-01) | Camber Pharmaceuticals, Inc. | 31722-919-01 | 31722-919 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (31722-919-30) | Camber Pharmaceuticals, Inc. | 31722-919-30 | 31722-919 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-920-01) | Camber Pharmaceuticals, Inc. | 31722-920-01 | 31722-920 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (31722-920-30) | Camber Pharmaceuticals, Inc. | 31722-920-30 | 31722-920 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-921-01) | Camber Pharmaceuticals, Inc. | 31722-921-01 | 31722-921 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (31722-921-30) | Camber Pharmaceuticals, Inc. | 31722-921-30 | 31722-921 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (31722-922-01) | Camber Pharmaceuticals, Inc. | 31722-922-01 | 31722-922 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (31722-922-30) | Camber Pharmaceuticals, Inc. | 31722-922-30 | 31722-922 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-923-01) | Camber Pharmaceuticals, Inc. | 31722-923-01 | 31722-923 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (31722-923-30) | Camber Pharmaceuticals, Inc. | 31722-923-30 | 31722-923 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (31722-924-01) | Camber Pharmaceuticals, Inc. | 31722-924-01 | 31722-924 | ANDA205064 | ANDA | N/A |
| ARIPIPRAZOLE | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (31722-924-30) | Camber Pharmaceuticals, Inc. | 31722-924-30 | 31722-924 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-326-10) | ScieGen Pharmaceuticals Inc | 50228-326-10 | 50228-326 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-326-30) | ScieGen Pharmaceuticals Inc | 50228-326-30 | 50228-326 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (50228-327-10) | ScieGen Pharmaceuticals Inc | 50228-327-10 | 50228-327 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-327-30) | ScieGen Pharmaceuticals Inc | 50228-327-30 | 50228-327 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (50228-328-10) | ScieGen Pharmaceuticals Inc | 50228-328-10 | 50228-328 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (50228-328-30) | ScieGen Pharmaceuticals Inc | 50228-328-30 | 50228-328 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-329-10) | ScieGen Pharmaceuticals Inc | 50228-329-10 | 50228-329 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-329-30) | ScieGen Pharmaceuticals Inc | 50228-329-30 | 50228-329 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-330-30) | ScieGen Pharmaceuticals Inc | 50228-330-30 | 50228-330 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Blister Pack (50228-330-51) | ScieGen Pharmaceuticals Inc | 50228-330-51 | 50228-330 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-331-30) | ScieGen Pharmaceuticals Inc | 50228-331-30 | 50228-331 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Blister Pack (50228-331-51) | ScieGen Pharmaceuticals Inc | 50228-331-51 | 50228-331 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (50228-475-10) | ScieGen Pharmaceuticals Inc | 50228-475-10 | 50228-475 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (50228-475-30) | ScieGen Pharmaceuticals Inc | 50228-475-30 | 50228-475 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-476-10) | ScieGen Pharmaceuticals Inc | 50228-476-10 | 50228-476 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-476-30) | ScieGen Pharmaceuticals Inc | 50228-476-30 | 50228-476 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-477-10) | ScieGen Pharmaceuticals Inc | 50228-477-10 | 50228-477 | ANDA206383 | ANDA | N/A |
| Arnica Montana; Calendula Officinalis Flowering Top; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 3 [hp_X]/14g, 2 [hp_X]/14g | 1 Tube In 1 Carton (71042-002-14) / 14 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-002-14 | 71042-002 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Arnica Montana; Lemon Balm Oil | Ointment | Topical | .1g/100g, 1 g/100g | 1 Tube In 1 Carton (71042-014-14) / 14.2 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-014-14 | 71042-014 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Arsenic Trioxide | Injection | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (14789-600-10) / 10 Ml In 1 Vial, Single-Dose | Nexus Pharmaceuticals Inc | 14789-600-10 | 14789-600 | ANDA209780 | ANDA | N/A |
| Arsenic Trioxide | Injection | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-226-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-226-10 | 25021-226 | ANDA215059 | ANDA | N/A |
| Arsenic Trioxide | Injection | Intravenous | 2mg/mL | 10 Vial In 1 Carton (25021-227-06) / 6 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-227-06 | 25021-227 | ANDA215059 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-477-30) | ScieGen Pharmaceuticals Inc | 50228-477-30 | 50228-477 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (50228-478-10) | ScieGen Pharmaceuticals Inc | 50228-478-10 | 50228-478 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-478-30) | ScieGen Pharmaceuticals Inc | 50228-478-30 | 50228-478 | ANDA206383 | ANDA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2413-2) | Jubilant HollisterStier LLC | 65044-2413-2 | 65044-2413 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2413-3) | Jubilant HollisterStier LLC | 65044-2413-3 | 65044-2413 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2413-4) | Jubilant HollisterStier LLC | 65044-2413-4 | 65044-2413 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2414-1) | Jubilant HollisterStier LLC | 65044-2414-1 | 65044-2414 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2416-2) | Jubilant HollisterStier LLC | 65044-2416-2 | 65044-2416 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2416-3) | Jubilant HollisterStier LLC | 65044-2416-3 | 65044-2416 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2416-4) | Jubilant HollisterStier LLC | 65044-2416-4 | 65044-2416 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 10 Ml In 1 Vial (65044-2417-2) | Jubilant HollisterStier LLC | 65044-2417-2 | 65044-2417 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 30 Ml In 1 Vial (65044-2417-3) | Jubilant HollisterStier LLC | 65044-2417-3 | 65044-2417 | BLA103888 | BLA | N/A |
| Artemisia Vulgaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 50 Ml In 1 Vial (65044-2417-4) | Jubilant HollisterStier LLC | 65044-2417-4 | 65044-2417 | BLA103888 | BLA | N/A |
| Ascorbic Acid | Lotion | Topical | 5g/50g | 50 G In 1 Bottle (83325-007-01) | Volans Epic LLC | 83325-007-01 | 83325-007 | M006 | OTC MONOGRAPH DRUG | N/A |
| Aspergillus Fumigatus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5020-2) | Jubilant HollisterStier LLC | 65044-5020-2 | 65044-5020 | BLA103888 | BLA | N/A |
| Aspergillus Fumigatus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5020-3) | Jubilant HollisterStier LLC | 65044-5020-3 | 65044-5020 | BLA103888 | BLA | N/A |
| Aspergillus Fumigatus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5020-4) | Jubilant HollisterStier LLC | 65044-5020-4 | 65044-5020 | BLA103888 | BLA | N/A |
| Aspergillus Fumigatus | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5021-1) | Jubilant HollisterStier LLC | 65044-5021-1 | 65044-5021 | BLA103888 | BLA | N/A |
| Aspergillus Niger Var. Niger | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5032-2) | Jubilant HollisterStier LLC | 65044-5032-2 | 65044-5032 | BLA103888 | BLA | N/A |
| Aspergillus Niger Var. Niger | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5032-3) | Jubilant HollisterStier LLC | 65044-5032-3 | 65044-5032 | BLA103888 | BLA | N/A |
| Aspergillus Niger Var. Niger | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5032-4) | Jubilant HollisterStier LLC | 65044-5032-4 | 65044-5032 | BLA103888 | BLA | N/A |
| Aspergillus Niger Var. Niger | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5033-1) | Jubilant HollisterStier LLC | 65044-5033-1 | 65044-5033 | BLA103888 | BLA | N/A |
| Aspirin | Suppository | Rectal | 300mg/1 | 12 Packet In 1 Carton (0574-7034-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7034-12 | 0574-7034 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Aspirin | Tablet | Oral | 325mg/1 | 24 Tablet In 1 Bottle, Plastic (60760-930-24) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-930-24 | 60760-930 | M013 | OTC MONOGRAPH DRUG | N/A |
| Aspirin | Tablet, Film Coated | Oral | 325mg/1 | 24 Tablet, Film Coated In 1 Bottle, Plastic (60760-161-24) | St. Mary's Medical Park Pharmacy | 60760-161-24 | 60760-161 | M013 | OTC MONOGRAPH DRUG | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (50228-479-10) | ScieGen Pharmaceuticals Inc | 50228-479-10 | 50228-479 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (50228-479-30) | ScieGen Pharmaceuticals Inc | 50228-479-30 | 50228-479 | ANDA206383 | ANDA | N/A |
| Aspirin; Butalbital; Caffeine | Capsule | Oral | 500mg/1, 50 mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (79739-7192-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7192-1 | 79739-7192 | ANDA205230 | ANDA | CIII |
| Aspirin; Butalbital; Caffeine | Capsule | Oral | 500mg/1, 50 mg/1, 40 mg/1 | 500 Capsule In 1 Bottle (79739-7192-5) | LGM PHARMA SOLUTIONS, LLC | 79739-7192-5 | 79739-7192 | ANDA205230 | ANDA | CIII |
| Aspirin; Butalbital; Caffeine | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1 | 100 Capsule In 1 Bottle (29033-215-01) | Nostrum Laboratories, Inc. | 29033-215-01 | 29033-215 | ANDA078149 | ANDA | CIII |
| Aspirin; Butalbital; Caffeine; Codeine Phosphate | Capsule | Oral | 325mg/1, 50 mg/1, 40 mg/1, 30 mg/1 | 100 Capsule In 1 Bottle (79739-6094-1) | LGM PHARMA SOLUTIONS, LLC | 79739-6094-1 | 79739-6094 | ANDA075231 | ANDA | CIII |
| Aripiprazole | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-480-10) | ScieGen Pharmaceuticals Inc | 50228-480-10 | 50228-480 | ANDA206383 | ANDA | N/A |
| Aspirin; Hydrocodone Bitartrate | Tablet | Oral | 500mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (79739-7182-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7182-1 | 79739-7182 | ANDA205479 | ANDA | CII |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-480-30) | ScieGen Pharmaceuticals Inc | 50228-480-30 | 50228-480 | ANDA206383 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (75834-281-00) | Nivagen Pharmaceuticals, Inc. | 75834-281-00 | 75834-281 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (75834-281-01) | Nivagen Pharmaceuticals, Inc. | 75834-281-01 | 75834-281 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 1 Tablet In 1 Drum (75834-281-10) | Nivagen Pharmaceuticals, Inc. | 75834-281-10 | 75834-281 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (75834-282-00) | Nivagen Pharmaceuticals, Inc. | 75834-282-00 | 75834-282 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (75834-282-01) | Nivagen Pharmaceuticals, Inc. | 75834-282-01 | 75834-282 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 1 Tablet In 1 Drum (75834-282-10) | Nivagen Pharmaceuticals, Inc. | 75834-282-10 | 75834-282 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (75834-283-00) | Nivagen Pharmaceuticals, Inc. | 75834-283-00 | 75834-283 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (75834-283-01) | Nivagen Pharmaceuticals, Inc. | 75834-283-01 | 75834-283 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 1 Tablet In 1 Drum (75834-283-10) | Nivagen Pharmaceuticals, Inc. | 75834-283-10 | 75834-283 | ANDA073026 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-642-90) | St Mary's Medical Park Pharmacy | 60760-642-90 | 60760-642 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-787-90) | St Mary's Medical Park Pharmacy | 60760-787-90 | 60760-787 | ANDA074056 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-643-30) | St. Mary's Medical Park Pharmacy | 60760-643-30 | 60760-643 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-643-90) | St. Mary's Medical Park Pharmacy | 60760-643-90 | 60760-643 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-256-90) | St. Mary's Medical Park Pharmacy | 60760-256-90 | 60760-256 | ANDA074052 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle, Plastic (60429-025-10) | Golden State Medical Supply, Inc. | 60429-025-10 | 60429-025 | ANDA073457 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle, Plastic (60429-025-90) | Golden State Medical Supply, Inc. | 60429-025-90 | 60429-025 | ANDA073457 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle, Plastic (60429-026-10) | Golden State Medical Supply, Inc. | 60429-026-10 | 60429-026 | ANDA073457 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle, Plastic (60429-026-90) | Golden State Medical Supply, Inc. | 60429-026-90 | 60429-026 | ANDA073457 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle, Plastic (60429-027-10) | Golden State Medical Supply, Inc. | 60429-027-10 | 60429-027 | ANDA073457 | ANDA | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle, Plastic (60429-027-90) | Golden State Medical Supply, Inc. | 60429-027-90 | 60429-027 | ANDA073457 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (50228-324-10) | ScieGen Pharmaceuticals Inc | 50228-324-10 | 50228-324 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (50228-324-30) | ScieGen Pharmaceuticals Inc | 50228-324-30 | 50228-324 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-325-10) | ScieGen Pharmaceuticals Inc | 50228-325-10 | 50228-325 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-325-30) | ScieGen Pharmaceuticals Inc | 50228-325-30 | 50228-325 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-326-10) | ScieGen Pharmaceuticals Inc | 50228-326-10 | 50228-326 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-326-30) | ScieGen Pharmaceuticals Inc | 50228-326-30 | 50228-326 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (50228-327-10) | ScieGen Pharmaceuticals Inc | 50228-327-10 | 50228-327 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-327-30) | ScieGen Pharmaceuticals Inc | 50228-327-30 | 50228-327 | ANDA206383 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (51407-100-30) | Golden State Medical Supply, Inc. | 51407-100-30 | 51407-100 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 18mg/1 | 30 Capsule In 1 Bottle (51407-101-30) | Golden State Medical Supply, Inc. | 51407-101-30 | 51407-101 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (51407-102-30) | Golden State Medical Supply, Inc. | 51407-102-30 | 51407-102 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (51407-103-30) | Golden State Medical Supply, Inc. | 51407-103-30 | 51407-103 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 60mg/1 | 30 Capsule In 1 Bottle (51407-104-30) | Golden State Medical Supply, Inc. | 51407-104-30 | 51407-104 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 80mg/1 | 30 Capsule In 1 Bottle (51407-105-30) | Golden State Medical Supply, Inc. | 51407-105-30 | 51407-105 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (51407-106-30) | Golden State Medical Supply, Inc. | 51407-106-30 | 51407-106 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (60505-2830-3) | Apotex Corp. | 60505-2830-3 | 60505-2830 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 18mg/1 | 30 Capsule In 1 Bottle (60505-2831-3) | Apotex Corp. | 60505-2831-3 | 60505-2831 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (60505-2832-3) | Apotex Corp. | 60505-2832-3 | 60505-2832 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (60505-2833-3) | Apotex Corp. | 60505-2833-3 | 60505-2833 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 60mg/1 | 30 Capsule In 1 Bottle (60505-2834-3) | Apotex Corp. | 60505-2834-3 | 60505-2834 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 80mg/1 | 30 Capsule In 1 Bottle (60505-2835-3) | Apotex Corp. | 60505-2835-3 | 60505-2835 | ANDA078983 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (60505-2836-3) | Apotex Corp. | 60505-2836-3 | 60505-2836 | ANDA078983 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (50228-328-10) | ScieGen Pharmaceuticals Inc | 50228-328-10 | 50228-328 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (50228-328-30) | ScieGen Pharmaceuticals Inc | 50228-328-30 | 50228-328 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-329-10) | ScieGen Pharmaceuticals Inc | 50228-329-10 | 50228-329 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-329-30) | ScieGen Pharmaceuticals Inc | 50228-329-30 | 50228-329 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-330-30) | ScieGen Pharmaceuticals Inc | 50228-330-30 | 50228-330 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Blister Pack (50228-330-51) | ScieGen Pharmaceuticals Inc | 50228-330-51 | 50228-330 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-331-30) | ScieGen Pharmaceuticals Inc | 50228-331-30 | 50228-331 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Blister Pack (50228-331-51) | ScieGen Pharmaceuticals Inc | 50228-331-51 | 50228-331 | ANDA207240 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (50228-475-10) | ScieGen Pharmaceuticals Inc | 50228-475-10 | 50228-475 | ANDA206383 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (75834-256-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-256-01 | 75834-256 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 20mg/1 | 5000 Tablet In 1 Bottle (75834-256-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-256-05 | 75834-256 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (75834-256-50) | NIVAGEN PHARMACEUTICALS, INC. | 75834-256-50 | 75834-256 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (75834-256-90) | NIVAGEN PHARMACEUTICALS, INC. | 75834-256-90 | 75834-256 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (75834-257-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-257-01 | 75834-257 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 40mg/1 | 2500 Tablet In 1 Bottle (75834-257-25) | NIVAGEN PHARMACEUTICALS, INC. | 75834-257-25 | 75834-257 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (75834-257-50) | NIVAGEN PHARMACEUTICALS, INC. | 75834-257-50 | 75834-257 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (75834-257-90) | NIVAGEN PHARMACEUTICALS, INC. | 75834-257-90 | 75834-257 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (75834-258-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-258-01 | 75834-258 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 80mg/1 | 2000 Tablet In 1 Bottle (75834-258-02) | NIVAGEN PHARMACEUTICALS, INC. | 75834-258-02 | 75834-258 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (75834-258-50) | NIVAGEN PHARMACEUTICALS, INC. | 75834-258-50 | 75834-258 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (75834-258-90) | NIVAGEN PHARMACEUTICALS, INC. | 75834-258-90 | 75834-258 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (75834-255-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-255-01 | 75834-255 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 10mg/1 | 5000 Tablet In 1 Bottle (75834-255-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-255-05 | 75834-255 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (75834-255-50) | NIVAGEN PHARMACEUTICALS, INC. | 75834-255-50 | 75834-255 | ANDA213853 | ANDA | N/A |
| Atorvastatin | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (75834-255-90) | NIVAGEN PHARMACEUTICALS, INC. | 75834-255-90 | 75834-255 | ANDA213853 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 10 Blister Pack In 1 Carton (60505-2671-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-2671-0 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2671-3) | Apotex Corp. | 60505-2671-3 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-2671-5) | Apotex Corp. | 60505-2671-5 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 2500 Tablet, Film Coated In 1 Bottle (60505-2671-7) | Apotex Corp. | 60505-2671-7 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-2671-8) | Apotex Corp. | 60505-2671-8 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2671-9) | Apotex Corp. | 60505-2671-9 | 60505-2671 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (60505-2578-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-2578-0 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2578-3) | Apotex Corp. | 60505-2578-3 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-2578-5) | Apotex Corp. | 60505-2578-5 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 5000 Tablet, Film Coated In 1 Bottle (60505-2578-7) | Apotex Corp. | 60505-2578-7 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-2578-8) | Apotex Corp. | 60505-2578-8 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2578-9) | Apotex Corp. | 60505-2578-9 | 60505-2578 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (60505-2579-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-2579-0 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2579-3) | Apotex Corp. | 60505-2579-3 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-2579-5) | Apotex Corp. | 60505-2579-5 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 5000 Tablet, Film Coated In 1 Bottle (60505-2579-7) | Apotex Corp. | 60505-2579-7 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-2579-8) | Apotex Corp. | 60505-2579-8 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2579-9) | Apotex Corp. | 60505-2579-9 | 60505-2579 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 10 Blister Pack In 1 Carton (60505-2580-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-2580-0 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2580-3) | Apotex Corp. | 60505-2580-3 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-2580-5) | Apotex Corp. | 60505-2580-5 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 4000 Tablet, Film Coated In 1 Bottle (60505-2580-7) | Apotex Corp. | 60505-2580-7 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-2580-8) | Apotex Corp. | 60505-2580-8 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Atorvastatin Calcium Propylene Glycol Solvate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2580-9) | Apotex Corp. | 60505-2580-9 | 60505-2580 | ANDA090548 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (50228-475-30) | ScieGen Pharmaceuticals Inc | 50228-475-30 | 50228-475 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-476-10) | ScieGen Pharmaceuticals Inc | 50228-476-10 | 50228-476 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-476-30) | ScieGen Pharmaceuticals Inc | 50228-476-30 | 50228-476 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-477-10) | ScieGen Pharmaceuticals Inc | 50228-477-10 | 50228-477 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-477-30) | ScieGen Pharmaceuticals Inc | 50228-477-30 | 50228-477 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (50228-478-10) | ScieGen Pharmaceuticals Inc | 50228-478-10 | 50228-478 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (50228-478-30) | ScieGen Pharmaceuticals Inc | 50228-478-30 | 50228-478 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (50228-479-10) | ScieGen Pharmaceuticals Inc | 50228-479-10 | 50228-479 | ANDA206383 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-979-30) | St Mary's Medical Park Pharmacy | 60760-979-30 | 60760-979 | ANDA211933 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-734-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-734-30 | 60760-734 | ANDA216436 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-593-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-593-30 | 60760-593 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-558-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-558-30 | 60760-558 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51407-078-10) | Golden State Medical Supply, Inc. | 51407-078-10 | 51407-078 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-078-90) | Golden State Medical Supply, Inc. | 51407-078-90 | 51407-078 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-079-05) | Golden State Medical Supply, Inc. | 51407-079-05 | 51407-079 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-079-90) | Golden State Medical Supply, Inc. | 51407-079-90 | 51407-079 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51407-080-10) | Golden State Medical Supply, Inc. | 51407-080-10 | 51407-080 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-080-90) | Golden State Medical Supply, Inc. | 51407-080-90 | 51407-080 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-081-05) | Golden State Medical Supply, Inc. | 51407-081-05 | 51407-081 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-081-90) | Golden State Medical Supply, Inc. | 51407-081-90 | 51407-081 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (58151-155-77) | Viatris Specialty LLC | 58151-155-77 | 58151-155 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (58151-156-77) | Viatris Specialty LLC | 58151-156-77 | 58151-156 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (58151-157-77) | Viatris Specialty LLC | 58151-157-77 | 58151-157 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (58151-158-77) | Viatris Specialty LLC | 58151-158-77 | 58151-158 | NDA020702 | NDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (50228-479-30) | ScieGen Pharmaceuticals Inc | 50228-479-30 | 50228-479 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-480-10) | ScieGen Pharmaceuticals Inc | 50228-480-10 | 50228-480 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-480-30) | ScieGen Pharmaceuticals Inc | 50228-480-30 | 50228-480 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (50228-324-10) | ScieGen Pharmaceuticals Inc | 50228-324-10 | 50228-324 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (50228-324-30) | ScieGen Pharmaceuticals Inc | 50228-324-30 | 50228-324 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-325-10) | ScieGen Pharmaceuticals Inc | 50228-325-10 | 50228-325 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-325-30) | ScieGen Pharmaceuticals Inc | 50228-325-30 | 50228-325 | ANDA206383 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (72865-180-05) | XLCare Pharmaceuticals, Inc. | 72865-180-05 | 72865-180 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (72865-180-30) | XLCare Pharmaceuticals, Inc. | 72865-180-30 | 72865-180 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (72865-181-05) | XLCare Pharmaceuticals, Inc. | 72865-181-05 | 72865-181 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (72865-181-30) | XLCare Pharmaceuticals, Inc. | 72865-181-30 | 72865-181 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (72865-182-05) | XLCare Pharmaceuticals, Inc. | 72865-182-05 | 72865-182 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (72865-182-30) | XLCare Pharmaceuticals, Inc. | 72865-182-30 | 72865-182 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (72865-183-05) | XLCare Pharmaceuticals, Inc. | 72865-183-05 | 72865-183 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (72865-183-30) | XLCare Pharmaceuticals, Inc. | 72865-183-30 | 72865-183 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (72865-184-05) | XLCare Pharmaceuticals, Inc. | 72865-184-05 | 72865-184 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (72865-184-30) | XLCare Pharmaceuticals, Inc. | 72865-184-30 | 72865-184 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (72865-185-05) | XLCare Pharmaceuticals, Inc. | 72865-185-05 | 72865-185 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (72865-185-30) | XLCare Pharmaceuticals, Inc. | 72865-185-30 | 72865-185 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (72865-153-05) | XLCare Pharmaceuticals, Inc. | 72865-153-05 | 72865-153 | ANDA205064 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0155-23) | Parke-Davis Div of Pfizer Inc | 0071-0155-23 | 0071-0155 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0156-23) | Parke-Davis Div of Pfizer Inc | 0071-0156-23 | 0071-0156 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0157-23) | Parke-Davis Div of Pfizer Inc | 0071-0157-23 | 0071-0157 | NDA020702 | NDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0158-23) | Parke-Davis Div of Pfizer Inc | 0071-0158-23 | 0071-0158 | NDA020702 | NDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle In 1 Carton (51407-642-87) / 210 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 51407-642-87 | 51407-642 | ANDA212918 | ANDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle, Plastic In 1 Carton (10702-223-21) / 210 Ml In 1 Bottle, Plastic | KVK-Tech, Inc. | 10702-223-21 | 10702-223 | ANDA210510 | ANDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle In 1 Carton (69452-252-87) / 210 Ml In 1 Bottle | Bionpharma Inc. | 69452-252-87 | 69452-252 | ANDA212918 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (72865-153-30) | XLCare Pharmaceuticals, Inc. | 72865-153-30 | 72865-153 | ANDA205064 | ANDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle In 1 Carton (42239-001-08) / 210 Ml In 1 Bottle | Abon Pharmaceuticals, LLC | 42239-001-08 | 42239-001 | ANDA214272 | ANDA | N/A |
| Atovaquone; Proguanil Hydrochloride | Tablet, Film Coated | Oral | 250mg/1, 100 mg/1 | 100 Tablet, Film Coated In 1 Bottle (66993-060-02) | Prasco Laboratories | 66993-060-02 | 66993-060 | NDA021078 | NDA AUTHORIZED GENERIC | N/A |
| Atovaquone; Proguanil Hydrochloride | Tablet, Film Coated | Oral | 250mg/1, 100 mg/1 | 24 Tablet, Film Coated In 1 Dose Pack (66993-060-27) | Prasco Laboratories | 66993-060-27 | 66993-060 | NDA021078 | NDA AUTHORIZED GENERIC | N/A |
| Atovaquone; Proguanil Hydrochloride | Tablet, Film Coated | Oral | 250mg/1, 100 mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-869-01) | Golden State Medical Supply, Inc. | 51407-869-01 | 51407-869 | ANDA202362 | ANDA | N/A |
| Atovaquone; Proguanil Hydrochloride | Tablet, Film Coated | Oral | 250mg/1, 100 mg/1 | 24 Tablet, Film Coated In 1 Bottle, Plastic (51407-869-24) | Golden State Medical Supply, Inc. | 51407-869-24 | 51407-869 | ANDA202362 | ANDA | N/A |
| Atracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (71288-701-05) / 5 Ml In 1 Vial, Single-Dose (71288-701-06) | Meitheal Pharmaceuticals Inc. | 71288-701-05 | 71288-701 | ANDA091488 | ANDA | N/A |
| Atracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-702-10) / 10 Ml In 1 Vial, Multi-Dose (71288-702-11) | Meitheal Pharmaceuticals Inc. | 71288-702-10 | 71288-702 | ANDA091489 | ANDA | N/A |
| Atracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-1105-02) / 10 Ml In 1 Vial, Multi-Dose (0409-1105-22) | Hospira, Inc. | 0409-1105-02 | 0409-1105 | ANDA090761 | ANDA | N/A |
| Atracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1109-01) / 5 Ml In 1 Vial, Single-Dose (0409-1109-11) | Hospira, Inc. | 0409-1109-01 | 0409-1109 | ANDA090782 | ANDA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2482-2) | Jubilant HollisterStier LLC | 65044-2482-2 | 65044-2482 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2482-3) | Jubilant HollisterStier LLC | 65044-2482-3 | 65044-2482 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2482-4) | Jubilant HollisterStier LLC | 65044-2482-4 | 65044-2482 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2483-1) | Jubilant HollisterStier LLC | 65044-2483-1 | 65044-2483 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2485-2) | Jubilant HollisterStier LLC | 65044-2485-2 | 65044-2485 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2485-3) | Jubilant HollisterStier LLC | 65044-2485-3 | 65044-2485 | BLA103888 | BLA | N/A |
| Atriplex Canescens Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2485-4) | Jubilant HollisterStier LLC | 65044-2485-4 | 65044-2485 | BLA103888 | BLA | N/A |
| Atropa Belladonna; Opium | Suppository | Rectal | 16.2mg/1, 60 mg/1 | 4 Packet In 1 Box (0574-7040-04) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7040-04 | 0574-7040 | N/A | UNAPPROVED DRUG OTHER | CII |
| Atropa Belladonna; Opium | Suppository | Rectal | 16.2mg/1, 60 mg/1 | 12 Packet In 1 Box (0574-7040-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7040-12 | 0574-7040 | N/A | UNAPPROVED DRUG OTHER | CII |
| Atropa Belladonna; Opium | Suppository | Rectal | 16.2mg/1, 30 mg/1 | 4 Packet In 1 Box (0574-7045-04) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7045-04 | 0574-7045 | N/A | UNAPPROVED DRUG OTHER | CII |
| Atropa Belladonna; Opium | Suppository | Rectal | 16.2mg/1, 30 mg/1 | 12 Packet In 1 Box (0574-7045-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7045-12 | 0574-7045 | N/A | UNAPPROVED DRUG OTHER | CII |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (70069-716-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-716-01 | 70069-716 | ANDA217791 | ANDA | N/A |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (70069-581-01) / 2 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-581-01 | 70069-581 | ANDA215618 | ANDA | N/A |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (70069-582-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-582-01 | 70069-582 | ANDA215618 | ANDA | N/A |
| Atropine Sulfate | Solution | Intravenous | .4mg/mL | 25 Vial In 1 Carton (70069-631-25) / 1 Ml In 1 Vial (70069-631-01) | Somerset Therapeutics, LLC | 70069-631-25 | 70069-631 | ANDA215969 | ANDA | N/A |
| Atropine Sulfate | Solution | Intravenous | 1mg/mL | 25 Vial In 1 Carton (70069-641-25) / 1 Ml In 1 Vial (70069-641-01) | Somerset Therapeutics, LLC | 70069-641-25 | 70069-641 | ANDA215969 | ANDA | N/A |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6226-0) / 2 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-6226-0 | 60505-6226 | ANDA215624 | ANDA | N/A |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6226-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-6226-1 | 60505-6226 | ANDA215624 | ANDA | N/A |
| Atropine Sulfate | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6226-2) / 15 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-6226-2 | 60505-6226 | ANDA215624 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (72865-154-05) | XLCare Pharmaceuticals, Inc. | 72865-154-05 | 72865-154 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (72865-154-30) | XLCare Pharmaceuticals, Inc. | 72865-154-30 | 72865-154 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (72865-155-05) | XLCare Pharmaceuticals, Inc. | 72865-155-05 | 72865-155 | ANDA205064 | ANDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | 1mg/mL | 25 Vial, Glass In 1 Tray (0517-1001-25) / 1 Ml In 1 Vial, Glass (0517-1001-01) | American Regent, Inc. | 0517-1001-25 | 0517-1001 | ANDA216120 | ANDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .4mg/mL | 25 Vial, Glass In 1 Tray (0517-1004-25) / 1 Ml In 1 Vial, Glass (0517-1004-01) | American Regent, Inc. | 0517-1004-25 | 0517-1004 | ANDA216120 | ANDA | N/A |
| Atropine Sulfate | Injection | Endotracheal; Intramedullary; Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Vial In 1 Carton (0641-6251-10) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0641-6251-10 | 0641-6251 | ANDA213561 | ANDA | N/A |
| Atropine Sulfate | Injection | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Vial In 1 Carton (0641-6006-10) / 20 Ml In 1 Vial (0641-6006-01) | Hikma Pharmaceuticals USA Inc. | 0641-6006-10 | 0641-6006 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 10 Carton In 1 Package (0409-1630-10) / 1 Syringe, Plastic In 1 Carton / 10 Ml In 1 Syringe, Plastic (0409-1630-15) | Hospira, Inc. | 0409-1630-10 | 0409-1630 | NDA021146 | NDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 10 Carton In 1 Package (0409-4910-34) / 1 Syringe, Glass In 1 Carton / 5 Ml In 1 Syringe, Glass (0409-4910-11) | Hospira, Inc. | 0409-4910-34 | 0409-4910 | NDA021146 | NDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 10 Carton In 1 Package (0409-4911-34) / 1 Syringe, Glass In 1 Carton / 10 Ml In 1 Syringe, Glass (0409-4911-11) | Hospira, Inc. | 0409-4911-34 | 0409-4911 | NDA021146 | NDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .05mg/mL | 10 Carton In 1 Package (0409-9630-05) / 1 Syringe, Plastic In 1 Carton / 5 Ml In 1 Syringe, Plastic (0409-9630-15) | Hospira, Inc. | 0409-9630-05 | 0409-9630 | NDA021146 | NDA | N/A |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (69315-910-01) | Leading Pharma, LLC | 69315-910-01 | 69315-910 | ANDA213413 | ANDA | CV |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 90 Tablet In 1 Bottle (69315-910-09) | Leading Pharma, LLC | 69315-910-09 | 69315-910 | ANDA213413 | ANDA | CV |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 1000 Tablet In 1 Bottle (69315-910-10) | Leading Pharma, LLC | 69315-910-10 | 69315-910 | ANDA213413 | ANDA | CV |
| Aripiprazole | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (72865-155-30) | XLCare Pharmaceuticals, Inc. | 72865-155-30 | 72865-155 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (72865-156-05) | XLCare Pharmaceuticals, Inc. | 72865-156-05 | 72865-156 | ANDA205064 | ANDA | N/A |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Solution | Oral | .025mg/5mL, 2.5 mg/5mL | 1 Bottle In 1 Carton (0054-3194-46) / 60 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-3194-46 | 0054-3194 | ANDA087708 | ANDA | CV |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (0025-0061-31) | Pfizer Laboratories Div Pfizer Inc | 0025-0061-31 | 0025-0061 | NDA012462 | NDA | CV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 1 Tray In 1 Case (66689-063-10) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-063-01) | VistaPharm, LLC | 66689-063-10 | 66689-063 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 4 Tray In 1 Case (66689-063-40) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-063-01) | VistaPharm, LLC | 66689-063-40 | 66689-063 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 5 Tray In 1 Case (66689-063-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-063-01) | VistaPharm, LLC | 66689-063-50 | 66689-063 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 10 Tray In 1 Case (66689-063-99) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-063-01) | VistaPharm, LLC | 66689-063-99 | 66689-063 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Aripiprazole | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (72865-156-30) | XLCare Pharmaceuticals, Inc. | 72865-156-30 | 72865-156 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (72865-157-05) | XLCare Pharmaceuticals, Inc. | 72865-157-05 | 72865-157 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (72865-157-30) | XLCare Pharmaceuticals, Inc. | 72865-157-30 | 72865-157 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (72865-158-05) | XLCare Pharmaceuticals, Inc. | 72865-158-05 | 72865-158 | ANDA205064 | ANDA | N/A |
| Aripiprazole | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (72865-158-30) | XLCare Pharmaceuticals, Inc. | 72865-158-30 | 72865-158 | ANDA205064 | ANDA | N/A |
| Aureobasidium Pullulans Var. Pullutans | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5233-1) | Jubilant HollisterStier LLC | 65044-5233-1 | 65044-5233 | BLA103888 | BLA | N/A |
| Aureobasidium Pullulans Var. Pullutans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5235-2) | Jubilant HollisterStier LLC | 65044-5235-2 | 65044-5235 | BLA103888 | BLA | N/A |
| Aureobasidium Pullulans Var. Pullutans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5235-3) | Jubilant HollisterStier LLC | 65044-5235-3 | 65044-5235 | BLA103888 | BLA | N/A |
| Aureobasidium Pullulans Var. Pullutans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5235-4) | Jubilant HollisterStier LLC | 65044-5235-4 | 65044-5235 | BLA103888 | BLA | N/A |
| Avena Sativa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2041-2) | Jubilant HollisterStier LLC | 65044-2041-2 | 65044-2041 | BLA103888 | BLA | N/A |
| Avena Sativa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2041-3) | Jubilant HollisterStier LLC | 65044-2041-3 | 65044-2041 | BLA103888 | BLA | N/A |
| Avena Sativa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2041-4) | Jubilant HollisterStier LLC | 65044-2041-4 | 65044-2041 | BLA103888 | BLA | N/A |
| Avena Sativa Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2042-1) | Jubilant HollisterStier LLC | 65044-2042-1 | 65044-2042 | BLA103888 | BLA | N/A |
| Avobenzone; Homosalate; Octisalate; Octocrylene | Liquid | Topical | 20mg/mL, 90 mg/mL, 45 mg/mL, 20 mg/mL | 60 Ml In 1 Bottle (71435-0004-0) | New Milani Group, LLC | 71435-0004-0 | 71435-0004 | M020 | OTC MONOGRAPH DRUG | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | 3g/100mL, 10 g/100mL, 8 g/100mL | 30 Ml In 1 Box (14141-140-01) | Bel Star S.A. (Colombia) | 14141-140-01 | 14141-140 | M020 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 120 Ml In 1 Bottle, Plastic (14141-990-01) | Bel Star S.A. (Colombia) | 14141-990-01 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 80 Ml In 1 Bottle, Plastic (14141-990-02) | Bel Star S.A. (Colombia) | 14141-990-02 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 1 Tube In 1 Box (14141-990-04) / 10 Ml In 1 Tube (14141-990-03) | Bel Star S.A. (Colombia) | 14141-990-04 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 5 Ml In 1 Packet (14141-990-05) | Bel Star S.A. (Colombia) | 14141-990-05 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 1 Ml In 1 Packet (14141-990-06) | Bel Star S.A. (Colombia) | 14141-990-06 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Lotion | Topical | .03g/mL, .1 g/mL, .08 g/mL | 1 Packet In 1 Carton (14141-990-08) / .07 Ml In 1 Packet (14141-990-07) | Bel Star S.A. (Colombia) | 14141-990-08 | 14141-990 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Homosalate; Octocrylene | Emulsion | Topical | 30mg/mL, 100 mg/mL, 80 mg/mL | 80 Ml In 1 Tube (14141-331-01) | BEL STAR SA | 14141-331-01 | 14141-331 | M020 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Octinoxate; Octocrylene; Oxybenzone | Cream | Topical | 30mg/mL, 73 mg/mL, 30 mg/mL, 20 mg/mL | 1 Tube In 1 Carton (71435-8202-6) / 30 Ml In 1 Tube | The Milani Group, Inc. | 71435-8202-6 | 71435-8202 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Avobenzone; Octinoxate; Octocrylene; Oxybenzone | Cream | Topical | 30mg/mL, 73 mg/mL, 30 mg/mL, 20 mg/mL | 30 Ml In 1 Tube (71435-0001-0) | New Milani Group, LLC | 71435-0001-0 | 71435-0001 | M020 | OTC MONOGRAPH DRUG | N/A |
| Avobenzone; Octisalate; Octocrylene | Cream | Topical | 1.8g/100mL, 4.5 g/100mL, 4.5 g/100mL | 30 Ml In 1 Bottle (14141-142-01) | BEL STAR S A | 14141-142-01 | 14141-142 | M020 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Octisalate; Octocrylene | Cream | Topical | 1.8g/100mL, 4.5 g/100mL, 4.5 g/100mL | 5 Ml In 1 Bottle (14141-142-02) | BEL STAR S A | 14141-142-02 | 14141-142 | M020 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Octisalate; Octocrylene | Lotion | Topical | .018g/mL, .045 g/mL, .045 g/mL | 1 Jar In 1 Box (14141-088-02) / 30 Ml In 1 Jar (14141-088-01) | Bel Star S.A. (Colombia) | 14141-088-02 | 14141-088 | part352 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Octisalate; Octocrylene | Emulsion | Topical | 18mg/mL, 45 mg/mL, 45 mg/mL | 1 Bottle, Glass In 1 Box (14141-315-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S A | 14141-315-01 | 14141-315 | M020 | OTC MONOGRAPH FINAL | N/A |
| Avobenzone; Octisalate; Octocrylene | Emulsion | Topical | 18mg/mL, 45 mg/mL, 45 mg/mL | 1 Bottle, Glass In 1 Box (14141-332-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-332-01 | 14141-332 | M020 | OTC MONOGRAPH FINAL | N/A |
| Arsenic Trioxide | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (70121-1483-7) / 10 Ml In 1 Vial, Single-Dose (70121-1483-1) | Amneal Pharmaceuticals LLC | 70121-1483-7 | 70121-1483 | ANDA210739 | ANDA | N/A |
| Arsenic Trioxide | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (70121-1658-1) / 6 Ml In 1 Vial, Single-Dose (70121-1658-6) | Amneal Pharmaceuticals LLC | 70121-1658-1 | 70121-1658 | ANDA210739 | ANDA | N/A |
| Arsenic Trioxide | Injection | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Carton (50742-438-10) / 10 Ml In 1 Vial, Glass | Ingenus Pharmaceuticals, LLC | 50742-438-10 | 50742-438 | ANDA209315 | ANDA | N/A |
| Axitinib | Tablet, Film Coated | Oral | 1mg/1 | 180 Tablet, Film Coated In 1 Bottle (0069-0145-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0145-01 | 0069-0145 | NDA202324 | NDA | N/A |
| Axitinib | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (0069-0151-11) | Pfizer Laboratories Div Pfizer Inc | 0069-0151-11 | 0069-0151 | NDA202324 | NDA | N/A |
| Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 100mg/1 | 1 Vial, Single-Dose In 1 Carton (71288-153-95) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-153-95 | 71288-153 | ANDA212128 | ANDA | N/A |
| Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 100mg/30mL | 1 Vial, Single-Dose In 1 Carton (71288-115-30) / 30 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-115-30 | 71288-115 | ANDA212128 | ANDA | N/A |
| Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 100mg/1 | 1 Injection, Powder, Lyophilized, For Solution In 1 Carton (60505-6271-1) | Apotex Corp | 60505-6271-1 | 60505-6271 | ANDA215905 | ANDA | N/A |
| Aspirin | Tablet | Oral | 81mg/1 | 1000 Tablet In 1 Bottle (57237-302-10) | Rising Health, LLC | 57237-302-10 | 57237-302 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 100mg/1 | 1 Vial In 1 Carton (0143-9606-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9606-01 | 0143-9606 | ANDA209337 | ANDA | N/A |
| Azadirachta Indica Seed Oil | Oil | Topical | 1[hp_X]/100mL | 1 Bottle In 1 Carton (76441-909-94) / 118 Ml In 1 Bottle | Sujanil Chemo Industries | 76441-909-94 | 76441-909 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Azathioprine | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-182-01) | Golden State Medical Supply, Inc. | 51407-182-01 | 51407-182 | ANDA075252 | ANDA | N/A |
| Aspirin | Tablet | Oral | 81mg/1 | 120 Tablet In 1 Bottle (57237-302-12) | Rising Health, LLC | 57237-302-12 | 57237-302 | part343 | OTC MONOGRAPH NOT FINAL | N/A |
| Aspirin; Dipyridamole | Capsule | Oral | 25mg/1, 200 mg/1 | 60 Capsule In 1 Bottle (65162-596-06) | Amneal Pharmaceuticals LLC | 65162-596-06 | 65162-596 | ANDA206392 | ANDA | N/A |
| Aspirin; Oxycodone Hydrochloride | Tablet | Oral | 325mg/1, 4.8355 mg/1 | 100 Tablet In 1 Bottle (42806-061-01) | Epic Pharma, LLC | 42806-061-01 | 42806-061 | ANDA040910 | ANDA | CII |
| Azathioprine Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial In 1 Box, Unit-Dose (0143-9566-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9566-01 | 0143-9566 | ANDA074419 | ANDA | N/A |
| Azelaic Acid | Gel | Topical | .15g/g | 1 Tube In 1 Carton (51672-1389-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1389-3 | 51672-1389 | ANDA210549 | ANDA | N/A |
| Azelastine Hydrochloride | Solution/ Drops | Ophthalmic | .5mg/mL | 1 Bottle In 1 Carton (70069-091-01) / 6 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-091-01 | 70069-091 | ANDA207411 | ANDA | N/A |
| Azelastine Hydrochloride | Spray, Metered | Nasal | 137ug/1 | 1 Bottle, Spray In 1 Carton (60505-0833-5) / 200 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0833-5 | 60505-0833 | ANDA077954 | ANDA | N/A |
| Azelastine Hydrochloride | Solution/ Drops | Intraocular | .5mg/mL | 1 Bottle, Plastic In 1 Carton (60505-0578-4) / 6 Ml In 1 Bottle, Plastic | Apotex Corp. | 60505-0578-4 | 60505-0578 | ANDA078621 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 150mg/1 | 1000 Capsule In 1 Bottle (31722-653-10) | Camber Pharmaceuticals, Inc. | 31722-653-10 | 31722-653 | ANDA212278 | ANDA | N/A |
| Azelastine Hydrochloride; Fluticasone Propionate | Spray, Metered | Nasal | 137ug/1, 50 ug/1 | 1 Bottle In 1 Carton (45802-066-01) / 120 Spray, Metered In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-066-01 | 45802-066 | ANDA208111 | ANDA | N/A |
| Azelastine Hydrochloride; Fluticasone Propionate | Spray, Metered | Nasal | 137ug/1, 50 ug/1 | 1 Bottle, Spray In 1 Carton (60505-0953-3) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0953-3 | 60505-0953 | ANDA207712 | ANDA | N/A |
| Azilsartan Kamedoxomil | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (60631-040-30) | Azurity Pharmaceuticals, Inc. | 60631-040-30 | 60631-040 | NDA200796 | NDA | N/A |
| Azilsartan Kamedoxomil | Tablet | Oral | 40mg/1 | 7 Tablet In 1 Bottle (60631-040-77) | Azurity Pharmaceuticals, Inc. | 60631-040-77 | 60631-040 | NDA200796 | NDA | N/A |
| Azilsartan Kamedoxomil | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (60631-080-30) | Azurity Pharmaceuticals, Inc. | 60631-080-30 | 60631-080 | NDA200796 | NDA | N/A |
| Azilsartan Kamedoxomil | Tablet | Oral | 80mg/1 | 7 Tablet In 1 Bottle (60631-080-77) | Azurity Pharmaceuticals, Inc. | 60631-080-77 | 60631-080 | NDA200796 | NDA | N/A |
| Azilsartan Kamedoxomil; Chlorthalidone | Tablet | Oral | 40mg/1, 12.5 mg/1 | 30 Tablet In 1 Bottle (60631-412-30) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-412-30 | 60631-412 | NDA202331 | NDA | N/A |
| Azilsartan Kamedoxomil; Chlorthalidone | Tablet | Oral | 40mg/1, 25 mg/1 | 30 Tablet In 1 Bottle (60631-425-30) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-425-30 | 60631-425 | NDA202331 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 1 Blister Pack In 1 Carton (69452-171-04) / 6 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-171-04 | 69452-171 | ANDA210000 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (69452-171-13) | Bionpharma Inc. | 69452-171-13 | 69452-171 | ANDA210000 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 3 Blister Pack In 1 Carton (69452-171-73) / 6 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-171-73 | 69452-171 | ANDA210000 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (69452-172-13) | Bionpharma Inc. | 69452-172-13 | 69452-172 | ANDA210001 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 500mg/1 | 3 Blister Pack In 1 Carton (69452-172-72) / 3 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-172-72 | 69452-172 | ANDA210001 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 500mg/1 | 1 Blister Pack In 1 Carton (69452-172-74) / 3 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-172-74 | 69452-172 | ANDA210001 | ANDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle (69452-173-13) | Bionpharma Inc. | 69452-173-13 | 69452-173 | ANDA209999 | ANDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 1g/1 | 10 Packet In 1 Box (0069-3051-07) / 1 Powder, For Suspension In 1 Packet (0069-3051-01) | Pfizer Laboratories Div Pfizer Inc | 0069-3051-07 | 0069-3051 | NDA050693 | NDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 1g/1 | 3 Packet In 1 Box (0069-3051-75) / 1 Powder, For Suspension In 1 Packet (0069-3051-01) | Pfizer Laboratories Div Pfizer Inc | 0069-3051-75 | 0069-3051 | NDA050693 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 3 Blister Pack In 1 Box (0069-3060-75) / 6 Tablet, Film Coated In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-3060-75 | 0069-3060 | NDA050711 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-3070-30) | Pfizer Laboratories Div Pfizer Inc | 0069-3070-30 | 0069-3070 | NDA050784 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 500mg/1 | 3 Blister Pack In 1 Carton (0069-3070-75) / 3 Tablet, Film Coated In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-3070-75 | 0069-3070 | NDA050784 | NDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (0069-3110-19) / 15 Ml In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-3110-19 | 0069-3110 | NDA050710 | NDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (0069-3120-19) / 15 Ml In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-3120-19 | 0069-3120 | NDA050710 | NDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (0069-3130-19) / 22.5 Ml In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-3130-19 | 0069-3130 | NDA050710 | NDA | N/A |
| Azithromycin Dihydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (0069-3140-19) / 30 Ml In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-3140-19 | 0069-3140 | NDA050710 | NDA | N/A |
| Azithromycin Dihydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/5mL | 10 Vial In 1 Carton (0069-3150-83) / 5 Ml In 1 Vial (0069-3150-84) | Pfizer Laboratories Div Pfizer Inc | 0069-3150-83 | 0069-3150 | NDA050733 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-4061-01) | Pfizer Laboratories Div Pfizer Inc | 0069-4061-01 | 0069-4061 | NDA050711 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 50 Blister Pack In 1 Box, Unit-Dose (0069-4061-89) / 1 Tablet, Film Coated In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-4061-89 | 0069-4061 | NDA050711 | NDA | N/A |
| Azithromycin Dihydrate | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (0069-9500-01) | Pfizer Laboratories Div Pfizer Inc | 0069-9500-01 | 0069-9500 | N/A | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | N/A |
| Azithromycin Dihydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/5mL | 10 Vial In 1 Carton (0069-0400-10) / 5 Ml In 1 Vial (0069-0400-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0400-10 | 0069-0400 | NDA050733 | NDA | N/A |
| Azithromycin Monohydrate | Tablet, Film Coated | Oral | 250mg/1 | 6 Dose Pack In 1 Carton (60760-808-06) / 1 Tablet, Film Coated In 1 Dose Pack | St. Mary's Medical Park Pharmacy | 60760-808-06 | 60760-808 | ANDA065211 | ANDA | N/A |
| Azithromycin Monohydrate | Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (51672-4200-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4200-3 | 51672-4200 | ANDA211521 | ANDA | N/A |
| Azithromycin Monohydrate | Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (51672-4200-5) / 15 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4200-5 | 51672-4200 | ANDA211521 | ANDA | N/A |
| Azithromycin Monohydrate | Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (51672-4200-7) / 22.5 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4200-7 | 51672-4200 | ANDA211521 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 150mg/1 | 100 Blister Pack In 1 Carton (31722-653-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-653-31 | 31722-653 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle (31722-653-60) | Camber Pharmaceuticals, Inc. | 31722-653-60 | 31722-653 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (31722-654-10) | Camber Pharmaceuticals, Inc. | 31722-654-10 | 31722-654 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 200mg/1 | 100 Blister Pack In 1 Carton (31722-654-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-654-31 | 31722-654 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle (31722-654-60) | Camber Pharmaceuticals, Inc. | 31722-654-60 | 31722-654 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (31722-655-05) | Camber Pharmaceuticals, Inc. | 31722-655-05 | 31722-655 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (31722-655-30) | Camber Pharmaceuticals, Inc. | 31722-655-30 | 31722-655 | ANDA212278 | ANDA | N/A |
| Atazanavir | Capsule | Oral | 300mg/1 | 100 Blister Pack In 1 Carton (31722-655-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-655-31 | 31722-655 | ANDA212278 | ANDA | N/A |
| Azithromycin Monohydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 10 Vial, Single-Dose In 1 Tray (0409-0144-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-0144-31) | Hospira, Inc. | 0409-0144-10 | 0409-0144 | ANDA065511 | ANDA | N/A |
| Azithromycin Monohydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 10 Vial, Single-Dose In 1 Tray (0409-0144-11) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-0144-21) | Hospira, Inc. | 0409-0144-11 | 0409-0144 | ANDA065500 | ANDA | N/A |
| Aztreonam | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (0409-0829-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-0829-11) | Hospira, Inc. | 0409-0829-01 | 0409-0829 | ANDA206517 | ANDA | N/A |
| Aztreonam | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial, Single-Dose In 1 Carton (0409-0830-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-0830-11) | Hospira, Inc. | 0409-0830-01 | 0409-0830 | ANDA206517 | ANDA | N/A |
| Bacitracin | Ointment | Topical | 500[USP'U]/g | 1 Tube In 1 Carton (45802-060-01) / 14 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-060-01 | 45802-060 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin | Ointment | Topical | 500[USP'U]/g | 1 Tube In 1 Carton (45802-060-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-060-03 | 45802-060 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin | Ointment | Topical | 500[USP'U]/g | 144 Packet In 1 Carton (45802-060-70) / .9 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-060-70 | 45802-060 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin | Ointment | Ophthalmic | 500[USP'U]/g | 1 Tube In 1 Carton (0574-4022-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4022-35 | 0574-4022 | ANDA061212 | ANDA | N/A |
| Bacitracin | Ointment | Topical | 500[USP'U]/g | 28.4 G In 1 Tube (0713-0280-31) | Cosette Pharmaceuticals, Inc. | 0713-0280-31 | 0713-0280 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc | Ointment | Topical | 500[USP'U]/g | 1 Tube In 1 Carton (51672-2075-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2075-1 | 51672-2075 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc | Ointment | Topical | 500[USP'U]/g | 1 Tube In 1 Carton (51672-2075-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2075-2 | 51672-2075 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Hydrocortisone Acetate; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Ophthalmic | 400[USP'U]/g, 10 mg/g, 3.5 mg/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (0574-4144-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4144-35 | 0574-4144 | ANDA062166 | ANDA | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Ophthalmic | 400[USP'U]/g, 3.5 mg/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (0574-4250-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4250-35 | 0574-4250 | ANDA060764 | ANDA | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | 1 Tube In 1 Carton (45802-143-01) / 14 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-143-01 | 45802-143 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | 1 Tube In 1 Carton (45802-143-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-143-03 | 45802-143 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | 144 Packet In 1 Carton (45802-143-70) / .9 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-143-70 | 45802-143 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 1 Tube In 1 Carton (51672-2120-1) / 14.2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-1 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 1 Tube In 1 Carton (51672-2120-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-2 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 1 Tube In 1 Carton (51672-2120-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-3 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 6 Applicator In 1 Carton (51672-2120-6) / .9 G In 1 Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-6 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 15 Applicator In 1 Carton (51672-2120-8) / .9 G In 1 Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-8 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 144 Applicator In 1 Carton (51672-2120-9) / .9 G In 1 Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2120-9 | 51672-2120 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 1 Tube In 1 Carton (51672-2016-1) / 14.2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2016-1 | 51672-2016 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[iU]/g, 3.5 mg/g, 5000 [iU]/g | 1 Tube In 1 Carton (51672-2016-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2016-2 | 51672-2016 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | 1 Tube In 1 Carton (0713-0268-31) / 28.4 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0268-31 | 0713-0268 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | .9 G In 1 Packet (82749-302-53) | Epic Medical Supply Corp | 82749-302-53 | 82749-302 | part333B | OTC MONOGRAPH FINAL | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Topical | 400[USP'U]/g, 3.5 mg/g, 5000 [USP'U]/g | 28.3 G In 1 Tube (82749-302-54) | Epic Medical Supply Corp | 82749-302-54 | 82749-302 | part333B | OTC MONOGRAPH FINAL | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (64980-437-01) | Rising Pharma Holdings, Inc. | 64980-437-01 | 64980-437 | ANDA077443 | ANDA | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride | Ointment | Topical | 500[USP'U]/g, 3.5 mg/g, 10000 [USP'U]/g, 10 mg/g | 1 Tube In 1 Carton (51672-2027-1) / 14.2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2027-1 | 51672-2027 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride | Ointment | Topical | 500[USP'U]/g, 3.5 mg/g, 10000 [USP'U]/g, 10 mg/g | 1 Tube In 1 Carton (51672-2027-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2027-2 | 51672-2027 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Neomycin; Polymyxin B Sulfate; Pramoxine Hydrochloride | Ointment | Topical | 500[USP'U]/g, 3.5 mg/g, 10000 [USP'U]/g, 10 mg/g | 28.4 G In 1 Tube (0713-0622-31) | Cosette Pharmaceuticals, Inc. | 0713-0622-31 | 0713-0622 | M004 | OTC MONOGRAPH DRUG | N/A |
| Bacitracin Zinc; Polymyxin B Sulfate | Ointment | Ophthalmic | 500[USP'U]/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (0574-4021-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4021-35 | 0574-4021 | ANDA065022 | ANDA | N/A |
| Bacitracin Zinc; Polymyxin B Sulfate | Ointment | Topical | 500[USP'U]/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (51672-2044-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2044-2 | 51672-2044 | M004 | OTC MONOGRAPH DRUG | N/A |
| Baclofen | Injection | Intrathecal | 2000ug/mL | 1 Vial In 1 Carton (14789-161-05) / 20 Ml In 1 Vial | Nexus Pharmaceuticals Inc | 14789-161-05 | 14789-161 | ANDA217324 | ANDA | N/A |
| Baclofen | Injection, Solution | Intrathecal | 500ug/mL | 1 Vial In 1 Carton (25021-678-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-678-20 | 25021-678 | ANDA210048 | ANDA | N/A |
| Baclofen | Injection, Solution | Intrathecal | 2000ug/mL | 1 Vial In 1 Carton (25021-679-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-679-20 | 25021-679 | ANDA210048 | ANDA | N/A |
| Baclofen | Injection, Solution | Intrathecal | 1000ug/mL | 1 Vial In 1 Carton (25021-680-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-680-20 | 25021-680 | ANDA210315 | ANDA | N/A |
| Baclofen | Injection, Solution | Intrathecal | 50ug/mL | 2 Syringe In 1 Carton (25021-681-71) / 1 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-681-71 | 25021-681 | ANDA210777 | ANDA | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (52536-600-11) / 120 Ml In 1 Bottle | Wilshire Pharmaceuticals, Inc. | 52536-600-11 | 52536-600 | NDA215602 | NDA AUTHORIZED GENERIC | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (52536-600-12) / 300 Ml In 1 Bottle | Wilshire Pharmaceuticals, Inc. | 52536-600-12 | 52536-600 | NDA215602 | NDA AUTHORIZED GENERIC | N/A |
| Atenolol | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (64980-437-10) | Rising Pharma Holdings, Inc. | 64980-437-10 | 64980-437 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (64980-438-01) | Rising Pharma Holdings, Inc. | 64980-438-01 | 64980-438 | ANDA077443 | ANDA | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (52652-6001-1) / 120 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc. | 52652-6001-1 | 52652-6001 | NDA215602 | NDA | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (52652-6001-2) / 300 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc. | 52652-6001-2 | 52652-6001 | NDA215602 | NDA | N/A |
| Atenolol | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (64980-438-10) | Rising Pharma Holdings, Inc. | 64980-438-10 | 64980-438 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (64980-439-01) | Rising Pharma Holdings, Inc. | 64980-439-01 | 64980-439 | ANDA077443 | ANDA | N/A |
| Atenolol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (64980-439-10) | Rising Pharma Holdings, Inc. | 64980-439-10 | 64980-439 | ANDA077443 | ANDA | N/A |
| Atenolol; Chlorthalidone | Tablet | Oral | 50mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (70954-390-10) | ANI Pharmaceuticals, Inc. | 70954-390-10 | 70954-390 | ANDA215560 | ANDA | N/A |
| Atenolol; Chlorthalidone | Tablet | Oral | 100mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (70954-391-10) | ANI Pharmaceuticals, Inc. | 70954-391-10 | 70954-391 | ANDA215560 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (31722-714-30) | Camber Pharmaceuticals, Inc. | 31722-714-30 | 31722-714 | ANDA202682 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 18mg/1 | 30 Capsule In 1 Bottle (31722-715-30) | Camber Pharmaceuticals, Inc. | 31722-715-30 | 31722-715 | ANDA202682 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (31722-716-30) | Camber Pharmaceuticals, Inc. | 31722-716-30 | 31722-716 | ANDA202682 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (31722-717-30) | Camber Pharmaceuticals, Inc. | 31722-717-30 | 31722-717 | ANDA202682 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 60mg/1 | 30 Capsule In 1 Bottle (31722-718-30) | Camber Pharmaceuticals, Inc. | 31722-718-30 | 31722-718 | ANDA202682 | ANDA | N/A |
| Atomoxetine | Capsule | Oral | 80mg/1 | 30 Capsule In 1 Bottle (31722-719-30) | Camber Pharmaceuticals, Inc. | 31722-719-30 | 31722-719 | ANDA202682 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 280 Capsule In 1 Bottle (51407-820-28) | Golden State Medical Supply, Inc. | 51407-820-28 | 51407-820 | ANDA077806 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 10 Blister Pack In 1 Carton (60505-2575-0) / 10 Capsule In 1 Blister Pack | Apotex Corp. | 60505-2575-0 | 60505-2575 | ANDA077883 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 30 Capsule In 1 Bottle (60505-2575-3) | Apotex Corp. | 60505-2575-3 | 60505-2575 | ANDA077883 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 350 Capsule In 1 Bottle (60505-2575-4) | Apotex Corp. | 60505-2575-4 | 60505-2575 | ANDA077883 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 280 Capsule In 1 Bottle (60505-2575-7) | Apotex Corp. | 60505-2575-7 | 60505-2575 | ANDA077883 | ANDA | N/A |
| Balsalazide Disodium | Capsule | Oral | 750mg/1 | 280 Capsule In 1 Bottle (0054-0079-28) | Hikma Pharmaceuticals USA Inc. | 0054-0079-28 | 0054-0079 | ANDA077806 | ANDA | N/A |
| Banana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3041-2) | Jubilant HollisterStier LLC | 65044-3041-2 | 65044-3041 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1780-2) | Jubilant HollisterStier LLC | 65044-1780-2 | 65044-1780 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1780-3) | Jubilant HollisterStier LLC | 65044-1780-3 | 65044-1780 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1780-5) | Jubilant HollisterStier LLC | 65044-1780-5 | 65044-1780 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1781-1) | Jubilant HollisterStier LLC | 65044-1781-1 | 65044-1781 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1783-2) | Jubilant HollisterStier LLC | 65044-1783-2 | 65044-1783 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1783-3) | Jubilant HollisterStier LLC | 65044-1783-3 | 65044-1783 | BLA103888 | BLA | N/A |
| Bassia Scoparia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1783-4) | Jubilant HollisterStier LLC | 65044-1783-4 | 65044-1783 | BLA103888 | BLA | N/A |
| Bazedoxifene Acetate; Estrogens, Conjugated | Tablet, Film Coated | Oral | 20mg/1, .45 mg/1 | 1 Pouch In 1 Carton (0008-1123-12) / 2 Blister Pack In 1 Pouch / 15 Tablet, Film Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1123-12 | 0008-1123 | NDA022247 | NDA | N/A |
| Beef | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3077-2) | Jubilant HollisterStier LLC | 65044-3077-2 | 65044-3077 | BLA103888 | BLA | N/A |
| Beef | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3078-1) | Jubilant HollisterStier LLC | 65044-3078-1 | 65044-3078 | BLA103888 | BLA | N/A |
| Benazepril Hydrochloride | Tablet, Coated | Oral | 20mg/1 | 90 Tablet, Coated In 1 Bottle, Plastic (60760-352-90) | St. Mary's Medical Park Pharmacy | 60760-352-90 | 60760-352 | ANDA076118 | ANDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (30698-448-01) | Validus Pharmaceuticals LLC | 30698-448-01 | 30698-448 | NDA019851 | NDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (30698-449-01) | Validus Pharmaceuticals LLC | 30698-449-01 | 30698-449 | NDA019851 | NDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (30698-450-01) | Validus Pharmaceuticals LLC | 30698-450-01 | 30698-450 | NDA019851 | NDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (64980-373-03) | Rising Pharma Holdings, Inc. | 64980-373-03 | 64980-373 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 18mg/1 | 30 Capsule In 1 Bottle (64980-374-03) | Rising Pharma Holdings, Inc. | 64980-374-03 | 64980-374 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (64980-375-03) | Rising Pharma Holdings, Inc. | 64980-375-03 | 64980-375 | ANDA079016 | ANDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (0574-0227-01) | Padagis US LLC | 0574-0227-01 | 0574-0227 | NDA020033 | NDA AUTHORIZED GENERIC | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (0574-0228-01) | Padagis US LLC | 0574-0228-01 | 0574-0228 | NDA020033 | NDA AUTHORIZED GENERIC | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (0574-0229-01) | Padagis US LLC | 0574-0229-01 | 0574-0229 | NDA020033 | NDA AUTHORIZED GENERIC | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (30698-452-01) | Validus Pharmaceuticals LLC | 30698-452-01 | 30698-452 | NDA020033 | NDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (30698-453-01) | Validus Pharmaceuticals LLC | 30698-453-01 | 30698-453 | NDA020033 | NDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (30698-454-01) | Validus Pharmaceuticals LLC | 30698-454-01 | 30698-454 | NDA020033 | NDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (64980-376-03) | Rising Pharma Holdings, Inc. | 64980-376-03 | 64980-376 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 1000 Capsule In 1 Bottle (64980-376-10) | Rising Pharma Holdings, Inc. | 64980-376-10 | 64980-376 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 60mg/1 | 30 Capsule In 1 Bottle (64980-377-03) | Rising Pharma Holdings, Inc. | 64980-377-03 | 64980-377 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 60mg/1 | 1000 Capsule In 1 Bottle (64980-377-10) | Rising Pharma Holdings, Inc. | 64980-377-10 | 64980-377 | ANDA079016 | ANDA | N/A |
| Bendamustine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 25mg/5mL | 1 Vial, Single-Dose In 1 Carton (71288-102-10) / 5 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-102-10 | 71288-102 | ANDA211001 | ANDA | N/A |
| Bendamustine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/20mL | 1 Vial, Single-Dose In 1 Carton (71288-103-20) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-103-20 | 71288-103 | ANDA211001 | ANDA | N/A |
| Bendamustine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 25mg/1 | 1 Vial, Single-Dose In 1 Carton (60505-6095-0) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Apotex Corp | 60505-6095-0 | 60505-6095 | ANDA204230 | ANDA | N/A |
| Bendamustine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/1 | 1 Vial, Single-Dose In 1 Carton (60505-6096-0) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Apotex Corp | 60505-6096-0 | 60505-6096 | ANDA204230 | ANDA | N/A |
| Bendamustine Hydrochloride | Injection, Solution | Intravenous | 25mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6228-0) / 5 Ml In 1 Vial, Multi-Dose | Apotex Corp | 60505-6228-0 | 60505-6228 | NDA215033 | NDA | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.2g/L | 208.198 L In 1 Drum (71212-101-00) | ChemStation | 71212-101-00 | 71212-101 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.2g/L | 4 Container In 1 Box (71212-101-01) / 3.79 L In 1 Container | ChemStation | 71212-101-01 | 71212-101 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.2g/L | 208.198 L In 1 Drum (71212-102-00) | Chemstation | 71212-102-00 | 71212-102 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.2g/L | 4 Bottle, Plastic In 1 Box (71212-102-01) / 3.79 L In 1 Bottle, Plastic | Chemstation | 71212-102-01 | 71212-102 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.2g/L | 6 Cartridge In 1 Box (71212-102-02) / 1.25 L In 1 Cartridge | Chemstation | 71212-102-02 | 71212-102 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Cloth | Topical | 1mg/mL | 20 Patch In 1 Bag (80684-007-20) / 3.5 Ml In 1 Patch | Fourstar Group USA, Inc. | 80684-007-20 | 80684-007 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13g/100g | 100 Pouch In 1 Box (77435-020-01) / 4.32 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-020-01 | 77435-020 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13g/100g | 100 Pouch In 1 Box (77435-021-01) / 4.32 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-021-01 | 77435-021 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13g/100g | 100 Pouch In 1 Box (77435-220-01) / .486 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-220-01 | 77435-220 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13g/100g | 100 Pouch In 1 Box (77435-221-01) / .486 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-221-01 | 77435-221 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 473 Ml In 1 Bottle, Pump (59062-3000-1) | KAS Direct LLC dba BabyGanics | 59062-3000-1 | 59062-3000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 250 Ml In 1 Bottle, Pump (59062-3000-2) | KAS Direct LLC dba BabyGanics | 59062-3000-2 | 59062-3000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 50 Ml In 1 Bottle, Pump (59062-3000-5) | KAS Direct LLC dba BabyGanics | 59062-3000-5 | 59062-3000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 473 Ml In 1 Bottle, Pump (59062-3001-1) | KAS Direct LLC dba BabyGanics | 59062-3001-1 | 59062-3001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 250 Ml In 1 Bottle, Pump (59062-3001-2) | KAS Direct LLC dba BabyGanics | 59062-3001-2 | 59062-3001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 50 Ml In 1 Bottle, Pump (59062-3001-5) | KAS Direct LLC dba BabyGanics | 59062-3001-5 | 59062-3001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 473 Ml In 1 Bottle, Pump (59062-4000-1) | KAS Direct LLC dba BabyGanics | 59062-4000-1 | 59062-4000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 250 Ml In 1 Bottle, Pump (59062-4000-2) | KAS Direct LLC dba BabyGanics | 59062-4000-2 | 59062-4000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 2 Bottle, Pump In 1 Carton (59062-4000-3) / 50 Ml In 1 Bottle, Pump (59062-4000-5) | KAS Direct LLC dba BabyGanics | 59062-4000-3 | 59062-4000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 50 Ml In 1 Bottle, Pump (59062-4000-5) | KAS Direct LLC dba BabyGanics | 59062-4000-5 | 59062-4000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 473 Ml In 1 Bottle, Pump (59062-4001-1) | KAS Direct LLC dba BabyGanics | 59062-4001-1 | 59062-4001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 250 Ml In 1 Bottle, Pump (59062-4001-2) | KAS Direct LLC dba BabyGanics | 59062-4001-2 | 59062-4001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 2 Bottle, Pump In 1 Carton (59062-4001-3) / 50 Ml In 1 Bottle, Pump (59062-4001-5) | KAS Direct LLC dba BabyGanics | 59062-4001-3 | 59062-4001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 50 Ml In 1 Bottle, Pump (59062-4001-5) | KAS Direct LLC dba BabyGanics | 59062-4001-5 | 59062-4001 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 250 Ml In 1 Bottle, Pump (59062-4100-1) | KAS Direct LLC dba BabyGanics | 59062-4100-1 | 59062-4100 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 250 Ml In 1 Bottle, Pump (59062-4101-1) | KAS Direct LLC dba BabyGanics | 59062-4101-1 | 59062-4101 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .1mg/mL | 250 Ml In 1 Bottle, Pump (59062-4200-1) | KAS Direct LLC dba BabyGanics | 59062-4200-1 | 59062-4200 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .12mg/mL | 250 Ml In 1 Bottle, Pump (59062-4201-1) | KAS Direct LLC dba BabyGanics | 59062-4201-1 | 59062-4201 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .125g/100mL | 1 Bottle In 1 Box (82985-002-01) / 200 Ml In 1 Bottle | AXM Premium Cleaning Services, L.P. | 82985-002-01 | 82985-002 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | .125g/100mL | 1 Bottle In 1 Box (82985-002-02) / 473 Ml In 1 Bottle | AXM Premium Cleaning Services, L.P. | 82985-002-02 | 82985-002 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Swab | Topical | .15g/100g | 10 Pouch In 1 Bag (77435-108-01) / 4.8 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-108-01 | 77435-108 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Swab | Topical | .15g/100g | 50 Pouch In 1 Canister (77435-108-02) / 10.5 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-108-02 | 77435-108 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Swab | Topical | .15g/100g | 60 Pouch In 1 Canister (77435-108-03) / 10.5 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-108-03 | 77435-108 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Swab | Topical | .08g/100g | 100 Pouch In 1 Canister (77435-112-01) / 4 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-112-01 | 77435-112 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 1000 Ml In 1 Bottle (77733-002-03) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-03 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 60 Ml In 1 Bottle (77733-002-04) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-04 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 125 Ml In 1 Bottle (77733-002-05) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-05 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 250 Ml In 1 Bottle (77733-002-06) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-06 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 500 Ml In 1 Bottle (77733-002-07) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-07 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Solution | Topical | .13g/100mL | 5000 Ml In 1 Bottle (77733-002-08) | Biorganicos Robech, S. de R.L. de C.V. | 77733-002-08 | 77733-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13g/100g | 8 Pouch In 1 Package (77435-301-01) / 6 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-301-01 | 77435-301 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Soap | Topical | 1mg/mL | 3785 Ml In 1 Bottle, Plastic (80042-003-00) | NEW WAVE CLEANING SOLUTIONS,LLC | 80042-003-00 | 80042-003 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Swab | Topical | .3g/100g | 75 Pouch In 1 Canister (77435-004-01) / 3.15 G In 1 Pouch | HAINING LILY CLEANING PRODUCTS CO., LTD | 77435-004-01 | 77435-004 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 1000 Ml In 1 Cartridge (43097-457-10) | People's Janitorial Supply | 43097-457-10 | 43097-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 1000 Ml In 1 Bag (43097-457-12) | People's Janitorial Supply | 43097-457-12 | 43097-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 3785 Ml In 1 Bottle, Plastic (43097-457-14) | People's Janitorial Supply | 43097-457-14 | 43097-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 50 Ml In 1 Bottle, Plastic (43097-457-18) | People's Janitorial Supply | 43097-457-18 | 43097-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Gel | Topical | .125g/100mL | 3 Bottle In 1 Package (82985-001-01) / 15 Ml In 1 Bottle | AXM Premium Cleaning Services, L.P. | 82985-001-01 | 82985-001 | M003 | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 1000 Ml In 1 Cartridge (13302-457-10) | Romaine Companies | 13302-457-10 | 13302-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Liquid | Topical | 1.3mg/mL | 3785 Ml In 1 Bottle, Plastic (13302-457-14) | Romaine Companies | 13302-457-14 | 13302-457 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13mg/1 | 48 Cloth In 1 Packet (77824-001-01) | Betone SA de CV | 77824-001-01 | 77824-001 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride | Cloth | Topical | .13mg/1 | 24 Cloth In 1 Box (77824-001-02) | Betone SA de CV | 77824-001-02 | 77824-001 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Benzalkonium Chloride; Lidocaine Hydrochloride | Cream | Topical | 1.3mg/g, 5 mg/g | 144 Packet In 1 Box (82749-009-01) / .9 G In 1 Packet | Epic Medical Supply Corp | 82749-009-01 | 82749-009 | M017 | OTC MONOGRAPH DRUG | N/A |
| Benzethonium Chloride | Solution | Topical | 1.3mg/g | 211 G In 1 Bottle (42829-002-21) | ASCENT CONSUMER PRODUCTS, INC | 42829-002-21 | 42829-002 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-914-01) | Golden State Medical Supply, Inc. | 60429-914-01 | 60429-914 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-927-01) | Golden State Medical Supply, Inc. | 60429-927-01 | 60429-927 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (60429-927-05) | Golden State Medical Supply, Inc. | 60429-927-05 | 60429-927 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (69452-143-20) | Bionpharma Inc. | 69452-143-20 | 69452-143 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (69452-143-30) | Bionpharma Inc. | 69452-143-30 | 69452-143 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle, Plastic (69452-144-20) | Bionpharma Inc. | 69452-144-20 | 69452-144 | ANDA081297 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle, Plastic (69452-144-30) | Bionpharma Inc. | 69452-144-30 | 69452-144 | ANDA081297 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 80mg/1 | 30 Capsule In 1 Bottle (64980-378-03) | Rising Pharma Holdings, Inc. | 64980-378-03 | 64980-378 | ANDA079016 | ANDA | N/A |
| Atomoxetine Hydrochloride | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (64980-379-03) | Rising Pharma Holdings, Inc. | 64980-379-03 | 64980-379 | ANDA079016 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-424-05) | Camber Pharmaceuticals, Inc. | 31722-424-05 | 31722-424 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-424-10) | Camber Pharmaceuticals, Inc. | 31722-424-10 | 31722-424 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-424-90) | Camber Pharmaceuticals, Inc. | 31722-424-90 | 31722-424 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-425-05) | Camber Pharmaceuticals, Inc. | 31722-425-05 | 31722-425 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-425-10) | Camber Pharmaceuticals, Inc. | 31722-425-10 | 31722-425 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-425-90) | Camber Pharmaceuticals, Inc. | 31722-425-90 | 31722-425 | ANDA214344 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (42192-617-05) | Acella Pharmaceuticals, LLC | 42192-617-05 | 42192-617 | ANDA091310 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (42192-618-01) | Acella Pharmaceuticals, LLC | 42192-618-01 | 42192-618 | ANDA091310 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (42192-618-05) | Acella Pharmaceuticals, LLC | 42192-618-05 | 42192-618 | ANDA091310 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-426-05) | Camber Pharmaceuticals, Inc. | 31722-426-05 | 31722-426 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-426-10) | Camber Pharmaceuticals, Inc. | 31722-426-10 | 31722-426 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-426-90) | Camber Pharmaceuticals, Inc. | 31722-426-90 | 31722-426 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-427-05) | Camber Pharmaceuticals, Inc. | 31722-427-05 | 31722-427 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 80mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-427-10) | Camber Pharmaceuticals, Inc. | 31722-427-10 | 31722-427 | ANDA214344 | ANDA | N/A |
| ATORVASTATIN CALCIUM | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-427-90) | Camber Pharmaceuticals, Inc. | 31722-427-90 | 31722-427 | ANDA214344 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (16571-136-09) | Rising Pharma Holdings, Inc. | 16571-136-09 | 16571-136 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (16571-136-10) | Rising Pharma Holdings, Inc. | 16571-136-10 | 16571-136 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (16571-136-50) | Rising Pharma Holdings, Inc. | 16571-136-50 | 16571-136 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (16571-137-09) | Rising Pharma Holdings, Inc. | 16571-137-09 | 16571-137 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (16571-137-10) | Rising Pharma Holdings, Inc. | 16571-137-10 | 16571-137 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (16571-137-50) | Rising Pharma Holdings, Inc. | 16571-137-50 | 16571-137 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (16571-138-09) | Rising Pharma Holdings, Inc. | 16571-138-09 | 16571-138 | ANDA209912 | ANDA | N/A |
| Benzoyl Peroxide | Gel | Topical | 2.5g/100g | 1 Tube In 1 Carton (45802-101-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-101-96 | 45802-101 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Gel | Topical | 5g/100g | 1 Tube In 1 Carton (45802-216-01) / 90 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-216-01 | 45802-216 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Gel | Topical | 5g/100g | 1 Tube In 1 Carton (45802-216-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-216-96 | 45802-216 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Liquid | Topical | 5g/100g | 142 G In 1 Bottle (45802-280-01) | Padagis Israel Pharmaceuticals Ltd | 45802-280-01 | 45802-280 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Liquid | Topical | 5g/100g | 227 G In 1 Bottle (45802-280-34) | Padagis Israel Pharmaceuticals Ltd | 45802-280-34 | 45802-280 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Gel | Topical | 10g/100g | 1 Tube In 1 Carton (45802-308-01) / 90 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-308-01 | 45802-308 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Gel | Topical | 10g/100g | 1 Tube In 1 Carton (45802-308-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-308-96 | 45802-308 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide | Suspension | Topical | 10g/100g | 142 G In 1 Bottle (45802-318-01) | Padagis Israel Pharmaceuticals Ltd | 45802-318-01 | 45802-318 | M006 | OTC MONOGRAPH DRUG | N/A |
| Benzoyl Peroxide | Suspension | Topical | 10g/100g | 227 G In 1 Bottle (45802-318-34) | Padagis Israel Pharmaceuticals Ltd | 45802-318-34 | 45802-318 | M006 | OTC MONOGRAPH DRUG | N/A |
| Benzoyl Peroxide | Gel | Topical | 80mg/mL | 60 Ml In 1 Tube (83722-001-00) | Dermastart Inc | 83722-001-00 | 83722-001 | OKM006 | OTC MONOGRAPH DRUG | N/A |
| Benzoyl Peroxide | Gel | Topical | 50mg/mL | 1 Tube In 1 Box (73010-127-00) / 30 Ml In 1 Tube | Apprendista, LLC | 73010-127-00 | 73010-127 | M006 | OTC MONOGRAPH DRUG | N/A |
| Benzoyl Peroxide | Liquid | Topical | 100mg/mL | 237 Ml In 1 Bottle (73010-900-00) | Apprendista, LLC | 73010-900-00 | 73010-900 | M006 | OTC MONOGRAPH DRUG | N/A |
| Benzoyl Peroxide | Cream | Topical | 5g/100g | 28 G In 1 Tube (68343-123-01) | Montani Cosmetics Inc | 68343-123-01 | 68343-123 | part333D | OTC MONOGRAPH FINAL | N/A |
| Benzoyl Peroxide; Clindamycin Phosphate | Gel | Topical | 25mg/g, 10 mg/g | 1 Bottle, Pump In 1 Carton (45802-597-01) / 50 G In 1 Bottle, Pump | Padagis Israel Pharmaceuticals Ltd | 45802-597-01 | 45802-597 | ANDA205397 | ANDA | N/A |
| Benzoyl Peroxide; Clindamycin Phosphate | Gel | Topical | 50mg/g, 10 mg/g | 1 Tube In 1 Carton (45802-736-84) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-736-84 | 45802-736 | ANDA090979 | ANDA | N/A |
| Benzoyl Peroxide; Clindamycin Phosphate | Gel | Topical | 50mg/g, 10 mg/g | 50 G In 1 Bottle, Pump (51672-1403-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1403-4 | 51672-1403 | ANDA208683 | ANDA | N/A |
| Benzoyl Peroxide; Clindamycin Phosphate | Gel | Topical | 50mg/g, 10 mg/g | 1 Tube In 1 Carton (51672-1366-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1366-6 | 51672-1366 | ANDA206218 | ANDA | N/A |
| Benzoyl Peroxide; Clindamycin Phosphate | Gel | Topical | 25mg/g, 10 mg/g | 1 Bottle, Pump In 1 Carton (51672-1367-3) / 50 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1367-3 | 51672-1367 | ANDA206575 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (16571-138-10) | Rising Pharma Holdings, Inc. | 16571-138-10 | 16571-138 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (16571-138-50) | Rising Pharma Holdings, Inc. | 16571-138-50 | 16571-138 | ANDA209912 | ANDA | N/A |
| Benzphetamine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (10702-040-01) | KVK-TECH, INC | 10702-040-01 | 10702-040 | ANDA090968 | ANDA | CIII |
| Benzphetamine Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (10702-040-03) | KVK-TECH, INC | 10702-040-03 | 10702-040 | ANDA090968 | ANDA | CIII |
| Benzphetamine Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (10702-040-10) | KVK-TECH, INC | 10702-040-10 | 10702-040 | ANDA090968 | ANDA | CIII |
| Benzphetamine Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (10702-040-50) | KVK-TECH, INC | 10702-040-50 | 10702-040 | ANDA090968 | ANDA | CIII |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (16571-139-09) | Rising Pharma Holdings, Inc. | 16571-139-09 | 16571-139 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (16571-139-10) | Rising Pharma Holdings, Inc. | 16571-139-10 | 16571-139 | ANDA209912 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (16571-139-50) | Rising Pharma Holdings, Inc. | 16571-139-50 | 16571-139 | ANDA209912 | ANDA | N/A |
| Benztropine Mesylate | Injection | Intramuscular; Intravenous | 1mg/mL | 5 Vial In 1 Carton (68475-512-02) / 2 Ml In 1 Vial (68475-512-01) | Navinta LLC | 68475-512-02 | 68475-512 | ANDA091525 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (69315-136-01) | Leading Pharma, LLC | 69315-136-01 | 69315-136 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (69315-136-10) | Leading Pharma, LLC | 69315-136-10 | 69315-136 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (69315-137-01) | Leading Pharma, LLC | 69315-137-01 | 69315-137 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (69315-137-10) | Leading Pharma, LLC | 69315-137-10 | 69315-137 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (69315-138-01) | Leading Pharma, LLC | 69315-138-01 | 69315-138 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (69315-138-10) | Leading Pharma, LLC | 69315-138-10 | 69315-138 | ANDA090168 | ANDA | N/A |
| Benztropine Mesylate | Injection | Intramuscular; Intravenous | 1mg/mL | 5 Ampule In 1 Carton (0143-9729-05) / 2 Ml In 1 Ampule (0143-9729-01) | Hikma Pharmaceuticals USA Inc. | 0143-9729-05 | 0143-9729 | ANDA090287 | ANDA | N/A |
| Benztropine Mesylate | Injection | Intramuscular; Intravenous | 1mg/mL | 5 Vial In 1 Box (0143-9233-05) / 2 Ml In 1 Vial (0143-9233-01) | Hikma Pharmaceuticals USA Inc. | 0143-9233-05 | 0143-9233 | ANDA209442 | ANDA | N/A |
| Benzyl Alcohol | Gel | Topical | .1g/g | 1 Tube In 1 Carton (50486-468-02) / 7.1 G In 1 Tube | Blairex Laboratories, Inc. | 50486-468-02 | 50486-468 | part356 | OTC MONOGRAPH NOT FINAL | N/A |
| Berberis Vulgaris Root Bark; Cullen Corylifolium Whole; Nigella Sativa Seed | Ointment | Topical | 83mg/125mL, 83 mg/125mL, 83 mg/125mL | 125 Ml In 1 Bottle (70957-0020-1) | Organic Care Australia Pty LTD | 70957-0020-1 | 70957-0020 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Berberis Vulgaris Root Bark; Cullen Corylifolium Whole; Nigella Sativa Seed | Ointment | Topical | 83mg/125mL, 83 mg/125mL, 83 mg/125mL | 250 Ml In 1 Bottle (70957-0020-2) | Organic Care Australia Pty LTD | 70957-0020-2 | 70957-0020 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Betaine | Powder, For Solution | Oral | 1g/g | 180 G In 1 Bottle (0713-0352-81) | Cosette Pharmaceuticals, Inc. | 0713-0352-81 | 0713-0352 | ANDA214864 | ANDA | N/A |
| Betaine | Powder, For Solution | Oral | 1g/g | 180 G In 1 Bottle (71863-115-18) | Eton Pharmaceuticals, Inc. | 71863-115-18 | 71863-115 | ANDA210508 | ANDA | N/A |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular | 3mg/mL, 3 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0517-0791-01) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0791-01 | 0517-0791 | ANDA090747 | ANDA | N/A |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular | 3mg/mL, 3 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0517-0799-01) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0799-01 | 0517-0799 | ANDA090747 | ANDA | N/A |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular | 3mg/mL, 3 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0517-0720-01) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0720-01 | 0517-0720 | ANDA090747 | ANDA | N/A |
| Betamethasone Dipropionate | Lotion | Topical | .5mg/g | 56.2 G In 1 Bottle, Plastic (45802-021-46) | Padagis Israel Pharmaceuticals Ltd | 45802-021-46 | 45802-021 | ANDA072538 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-505-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-505-14 | 45802-505 | ANDA215847 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-505-84) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-505-84 | 45802-505 | ANDA215847 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-376-32) / 50 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-376-32 | 45802-376 | ANDA076592 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-376-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-376-35 | 45802-376 | ANDA076592 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Box (66993-897-15) / 15 G In 1 Tube | Prasco Laboratories | 66993-897-15 | 66993-897 | NDA018741 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Box (66993-897-49) / 50 G In 1 Tube | Prasco Laboratories | 66993-897-49 | 66993-897 | NDA018741 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51407-273-15) / 15 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-273-15 | 51407-273 | ANDA073552 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51407-273-45) / 45 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-273-45 | 51407-273 | ANDA073552 | ANDA | N/A |
| Betamethasone Dipropionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1309-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1309-1 | 51672-1309 | ANDA076508 | ANDA | N/A |
| Betamethasone Dipropionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1309-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1309-3 | 51672-1309 | ANDA076508 | ANDA | N/A |
| Betamethasone Dipropionate | Cream, Augmented | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1310-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1310-1 | 51672-1310 | ANDA076543 | ANDA | N/A |
| Betamethasone Dipropionate | Cream, Augmented | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1310-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1310-2 | 51672-1310 | ANDA076543 | ANDA | N/A |
| Betamethasone Dipropionate | Cream, Augmented | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1310-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1310-3 | 51672-1310 | ANDA076543 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment, Augmented | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1317-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1317-1 | 51672-1317 | ANDA076753 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment, Augmented | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1317-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1317-3 | 51672-1317 | ANDA076753 | ANDA | N/A |
| Betamethasone Dipropionate | Ointment, Augmented | Topical | .5mg/g | 5 G In 1 Tube (51672-1317-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1317-5 | 51672-1317 | ANDA076753 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1274-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1274-1 | 51672-1274 | ANDA073552 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1274-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1274-6 | 51672-1274 | ANDA073552 | ANDA | N/A |
| Betamethasone Dipropionate | Lotion, Augmented | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-1340-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1340-3 | 51672-1340 | ANDA077477 | ANDA | N/A |
| Betamethasone Dipropionate | Lotion, Augmented | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-1340-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1340-4 | 51672-1340 | ANDA077477 | ANDA | N/A |
| Betamethasone Dipropionate | Spray | Topical | .5mg/g | 1 Bottle In 1 Carton (51672-1390-4) / 60 G In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1390-4 | 51672-1390 | ANDA211722 | ANDA | N/A |
| Betamethasone Dipropionate | Spray | Topical | .5mg/g | 1 Bottle In 1 Carton (51672-1390-8) / 120 G In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1390-8 | 51672-1390 | ANDA211722 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0659-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0659-15 | 0713-0659 | ANDA210217 | ANDA | N/A |
| Betamethasone Dipropionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0659-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0659-37 | 0713-0659 | ANDA210217 | ANDA | N/A |
| Betamethasone Dipropionate | Lotion | Topical | .5mg/mL | 1 Bottle In 1 Carton (0713-0807-53) / 60 Ml In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0807-53 | 0713-0807 | ANDA071467 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Ointment | Topical | .643mg/g, 50 ug/g | 1 Tube In 1 Carton (45802-816-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-816-01 | 45802-816 | ANDA200174 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Ointment | Topical | .643mg/g, 50 ug/g | 1 Tube In 1 Carton (45802-816-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-816-96 | 45802-816 | ANDA200174 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | 50mg/g, 50 ug/g | 1 Bottle In 1 Carton (51672-1402-4) / 60 G In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1402-4 | 51672-1402 | ANDA213269 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | 50mg/g, 50 ug/g | 2 Bottle In 1 Carton (51672-1402-8) / 60 G In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1402-8 | 51672-1402 | ANDA213269 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | .5mg/g, 50 ug/g | 2 Bottle In 1 Carton (63646-040-12) / 60 G In 1 Bottle | TOLMAR Inc. | 63646-040-12 | 63646-040 | ANDA210765 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | .5mg/g, 50 ug/g | 1 Bottle In 1 Carton (63646-040-60) / 60 G In 1 Bottle | TOLMAR Inc. | 63646-040-60 | 63646-040 | ANDA210765 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | .5mg/g, 50 ug/g | 1 Bottle In 1 Carton (0713-0848-60) / 60 G In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0848-60 | 0713-0848 | ANDA210765 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene | Suspension | Topical | .5mg/g, 50 ug/g | 2 Bottle In 1 Carton (0713-0848-92) / 60 G In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0848-92 | 0713-0848 | ANDA210765 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene Hydrate | Suspension | Topical | .5mg/g, 50 ug/g | 1 Bottle In 1 Carton (66993-937-61) / 60 G In 1 Bottle | Prasco Laboratories | 66993-937-61 | 66993-937 | NDA022185 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate; Calcipotriene Hydrate | Suspension | Topical | .5mg/g, 50 ug/g | 2 Bottle In 1 Package (66993-937-78) / 60 G In 1 Bottle | Prasco Laboratories | 66993-937-78 | 66993-937 | NDA022185 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate; Calcipotriene Monohydrate | Suspension | Topical | .5mg/g, 50 ug/g | 2 Bottle In 1 Carton (45802-889-18) / 60 G In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-889-18 | 45802-889 | ANDA212367 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene Monohydrate | Suspension | Topical | .5mg/g, 50 ug/g | 1 Bottle In 1 Carton (45802-889-96) / 60 G In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-889-96 | 45802-889 | ANDA212367 | ANDA | N/A |
| Betamethasone Dipropionate; Calcipotriene Monohydrate | Ointment | Topical | .5mg/g, 50 ug/g | 1 Tube In 1 Carton (66993-938-61) / 60 G In 1 Tube | Prasco Laboratories | 66993-938-61 | 66993-938 | NDA021852 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate; Calcipotriene Monohydrate | Ointment | Topical | .5mg/g, 50 ug/g | 1 Tube In 1 Carton (66993-938-65) / 100 G In 1 Tube | Prasco Laboratories | 66993-938-65 | 66993-938 | NDA021852 | NDA AUTHORIZED GENERIC | N/A |
| Betamethasone Dipropionate; Clotrimazole | Cream | Topical | .5mg/g, 10 mg/g | 1 Tube In 1 Carton (51672-4048-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4048-1 | 51672-4048 | ANDA075673 | ANDA | N/A |
| Betamethasone Dipropionate; Clotrimazole | Cream | Topical | .5mg/g, 10 mg/g | 1 Tube In 1 Carton (51672-4048-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4048-6 | 51672-4048 | ANDA075673 | ANDA | N/A |
| Betamethasone Dipropionate; Clotrimazole | Lotion | Topical | .5mg/mL, 10 mg/mL | 1 Bottle In 1 Carton (51672-1308-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1308-3 | 51672-1308 | ANDA076493 | ANDA | N/A |
| Betamethasone Valerate | Aerosol, Foam | Topical | 1.2mg/g | 1 Can In 1 Carton (45802-053-01) / 50 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-053-01 | 45802-053 | ANDA078337 | ANDA | N/A |
| Betamethasone Valerate | Aerosol, Foam | Topical | 1.2mg/g | 1 Can In 1 Carton (45802-053-02) / 100 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-053-02 | 45802-053 | ANDA078337 | ANDA | N/A |
| Betamethasone Valerate | Aerosol, Foam | Topical | 1.2mg/g | 1 Can In 1 Carton (51672-4188-3) / 50 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4188-3 | 51672-4188 | ANDA208204 | ANDA | N/A |
| Betamethasone Valerate | Aerosol, Foam | Topical | 1.2mg/g | 1 Can In 1 Carton (51672-4188-7) / 100 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4188-7 | 51672-4188 | ANDA208204 | ANDA | N/A |
| Betamethasone Valerate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1269-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1269-1 | 51672-1269 | ANDA072041 | ANDA | N/A |
| Betamethasone Valerate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1269-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1269-6 | 51672-1269 | ANDA072041 | ANDA | N/A |
| Betamethasone Valerate | Cream | Topical | 1.2mg/g | 1 Tube In 1 Carton (0713-0326-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0326-15 | 0713-0326 | NDA018642 | NDA | N/A |
| Betamethasone Valerate | Cream | Topical | 1.2mg/g | 1 Tube In 1 Carton (0713-0326-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0326-37 | 0713-0326 | NDA018642 | NDA | N/A |
| Betamethasone Valerate | Ointment | Topical | 1.2mg/g | 1 Tube In 1 Carton (0713-0327-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0327-15 | 0713-0327 | ANDA070069 | ANDA | N/A |
| Betamethasone Valerate | Ointment | Topical | 1.2mg/g | 1 Tube In 1 Carton (0713-0327-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0327-37 | 0713-0327 | ANDA070069 | ANDA | N/A |
| Betaxolol Hydrochloride | Tablet, Coated | Oral | 10mg/1 | 100 Tablet, Coated In 1 Bottle (10702-013-01) | KVK-TECH, INC. | 10702-013-01 | 10702-013 | ANDA078962 | ANDA | N/A |
| Betaxolol Hydrochloride | Tablet, Coated | Oral | 20mg/1 | 100 Tablet, Coated In 1 Bottle (10702-014-01) | KVK-TECH, INC. | 10702-014-01 | 10702-014 | ANDA078962 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-451-10) | ScieGen Pharmaceuticals, Inc. | 50228-451-10 | 50228-451 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-451-90) | ScieGen Pharmaceuticals, Inc. | 50228-451-90 | 50228-451 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-452-05) | ScieGen Pharmaceuticals, Inc. | 50228-452-05 | 50228-452 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-452-90) | ScieGen Pharmaceuticals, Inc. | 50228-452-90 | 50228-452 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-453-10) | ScieGen Pharmaceuticals, Inc. | 50228-453-10 | 50228-453 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-453-90) | ScieGen Pharmaceuticals, Inc. | 50228-453-90 | 50228-453 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-454-05) | ScieGen Pharmaceuticals, Inc. | 50228-454-05 | 50228-454 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-454-90) | ScieGen Pharmaceuticals, Inc. | 50228-454-90 | 50228-454 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-451-10) | ScieGen Pharmaceuticals, Inc. | 50228-451-10 | 50228-451 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-451-90) | ScieGen Pharmaceuticals, Inc. | 50228-451-90 | 50228-451 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-452-05) | ScieGen Pharmaceuticals, Inc. | 50228-452-05 | 50228-452 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-452-90) | ScieGen Pharmaceuticals, Inc. | 50228-452-90 | 50228-452 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-453-10) | ScieGen Pharmaceuticals, Inc. | 50228-453-10 | 50228-453 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-453-90) | ScieGen Pharmaceuticals, Inc. | 50228-453-90 | 50228-453 | ANDA205519 | ANDA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-454-05) | ScieGen Pharmaceuticals, Inc. | 50228-454-05 | 50228-454 | ANDA205519 | ANDA | N/A |
| Betiatide | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/1 | 5 Vial In 1 Carton (65174-261-05) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (65174-261-01) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-261-05 | 65174-261 | NDA216820 | NDA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1168-2) | Jubilant HollisterStier LLC | 65044-1168-2 | 65044-1168 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1168-3) | Jubilant HollisterStier LLC | 65044-1168-3 | 65044-1168 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1168-4) | Jubilant HollisterStier LLC | 65044-1168-4 | 65044-1168 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1169-1) | Jubilant HollisterStier LLC | 65044-1169-1 | 65044-1169 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1171-2) | Jubilant HollisterStier LLC | 65044-1171-2 | 65044-1171 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1171-3) | Jubilant HollisterStier LLC | 65044-1171-3 | 65044-1171 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1171-4) | Jubilant HollisterStier LLC | 65044-1171-4 | 65044-1171 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 20000 [PNU]/mL, 40000 [PNU]/mL | 10 Ml In 1 Vial (65044-1172-2) | Jubilant HollisterStier LLC | 65044-1172-2 | 65044-1172 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 20000 [PNU]/mL, 40000 [PNU]/mL | 30 Ml In 1 Vial (65044-1172-3) | Jubilant HollisterStier LLC | 65044-1172-3 | 65044-1172 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL, 20000 [PNU]/mL, 40000 [PNU]/mL | 50 Ml In 1 Vial (65044-1172-4) | Jubilant HollisterStier LLC | 65044-1172-4 | 65044-1172 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2859-1) | Jubilant HollisterStier LLC | 65044-2859-1 | 65044-2859 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-2861-2) | Jubilant HollisterStier LLC | 65044-2861-2 | 65044-2861 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-2861-3) | Jubilant HollisterStier LLC | 65044-2861-3 | 65044-2861 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .033g/mL, .033 g/mL, .033 g/mL, .1 g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-2861-4) | Jubilant HollisterStier LLC | 65044-2861-4 | 65044-2861 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-2862-2) | Jubilant HollisterStier LLC | 65044-2862-2 | 65044-2862 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-2862-3) | Jubilant HollisterStier LLC | 65044-2862-3 | 65044-2862 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-2862-4) | Jubilant HollisterStier LLC | 65044-2862-4 | 65044-2862 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2863-2) | Jubilant HollisterStier LLC | 65044-2863-2 | 65044-2863 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2863-3) | Jubilant HollisterStier LLC | 65044-2863-3 | 65044-2863 | BLA103888 | BLA | N/A |
| Betula Nigra Pollen; Betula Papyrifera Pollen; Betula Pendula Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .017g/mL, .017 g/mL, .017 g/mL, .05 g/mL, .05 g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2863-4) | Jubilant HollisterStier LLC | 65044-2863-4 | 65044-2863 | BLA103888 | BLA | N/A |
| Atorvastatin Calcium Trihydrate | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-454-90) | ScieGen Pharmaceuticals, Inc. | 50228-454-90 | 50228-454 | ANDA205519 | ANDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle In 1 Carton (65162-693-88) / 210 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-693-88 | 65162-693 | ANDA202960 | ANDA | N/A |
| Atovaquone | Suspension | Oral | 750mg/5mL | 1 Bottle In 1 Carton (31722-629-21) / 210 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-629-21 | 31722-629 | ANDA210692 | ANDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 10 Carton In 1 Package (70121-1705-7) / 1 Syringe, Glass In 1 Carton (70121-1705-1) / 5 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-1705-7 | 70121-1705 | ANDA215342 | ANDA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 100mg/4mL | 1 Vial, Single-Use In 1 Carton (0069-0315-01) / 4 Ml In 1 Vial, Single-Use | Pfizer Laboratories Div Pfizer Inc | 0069-0315-01 | 0069-0315 | BLA761099 | BLA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 400mg/16mL | 1 Vial, Single-Use In 1 Carton (0069-0342-01) / 16 Ml In 1 Vial, Single-Use | Pfizer Laboratories Div Pfizer Inc | 0069-0342-01 | 0069-0342 | BLA761099 | BLA | N/A |
| Bexagliflozin | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (51407-918-30) | Golden State Medical Supply, Inc. | 51407-918-30 | 51407-918 | NDA214373 | NDA AUTHORIZED GENERIC | N/A |
| Bexagliflozin | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (51407-918-90) | Golden State Medical Supply, Inc. | 51407-918-90 | 51407-918 | NDA214373 | NDA AUTHORIZED GENERIC | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 1 Syringe, Glass In 1 Carton (70121-1706-1) / 10 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-1706-1 | 70121-1706 | ANDA215342 | ANDA | N/A |
| Atropine Sulfate | Injection, Solution | Intravenous | .1mg/mL | 10 Tray In 1 Carton (70121-1706-2) / 5 Syringe, Glass In 1 Tray / 10 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-1706-2 | 70121-1706 | ANDA215342 | ANDA | N/A |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (62559-490-01) | ANI Pharmaceuticals, Inc. | 62559-490-01 | 62559-490 | ANDA086727 | ANDA | CV |
| Bexarotene | Capsule, Liquid Filled | Oral | 75mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (0054-0399-25) | Hikma Pharmaceuticals USA Inc. | 0054-0399-25 | 0054-0399 | ANDA203663 | ANDA | N/A |
| Atropine Sulfate; Diphenoxylate Hydrochloride | Tablet | Oral | .025mg/1, 2.5 mg/1 | 1000 Tablet In 1 Bottle (62559-490-10) | ANI Pharmaceuticals, Inc. | 62559-490-10 | 62559-490 | ANDA086727 | ANDA | CV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Tablet | Oral | .0194mg/1, .1037 mg/1, 16.2 mg/1, .0065 mg/1 | 100 Tablet In 1 Bottle, Plastic (50742-667-01) | Ingenus Pharmaceuticals, LLC | 50742-667-01 | 50742-667 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Bimatoprost | Solution/ Drops | Ophthalmic | .3mg/mL | 1 Bottle In 1 Carton (70069-401-01) / 2.5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-401-01 | 70069-401 | ANDA207601 | ANDA | N/A |
| Bimatoprost | Solution/ Drops | Ophthalmic | .3mg/mL | 1 Bottle In 1 Carton (70069-402-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-402-01 | 70069-402 | ANDA207601 | ANDA | N/A |
| Bimatoprost | Solution/ Drops | Ophthalmic | .3mg/mL | 1 Bottle In 1 Carton (70069-403-01) / 7.5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-403-01 | 70069-403 | ANDA207601 | ANDA | N/A |
| Bimatoprost | Solution/ Drops | Ophthalmic | .3mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0583-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0583-1 | 60505-0583 | ANDA090449 | ANDA | N/A |
| Bimatoprost | Solution/ Drops | Ophthalmic | .3mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0583-4) / 2.5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0583-4 | 60505-0583 | ANDA090449 | ANDA | N/A |
| Bisacodyl | Suppository | Rectal | 10mg/1 | 12 Blister Pack In 1 Carton (0574-7050-12) / 1 Suppository In 1 Blister Pack | Padagis US LLC | 0574-7050-12 | 0574-7050 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Bisacodyl | Suppository | Rectal | 10mg/1 | 50 Blister Pack In 1 Carton (0574-7050-50) / 1 Suppository In 1 Blister Pack | Padagis US LLC | 0574-7050-50 | 0574-7050 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 118 Ml In 1 Bottle (50742-665-04) | Ingenus Pharmaceuticals, LLC | 50742-665-04 | 50742-665 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 473 Ml In 1 Bottle (50742-665-16) | Ingenus Pharmaceuticals, LLC | 50742-665-16 | 50742-665 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 118 Ml In 1 Bottle (50742-666-04) | Ingenus Pharmaceuticals, LLC | 50742-666-04 | 50742-666 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Bisoprolol Fumarate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (70954-455-10) | Novitium Pharma LLC | 70954-455-10 | 70954-455 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-455-20) | Novitium Pharma LLC | 70954-455-20 | 70954-455 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (70954-456-10) | Novitium Pharma LLC | 70954-456-10 | 70954-456 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (70954-456-20) | Novitium Pharma LLC | 70954-456-20 | 70954-456 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-645-01) | Golden State Medical Supply, Inc. | 51407-645-01 | 51407-645 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (51407-645-30) | Golden State Medical Supply, Inc. | 51407-645-30 | 51407-645 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-646-01) | Golden State Medical Supply, Inc. | 51407-646-01 | 51407-646 | ANDA215563 | ANDA | N/A |
| Bisoprolol Fumarate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (51407-646-30) | Golden State Medical Supply, Inc. | 51407-646-30 | 51407-646 | ANDA215563 | ANDA | N/A |
| Atropine Sulfate; Hyoscyamine Sulfate; Phenobarbital; Scopolamine Hydrobromide | Elixir | Oral | .0194mg/5mL, .1037 mg/5mL, 16.2 mg/5mL, .0065 mg/5mL | 473 Ml In 1 Bottle (50742-666-16) | Ingenus Pharmaceuticals, LLC | 50742-666-16 | 50742-666 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Avobenzone; Octocrylene | Lotion | Topical | .9g/30mL, 2.34 g/30mL | 177 Ml In 1 Tube (58418-004-06) | Epic Laboratories, LLC | 58418-004-06 | 58418-004 | M020 | OTC MONOGRAPH DRUG | N/A |
| Avobenzone; Octocrylene | Lotion | Topical | .9g/30mL, 2.34 g/30mL | 177 Ml In 1 Tube (58418-000-06) | Epic Laboratories, LLC | 58418-000-06 | 58418-000 | M020 | OTC MONOGRAPH DRUG | N/A |
| Avobenzone; Octocrylene | Lotion | Topical | .9g/30mL, 2.34 g/30mL | 177 Ml In 1 Tube (58418-003-06) | Epic Laboratories, LLC | 58418-003-06 | 58418-003 | M020 | OTC MONOGRAPH DRUG | N/A |
| Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 100mg/1 | 1 Injection, Powder, Lyophilized, For Solution In 1 Carton (70121-1237-1) | Amneal Pharmaceuticals LLC | 70121-1237-1 | 70121-1237 | ANDA211549 | ANDA | N/A |
| Azathioprine | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (16571-835-01) | Rising Pharma Holdings, Inc. | 16571-835-01 | 16571-835 | ANDA075568 | ANDA | N/A |
| Azathioprine | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (16571-835-10) | Rising Pharma Holdings, Inc. | 16571-835-10 | 16571-835 | ANDA075568 | ANDA | N/A |
| Azathioprine | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (16571-835-50) | Rising Pharma Holdings, Inc. | 16571-835-50 | 16571-835 | ANDA075568 | ANDA | N/A |
| Azelastine Hydrochloride | Spray, Metered | Nasal | 1mg/mL | 1 Bottle, Spray In 1 Carton (65162-676-84) / 30 Ml In 1 Bottle, Spray | Amneal Pharmaceuticals LLC | 65162-676-84 | 65162-676 | ANDA204660 | ANDA | N/A |
| Bivalirudin | Injection, Powder, Lyophilized, For Solution | Intravenous | 250mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-427-11) / 5 Ml In 1 Vial, Single-Dose (71288-427-10) | Meitheal Pharmaceuticals Inc. | 71288-427-11 | 71288-427 | ANDA091602 | ANDA | N/A |
| Bivalirudin | Injection, Powder, Lyophilized, For Solution | Intravenous | 250mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-427-92) / 5 Ml In 1 Vial, Single-Dose (71288-427-91) | Meitheal Pharmaceuticals Inc. | 71288-427-92 | 71288-427 | ANDA091602 | ANDA | N/A |
| Black Walnut | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3695-2) | Jubilant HollisterStier LLC | 65044-3695-2 | 65044-3695 | BLA103888 | BLA | N/A |
| Blattella Germanica | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-6581-2) | Jubilant HollisterStier LLC | 65044-6581-2 | 65044-6581 | BLA103888 | BLA | N/A |
| Blattella Germanica | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-6581-3) | Jubilant HollisterStier LLC | 65044-6581-3 | 65044-6581 | BLA103888 | BLA | N/A |
| Blattella Germanica | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-6581-4) | Jubilant HollisterStier LLC | 65044-6581-4 | 65044-6581 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-6584-2) | Jubilant HollisterStier LLC | 65044-6584-2 | 65044-6584 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-6584-3) | Jubilant HollisterStier LLC | 65044-6584-3 | 65044-6584 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-6584-4) | Jubilant HollisterStier LLC | 65044-6584-4 | 65044-6584 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-6585-1) | Jubilant HollisterStier LLC | 65044-6585-1 | 65044-6585 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-6587-2) | Jubilant HollisterStier LLC | 65044-6587-2 | 65044-6587 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-6587-3) | Jubilant HollisterStier LLC | 65044-6587-3 | 65044-6587 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-6587-4) | Jubilant HollisterStier LLC | 65044-6587-4 | 65044-6587 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-6588-2) | Jubilant HollisterStier LLC | 65044-6588-2 | 65044-6588 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-6588-3) | Jubilant HollisterStier LLC | 65044-6588-3 | 65044-6588 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-6588-4) | Jubilant HollisterStier LLC | 65044-6588-4 | 65044-6588 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-6589-2) | Jubilant HollisterStier LLC | 65044-6589-2 | 65044-6589 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-6589-3) | Jubilant HollisterStier LLC | 65044-6589-3 | 65044-6589 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-6589-4) | Jubilant HollisterStier LLC | 65044-6589-4 | 65044-6589 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 5000[PNU]/mL, 5000 [PNU]/mL | 10 Ml In 1 Vial (65044-6590-2) | Jubilant HollisterStier LLC | 65044-6590-2 | 65044-6590 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 5000[PNU]/mL, 5000 [PNU]/mL | 30 Ml In 1 Vial (65044-6590-3) | Jubilant HollisterStier LLC | 65044-6590-3 | 65044-6590 | BLA103888 | BLA | N/A |
| Blattella Germanica; Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | 5000[PNU]/mL, 5000 [PNU]/mL | 50 Ml In 1 Vial (65044-6590-4) | Jubilant HollisterStier LLC | 65044-6590-4 | 65044-6590 | BLA103888 | BLA | N/A |
| Bleomycin Sulfate | Powder, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 15[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (71288-106-10) / 15 Powder, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-106-10 | 71288-106 | ANDA205030 | ANDA | N/A |
| Bleomycin Sulfate | Powder, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 30[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (71288-107-20) / 30 Powder, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-107-20 | 71288-107 | ANDA205030 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (65162-758-83) / 15 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-758-83 | 65162-758 | ANDA205666 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 15[USP'U]/1 | 1 Vial In 1 Box, Unit-Dose (0143-9240-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9240-01 | 0143-9240 | ANDA065042 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 30[USP'U]/1 | 1 Vial In 1 Box, Unit-Dose (0143-9241-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9241-01 | 0143-9241 | ANDA065042 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 30[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (61703-323-22) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 61703-323-22 | 61703-323 | ANDA065031 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 15[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (61703-332-18) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 61703-332-18 | 61703-332 | ANDA065031 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 30[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (0409-0323-20) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0323-20 | 0409-0323 | ANDA065031 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intrapleural; Intravenous; Subcutaneous | 15[USP'U]/1 | 1 Vial, Single-Dose In 1 Carton (0409-0332-20) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0332-20 | 0409-0332 | ANDA065031 | ANDA | N/A |
| Bnt162B2 Omicron (Kp.2) | Injection, Suspension | Intramuscular | .042mg/.418mL | 10 Syringe, Glass In 1 Carton (0069-2432-10) / .418 Ml In 1 Syringe, Glass (0069-2432-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2432-10 | 0069-2432 | BLA125742 | BLA | N/A |
| Bnt162B2 Omicron (Kp.2) | Injection, Suspension | Intramuscular | .0158mg/1.58mL | 10 Vial, Multi-Dose In 1 Carton (59267-4426-2) / 1.58 Ml In 1 Vial, Multi-Dose (59267-4426-1) | Pfizer Manufacturing Belgium NV | 59267-4426-2 | 59267-4426 | N/A | EMERGENCY USE AUTHORIZATION | N/A |
| Bnt162B2 Omicron (Kp.2) | Injection, Suspension | Intramuscular | .0158mg/.48mL | 10 Vial, Single-Dose In 1 Carton (59267-4438-2) / .48 Ml In 1 Vial, Single-Dose (59267-4438-1) | Pfizer Manufacturing Belgium NV | 59267-4438-2 | 59267-4438 | N/A | EMERGENCY USE AUTHORIZATION | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial, Single-Dose In 1 Carton (71288-118-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-118-10 | 71288-118 | ANDA212958 | ANDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial In 1 Carton (25021-244-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-244-10 | 25021-244 | ANDA208392 | ANDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial In 1 Carton (60505-6050-4) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Apotex Corp | 60505-6050-4 | 60505-6050 | ANDA205533 | ANDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial In 1 Carton (0143-9098-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9098-01 | 0143-9098 | ANDA215011 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (65162-759-39) / 22.5 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-759-39 | 65162-759 | ANDA205666 | ANDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial, Single-Dose In 1 Carton (0409-1700-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1700-01 | 0409-1700 | ANDA208460 | ANDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 2.5mg/1 | 1 Vial, Single-Dose In 1 Carton (0409-1703-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1703-01 | 0409-1703 | NDA209191 | NDA | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 1mg/1 | 1 Vial, Single-Dose In 1 Carton (0409-1704-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1704-01 | 0409-1704 | NDA209191 | NDA | N/A |
| Bos Taurus Dander; Bos Taurus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 10 Ml In 1 Vial (65044-4811-2) | Jubilant HollisterStier LLC | 65044-4811-2 | 65044-4811 | BLA103888 | BLA | N/A |
| Bos Taurus Dander; Bos Taurus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 30 Ml In 1 Vial (65044-4811-3) | Jubilant HollisterStier LLC | 65044-4811-3 | 65044-4811 | BLA103888 | BLA | N/A |
| Bos Taurus Dander; Bos Taurus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 50 Ml In 1 Vial (65044-4811-4) | Jubilant HollisterStier LLC | 65044-4811-4 | 65044-4811 | BLA103888 | BLA | N/A |
| Bos Taurus Dander; Bos Taurus Hair | Injection, Solution | Percutaneous | .01g/mL, .01 g/mL | 5 Ml In 1 Vial (65044-4812-1) | Jubilant HollisterStier LLC | 65044-4812-1 | 65044-4812 | BLA103888 | BLA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 1 Bottle In 1 Carton (65162-760-84) / 30 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-760-84 | 65162-760 | ANDA205666 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (65162-708-83) / 15 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-708-83 | 65162-708 | ANDA205666 | ANDA | N/A |
| Bosutinib Monohydrate | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0193-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0193-01 | 0069-0193 | NDA203341 | NDA | N/A |
| Bosutinib Monohydrate | Capsule | Oral | 100mg/1 | 150 Capsule In 1 Bottle (0069-1014-15) | Pfizer Laboratories Div Pfizer Inc | 0069-1014-15 | 0069-1014 | NDA217729 | NDA | N/A |
| Bosutinib Monohydrate | Tablet, Film Coated | Oral | 100mg/1 | 120 Tablet, Film Coated In 1 Bottle (0069-0135-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0135-01 | 0069-0135 | NDA203341 | NDA | N/A |
| Bosutinib Monohydrate | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0136-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0136-01 | 0069-0136 | NDA203341 | NDA | N/A |
| Bosutinib Monohydrate | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (0069-0504-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0504-30 | 0069-0504 | NDA217729 | NDA | N/A |
| Botrytis Cinerea | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5048-2) | Jubilant HollisterStier LLC | 65044-5048-2 | 65044-5048 | BLA103888 | BLA | N/A |
| Botrytis Cinerea | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5048-3) | Jubilant HollisterStier LLC | 65044-5048-3 | 65044-5048 | BLA103888 | BLA | N/A |
| Botrytis Cinerea | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5048-4) | Jubilant HollisterStier LLC | 65044-5048-4 | 65044-5048 | BLA103888 | BLA | N/A |
| Botrytis Cinerea | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5049-1) | Jubilant HollisterStier LLC | 65044-5049-1 | 65044-5049 | BLA103888 | BLA | N/A |
| Brazil Nut | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3107-2) | Jubilant HollisterStier LLC | 65044-3107-2 | 65044-3107 | BLA103888 | BLA | N/A |
| Brilliant Green; Gentian Violet; Proflavine Hemisulfate | Swab | Topical | 2.29mg/mL, 2.2 mg/mL, 1.14 mg/mL | 100 Applicator In 1 Box (66689-710-06) / 1 Ml In 1 Applicator | VistaPharm, LLC | 66689-710-06 | 66689-710 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Brimonidine Tartrate | Gel | Topical | 5mg/g | 1 Bottle, Pump In 1 Carton (45802-078-30) / 30 G In 1 Bottle, Pump | Padagis Israel Pharmaceuticals Ltd | 45802-078-30 | 45802-078 | ANDA209158 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle In 1 Carton (70069-566-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-566-01 | 70069-566 | ANDA216906 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle In 1 Carton (70069-567-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-567-01 | 70069-567 | ANDA216906 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle In 1 Carton (70069-568-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-568-01 | 70069-568 | ANDA216906 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 2mg/mL | 1 Bottle In 1 Carton (70069-231-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-231-01 | 70069-231 | ANDA208992 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 2mg/mL | 1 Bottle In 1 Carton (70069-232-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-232-01 | 70069-232 | ANDA208992 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 2mg/mL | 1 Bottle In 1 Carton (70069-233-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-233-01 | 70069-233 | ANDA208992 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1.5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0564-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0564-1 | 60505-0564 | ANDA078479 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1.5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0564-2) / 10 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0564-2 | 60505-0564 | ANDA078479 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1.5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0564-3) / 15 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0564-3 | 60505-0564 | ANDA078479 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0577-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0577-1 | 60505-0577 | ANDA078480 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0577-2) / 10 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0577-2 | 60505-0577 | ANDA078480 | ANDA | N/A |
| Brimonidine Tartrate | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0577-3) / 15 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0577-3 | 60505-0577 | ANDA078480 | ANDA | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution/ Drops | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6225-0) / 5 Ml In 1 Bottle, Dropper | Apotex Corp | 60505-6225-0 | 60505-6225 | NDA021398 | NDA AUTHORIZED GENERIC | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution/ Drops | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6225-1) / 10 Ml In 1 Bottle, Dropper | Apotex Corp | 60505-6225-1 | 60505-6225 | NDA021398 | NDA AUTHORIZED GENERIC | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution/ Drops | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-6225-2) / 15 Ml In 1 Bottle, Dropper | Apotex Corp | 60505-6225-2 | 60505-6225 | NDA021398 | NDA AUTHORIZED GENERIC | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0589-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0589-1 | 60505-0589 | ANDA091442 | ANDA | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0589-2) / 10 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0589-2 | 60505-0589 | ANDA091442 | ANDA | N/A |
| Brimonidine Tartrate; Timolol Maleate | Solution | Ophthalmic | 2mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0589-3) / 15 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0589-3 | 60505-0589 | ANDA091442 | ANDA | N/A |
| Brinzolamide | Suspension/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (0574-4012-10) / 10 Ml In 1 Bottle | Padagis US LLC | 0574-4012-10 | 0574-4012 | ANDA211914 | ANDA | N/A |
| Brinzolamide | Suspension/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (0574-4012-15) / 15 Ml In 1 Bottle | Padagis US LLC | 0574-4012-15 | 0574-4012 | ANDA211914 | ANDA | N/A |
| Bromfenac Sodium | Solution/ Drops | Ophthalmic | .7mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1006-1) / 1.6 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-1006-1 | 60505-1006 | ANDA207334 | ANDA | N/A |
| Bromfenac Sodium | Solution/ Drops | Ophthalmic | .7mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1006-2) / 3 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-1006-2 | 60505-1006 | ANDA207334 | ANDA | N/A |
| Bromocriptine Mesylate | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (0574-0106-01) | Padagis US LLC | 0574-0106-01 | 0574-0106 | ANDA077646 | ANDA | N/A |
| Bromocriptine Mesylate | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle, Plastic (0574-0106-03) | Padagis US LLC | 0574-0106-03 | 0574-0106 | ANDA077646 | ANDA | N/A |
| Bromocriptine Mesylate | Capsule, Gelatin Coated | Oral | 5mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (30698-201-01) | Validus Pharmaceuticals LLC | 30698-201-01 | 30698-201 | NDA017962 | NDA | N/A |
| Bromocriptine Mesylate | Capsule, Gelatin Coated | Oral | 5mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (30698-201-30) | Validus Pharmaceuticals LLC | 30698-201-30 | 30698-201 | NDA017962 | NDA | N/A |
| Bromocriptine Mesylate | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (30698-202-01) | Validus Pharmaceuticals LLC | 30698-202-01 | 30698-202 | NDA017962 | NDA | N/A |
| Bromocriptine Mesylate | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (30698-202-30) | Validus Pharmaceuticals LLC | 30698-202-30 | 30698-202 | NDA017962 | NDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 118 Ml In 1 Bottle, Plastic (0574-1104-04) | Padagis US LLC | 0574-1104-04 | 0574-1104 | ANDA205292 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 473 Ml In 1 Bottle, Plastic (0574-1104-16) | Padagis US LLC | 0574-1104-16 | 0574-1104 | ANDA205292 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 118 Ml In 1 Bottle (51672-4165-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4165-8 | 51672-4165 | ANDA205112 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 473 Ml In 1 Bottle (51672-4165-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4165-9 | 51672-4165 | ANDA205112 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 118 Ml In 1 Bottle, Plastic (42192-607-04) | Acella Pharmaceuticals, LLC | 42192-607-04 | 42192-607 | ANDA203375 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 473 Ml In 1 Bottle, Plastic (42192-607-16) | Acella Pharmaceuticals, LLC | 42192-607-16 | 42192-607 | ANDA203375 | ANDA | N/A |
| Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride | Syrup | Oral | 2mg/5mL, 10 mg/5mL, 30 mg/5mL | 40 Cup, Unit-Dose In 1 Case (42192-607-40) / 5 Ml In 1 Cup, Unit-Dose (42192-607-05) | Acella Pharmaceuticals, LLC | 42192-607-40 | 42192-607 | ANDA203375 | ANDA | N/A |
| Bromus Inermis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1237-2) | Jubilant HollisterStier LLC | 65044-1237-2 | 65044-1237 | BLA103888 | BLA | N/A |
| Bromus Inermis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1237-3) | Jubilant HollisterStier LLC | 65044-1237-3 | 65044-1237 | BLA103888 | BLA | N/A |
| Bromus Inermis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1237-4) | Jubilant HollisterStier LLC | 65044-1237-4 | 65044-1237 | BLA103888 | BLA | N/A |
| Bromus Inermis Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1238-1) | Jubilant HollisterStier LLC | 65044-1238-1 | 65044-1238 | BLA103888 | BLA | N/A |
| Brown Rice | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3548-2) | Jubilant HollisterStier LLC | 65044-3548-2 | 65044-3548 | BLA103888 | BLA | N/A |
| Bryonia Alba Root; Lactic Acid | Liquid | Oral | 3[hp_X]/15mL, 3 [hp_X]/15mL | 1 Bottle, Plastic In 1 Carton (52389-621-04) / 118 Ml In 1 Bottle, Plastic | Alva-Amco Pharmacal Companies, Inc. | 52389-621-04 | 52389-621 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 100mg/5mL | 15 Ml In 1 Bottle, Plastic (42806-147-31) | Epic Pharma, LLC | 42806-147-31 | 42806-147 | ANDA207531 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 15 Ml In 1 Bottle, Plastic (42806-149-32) | Epic Pharma, LLC | 42806-149-32 | 42806-149 | ANDA207531 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 22.5 Ml In 1 Bottle, Plastic (42806-150-33) | Epic Pharma, LLC | 42806-150-33 | 42806-150 | ANDA207531 | ANDA | N/A |
| Azithromycin Monohydrate | Powder, For Suspension | Oral | 200mg/5mL | 30 Ml In 1 Bottle, Plastic (42806-151-34) | Epic Pharma, LLC | 42806-151-34 | 42806-151 | ANDA207531 | ANDA | N/A |
| Budesonide | Aerosol, Foam | Rectal | 2mg/1 | 2 Canister In 1 Carton (45802-627-86) / 1 Aerosol, Foam In 1 Canister (45802-627-01) | Padagis Israel Pharmaceuticals Ltd | 45802-627-86 | 45802-627 | ANDA215328 | ANDA | N/A |
| Budesonide | Capsule | Oral | 3mg/1 | 1 Bottle In 1 Carton (0574-9855-10) / 100 Capsule In 1 Bottle | Padagis US LLC | 0574-9855-10 | 0574-9855 | NDA021324 | NDA | N/A |
| Budesonide | Tablet, Film Coated, Extended Release | Oral | 9mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (51407-824-30) | Golden State Medical Supply, Inc. | 51407-824-30 | 51407-824 | ANDA205457 | ANDA | N/A |
| Budesonide | Capsule, Delayed Release Pellets | Oral | 3mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-128-01) | Golden State Medical Supply, Inc. | 51407-128-01 | 51407-128 | ANDA206623 | ANDA | N/A |
| Budesonide | Spray, Metered | Nasal | 32ug/1 | 1 Bottle, Spray In 1 Bottle, Spray (60505-6129-2) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-6129-2 | 60505-6129 | ANDA078949 | ANDA | N/A |
| Budesonide | Spray, Metered | Nasal | 32ug/1 | 2 Bottle, Spray In 1 Carton (60505-6129-6) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-6129-6 | 60505-6129 | ANDA078949 | ANDA | N/A |
| Budesonide | Spray, Metered | Nasal | 32ug/1 | 3 Bottle, Spray In 1 Carton (60505-6129-7) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-6129-7 | 60505-6129 | ANDA078949 | ANDA | N/A |
| Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Ophthalmic | 400[USP'U]/g, 3.5 mg/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (16571-754-53) / 3.5 G In 1 Tube | Rising Pharma Holdings, Inc. | 16571-754-53 | 16571-754 | NDA050417 | NDA AUTHORIZED GENERIC | N/A |
| Baclofen | Injection | Intrathecal | .05mg/mL | 5 Ampule In 1 Box (70121-2496-5) / 1 Ml In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2496-5 | 70121-2496 | NDA020075 | NDA | N/A |
| Baclofen | Granule | Oral | 5mg/1 | 90 Packet In 1 Carton (64896-076-09) / 1 Granule In 1 Packet | Amneal Pharmaceuticals LLC | 64896-076-09 | 64896-076 | NDA215422 | NDA | N/A |
| Baclofen | Granule | Oral | 10mg/1 | 90 Packet In 1 Carton (64896-077-09) / 1 Granule In 1 Packet | Amneal Pharmaceuticals LLC | 64896-077-09 | 64896-077 | NDA215422 | NDA | N/A |
| Baclofen | Granule | Oral | 20mg/1 | 90 Packet In 1 Carton (64896-078-09) / 1 Granule In 1 Packet | Amneal Pharmaceuticals LLC | 64896-078-09 | 64896-078 | NDA215422 | NDA | N/A |
| Bumetanide | Injection, Solution | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (25021-321-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-321-04 | 25021-321 | ANDA074441 | ANDA | N/A |
| Bumetanide | Injection, Solution | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (25021-321-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-321-10 | 25021-321 | ANDA074441 | ANDA | N/A |
| Bumetanide | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (51672-4223-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4223-1 | 51672-4223 | ANDA213458 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (51672-4224-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4224-1 | 51672-4224 | ANDA213458 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51672-4225-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4225-1 | 51672-4225 | ANDA213458 | ANDA | N/A |
| Bumetanide | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (30698-630-01) | Validus Pharmaceuticals LLC | 30698-630-01 | 30698-630 | NDA018225 | NDA | N/A |
| Bumetanide | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (30698-631-01) | Validus Pharmaceuticals LLC | 30698-631-01 | 30698-631 | NDA018225 | NDA | N/A |
| Bumetanide | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (30698-632-01) | Validus Pharmaceuticals LLC | 30698-632-01 | 30698-632 | NDA018225 | NDA | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (62559-204-03) / 300 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-204-03 | 62559-204 | ANDA217252 | ANDA | N/A |
| Baclofen | Suspension | Oral | 5mg/mL | 1 Bottle In 1 Carton (62559-204-12) / 120 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-204-12 | 62559-204 | ANDA217252 | ANDA | N/A |
| Baclofen | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-138-01) | Camber Pharmaceuticals, Inc. | 31722-138-01 | 31722-138 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (31722-138-10) | Camber Pharmaceuticals, Inc. | 31722-138-10 | 31722-138 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-998-01) | Camber Pharmaceuticals, Inc. | 31722-998-01 | 31722-998 | ANDA212378 | ANDA | N/A |
| Bumetanide | Injection | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0641-6007-10) / 10 Ml In 1 Vial (0641-6007-01) | Hikma Pharmaceuticals USA Inc. | 0641-6007-10 | 0641-6007 | ANDA079196 | ANDA | N/A |
| Bumetanide | Injection | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0641-6008-10) / 4 Ml In 1 Vial (0641-6008-01) | Hikma Pharmaceuticals USA Inc. | 0641-6008-10 | 0641-6008 | ANDA079196 | ANDA | N/A |
| Bumetanide | Injection | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0641-6284-10) / 4 Ml In 1 Vial (0641-6284-01) | Hikma Pharmaceuticals USA Inc. | 0641-6284-10 | 0641-6284 | ANDA079196 | ANDA | N/A |
| Bumetanide | Injection | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0641-6285-10) / 10 Ml In 1 Vial (0641-6285-01) | Hikma Pharmaceuticals USA Inc. | 0641-6285-10 | 0641-6285 | ANDA079196 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-721-11) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-721-11 | 71288-721 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-722-32) / 30 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-722-32 | 71288-722 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-723-52) / 50 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc | 71288-723-52 | 71288-723 | ANDA216039 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-724-11) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-724-11 | 71288-724 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-725-32) / 30 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-725-32 | 71288-725 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Perineural | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-726-52) / 50 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc | 71288-726-52 | 71288-726 | ANDA216039 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-727-11) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-727-11 | 71288-727 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-728-32) / 30 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-728-32 | 71288-728 | ANDA216040 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 1 Vial In 1 Carton (70069-752-01) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-752-01 | 70069-752 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 10 Vial In 1 Carton (70069-752-10) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-752-10 | 70069-752 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 25 Vial In 1 Carton (70069-752-25) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-752-25 | 70069-752 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 5mg/mL | 1 Vial In 1 Carton (70069-753-01) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-753-01 | 70069-753 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 5mg/mL | 10 Vial In 1 Carton (70069-753-10) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-753-10 | 70069-753 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 5mg/mL | 25 Vial In 1 Carton (70069-753-25) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-753-25 | 70069-753 | ANDA217792 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0143-9328-10) / 50 Ml In 1 Vial, Multi-Dose (0143-9328-01) | Hikma Pharmaceuticals USA Inc. | 0143-9328-10 | 0143-9328 | ANDA205141 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Perineural | 5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0143-9329-10) / 50 Ml In 1 Vial, Multi-Dose (0143-9329-01) | Hikma Pharmaceuticals USA Inc. | 0143-9329-10 | 0143-9329 | ANDA205141 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9330-10) / 10 Ml In 1 Vial, Single-Dose (0143-9330-01) | Hikma Pharmaceuticals USA Inc. | 0143-9330-10 | 0143-9330 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9331-10) / 10 Ml In 1 Vial, Single-Dose (0143-9331-01) | Hikma Pharmaceuticals USA Inc. | 0143-9331-10 | 0143-9331 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9332-10) / 10 Ml In 1 Vial, Single-Dose (0143-9332-01) | Hikma Pharmaceuticals USA Inc. | 0143-9332-10 | 0143-9332 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9333-10) / 30 Ml In 1 Vial, Single-Dose (0143-9333-01) | Hikma Pharmaceuticals USA Inc. | 0143-9333-10 | 0143-9333 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9334-10) / 30 Ml In 1 Vial, Single-Dose (0143-9334-01) | Hikma Pharmaceuticals USA Inc. | 0143-9334-10 | 0143-9334 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9335-10) / 30 Ml In 1 Vial, Single-Dose (0143-9335-01) | Hikma Pharmaceuticals USA Inc. | 0143-9335-10 | 0143-9335 | ANDA204842 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Subarachnoid | 7.5mg/mL | 10 Ampule In 1 Carton (0409-3613-01) / 2 Ml In 1 Ampule (0409-3613-11) | Hospira, Inc. | 0409-3613-01 | 0409-3613 | ANDA071810 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1159-10) / 30 Ml In 1 Vial, Single-Dose (0409-1159-09) | Hospira, Inc. | 0409-1159-10 | 0409-1159 | ANDA070583 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1159-01) / 10 Ml In 1 Vial, Single-Dose (0409-1159-18) | Hospira, Inc. | 0409-1159-01 | 0409-1159 | ANDA070583 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1159-02) / 30 Ml In 1 Vial, Single-Dose (0409-1159-19) | Hospira, Inc. | 0409-1159-02 | 0409-1159 | ANDA070583 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-1160-01) / 50 Ml In 1 Vial, Multi-Dose (0409-1160-18) | Hospira, Inc. | 0409-1160-01 | 0409-1160 | ANDA070590 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1162-10) / 30 Ml In 1 Vial, Single-Dose (0409-1162-09) | Hospira, Inc. | 0409-1162-10 | 0409-1162 | ANDA070584 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1162-01) / 10 Ml In 1 Vial, Single-Dose (0409-1162-18) | Hospira, Inc. | 0409-1162-01 | 0409-1162 | ANDA070584 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1162-02) / 30 Ml In 1 Vial, Single-Dose (0409-1162-19) | Hospira, Inc. | 0409-1162-02 | 0409-1162 | ANDA070584 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Perineural | 5mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-1163-01) / 50 Ml In 1 Vial, Multi-Dose (0409-1163-18) | Hospira, Inc. | 0409-1163-01 | 0409-1163 | ANDA070597 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1165-01) / 10 Ml In 1 Vial, Single-Dose (0409-1165-18) | Hospira, Inc. | 0409-1165-01 | 0409-1165 | ANDA070585 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1165-02) / 30 Ml In 1 Vial, Single-Dose (0409-1165-19) | Hospira, Inc. | 0409-1165-02 | 0409-1165 | ANDA070585 | ANDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Perineural | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1610-50) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1610-50 | 0409-1610 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-1559-10) / 10 Ml In 1 Vial, Single-Dose (0409-1559-18) | Hospira, Inc. | 0409-1559-10 | 0409-1559 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1559-30) / 30 Ml In 1 Vial, Single-Dose (0409-1559-19) | Hospira, Inc. | 0409-1559-30 | 0409-1559 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-1560-10) / 10 Ml In 1 Vial, Single-Dose (0409-1560-18) | Hospira, Inc. | 0409-1560-10 | 0409-1560 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1560-29) / 30 Ml In 1 Vial, Single-Dose (0409-1560-19) | Hospira, Inc. | 0409-1560-29 | 0409-1560 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-1582-10) / 10 Ml In 1 Vial, Single-Dose (0409-1582-18) | Hospira, Inc. | 0409-1582-10 | 0409-1582 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Epidural; Retrobulbar | 7.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1582-29) / 30 Ml In 1 Vial, Single-Dose (0409-1582-19) | Hospira, Inc. | 0409-1582-29 | 0409-1582 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 2.5mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1587-50) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1587-50 | 0409-1587 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Subarachnoid | 7.5mg/mL | 2 Cello Pack In 1 Carton (0409-1761-10) / 5 Ampule In 1 Cello Pack (0409-1761-05) / 2 Ml In 1 Ampule (0409-1761-18) | Hospira, Inc. | 0409-1761-10 | 0409-1761 | NDA018692 | NDA | N/A |
| Bupivacaine Hydrochloride | Injection, Solution | Subarachnoid | 7.5mg/mL | 800 Ampule In 1 Case (0409-1761-62) / 2 Ml In 1 Ampule (0409-1761-18) | Hospira, Inc. | 0409-1761-62 | 0409-1761 | NDA018692 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, 5 ug/mL | 10 Vial, Single-Dose In 1 Carton (0409-9042-01) / 10 Ml In 1 Vial, Single-Dose (0409-9042-11) | Hospira, Inc. | 0409-9042-01 | 0409-9042 | ANDA071165 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, 5 ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9042-17) / 30 Ml In 1 Vial, Single-Dose (0409-9042-16) | Hospira, Inc. | 0409-9042-17 | 0409-9042 | ANDA071165 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Infiltration; Perineural | 2.5mg/mL, 5 ug/mL | 25 Carton In 1 Box (0409-9043-01) / 1 Vial, Multi-Dose In 1 Carton (0409-9043-11) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-9043-01 | 0409-9043 | ANDA071167 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, 5 ug/mL | 10 Vial, Single-Dose In 1 Carton (0409-9045-01) / 10 Ml In 1 Vial, Single-Dose (0409-9045-11) | Hospira, Inc. | 0409-9045-01 | 0409-9045 | ANDA071168 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, 5 ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9045-17) / 30 Ml In 1 Vial, Single-Dose (0409-9045-16) | Hospira, Inc. | 0409-9045-17 | 0409-9045 | ANDA071168 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Perineural | 5mg/mL, 5 ug/mL | 25 Carton In 1 Box (0409-9046-01) / 1 Vial, Multi-Dose In 1 Carton (0409-9046-11) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-9046-01 | 0409-9046 | ANDA071170 | ANDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Perineural | 5mg/mL, .0091 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-6581-01) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-6581-01 | 0409-6581 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-5738-10) / 10 Ml In 1 Vial, Single-Dose (0409-5738-01) | Hospira, Inc. | 0409-5738-10 | 0409-5738 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1746-10) / 10 Ml In 1 Vial, Single-Dose (0409-1746-70) | Hospira, Inc. | 0409-1746-10 | 0409-1746 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1746-30) / 30 Ml In 1 Vial, Single-Dose (0409-1746-71) | Hospira, Inc. | 0409-1746-30 | 0409-1746 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1749-10) / 10 Ml In 1 Vial, Single-Dose (0409-1749-70) | Hospira, Inc. | 0409-1749-10 | 0409-1749 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1749-29) / 30 Ml In 1 Vial, Single-Dose (0409-1749-71) | Hospira, Inc. | 0409-1749-29 | 0409-1749 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-8126-10) / 10 Ml In 1 Vial, Single-Dose (0409-8126-01) | Hospira, Inc. | 0409-8126-10 | 0409-8126 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Infiltration; Perineural | 2.5mg/mL, .0091 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1752-50) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1752-50 | 0409-1752 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Infiltration; Perineural | 2.5mg/mL, .0091 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-3812-01) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-3812-01 | 0409-3812 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Perineural | 5mg/mL, .0091 mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1755-50) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1755-50 | 0409-1755 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 2.5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1541-10) / 30 Ml In 1 Vial, Single-Dose (0409-1541-01) | Hospira, Inc. | 0409-1541-10 | 0409-1541 | NDA016964 | NDA | N/A |
| Bupivacaine Hydrochloride; Epinephrine Bitartrate | Injection, Solution | Epidural; Intracaudal; Perineural | 5mg/mL, .0091 mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-4208-10) / 30 Ml In 1 Vial, Single-Dose (0409-4208-01) | Hospira, Inc. | 0409-4208-10 | 0409-4208 | NDA016964 | NDA | N/A |
| Buprenorphine | Patch, Extended Release | Transdermal | 5ug/h | 4 Pouch In 1 Carton (47781-406-04) / 1 Patch In 1 Pouch (47781-406-11) / 168 H In 1 Patch | Alvogen Inc. | 47781-406-04 | 47781-406 | ANDA207490 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 10ug/h | 4 Pouch In 1 Carton (47781-407-04) / 1 Patch In 1 Pouch (47781-407-11) / 168 H In 1 Patch | Alvogen Inc. | 47781-407-04 | 47781-407 | ANDA207490 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 20ug/h | 4 Pouch In 1 Carton (47781-408-04) / 1 Patch In 1 Pouch (47781-408-11) / 168 H In 1 Patch | Alvogen Inc. | 47781-408-04 | 47781-408 | ANDA207490 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 15ug/h | 4 Pouch In 1 Carton (47781-419-04) / 1 Patch In 1 Pouch (47781-419-11) / 168 H In 1 Patch | Alvogen Inc. | 47781-419-04 | 47781-419 | ANDA207490 | ANDA | CIII |
| Baclofen | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (31722-998-05) | Camber Pharmaceuticals, Inc. | 31722-998-05 | 31722-998 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (31722-998-10) | Camber Pharmaceuticals, Inc. | 31722-998-10 | 31722-998 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-999-01) | Camber Pharmaceuticals, Inc. | 31722-999-01 | 31722-999 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (31722-999-05) | Camber Pharmaceuticals, Inc. | 31722-999-05 | 31722-999 | ANDA212378 | ANDA | N/A |
| Baclofen | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (31722-999-10) | Camber Pharmaceuticals, Inc. | 31722-999-10 | 31722-999 | ANDA212378 | ANDA | N/A |
| Buprenorphine Hydrochloride | Tablet | Sublingual | 2mg/1 | 30 Tablet In 1 Bottle (0054-0176-13) | Hikma Pharmaceuticals USA Inc. | 0054-0176-13 | 0054-0176 | ANDA078633 | ANDA | CIII |
| Buprenorphine Hydrochloride | Tablet | Sublingual | 8mg/1 | 30 Tablet In 1 Bottle (0054-0177-13) | Hikma Pharmaceuticals USA Inc. | 0054-0177-13 | 0054-0177 | ANDA078633 | ANDA | CIII |
| Buprenorphine Hydrochloride | Injection | Intramuscular; Intravenous | .324mg/mL | 5 Vial In 1 Carton (0143-9246-05) / 1 Ml In 1 Vial (0143-9246-01) | Hikma Pharmaceuticals USA Inc. | 0143-9246-05 | 0143-9246 | ANDA076931 | ANDA | CIII |
| Buprenorphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | .3mg/mL | 10 Cartridge In 1 Carton (0409-2012-32) / 1 Ml In 1 Cartridge (0409-2012-03) | Hospira, Inc. | 0409-2012-32 | 0409-2012 | ANDA074137 | ANDA | CIII |
| Baclofen | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (16571-169-01) | Rising Pharma Holdings, Inc. | 16571-169-01 | 16571-169 | ANDA214374 | ANDA | N/A |
| Baclofen | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (16571-171-01) | Rising Pharma Holdings, Inc. | 16571-171-01 | 16571-171 | ANDA214374 | ANDA | N/A |
| Baclofen | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (16571-171-10) | Rising Pharma Holdings, Inc. | 16571-171-10 | 16571-171 | ANDA214374 | ANDA | N/A |
| Baclofen | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (16571-171-50) | Rising Pharma Holdings, Inc. | 16571-171-50 | 16571-171 | ANDA214374 | ANDA | N/A |
| Baclofen | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (16571-172-01) | Rising Pharma Holdings, Inc. | 16571-172-01 | 16571-172 | ANDA214374 | ANDA | N/A |
| Baclofen | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (16571-172-10) | Rising Pharma Holdings, Inc. | 16571-172-10 | 16571-172 | ANDA214374 | ANDA | N/A |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Film | Buccal; Sublingual | 2mg/1, .5 mg/1 | 30 Pouch In 1 Carton (47781-355-03) / 1 Film In 1 Pouch (47781-355-11) | Alvogen Inc. | 47781-355-03 | 47781-355 | ANDA205954 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Film | Buccal; Sublingual | 4mg/1, 1 mg/1 | 30 Pouch In 1 Carton (47781-356-03) / 1 Film In 1 Pouch (47781-356-11) | Alvogen Inc. | 47781-356-03 | 47781-356 | ANDA205954 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Film | Buccal; Sublingual | 8mg/1, 2 mg/1 | 30 Pouch In 1 Carton (47781-357-03) / 1 Film In 1 Pouch (47781-357-11) | Alvogen Inc. | 47781-357-03 | 47781-357 | ANDA205954 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Film | Buccal; Sublingual | 12mg/1, 3 mg/1 | 30 Pouch In 1 Carton (47781-358-03) / 1 Film In 1 Pouch (47781-358-11) | Alvogen Inc. | 47781-358-03 | 47781-358 | ANDA205954 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 2mg/1, .5 mg/1 | 30 Tablet In 1 Bottle (0054-0188-13) | Hikma Pharmaceuticals USA Inc. | 0054-0188-13 | 0054-0188 | ANDA203326 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 8mg/1, 2 mg/1 | 30 Tablet In 1 Bottle (0054-0189-13) | Hikma Pharmaceuticals USA Inc. | 0054-0189-13 | 0054-0189 | ANDA203326 | ANDA | CIII |
| Baclofen | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (16571-172-50) | Rising Pharma Holdings, Inc. | 16571-172-50 | 16571-172 | ANDA214374 | ANDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (65162-751-03) | Amneal Pharmaceuticals LLC | 65162-751-03 | 65162-751 | ANDA076820 | ANDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (65162-751-10) | Amneal Pharmaceuticals LLC | 65162-751-10 | 65162-751 | ANDA076820 | ANDA | N/A |
| Benazepril Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-751-50) | Amneal Pharmaceuticals LLC | 65162-751-50 | 65162-751 | ANDA076820 | ANDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 6.25 mg/1 | 100 Tablet In 1 Bottle (62559-414-01) | ANI Pharmaceuticals, Inc. | 62559-414-01 | 62559-414 | ANDA076342 | ANDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (62559-415-01) | ANI Pharmaceuticals, Inc. | 62559-415-01 | 62559-415 | ANDA076342 | ANDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (62559-416-01) | ANI Pharmaceuticals, Inc. | 62559-416-01 | 62559-416 | ANDA076342 | ANDA | N/A |
| Benazepril Hydrochloride; Hydrochlorothiazide | Tablet | Oral | 20mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (62559-417-01) | ANI Pharmaceuticals, Inc. | 62559-417-01 | 62559-417 | ANDA076342 | ANDA | N/A |
| Benzonatate | Capsule, Liquid Filled | Oral | 100mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (65162-536-10) | Amneal Pharmaceuticals LLC | 65162-536-10 | 65162-536 | ANDA040682 | ANDA | N/A |
| Benzonatate | Capsule, Liquid Filled | Oral | 100mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (65162-536-50) | Amneal Pharmaceuticals LLC | 65162-536-50 | 65162-536 | ANDA040682 | ANDA | N/A |
| Benzonatate | Capsule, Liquid Filled | Oral | 200mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (65162-537-10) | Amneal Pharmaceuticals LLC | 65162-537-10 | 65162-537 | ANDA040682 | ANDA | N/A |
| Benzonatate | Capsule, Liquid Filled | Oral | 200mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (65162-537-50) | Amneal Pharmaceuticals LLC | 65162-537-50 | 65162-537 | ANDA040682 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (31722-956-01) | Camber Pharmaceuticals, Inc. | 31722-956-01 | 31722-956 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (31722-956-05) | Camber Pharmaceuticals, Inc. | 31722-956-05 | 31722-956 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (31722-956-30) | Camber Pharmaceuticals, Inc. | 31722-956-30 | 31722-956 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (31722-957-01) | Camber Pharmaceuticals, Inc. | 31722-957-01 | 31722-957 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (31722-957-05) | Camber Pharmaceuticals, Inc. | 31722-957-05 | 31722-957 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (31722-957-30) | Camber Pharmaceuticals, Inc. | 31722-957-30 | 31722-957 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (31722-958-01) | Camber Pharmaceuticals, Inc. | 31722-958-01 | 31722-958 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (31722-958-05) | Camber Pharmaceuticals, Inc. | 31722-958-05 | 31722-958 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (31722-958-30) | Camber Pharmaceuticals, Inc. | 31722-958-30 | 31722-958 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (42806-714-01) | Epic Pharma LLC | 42806-714-01 | 42806-714 | ANDA206948 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (42806-714-05) | Epic Pharma LLC | 42806-714-05 | 42806-714 | ANDA206948 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle, Plastic (51407-206-05) | Golden State Medical Supply, Inc. | 51407-206-05 | 51407-206 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (51407-206-30) | Golden State Medical Supply, Inc. | 51407-206-30 | 51407-206 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (51407-206-90) | Golden State Medical Supply, Inc. | 51407-206-90 | 51407-206 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle, Plastic (51407-207-05) | Golden State Medical Supply, Inc. | 51407-207-05 | 51407-207 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (51407-207-30) | Golden State Medical Supply, Inc. | 51407-207-30 | 51407-207 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (51407-207-90) | Golden State Medical Supply, Inc. | 51407-207-90 | 51407-207 | ANDA210081 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-746-01) | Golden State Medical Supply, Inc. | 60429-746-01 | 60429-746 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0157-1) | Apotex Corp | 60505-0157-1 | 60505-0157 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0157-3) | Apotex Corp | 60505-0157-3 | 60505-0157 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-0157-5) | Apotex Corp | 60505-0157-5 | 60505-0157 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0157-7) | Apotex Corp | 60505-0157-7 | 60505-0157 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-0157-9) | Apotex Corp | 60505-0157-9 | 60505-0157 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0158-1) | Apotex Corp | 60505-0158-1 | 60505-0158 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0158-3) | Apotex Corp | 60505-0158-3 | 60505-0158 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-0158-5) | Apotex Corp | 60505-0158-5 | 60505-0158 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0158-7) | Apotex Corp | 60505-0158-7 | 60505-0158 | ANDA076143 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated | Oral | 75mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-0158-9) | Apotex Corp | 60505-0158-9 | 60505-0158 | ANDA076143 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (42806-715-01) | Epic Pharma LLC | 42806-715-01 | 42806-715 | ANDA206948 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (42806-715-05) | Epic Pharma LLC | 42806-715-05 | 42806-715 | ANDA206948 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (64980-634-01) | Rising Pharma Holdings, Inc. | 64980-634-01 | 64980-634 | ANDA202765 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (64980-634-50) | Rising Pharma Holdings, Inc. | 64980-634-50 | 64980-634 | ANDA202765 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (64980-635-01) | Rising Pharma Holdings, Inc. | 64980-635-01 | 64980-635 | ANDA202765 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (64980-635-50) | Rising Pharma Holdings, Inc. | 64980-635-50 | 64980-635 | ANDA202765 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (72865-117-01) | XLCare Pharmaceuticals, Inc. | 72865-117-01 | 72865-117 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (72865-117-05) | XLCare Pharmaceuticals, Inc. | 72865-117-05 | 72865-117 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (72865-117-30) | XLCare Pharmaceuticals, Inc. | 72865-117-30 | 72865-117 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (72865-118-01) | XLCare Pharmaceuticals, Inc. | 72865-118-01 | 72865-118 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (72865-118-05) | XLCare Pharmaceuticals, Inc. | 72865-118-05 | 72865-118 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (72865-118-30) | XLCare Pharmaceuticals, Inc. | 72865-118-30 | 72865-118 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (72865-119-01) | XLCare Pharmaceuticals, Inc. | 72865-119-01 | 72865-119 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (72865-119-05) | XLCare Pharmaceuticals, Inc. | 72865-119-05 | 72865-119 | ANDA211518 | ANDA | N/A |
| Benzonatate | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (72865-119-30) | XLCare Pharmaceuticals, Inc. | 72865-119-30 | 72865-119 | ANDA211518 | ANDA | N/A |
| Benzoyl Peroxide; Erythromycin | Gel | Topical | 50mg/g, 30 mg/g | 23.3 G In 1 Jar (64980-328-01) | Rising Pharma Holdings, Inc. | 64980-328-01 | 64980-328 | ANDA065385 | ANDA | N/A |
| Benzoyl Peroxide; Erythromycin | Gel | Topical | 50mg/g, 30 mg/g | 46.6 G In 1 Jar (64980-328-02) | Rising Pharma Holdings, Inc. | 64980-328-02 | 64980-328 | ANDA065385 | ANDA | N/A |
| Benzphetamine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-081-01) | Epic Pharma, LLC | 42806-081-01 | 42806-081 | ANDA090346 | ANDA | CIII |
| Benzphetamine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-081-05) | Epic Pharma, LLC | 42806-081-05 | 42806-081 | ANDA090346 | ANDA | CIII |
| Benzphetamine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-081-30) | Epic Pharma, LLC | 42806-081-30 | 42806-081 | ANDA090346 | ANDA | CIII |
| Betaxolol Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-038-01) | Epic Pharma LLC | 42806-038-01 | 42806-038 | ANDA075541 | ANDA | N/A |
| Betaxolol Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-038-10) | Epic Pharma LLC | 42806-038-10 | 42806-038 | ANDA075541 | ANDA | N/A |
| Betaxolol Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-039-01) | Epic Pharma LLC | 42806-039-01 | 42806-039 | ANDA075541 | ANDA | N/A |
| Betaxolol Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-039-10) | Epic Pharma LLC | 42806-039-10 | 42806-039 | ANDA075541 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (65162-571-10) | Amneal Pharmaceuticals LLC | 65162-571-10 | 65162-571 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (65162-571-11) | Amneal Pharmaceuticals LLC | 65162-571-11 | 65162-571 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-571-50) | Amneal Pharmaceuticals LLC | 65162-571-50 | 65162-571 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (65162-572-10) | Amneal Pharmaceuticals LLC | 65162-572-10 | 65162-572 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-572-11) | Amneal Pharmaceuticals LLC | 65162-572-11 | 65162-572 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-572-50) | Amneal Pharmaceuticals LLC | 65162-572-50 | 65162-572 | ANDA040855 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 450mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (47781-637-30) | Alvogen Inc. | 47781-637-30 | 47781-637 | NDA022497 | NDA AUTHORIZED GENERIC | N/A |
| Bethanechol Chloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (65162-573-10) | Amneal Pharmaceuticals LLC | 65162-573-10 | 65162-573 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (65162-573-11) | Amneal Pharmaceuticals LLC | 65162-573-11 | 65162-573 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (65162-573-50) | Amneal Pharmaceuticals LLC | 65162-573-50 | 65162-573 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (65162-574-10) | Amneal Pharmaceuticals LLC | 65162-574-10 | 65162-574 | ANDA040855 | ANDA | N/A |
| Bethanechol Chloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-574-50) | Amneal Pharmaceuticals LLC | 65162-574-50 | 65162-574 | ANDA040855 | ANDA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 100mg/4mL | 1 Vial In 1 Carton (70121-1754-1) / 4 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1754-1 | 70121-1754 | BLA761231 | BLA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 100mg/4mL | 10 Vial In 1 Carton (70121-1754-7) / 4 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1754-7 | 70121-1754 | BLA761231 | BLA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 400mg/16mL | 1 Vial In 1 Carton (70121-1755-1) / 16 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1755-1 | 70121-1755 | BLA761231 | BLA | N/A |
| Bevacizumab | Injection, Solution | Intravenous | 400mg/16mL | 10 Vial In 1 Carton (70121-1755-7) / 16 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1755-7 | 70121-1755 | BLA761231 | BLA | N/A |
| Bexarotene | Capsule, Liquid Filled | Oral | 75mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (43975-315-10) | ANI Pharmaceuticals, Inc. | 43975-315-10 | 43975-315 | ANDA209861 | ANDA | N/A |
| Bexarotene | Capsule | Oral | 75mg/1 | 1 Bottle In 1 Carton (43602-176-01) / 100 Capsule In 1 Bottle | Ascent pharmaceutical Inc | 43602-176-01 | 43602-176 | ANDA208628 | ANDA | N/A |
| Bexarotene | Capsule | Oral | 75mg/1 | 1 Bottle In 1 Carton (43602-176-05) / 500 Capsule In 1 Bottle | Ascent pharmaceutical Inc | 43602-176-05 | 43602-176 | ANDA208628 | ANDA | N/A |
| Bicalutamide | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (62559-890-30) | ANI Pharmaceuticals, Inc. | 62559-890-30 | 62559-890 | NDA020498 | NDA | N/A |
| Bicalutamide | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (62559-680-30) | ANI Pharmaceuticals, Inc. | 62559-680-30 | 62559-680 | NDA020498 | NDA | N/A |
| Bisacodyl | Suppository | Rectal | 10mg/1 | 6 Blister Pack In 1 Carton (57237-327-03) / 5 Suppository In 1 Blister Pack (57237-327-51) | Rising Pharma Holdings, Inc. | 57237-327-03 | 57237-327 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Bisacodyl | Suppository | Rectal | 10mg/1 | 3 Blister Pack In 1 Carton (57237-327-21) / 4 Suppository In 1 Blister Pack (57237-327-04) | Rising Pharma Holdings, Inc. | 57237-327-21 | 57237-327 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride | Capsule | Oral | 140mg/1, 125 mg/1, 125 mg/1 | 120 Capsule In 1 Carton (50742-283-13) | Ingenus Pharmaceuticals, LLC | 50742-283-13 | 50742-283 | ANDA217511 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 2.5mg/1, 6.25 mg/1 | 30 Tablet In 1 Bottle (70954-412-10) | ANI Pharmaceuticals, Inc. | 70954-412-10 | 70954-412 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 2.5mg/1, 6.25 mg/1 | 100 Tablet In 1 Bottle (70954-412-30) | ANI Pharmaceuticals, Inc. | 70954-412-30 | 70954-412 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 2.5mg/1, 6.25 mg/1 | 500 Tablet In 1 Bottle (70954-412-40) | ANI Pharmaceuticals, Inc. | 70954-412-40 | 70954-412 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 6.25 mg/1 | 30 Tablet In 1 Bottle (70954-413-10) | ANI Pharmaceuticals, Inc. | 70954-413-10 | 70954-413 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 6.25 mg/1 | 100 Tablet In 1 Bottle (70954-413-30) | ANI Pharmaceuticals, Inc. | 70954-413-30 | 70954-413 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 6.25 mg/1 | 500 Tablet In 1 Bottle (70954-413-40) | ANI Pharmaceuticals, Inc. | 70954-413-40 | 70954-413 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 6.25 mg/1 | 30 Tablet In 1 Bottle (70954-414-10) | ANI Pharmaceuticals, Inc. | 70954-414-10 | 70954-414 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 6.25 mg/1 | 100 Tablet In 1 Bottle (70954-414-30) | ANI Pharmaceuticals, Inc. | 70954-414-30 | 70954-414 | ANDA215562 | ANDA | N/A |
| Bisoprolol Fumarate; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 6.25 mg/1 | 500 Tablet In 1 Bottle (70954-414-40) | ANI Pharmaceuticals, Inc. | 70954-414-40 | 70954-414 | ANDA215562 | ANDA | N/A |
| Bleomycin Sulfate | Injection, Powder, Lyophilized, For Solution | Intra-Arterial; Intramuscular; Intravenous | 15000[iU]/1 | 1 Injection, Powder, Lyophilized, For Solution In 1 Carton (70121-1567-1) | Amneal Pharmaceuticals LLC | 70121-1567-1 | 70121-1567 | N/A | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | N/A |
| Bortezomib | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | 3.5mg/1 | 1 Vial In 1 Carton (50742-484-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-484-01 | 50742-484 | ANDA210824 | ANDA | N/A |
| Bosentan Anhydrous | Tablet, Film Coated | Oral | 62.5mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-873-06) | Amneal Pharmaceuticals LLC | 65162-873-06 | 65162-873 | ANDA209742 | ANDA | N/A |
| Bosentan Anhydrous | Tablet, Film Coated | Oral | 125mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-874-06) | Amneal Pharmaceuticals LLC | 65162-874-06 | 65162-874 | ANDA209742 | ANDA | N/A |
| Budesonide | Capsule, Delayed Release | Oral | 3mg/1 | 100 Capsule, Delayed Release In 1 Bottle (65162-778-10) | Amneal Pharmaceuticals LLC | 65162-778-10 | 65162-778 | ANDA206200 | ANDA | N/A |
| Budesonide | Capsule, Delayed Release | Oral | 3mg/1 | 180 Capsule, Delayed Release In 1 Bottle (65162-778-18) | Amneal Pharmaceuticals LLC | 65162-778-18 | 65162-778 | ANDA206200 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (75834-266-01) | Nivagen Pharmaceuticals Inc. | 75834-266-01 | 75834-266 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (75834-266-05) | Nivagen Pharmaceuticals Inc. | 75834-266-05 | 75834-266 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (75834-267-01) | Nivagen Pharmaceuticals Inc. | 75834-267-01 | 75834-267 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (75834-268-01) | Nivagen Pharmaceuticals Inc. | 75834-268-01 | 75834-268 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (75834-268-05) | Nivagen Pharmaceuticals Inc. | 75834-268-05 | 75834-268 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (75834-269-01) | Nivagen Pharmaceuticals Inc. | 75834-269-01 | 75834-269 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (75834-269-05) | Nivagen Pharmaceuticals Inc. | 75834-269-05 | 75834-269 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 60 Tablet In 1 Bottle (75834-269-60) | Nivagen Pharmaceuticals Inc. | 75834-269-60 | 75834-269 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 30mg/1 | 60 Tablet In 1 Bottle (75834-270-60) | Nivagen Pharmaceuticals Inc. | 75834-270-60 | 75834-270 | ANDA209696 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-413-01) | Golden State Medical Supply, Inc. | 51407-413-01 | 51407-413 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (51407-413-05) | Golden State Medical Supply, Inc. | 51407-413-05 | 51407-413 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (51407-414-01) | Golden State Medical Supply, Inc. | 51407-414-01 | 51407-414 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-415-01) | Golden State Medical Supply, Inc. | 51407-415-01 | 51407-415 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (51407-415-05) | Golden State Medical Supply, Inc. | 51407-415-05 | 51407-415 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (51407-416-05) | Golden State Medical Supply, Inc. | 51407-416-05 | 51407-416 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 60 Tablet In 1 Bottle (51407-416-60) | Golden State Medical Supply, Inc. | 51407-416-60 | 51407-416 | ANDA202330 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 30mg/1 | 60 Tablet In 1 Bottle (51407-417-60) | Golden State Medical Supply, Inc. | 51407-417-60 | 51407-417 | ANDA202330 | ANDA | N/A |
| Budesonide | Capsule, Delayed Release | Oral | 3mg/1 | 300 Capsule, Delayed Release In 1 Bottle (65162-778-30) | Amneal Pharmaceuticals LLC | 65162-778-30 | 65162-778 | ANDA206200 | ANDA | N/A |
| Budesonide | Capsule, Delayed Release | Oral | 3mg/1 | 21 Capsule, Delayed Release In 1 Bottle (65162-778-49) | Amneal Pharmaceuticals LLC | 65162-778-49 | 65162-778 | ANDA206200 | ANDA | N/A |
| Budesonide | Inhalant | Respiratory (Inhalation) | .25mg/2mL | 6 Pouch In 1 Carton (0487-9601-01) / 5 Ampule In 1 Pouch / 2 Ml In 1 Ampule | Nephron Pharmaceuticals Corporation | 0487-9601-01 | 0487-9601 | ANDA078202 | ANDA | N/A |
| Budesonide | Inhalant | Respiratory (Inhalation) | .25mg/2mL | 30 Pouch In 1 Carton (0487-9601-30) / 1 Ampule In 1 Pouch / 2 Ml In 1 Ampule | Nephron Pharmaceuticals Corporation | 0487-9601-30 | 0487-9601 | ANDA078202 | ANDA | N/A |
| Budesonide | Inhalant | Respiratory (Inhalation) | .5mg/2mL | 6 Pouch In 1 Carton (0487-9701-01) / 5 Ampule In 1 Pouch / 2 Ml In 1 Ampule | Nephron Pharmaceuticals Corporation | 0487-9701-01 | 0487-9701 | ANDA078202 | ANDA | N/A |
| Budesonide | Inhalant | Respiratory (Inhalation) | .5mg/2mL | 30 Pouch In 1 Carton (0487-9701-30) / 1 Ampule In 1 Pouch / 2 Ml In 1 Ampule | Nephron Pharmaceuticals Corporation | 0487-9701-30 | 0487-9701 | ANDA078202 | ANDA | N/A |
| Budesonide | Capsule | Oral | 3mg/1 | 100 Capsule In 1 Bottle (64980-255-01) | Rising Pharmaceuticals, Inc. | 64980-255-01 | 64980-255 | ANDA207367 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (16571-677-01) | Rising Pharma Holdings, Inc | 16571-677-01 | 16571-677 | ANDA212019 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (16571-677-10) | Rising Pharma Holdings, Inc | 16571-677-10 | 16571-677 | ANDA212019 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (16571-678-01) | Rising Pharma Holdings, Inc | 16571-678-01 | 16571-678 | ANDA212019 | ANDA | N/A |
| Bumetanide | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (16571-678-10) | Rising Pharma Holdings, Inc | 16571-678-10 | 16571-678 | ANDA212019 | ANDA | N/A |
| Bumetanide | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (16571-679-01) | Rising Pharma Holdings, Inc | 16571-679-01 | 16571-679 | ANDA212019 | ANDA | N/A |
| Buprenorphine | Patch, Extended Release | Transdermal | 5ug/h | 4 Pouch In 1 Carton (50742-372-04) / 1 Patch In 1 Pouch / 168 H In 1 Patch | INGENUS PHARMACEUTICALS, LLC | 50742-372-04 | 50742-372 | ANDA210272 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 7.5ug/h | 4 Pouch In 1 Carton (50742-373-04) / 1 Patch In 1 Pouch / 168 H In 1 Patch | INGENUS PHARMACEUTICALS, LLC | 50742-373-04 | 50742-373 | ANDA210272 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 10ug/h | 4 Pouch In 1 Carton (50742-374-04) / 1 Patch In 1 Pouch / 168 H In 1 Patch | INGENUS PHARMACEUTICALS, LLC | 50742-374-04 | 50742-374 | ANDA210272 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 15ug/h | 4 Pouch In 1 Carton (50742-375-04) / 1 Patch In 1 Pouch / 168 H In 1 Patch | INGENUS PHARMACEUTICALS, LLC | 50742-375-04 | 50742-375 | ANDA210272 | ANDA | CIII |
| Buprenorphine | Patch, Extended Release | Transdermal | 20ug/h | 4 Pouch In 1 Carton (50742-376-04) / 1 Patch In 1 Pouch / 168 H In 1 Patch | INGENUS PHARMACEUTICALS, LLC | 50742-376-04 | 50742-376 | ANDA210272 | ANDA | CIII |
| Busulfan | Injection, Solution | Intravenous | 6mg/mL | 8 Vial, Single-Dose In 1 Carton (71288-116-11) / 10 Ml In 1 Vial, Single-Dose (71288-116-10) | Meitheal Pharmaceuticals Inc. | 71288-116-11 | 71288-116 | ANDA212127 | ANDA | N/A |
| Busulfan | Injection, Solution | Intravenous | 6mg/mL | 8 Vial, Single-Dose In 1 Carton (71288-158-96) / 10 Ml In 1 Vial, Single-Dose (71288-158-95) | Meitheal Pharmaceuticals Inc. | 71288-158-96 | 71288-158 | ANDA212127 | ANDA | N/A |
| Busulfan | Injection, Solution, Concentrate | Intravenous | 6mg/mL | 8 Vial In 1 Carton (25021-241-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-241-10 | 25021-241 | ANDA207050 | ANDA | N/A |
| Busulfan | Tablet, Film Coated | Oral | 2mg/1 | 25 Tablet, Film Coated In 1 Bottle (80725-620-25) | Waylis Therapeutics LLC | 80725-620-25 | 80725-620 | NDA009386 | NDA | N/A |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film | Buccal; Sublingual | 8mg/1, 2 mg/1 | 30 Pouch In 1 Carton (50742-364-30) / 1 Film In 1 Pouch (50742-364-01) | INGENUS PHARMACEUTICALS, LLC | 50742-364-30 | 50742-364 | ANDA212756 | ANDA | CIII |
| Busulfan | Injection, Solution | Intravenous | 6mg/mL | 8 Carton In 1 Carton (0409-1112-01) / 1 Vial, Single-Dose In 1 Carton (0409-1112-10) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1112-01 | 0409-1112 | ANDA205672 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2100-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2100-1 | 51672-2100 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2100-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2100-2 | 51672-2100 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2100-8) / 12 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2100-8 | 51672-2100 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2100-9) / 24 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2100-9 | 51672-2100 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2101-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2101-1 | 51672-2101 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2101-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2101-2 | 51672-2101 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2101-8) / 12 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2101-8 | 51672-2101 | ANDA205181 | ANDA | N/A |
| Butenafine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-2101-9) / 24 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-2101-9 | 51672-2101 | ANDA205181 | ANDA | N/A |
| Butoconazole Nitrate | Cream | Vaginal | 100mg/5g | 1 Tube, With Applicator In 1 Carton (45802-396-01) / 5.8 G In 1 Tube, With Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-396-01 | 45802-396 | ANDA200923 | ANDA | N/A |
| Butoconazole Nitrate | Cream | Vaginal | 100mg/5g | 1 Tube, With Applicator In 1 Carton (45802-396-02) / 5.8 G In 1 Tube, With Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-396-02 | 45802-396 | ANDA200923 | ANDA | N/A |
| Butorphanol Tartrate | Spray | Nasal | 10mg/mL | 1 Bottle, Spray In 1 Container (60505-0813-1) / 2.5 Ml In 1 Bottle, Spray | Apotex Corp. | 60505-0813-1 | 60505-0813 | ANDA075499 | ANDA | CIV |
| Butorphanol Tartrate | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 1 Ml In 1 Vial, Single-Dose (0143-9864-10) | Hikma Pharmaceuticals USA Inc. | 0143-9864-10 | 0143-9864 | ANDA078400 | ANDA | CIV |
| Butorphanol Tartrate | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 1 Ml In 1 Vial, Single-Dose (0143-9867-10) | Hikma Pharmaceuticals USA Inc. | 0143-9867-10 | 0143-9867 | ANDA078400 | ANDA | CIV |
| Butorphanol Tartrate | Spray, Metered | Nasal | 10mg/mL | 1 Bottle, Spray In 1 Container (0054-3090-36) / 2.5 Ml In 1 Bottle, Spray | Hikma Pharmaceuticals USA Inc. | 0054-3090-36 | 0054-3090 | ANDA075824 | ANDA | CIV |
| Butorphanol Tartrate | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1623-01) / 1 Ml In 1 Vial, Single-Dose (0409-1623-21) | Hospira, Inc. | 0409-1623-01 | 0409-1623 | ANDA074626 | ANDA | CIV |
| Butorphanol Tartrate | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1626-01) / 1 Ml In 1 Vial, Single-Dose (0409-1626-21) | Hospira, Inc. | 0409-1626-01 | 0409-1626 | ANDA074626 | ANDA | CIV |
| Butorphanol Tartrate | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1626-02) / 2 Ml In 1 Vial, Single-Dose (0409-1626-42) | Hospira, Inc. | 0409-1626-02 | 0409-1626 | ANDA074626 | ANDA | CIV |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film | Buccal; Sublingual | 12mg/1, 3 mg/1 | 30 Pouch In 1 Carton (50742-365-30) / 1 Film In 1 Pouch (50742-365-01) | INGENUS PHARMACEUTICALS, LLC | 50742-365-30 | 50742-365 | ANDA212756 | ANDA | CIII |
| Caffeine | Tablet, Film Coated | Oral | 100mg/1 | 2 Blister Pack In 1 Carton (52389-656-60) / 30 Tablet, Film Coated In 1 Blister Pack (52389-656-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-656-60 | 52389-656 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine | Tablet, Film Coated | Oral | 100mg/1 | 2 Bottle, Plastic In 1 Package (52389-155-02) / 80 Tablet, Film Coated In 1 Bottle, Plastic | Alva-Amco Pharmacal Companies, Inc. | 52389-155-02 | 52389-155 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine | Tablet, Film Coated | Oral | 100mg/1 | 80 Tablet, Film Coated In 1 Bottle, Plastic (52389-155-80) | Alva-Amco Pharmacal Companies, Inc. | 52389-155-80 | 52389-155 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine | Tablet, Film Coated | Oral | 100mg/1 | 1 Bottle In 1 Carton (52389-155-90) / 90 Tablet, Film Coated In 1 Bottle | Alva-Amco Pharmacal Companies, Inc. | 52389-155-90 | 52389-155 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine | Tablet, Film Coated | Oral | 100mg/1 | 1 Blister Pack In 1 Carton (52389-406-22) / 22 Tablet, Film Coated In 1 Blister Pack (52389-406-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-406-22 | 52389-406 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine | Injection, Solution | Intramuscular; Intravenous | 125mg/mL | 10 Vial, Single-Dose In 1 Box (0517-2502-10) / 2 Ml In 1 Vial, Single-Dose (0517-2502-01) | American Regent, Inc. | 0517-2502-10 | 0517-2502 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Caffeine Citrate | Solution | Oral | 20mg/mL | 10 Vial In 1 Carton (25021-602-03) / 3 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-602-03 | 25021-602 | ANDA091102 | ANDA | N/A |
| Caffeine Citrate | Solution | Intravenous | 20mg/mL | 1 Vial In 1 Carton (25021-601-03) / 3 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-601-03 | 25021-601 | ANDA090827 | ANDA | N/A |
| Caffeine Citrate | Injection, Solution | Intravenous | 20mg/mL | 10 Vial, Single-Dose In 1 Box (0517-0020-10) / 3 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0020-10 | 0517-0020 | ANDA077906 | ANDA | N/A |
| Caffeine Citrate | Injection, Solution | Intravenous | 20mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-0020-25) / 3 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0020-25 | 0517-0020 | ANDA077906 | ANDA | N/A |
| Caffeine Citrate | Injection | Intravenous | 20mg/mL | 10 Vial In 1 Box (0641-6164-10) / 3 Ml In 1 Vial (0641-6164-01) | Hikma Pharmaceuticals USA Inc. | 0641-6164-10 | 0641-6164 | NDA020793 | NDA | N/A |
| Caffeine Citrate | Injection | Intravenous | 20mg/mL | 10 Vial In 1 Box (0641-6267-10) / 3 Ml In 1 Vial (0641-6267-01) | Hikma Pharmaceuticals USA Inc. | 0641-6267-10 | 0641-6267 | NDA020793 | NDA | N/A |
| Caffeine; Ergotamine Tartrate | Suppository | Rectal | 100mg/1, 2 mg/1 | 12 Suppository In 1 Box (0713-0166-12) | Cosette Pharmaceuticals, Inc. | 0713-0166-12 | 0713-0166 | ANDA086557 | ANDA | N/A |
| Caffeine; Magnesium Salicylate | Tablet, Coated | Oral | 50mg/1, 162.5 mg/1 | 2 Blister Pack In 1 Carton (52389-306-36) / 18 Tablet, Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-306-36 | 52389-306 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine; Magnesium Salicylate | Tablet, Coated | Oral | 50mg/1, 162.5 mg/1 | 1 Blister Pack In 1 Carton (52389-306-42) / 42 Tablet, Coated In 1 Blister Pack (52389-306-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-306-42 | 52389-306 | M027 | OTC MONOGRAPH DRUG | N/A |
| Caffeine; Magnesium Salicylate | Tablet, Coated | Oral | 50mg/1, 162.5 mg/1 | 2 Blister Pack In 1 Carton (52389-306-84) / 42 Tablet, Coated In 1 Blister Pack (52389-306-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-306-84 | 52389-306 | M027 | OTC MONOGRAPH DRUG | N/A |
| Cajuput Oil; Calendula Officinalis Whole | Ointment | Topical | .1kg/kg, 1 kg/kg | 1 Tube In 1 Carton (71042-026-14) / .0142 Kg In 1 Tube | OrganiCare Nature's Science, LLC | 71042-026-14 | 71042-026 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calcipotriene | Cream | Topical | 50ug/g | 1 Tube In 1 Carton (66993-877-61) / 60 G In 1 Tube | Prasco Laboratories | 66993-877-61 | 66993-877 | NDA020554 | NDA AUTHORIZED GENERIC | N/A |
| Calcipotriene | Cream | Topical | 50ug/g | 1 Tube In 1 Carton (66993-877-78) / 120 G In 1 Tube | Prasco Laboratories | 66993-877-78 | 66993-877 | NDA020554 | NDA AUTHORIZED GENERIC | N/A |
| Calcipotriene | Ointment | Topical | 50ug/g | 1 Tube In 1 Carton (66993-878-61) / 60 G In 1 Tube | Prasco Laboratories | 66993-878-61 | 66993-878 | NDA020273 | NDA AUTHORIZED GENERIC | N/A |
| Calcipotriene | Ointment | Topical | 50ug/g | 1 Tube In 1 Carton (66993-878-78) / 120 G In 1 Tube | Prasco Laboratories | 66993-878-78 | 66993-878 | NDA020273 | NDA AUTHORIZED GENERIC | N/A |
| Calcipotriene | Cream | Topical | 50ug/g | 1 Tube In 1 Carton (51407-605-12) / 120 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-605-12 | 51407-605 | ANDA205772 | ANDA | N/A |
| Calcipotriene | Cream | Topical | 50ug/g | 1 Tube In 1 Carton (51407-605-60) / 60 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-605-60 | 51407-605 | ANDA205772 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | 50ug/g | 1 Tube In 1 Carton (51407-606-12) / 120 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-606-12 | 51407-606 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | 50ug/g | 60 G In 1 Tube (51407-606-60) | Golden State Medical Supply, Inc. | 51407-606-60 | 51407-606 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-4154-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4154-3 | 51672-4154 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-4154-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4154-4 | 51672-4154 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 10 Tube In 1 Carton (51672-4154-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4154-5 | 51672-4154 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-5278-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5278-3 | 51672-5278 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-5278-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5278-4 | 51672-5278 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Ointment | Topical | .05mg/g | 10 Tube In 1 Carton (51672-5278-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5278-5 | 51672-5278 | ANDA090633 | ANDA | N/A |
| Calcipotriene | Solution | Topical | .05mg/mL | 1 Bottle In 1 Carton (0713-0318-53) / 60 Ml In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0318-53 | 0713-0318 | ANDA078468 | ANDA | N/A |
| Calcitonin Salmon | Spray, Metered | Nasal | 200[iU]/1 | 1 Bottle, Glass In 1 Carton (60505-0823-0) / 14 Spray, Metered In 1 Bottle, Glass | Apotex Corp. | 60505-0823-0 | 60505-0823 | ANDA076396 | ANDA | N/A |
| Calcitonin Salmon | Spray, Metered | Nasal | 200[iU]/1 | 1 Bottle, Glass In 1 Carton (60505-0823-6) / 30 Spray, Metered In 1 Bottle, Glass | Apotex Corp. | 60505-0823-6 | 60505-0823 | ANDA076396 | ANDA | N/A |
| Calcitonin Salmon | Injection, Solution | Intramuscular; Subcutaneous | 200[USP'U]/mL | 1 Vial, Multi-Dose In 1 Carton (24201-400-02) / 2 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals) | 24201-400-02 | 24201-400 | ANDA212416 | ANDA | N/A |
| Calcitriol | Ointment | Topical | 3ug/g | 1 Tube In 1 Carton (45802-608-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-608-01 | 45802-608 | NDA022087 | NDA AUTHORIZED GENERIC | N/A |
| Calcitriol | Solution | Oral | 1ug/mL | 1 Bottle, Glass In 1 Carton (39328-042-15) / 15 Ml In 1 Bottle, Glass | Patrin Pharma, Inc | 39328-042-15 | 39328-042 | ANDA203973 | ANDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .25ug/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (51407-169-01) | Golden State Medical Supply, Inc. | 51407-169-01 | 51407-169 | ANDA091174 | ANDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .5ug/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (51407-170-01) | Golden State Medical Supply, Inc. | 51407-170-01 | 51407-170 | ANDA091174 | ANDA | N/A |
| Calcitriol | Capsule, Gelatin Coated | Oral | .25ug/1 | 100 Capsule, Gelatin Coated In 1 Bottle (30698-143-01) | Validus Pharmaceuticals LLC | 30698-143-01 | 30698-143 | NDA018044 | NDA | N/A |
| Calcitriol | Capsule, Gelatin Coated | Oral | .25ug/1 | 30 Capsule, Gelatin Coated In 1 Bottle (30698-143-23) | Validus Pharmaceuticals LLC | 30698-143-23 | 30698-143 | NDA018044 | NDA | N/A |
| Calcitriol | Capsule, Gelatin Coated | Oral | .5ug/1 | 100 Capsule, Gelatin Coated In 1 Bottle (30698-144-01) | Validus Pharmaceuticals LLC | 30698-144-01 | 30698-144 | NDA018044 | NDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .25ug/1 | 30 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-207-13) | BIONPHARMA INC. | 69452-207-13 | 69452-207 | ANDA091174 | ANDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .25ug/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-207-20) | BIONPHARMA INC. | 69452-207-20 | 69452-207 | ANDA091174 | ANDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .5ug/1 | 30 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-208-13) | BIONPHARMA INC. | 69452-208-13 | 69452-208 | ANDA091174 | ANDA | N/A |
| Calcitriol | Capsule, Liquid Filled | Oral | .5ug/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-208-20) | BIONPHARMA INC. | 69452-208-20 | 69452-208 | ANDA091174 | ANDA | N/A |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 8mg/1, 2 mg/1 | 30 Tablet In 1 Bottle (65162-415-03) | Amneal Pharmaceuticals LLC | 65162-415-03 | 65162-415 | ANDA203136 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 8mg/1, 2 mg/1 | 90 Tablet In 1 Bottle (65162-415-09) | Amneal Pharmaceuticals LLC | 65162-415-09 | 65162-415 | ANDA203136 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 2mg/1, .5 mg/1 | 30 Tablet In 1 Bottle (65162-416-03) | Amneal Pharmaceuticals LLC | 65162-416-03 | 65162-416 | ANDA203136 | ANDA | CIII |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate | Tablet | Sublingual | 2mg/1, .5 mg/1 | 90 Tablet In 1 Bottle (65162-416-09) | Amneal Pharmaceuticals LLC | 65162-416-09 | 65162-416 | ANDA203136 | ANDA | CIII |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-066-01) | Camber Pharmaceuticals, Inc. | 31722-066-01 | 31722-066 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 500 Tablet, Extended Release In 1 Bottle (31722-066-05) | Camber Pharmaceuticals, Inc. | 31722-066-05 | 31722-066 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 60 Tablet, Extended Release In 1 Bottle (31722-066-60) | Camber Pharmaceuticals, Inc. | 31722-066-60 | 31722-066 | ANDA216800 | ANDA | N/A |
| Calcitriol | Solution | Oral | 1ug/mL | 1 Bottle, Glass In 1 Carton (0054-3120-41) / 15 Ml In 1 Bottle, Glass | Hikma Pharmaceuticals USA Inc. | 0054-3120-41 | 0054-3120 | ANDA076242 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .25ug/1 | 30 Capsule In 1 Bottle, Plastic (0054-0007-13) | Hikma Pharmaceuticals USA Inc. | 0054-0007-13 | 0054-0007 | ANDA076917 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .25ug/1 | 100 Capsule In 1 Bottle, Plastic (0054-0007-25) | Hikma Pharmaceuticals USA Inc. | 0054-0007-25 | 0054-0007 | ANDA076917 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 200 Capsule In 1 Bottle (75834-323-02) | Nivagen Pharmaceuticals, Inc. | 75834-323-02 | 75834-323 | ANDA217205 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 200 Capsule In 1 Bottle (29033-026-02) | Nostrum Laboratories, Inc. | 29033-026-02 | 29033-026 | ANDA203179 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-067-01) | Camber Pharmaceuticals, Inc. | 31722-067-01 | 31722-067 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (31722-067-05) | Camber Pharmaceuticals, Inc. | 31722-067-05 | 31722-067 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 250 Tablet, Extended Release In 1 Bottle (31722-067-25) | Camber Pharmaceuticals, Inc. | 31722-067-25 | 31722-067 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 60 Tablet, Extended Release In 1 Bottle (31722-067-60) | Camber Pharmaceuticals, Inc. | 31722-067-60 | 31722-067 | ANDA216800 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 30 Capsule In 1 Bottle (0054-0088-13) | Hikma Pharmaceuticals USA Inc. | 0054-0088-13 | 0054-0088 | ANDA077728 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 200 Capsule In 1 Bottle (0054-0088-26) | Hikma Pharmaceuticals USA Inc. | 0054-0088-26 | 0054-0088 | ANDA077728 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (31722-067-90) | Camber Pharmaceuticals, Inc. | 31722-067-90 | 31722-067 | ANDA216800 | ANDA | N/A |
| Calcium Chloride | Injection, Solution | Intravenous | 100mg/mL | 10 Vial, Glass In 1 Box (0517-6710-10) / 10 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-6710-10 | 0517-6710 | ANDA209088 | ANDA | N/A |
| Calcium Chloride | Injection, Solution | Intravenous | 100mg/mL | 10 Carton In 1 Container (0409-1631-10) / 1 Syringe, Plastic In 1 Carton (0409-1631-40) / 10 Ml In 1 Syringe, Plastic | Hospira, Inc. | 0409-1631-10 | 0409-1631 | NDA021117 | NDA | N/A |
| Calcium Chloride | Injection, Solution | Intravenous; Intraventricular | 100mg/mL | 10 Carton In 1 Container (0409-4928-34) / 1 Syringe In 1 Carton / 10 Ml In 1 Syringe | Hospira, Inc. | 0409-4928-34 | 0409-4928 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate Anhydrous; Sodium Chloride | Injection, Solution, Concentrate | Intravenous | 331mg/20mL, 508 mg/20mL, 1491 mg/20mL, 2420 mg/20mL, 321 mg/20mL | 25 Vial, Single-Dose In 1 Carton (0409-5779-01) / 20 Ml In 1 Vial, Single-Dose (0409-5779-11) | Hospira, Inc. | 0409-5779-01 | 0409-5779 | NDA018895 | NDA | N/A |
| Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride | Injection, Solution | Intra-Arterial | 17.6mg/100mL, 325.3 mg/100mL, 119.3 mg/100mL, 643 mg/100mL | 12 Pouch In 1 Case (0409-7969-05) / 1 Bag In 1 Pouch / 1000 Ml In 1 Bag (0409-7969-11) | Hospira, Inc. | 0409-7969-05 | 0409-7969 | NDA018608 | NDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 25 Vial In 1 Carton (75834-171-19) / 10 Ml In 1 Vial (75834-171-01) | Nivagen Pharmaceuticals, Inc. | 75834-171-19 | 75834-171 | ANDA213071 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 10 Vial, Plastic In 1 Carton (70069-727-10) / 50 Ml In 1 Vial, Plastic | Somerset Therapeutics, LLC | 70069-727-10 | 70069-727 | ANDA217689 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 25 Vial, Plastic In 1 Carton (70069-727-25) / 50 Ml In 1 Vial, Plastic | Somerset Therapeutics, LLC | 70069-727-25 | 70069-727 | ANDA217689 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 10 Vial, Plastic In 1 Carton (70069-728-10) / 100 Ml In 1 Vial, Plastic | Somerset Therapeutics, LLC | 70069-728-10 | 70069-728 | ANDA217689 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 20 Vial, Plastic In 1 Carton (70069-728-20) / 100 Ml In 1 Vial, Plastic | Somerset Therapeutics, LLC | 70069-728-20 | 70069-728 | ANDA217689 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 25 Vial In 1 Carton (0143-9180-25) / 10 Ml In 1 Vial (0143-9180-01) | Hikma Pharmaceuticals USA Inc. | 0143-9180-25 | 0143-9180 | ANDA213071 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 25 Vial In 1 Carton (0143-9184-25) / 50 Ml In 1 Vial (0143-9184-01) | Hikma Pharmaceuticals USA Inc. | 0143-9184-25 | 0143-9184 | ANDA213071 | ANDA | N/A |
| Calcium Gluconate Monohydrate | Injection, Solution | Intravenous | 98mg/mL | 20 Vial In 1 Carton (0143-9185-20) / 100 Ml In 1 Vial (0143-9185-01) | Hikma Pharmaceuticals USA Inc. | 0143-9185-20 | 0143-9185 | ANDA213071 | ANDA | N/A |
| Calendula Officinalis Flowering Top; Cholecalciferol; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 3 [hp_X]/14g, 2 [hp_X]/14g | 1 Tube In 1 Carton (71042-003-14) / 14 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-003-14 | 71042-003 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calendula Officinalis Flowering Top; Clove Oil; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/12g, 1 [hp_X]/12g, 2 [hp_X]/12g | 1 Tube In 1 Carton (71042-004-12) / 12 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-004-12 | 71042-004 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calendula Officinalis Flowering Top; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 2 [hp_X]/14g | 1 Pouch In 1 Blister Pack (71042-001-01) / 1 G In 1 Pouch | OrganiCare Nature's Science, LLC | 71042-001-01 | 71042-001 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calendula Officinalis Flowering Top; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 2 [hp_X]/14g | 1 Tube In 1 Carton (71042-001-14) / 14 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-001-14 | 71042-001 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calendula Officinalis Flowering Top; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 2 [hp_X]/14g | 1 Tube In 1 Carton (71042-001-28) / 28.3 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-001-28 | 71042-001 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Calendula Officinalis Whole; Melaleuca Cajuputi Whole | Ointment | Topical | .01g/100g, .01 g/100g | 1 Tube In 1 Carton (71042-029-14) / 14.2 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-029-14 | 71042-029 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Camphor (Natural) | Salve | Topical | 4g/100g | 1 Jar In 1 Carton (83670-202-02) / 56 G In 1 Jar | Everlaan Organics Inc | 83670-202-02 | 83670-202 | M017 | OTC MONOGRAPH DRUG | N/A |
| Camphor (Natural); Eucalyptus Oil; Menthol | Ointment | Topical | 5g/100g, 1.3 g/100g, 2.8 g/100g | 1 Jar In 1 Carton (83670-200-02) / 56 G In 1 Jar | Everlaan Organics Inc | 83670-200-02 | 83670-200 | M012 | OTC MONOGRAPH DRUG | N/A |
| Camphor (Natural); Eucalyptus Oil; Menthol | Ointment | Topical | 4.7g/100g, 1.2 g/100g, 2.6 g/100g | 1 Jar In 1 Carton (83670-201-02) / 56 G In 1 Jar | Everlaan Organics Inc | 83670-201-02 | 83670-201 | M012 | OTC MONOGRAPH DRUG | N/A |
| Camphor (Natural); Menthol | Liquid | Topical | 30mg/mL, 100 mg/mL | 1 Bottle In 1 Box (71856-070-01) / 30 Ml In 1 Bottle | Biostar Nutrition Pte. Ltd. | 71856-070-01 | 71856-070 | M017 | OTC MONOGRAPH DRUG | N/A |
| Camphor (Natural); Methyl Salicylate | Salve | Topical | 4g/100g, 10 g/100g | 1 Jar In 1 Carton (83670-203-02) / 56 G In 1 Jar | Everlaan Organics Inc | 83670-203-02 | 83670-203 | M017 | OTC MONOGRAPH DRUG | N/A |
| Camphor (Synthetic); Menthol | Ointment | Topical | 4.35g/100g, 2.61 g/100g | 57 G In 1 Jar (10578-001-02) | Indiana Botanic Gardens | 10578-001-02 | 10578-001 | part341 | OTC MONOGRAPH FINAL | N/A |
| Camphor (Synthetic); Menthol | Ointment | Topical | 4.35g/100g, 2.61 g/100g | 114 G In 1 Jar (10578-001-04) | Indiana Botanic Gardens | 10578-001-04 | 10578-001 | part341 | OTC MONOGRAPH FINAL | N/A |
| Camphor (Synthetic); Menthol, Unspecified Form; Petrolatum; Phenol | Cream | Topical | 30mg/g, 10 mg/g, 892 mg/g, 15 mg/g | 1 Tube In 1 Package (66923-000-01) / 2 G In 1 Tube | Ranir LLC | 66923-000-01 | 66923-000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Camphor (Synthetic); Menthol, Unspecified Form; Petrolatum; Phenol | Cream | Topical | 30mg/g, 10 mg/g, 892 mg/g, 15 mg/g | 1 Bottle, Pump In 1 Package (66923-000-02) / 2 G In 1 Bottle, Pump | Ranir LLC | 66923-000-02 | 66923-000 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Candesartan Cilexetil | Tablet | Oral | 4mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-882-90) | Golden State Medical Supply, Inc. | 51407-882-90 | 51407-882 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil | Tablet | Oral | 8mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-883-90) | Golden State Medical Supply, Inc. | 51407-883-90 | 51407-883 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil | Tablet | Oral | 16mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-884-90) | Golden State Medical Supply, Inc. | 51407-884-90 | 51407-884 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil | Tablet | Oral | 32mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-885-90) | Golden State Medical Supply, Inc. | 51407-885-90 | 51407-885 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-068-01) | Camber Pharmaceuticals, Inc. | 31722-068-01 | 31722-068 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 500 Tablet, Extended Release In 1 Bottle (31722-068-05) | Camber Pharmaceuticals, Inc. | 31722-068-05 | 31722-068 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 60 Tablet, Extended Release In 1 Bottle (31722-068-60) | Camber Pharmaceuticals, Inc. | 31722-068-60 | 31722-068 | ANDA216800 | ANDA | N/A |
| Bupropion hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 90 Tablet, Extended Release In 1 Bottle (31722-068-90) | Camber Pharmaceuticals, Inc. | 31722-068-90 | 31722-068 | ANDA216800 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-410-01) | Epic Pharma LLC | 42806-410-01 | 42806-410 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-410-05) | Epic Pharma LLC | 42806-410-05 | 42806-410 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-410-60) | Epic Pharma LLC | 42806-410-60 | 42806-410 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-411-60) | Epic Pharma LLC | 42806-411-60 | 42806-411 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-415-01) | Epic Pharma LLC | 42806-415-01 | 42806-415 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-415-05) | Epic Pharma LLC | 42806-415-05 | 42806-415 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 250 Tablet, Extended Release In 1 Bottle (42806-415-52) | Epic Pharma LLC | 42806-415-52 | 42806-415 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-415-60) | Epic Pharma LLC | 42806-415-60 | 42806-415 | ANDA075932 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-349-05) | Epic Pharma, LLC | 42806-349-05 | 42806-349 | ANDA207224 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle (42806-349-09) | Epic Pharma, LLC | 42806-349-09 | 42806-349 | ANDA207224 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (42806-413-60) | Epic Pharma, LLC | 42806-413-60 | 42806-413 | ANDA216766 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle, Plastic (42806-414-05) | Epic Pharma, LLC | 42806-414-05 | 42806-414 | ANDA210015 | ANDA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5052-1) | Jubilant HollisterStier LLC | 65044-5052-1 | 65044-5052 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5052-3) | Jubilant HollisterStier LLC | 65044-5052-3 | 65044-5052 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5052-4) | Jubilant HollisterStier LLC | 65044-5052-4 | 65044-5052 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5053-1) | Jubilant HollisterStier LLC | 65044-5053-1 | 65044-5053 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .001g/mL | 10 Ml In 1 Vial (65044-5055-1) | Jubilant HollisterStier LLC | 65044-5055-1 | 65044-5055 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .001g/mL | 30 Ml In 1 Vial (65044-5055-3) | Jubilant HollisterStier LLC | 65044-5055-3 | 65044-5055 | BLA103888 | BLA | N/A |
| Candida Albicans | Injection, Solution | Percutaneous; Subcutaneous | .001g/mL | 50 Ml In 1 Vial (65044-5055-4) | Jubilant HollisterStier LLC | 65044-5055-4 | 65044-5055 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .005g/mL, .005 g/mL | 10 Ml In 1 Vial (65044-4824-2) | Jubilant HollisterStier LLC | 65044-4824-2 | 65044-4824 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .005g/mL, .005 g/mL | 30 Ml In 1 Vial (65044-4824-3) | Jubilant HollisterStier LLC | 65044-4824-3 | 65044-4824 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .005g/mL, .005 g/mL | 50 Ml In 1 Vial (65044-4824-4) | Jubilant HollisterStier LLC | 65044-4824-4 | 65044-4824 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous | .005g/mL, .005 g/mL | 5 Ml In 1 Vial (65044-4825-1) | Jubilant HollisterStier LLC | 65044-4825-1 | 65044-4825 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-4083-2) | Jubilant HollisterStier LLC | 65044-4083-2 | 65044-4083 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-4083-3) | Jubilant HollisterStier LLC | 65044-4083-3 | 65044-4083 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-4083-4) | Jubilant HollisterStier LLC | 65044-4083-4 | 65044-4083 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-4084-1) | Jubilant HollisterStier LLC | 65044-4084-1 | 65044-4084 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-4085-2) | Jubilant HollisterStier LLC | 65044-4085-2 | 65044-4085 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-4085-3) | Jubilant HollisterStier LLC | 65044-4085-3 | 65044-4085 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-4085-4) | Jubilant HollisterStier LLC | 65044-4085-4 | 65044-4085 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous | .0008g/mL, .0008 g/mL | 5 Ml In 1 Vial (65044-4850-1) | Jubilant HollisterStier LLC | 65044-4850-1 | 65044-4850 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .0008g/mL, .0008 g/mL | 10 Ml In 1 Vial (65044-4850-2) | Jubilant HollisterStier LLC | 65044-4850-2 | 65044-4850 | BLA103888 | BLA | N/A |
| Canis Lupus Familiaris Dander; Canis Lupus Familiaris Hair | Injection, Solution | Percutaneous; Subcutaneous | .0008g/mL, .0008 g/mL | 50 Ml In 1 Vial (65044-4850-4) | Jubilant HollisterStier LLC | 65044-4850-4 | 65044-4850 | BLA103888 | BLA | N/A |
| Cantaloupe | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3116-2) | Jubilant HollisterStier LLC | 65044-3116-2 | 65044-3116 | BLA103888 | BLA | N/A |
| Capecitabine | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (51407-096-12) | Golden State Medical Supply, Inc. | 51407-096-12 | 51407-096 | ANDA200483 | ANDA | N/A |
| Capecitabine | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-639-60) | Golden State Medical Supply, Inc. | 51407-639-60 | 51407-639 | ANDA091649 | ANDA | N/A |
| Capecitabine | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (51407-640-12) | Golden State Medical Supply, Inc. | 51407-640-12 | 51407-640 | ANDA091649 | ANDA | N/A |
| Capsaicin | Oil | Topical | 1mg/mL | 1 Bottle In 1 Box (80295-100-01) / 30 Ml In 1 Bottle | Leading Edge Pharms, Inc. | 80295-100-01 | 80295-100 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Captopril | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (51407-600-01) | Golden State Medical Supply, Inc. | 51407-600-01 | 51407-600 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (51407-601-01) | Golden State Medical Supply, Inc. | 51407-601-01 | 51407-601 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (51407-601-10) | Golden State Medical Supply, Inc. | 51407-601-10 | 51407-601 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-602-01) | Golden State Medical Supply, Inc. | 51407-602-01 | 51407-602 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (51407-602-10) | Golden State Medical Supply, Inc. | 51407-602-10 | 51407-602 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (51407-603-01) | Golden State Medical Supply, Inc. | 51407-603-01 | 51407-603 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (0143-1171-01) | Hikma Pharmaceuticals USA Inc. | 0143-1171-01 | 0143-1171 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (0143-1171-10) | Hikma Pharmaceuticals USA Inc. | 0143-1171-10 | 0143-1171 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (0143-1172-01) | Hikma Pharmaceuticals USA Inc. | 0143-1172-01 | 0143-1172 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (0143-1172-10) | Hikma Pharmaceuticals USA Inc. | 0143-1172-10 | 0143-1172 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (0143-1173-01) | Hikma Pharmaceuticals USA Inc. | 0143-1173-01 | 0143-1173 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (0143-1173-10) | Hikma Pharmaceuticals USA Inc. | 0143-1173-10 | 0143-1173 | ANDA074505 | ANDA | N/A |
| Captopril | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (0143-1174-01) | Hikma Pharmaceuticals USA Inc. | 0143-1174-01 | 0143-1174 | ANDA074505 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (42806-414-09) | Epic Pharma, LLC | 42806-414-09 | 42806-414 | ANDA210015 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (42806-414-30) | Epic Pharma, LLC | 42806-414-30 | 42806-414 | ANDA210015 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle, Plastic (42806-416-05) | Epic Pharma, LLC | 42806-416-05 | 42806-416 | ANDA210015 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (42806-416-09) | Epic Pharma, LLC | 42806-416-09 | 42806-416 | ANDA210015 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (75834-220-00) | NIVAGEN PHARMACEUTICALS, INC. | 75834-220-00 | 75834-220 | ANDA207798 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (75834-220-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-220-01 | 75834-220 | ANDA207798 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (75834-221-00) | NIVAGEN PHARMACEUTICALS, INC. | 75834-221-00 | 75834-221 | ANDA207798 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (75834-221-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-221-01 | 75834-221 | ANDA207798 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 120 Capsule, Extended Release In 1 Bottle (29033-019-12) | Nostrum Laboratories, Inc. | 29033-019-12 | 29033-019 | ANDA076697 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 120 Capsule, Extended Release In 1 Bottle (29033-020-12) | Nostrum Laboratories, Inc. | 29033-020-12 | 29033-020 | ANDA076697 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 120 Capsule, Extended Release In 1 Bottle (29033-004-12) | Nostrum Laboratories, Inc. | 29033-004-12 | 29033-004 | ANDA076697 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 120 Capsule, Extended Release In 1 Bottle (66993-407-32) | Prasco Laboratories | 66993-407-32 | 66993-407 | NDA020712 | NDA AUTHORIZED GENERIC | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 120 Capsule, Extended Release In 1 Bottle (66993-408-32) | Prasco Laboratories | 66993-408-32 | 66993-408 | NDA020712 | NDA AUTHORIZED GENERIC | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 120 Capsule, Extended Release In 1 Bottle (66993-409-32) | Prasco Laboratories | 66993-409-32 | 66993-409 | NDA020712 | NDA AUTHORIZED GENERIC | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 100mg/1 | 500 Tablet, Chewable In 1 Bottle (60429-934-05) | Golden State Medical Supply, Inc. | 60429-934-05 | 60429-934 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51407-215-01) | Golden State Medical Supply, Inc. | 51407-215-01 | 51407-215 | ANDA074649 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51407-215-10) | Golden State Medical Supply, Inc. | 51407-215-10 | 51407-215 | ANDA074649 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-355-12) | AustarPharma LLC | 35561-355-12 | 35561-355 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-356-12) | AustarPharma LLC | 35561-356-12 | 35561-356 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-357-12) | AustarPharma LLC | 35561-357-12 | 35561-357 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Suspension | Oral | 100mg/5mL | 450 Ml In 1 Bottle (51672-4047-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4047-9 | 51672-4047 | ANDA076729 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51672-4005-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4005-1 | 51672-4005 | ANDA074649 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51672-4005-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4005-2 | 51672-4005 | ANDA074649 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51672-4005-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4005-3 | 51672-4005 | ANDA074649 | ANDA | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 200mg/1 | 100 Tablet, Chewable In 1 Bottle (51672-4050-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4050-1 | 51672-4050 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4123-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4123-1 | 51672-4123 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4123-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4123-3 | 51672-4123 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4123-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4123-6 | 51672-4123 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4124-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4124-1 | 51672-4124 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4124-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4124-3 | 51672-4124 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4124-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4124-6 | 51672-4124 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4125-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4125-1 | 51672-4125 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4125-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4125-3 | 51672-4125 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4125-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4125-6 | 51672-4125 | ANDA078115 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 120 Capsule, Extended Release In 1 Bottle (51672-4149-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4149-1 | 51672-4149 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 1000 Capsule, Extended Release In 1 Bottle (51672-4149-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4149-3 | 51672-4149 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 30 Capsule, Extended Release In 1 Bottle (51672-4149-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4149-6 | 51672-4149 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 120 Capsule, Extended Release In 1 Bottle (51672-4150-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4150-1 | 51672-4150 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 1000 Capsule, Extended Release In 1 Bottle (51672-4150-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4150-3 | 51672-4150 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 120 Capsule, Extended Release In 1 Bottle (51672-4151-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4151-1 | 51672-4151 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 1000 Capsule, Extended Release In 1 Bottle (51672-4151-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4151-3 | 51672-4151 | ANDA201106 | ANDA | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (51672-4041-0) / 10 Tablet, Chewable In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4041-0 | 51672-4041 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 100mg/1 | 100 Tablet, Chewable In 1 Bottle (51672-4041-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4041-1 | 51672-4041 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 100mg/1 | 500 Tablet, Chewable In 1 Bottle (51672-4041-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4041-2 | 51672-4041 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Tablet, Chewable | Oral | 100mg/1 | 5 Blister Pack In 1 Carton (51672-4041-9) / 10 Tablet, Chewable In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4041-9 | 51672-4041 | ANDA075687 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 120 Capsule, Extended Release In 1 Bottle (30698-419-12) | Validus Pharmaceuticals LLC | 30698-419-12 | 30698-419 | NDA021710 | NDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 120 Capsule, Extended Release In 1 Bottle (30698-421-12) | Validus Pharmaceuticals LLC | 30698-421-12 | 30698-421 | NDA021710 | NDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 120 Capsule, Extended Release In 1 Bottle (30698-423-12) | Validus Pharmaceuticals LLC | 30698-423-12 | 30698-423 | NDA021710 | NDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (42806-416-30) | Epic Pharma, LLC | 42806-416-30 | 42806-416 | ANDA210015 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (60505-0183-0) | Apotex Corp. | 60505-0183-0 | 60505-0183 | ANDA075948 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (60505-0183-1) | Apotex Corp. | 60505-0183-1 | 60505-0183 | ANDA075948 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 100mg/1 | 120 Capsule, Extended Release In 1 Bottle (60505-2805-7) | Apotex Corp. | 60505-2805-7 | 60505-2805 | ANDA078986 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 200mg/1 | 120 Capsule, Extended Release In 1 Bottle (60505-2806-7) | Apotex Corp. | 60505-2806-7 | 60505-2806 | ANDA078986 | ANDA | N/A |
| Carbamazepine | Capsule, Extended Release | Oral | 300mg/1 | 120 Capsule, Extended Release In 1 Bottle (60505-2807-7) | Apotex Corp. | 60505-2807-7 | 60505-2807 | ANDA078986 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-355-12) | AustarPharma LLC | 35561-355-12 | 35561-355 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-356-12) | AustarPharma LLC | 35561-356-12 | 35561-356 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (35561-357-12) | AustarPharma LLC | 35561-357-12 | 35561-357 | ANDA215591 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (69452-312-20) | Bionpharma Inc., | 69452-312-20 | 69452-312 | ANDA218221 | ANDA | N/A |
| Carbamazepine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (69452-312-32) | Bionpharma Inc., | 69452-312-32 | 69452-312 | ANDA218221 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-424-01) | Epic Pharma, LLC | 42806-424-01 | 42806-424 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-424-05) | Epic Pharma, LLC | 42806-424-05 | 42806-424 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 100mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-424-60) | Epic Pharma, LLC | 42806-424-60 | 42806-424 | ANDA211347 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (59746-789-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-789-01 | 59746-789 | ANDA216594 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (59746-790-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-790-01 | 59746-790 | ANDA216594 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (59746-791-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-791-01 | 59746-791 | ANDA216594 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-425-01) | Epic Pharma, LLC | 42806-425-01 | 42806-425 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-425-05) | Epic Pharma, LLC | 42806-425-05 | 42806-425 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 250 Tablet, Extended Release In 1 Bottle (42806-425-52) | Epic Pharma, LLC | 42806-425-52 | 42806-425 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-425-60) | Epic Pharma, LLC | 42806-425-60 | 42806-425 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-426-01) | Epic Pharma, LLC | 42806-426-01 | 42806-426 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-426-05) | Epic Pharma, LLC | 42806-426-05 | 42806-426 | ANDA211347 | ANDA | N/A |
| Carbamide Peroxide | Liquid | Auricular (Otic) | .065mg/mL | 1 Bottle, Dropper In 1 Carton (69452-377-75) / 15 Ml In 1 Bottle, Dropper | Bionpharma Inc. | 69452-377-75 | 69452-377 | M014 | OTC MONOGRAPH FINAL | N/A |
| Carbamide Peroxide | Liquid | Auricular (Otic) | .065mg/mL | 2 Bottle, Dropper In 1 Carton (69452-377-95) / 15 Ml In 1 Bottle, Dropper | Bionpharma Inc. | 69452-377-95 | 69452-377 | M014 | OTC MONOGRAPH FINAL | N/A |
| Carbidopa | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (47781-332-01) | Alvogen Inc. | 47781-332-01 | 47781-332 | ANDA204291 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 200mg/1 | 60 Tablet, Extended Release In 1 Bottle (42806-426-60) | Epic Pharma, LLC | 42806-426-60 | 42806-426 | ANDA211347 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-348-05) | Epic Pharma, LLC | 42806-348-05 | 42806-348 | ANDA207224 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (42806-348-09) | Epic Pharma, LLC | 42806-348-09 | 42806-348 | ANDA207224 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (42806-348-30) | Epic Pharma, LLC | 42806-348-30 | 42806-348 | ANDA207224 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (16571-862-03) | Rising Pharma Holdings, Inc. | 16571-862-03 | 16571-862 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (16571-862-09) | Rising Pharma Holdings, Inc. | 16571-862-09 | 16571-862 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 1000 Tablet, Extended Release In 1 Bottle (16571-862-10) | Rising Pharma Holdings, Inc. | 16571-862-10 | 16571-862 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 120 Tablet, Extended Release In 1 Bottle (16571-862-12) | Rising Pharma Holdings, Inc. | 16571-862-12 | 16571-862 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (16571-862-50) | Rising Pharma Holdings, Inc. | 16571-862-50 | 16571-862 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle (16571-863-03) | Rising Pharma Holdings, Inc. | 16571-863-03 | 16571-863 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle (16571-863-09) | Rising Pharma Holdings, Inc. | 16571-863-09 | 16571-863 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 1000 Tablet, Extended Release In 1 Bottle (16571-863-10) | Rising Pharma Holdings, Inc. | 16571-863-10 | 16571-863 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (16571-863-50) | Rising Pharma Holdings, Inc. | 16571-863-50 | 16571-863 | ANDA211020 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-01) | ScieGen Pharmaceuticals, Inc. | 50228-174-01 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-05) | ScieGen Pharmaceuticals, Inc. | 50228-174-05 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-10) | ScieGen Pharmaceuticals, Inc. | 50228-174-10 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-30) | ScieGen Pharmaceuticals, Inc. | 50228-174-30 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-60) | ScieGen Pharmaceuticals, Inc. | 50228-174-60 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-01) | ScieGen Pharmaceuticals, Inc. | 50228-175-01 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-05) | ScieGen Pharmaceuticals, Inc. | 50228-175-05 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-10) | ScieGen Pharmaceuticals, Inc. | 50228-175-10 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-30) | ScieGen Pharmaceuticals, Inc. | 50228-175-30 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-60) | ScieGen Pharmaceuticals, Inc. | 50228-175-60 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-01) | ScieGen Pharmaceuticals, Inc. | 50228-176-01 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-10) | ScieGen Pharmaceuticals, Inc. | 50228-176-10 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-30) | ScieGen Pharmaceuticals, Inc. | 50228-176-30 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-60) | ScieGen Pharmaceuticals, Inc. | 50228-176-60 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-11) | ScieGen Pharmaceuticals, Inc. | 50228-338-11 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-31) | ScieGen Pharmaceuticals, Inc. | 50228-338-31 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-61) | ScieGen Pharmaceuticals, Inc. | 50228-338-61 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-01) | ScieGen Pharmaceuticals, Inc. | 50228-174-01 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-05) | ScieGen Pharmaceuticals, Inc. | 50228-174-05 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-10) | ScieGen Pharmaceuticals, Inc. | 50228-174-10 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-30) | ScieGen Pharmaceuticals, Inc. | 50228-174-30 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-174-60) | ScieGen Pharmaceuticals, Inc. | 50228-174-60 | 50228-174 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-01) | ScieGen Pharmaceuticals, Inc. | 50228-175-01 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-05) | ScieGen Pharmaceuticals, Inc. | 50228-175-05 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-10) | ScieGen Pharmaceuticals, Inc. | 50228-175-10 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-30) | ScieGen Pharmaceuticals, Inc. | 50228-175-30 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-175-60) | ScieGen Pharmaceuticals, Inc. | 50228-175-60 | 50228-175 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-01) | ScieGen Pharmaceuticals, Inc. | 50228-176-01 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-10) | ScieGen Pharmaceuticals, Inc. | 50228-176-10 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-30) | ScieGen Pharmaceuticals, Inc. | 50228-176-30 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-176-60) | ScieGen Pharmaceuticals, Inc. | 50228-176-60 | 50228-176 | ANDA205794 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-11) | ScieGen Pharmaceuticals, Inc. | 50228-338-11 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-31) | ScieGen Pharmaceuticals, Inc. | 50228-338-31 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-338-61) | ScieGen Pharmaceuticals, Inc. | 50228-338-61 | 50228-338 | ANDA206122 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-05) | ScieGen Pharmaceuticals,Inc. | 50228-144-05 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-30) | ScieGen Pharmaceuticals,Inc. | 50228-144-30 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-90) | ScieGen Pharmaceuticals,Inc. | 50228-144-90 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-05) | ScieGen Pharmaceuticals,Inc. | 50228-145-05 | 50228-145 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-30) | ScieGen Pharmaceuticals,Inc. | 50228-145-30 | 50228-145 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-90) | ScieGen Pharmaceuticals,Inc. | 50228-145-90 | 50228-145 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-05) | ScieGen Pharmaceuticals,Inc. | 50228-144-05 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-30) | ScieGen Pharmaceuticals,Inc. | 50228-144-30 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-144-90) | ScieGen Pharmaceuticals,Inc. | 50228-144-90 | 50228-144 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-05) | ScieGen Pharmaceuticals,Inc. | 50228-145-05 | 50228-145 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-30) | ScieGen Pharmaceuticals,Inc. | 50228-145-30 | 50228-145 | ANDA207479 | ANDA | N/A |
| Bupropion Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-145-90) | ScieGen Pharmaceuticals,Inc. | 50228-145-90 | 50228-145 | ANDA207479 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-663-01) | EPIC PHARMA, LLC | 42806-663-01 | 42806-663 | ANDA202087 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6282-1) / 5 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6282-1 | 60505-6282 | ANDA077861 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6282-3) / 15 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6282-3 | 60505-6282 | ANDA077861 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6282-6) / 45 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6282-6 | 60505-6282 | ANDA077861 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6282-7) / 60 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6282-7 | 60505-6282 | ANDA077861 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (42806-663-05) | EPIC PHARMA, LLC | 42806-663-05 | 42806-663 | ANDA202087 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (42806-664-01) | EPIC PHARMA, LLC | 42806-664-01 | 42806-664 | ANDA202087 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-150-05) / 15 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-150-05 | 61703-150 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-262-05) / 45 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-262-05 | 61703-262 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-339-18) / 5 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-339-18 | 61703-339 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-339-22) / 15 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-339-22 | 61703-339 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-339-50) / 45 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-339-50 | 61703-339 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-339-56) / 60 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-339-56 | 61703-339 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-360-18) / 5 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-360-18 | 61703-360 | ANDA076517 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-600-05) / 60 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-600-05 | 61703-600 | ANDA077059 | ANDA | N/A |
| Carboprost Tromethamine | Injection | Intramuscular | 250ug/mL | 10 Carton In 1 Box (81298-5010-3) / 1 Vial, Single-Dose In 1 Carton (81298-5010-1) / 1 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-5010-3 | 81298-5010 | ANDA214499 | ANDA | N/A |
| Carboprost Tromethamine | Injection | Intramuscular | 250ug/mL | 1 Carton In 1 Box (81298-5010-5) / 1 Vial, Single-Dose In 1 Carton (81298-5010-1) / 1 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-5010-5 | 81298-5010 | ANDA214499 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (42806-664-05) | EPIC PHARMA, LLC | 42806-664-05 | 42806-664 | ANDA202087 | ANDA | N/A |
| Carboprost Tromethamine | Injection, Solution | Intramuscular | 250ug/mL | 10 Vial In 1 Carton (0409-0064-10) / 1 Ml In 1 Vial | Hospira, Inc. | 0409-0064-10 | 0409-0064 | ANDA217657 | ANDA | N/A |
| Carglumic Acid | Tablet, For Suspension | Oral | 200mg/1 | 5 Tablet, For Suspension In 1 Bottle (68475-006-01) | Navinta LLC | 68475-006-01 | 68475-006 | ANDA213395 | ANDA | N/A |
| Carglumic Acid | Tablet, For Suspension | Oral | 200mg/1 | 60 Tablet, For Suspension In 1 Bottle (68475-006-02) | Navinta LLC | 68475-006-02 | 68475-006 | ANDA213395 | ANDA | N/A |
| Carglumic Acid | Tablet, For Suspension | Oral | 200mg/1 | 1 Bottle In 1 Carton (71863-114-60) / 60 Tablet, For Suspension In 1 Bottle | Eton Pharmaceuticals, Inc. | 71863-114-60 | 71863-114 | ANDA213729 | ANDA | N/A |
| Carisoprodol | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (29033-207-01) | Nostrum Laboratories, Inc. | 29033-207-01 | 29033-207 | ANDA207237 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle (29033-207-30) | Nostrum Laboratories, Inc. | 29033-207-30 | 29033-207 | ANDA207237 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (29033-214-01) | Nostrum Laboratories, Inc. | 29033-214-01 | 29033-214 | ANDA207237 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 500 Tablet In 1 Bottle (29033-214-05) | Nostrum Laboratories, Inc. | 29033-214-05 | 29033-214 | ANDA207237 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 1000 Tablet In 1 Bottle (29033-214-10) | Nostrum Laboratories, Inc. | 29033-214-10 | 29033-214 | ANDA207237 | ANDA | CIV |
| Buspirone Hydrochloride | Tablet | Oral | 30mg/1 | 60 Tablet In 1 Bottle (42806-665-60) | EPIC PHARMA, LLC | 42806-665-60 | 42806-665 | ANDA202087 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-082-01) | Epic Pharma, LLC | 42806-082-01 | 42806-082 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (42806-082-05) | Epic Pharma, LLC | 42806-082-05 | 42806-082 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (42806-083-01) | Epic Pharma, LLC | 42806-083-01 | 42806-083 | ANDA208972 | ANDA | N/A |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (60429-508-01) | Golden State Medical Supply, Inc. | 60429-508-01 | 60429-508 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 1000 Tablet In 1 Bottle (60429-508-10) | Golden State Medical Supply, Inc. | 60429-508-10 | 60429-508 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (52536-682-10) | Wilshire Pharmaceuticals, Inc. | 52536-682-10 | 52536-682 | ANDA205126 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (52536-688-10) | Wilshire Pharmaceuticals, Inc. | 52536-688-10 | 52536-688 | ANDA205126 | ANDA | CIV |
| Buspirone Hydrochloride | Tablet | Oral | 7.5mg/1 | 500 Tablet In 1 Bottle (42806-083-05) | Epic Pharma, LLC | 42806-083-05 | 42806-083 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-084-01) | Epic Pharma, LLC | 42806-084-01 | 42806-084 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (42806-084-05) | Epic Pharma, LLC | 42806-084-05 | 42806-084 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (42806-085-01) | Epic Pharma, LLC | 42806-085-01 | 42806-085 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (42806-085-05) | Epic Pharma, LLC | 42806-085-05 | 42806-085 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (42806-086-05) | Epic Pharma, LLC | 42806-086-05 | 42806-086 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 30mg/1 | 60 Tablet In 1 Bottle (42806-086-60) | Epic Pharma, LLC | 42806-086-60 | 42806-086 | ANDA208972 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-662-01) | EPIC PHARMA, LLC | 42806-662-01 | 42806-662 | ANDA202087 | ANDA | N/A |
| Buspirone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (42806-662-05) | EPIC PHARMA, LLC | 42806-662-05 | 42806-662 | ANDA202087 | ANDA | N/A |
| Busulfan | Injection | Intravenous | 6mg/mL | 8 Vial, Single-Dose In 1 Carton (70121-1244-7) / 10 Ml In 1 Vial, Single-Dose (70121-1244-1) | Amneal Pharmaceuticals LLC | 70121-1244-7 | 70121-1244 | ANDA209580 | ANDA | N/A |
| Carrot | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3125-2) | Jubilant HollisterStier LLC | 65044-3125-2 | 65044-3125 | BLA103888 | BLA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 6.25mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-532-60) | St. Mary's Medical Park Pharmacy | 60760-532-60 | 60760-532 | ANDA078251 | ANDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 6.25mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-582-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-582-60 | 60760-582 | ANDA077614 | ANDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 6.25mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-376-60) | St. Mary's Medical Park Pharmacy | 60760-376-60 | 60760-376 | ANDA078384 | ANDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 3.125mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (80725-139-20) | Waylis Therapeutics LLC | 80725-139-20 | 80725-139 | NDA020297 | NDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 6.25mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (80725-140-20) | Waylis Therapeutics LLC | 80725-140-20 | 80725-140 | NDA020297 | NDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 12.5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (80725-141-20) | Waylis Therapeutics LLC | 80725-141-20 | 80725-141 | NDA020297 | NDA | N/A |
| Carvedilol | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (80725-142-20) | Waylis Therapeutics LLC | 80725-142-20 | 80725-142 | NDA020297 | NDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 10mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (51407-050-30) | Golden State Medical Supply, Inc. | 51407-050-30 | 51407-050 | ANDA090132 | ANDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 20mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (51407-051-30) | Golden State Medical Supply, Inc. | 51407-051-30 | 51407-051 | ANDA090132 | ANDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 40mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (51407-052-30) | Golden State Medical Supply, Inc. | 51407-052-30 | 51407-052 | ANDA090132 | ANDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (51407-053-30) | Golden State Medical Supply, Inc. | 51407-053-30 | 51407-053 | ANDA090132 | ANDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 10mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (80725-383-13) | Waylis Therapeutics LLC | 80725-383-13 | 80725-383 | NDA022012 | NDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 20mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (80725-385-13) | Waylis Therapeutics LLC | 80725-385-13 | 80725-385 | NDA022012 | NDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 40mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (80725-387-13) | Waylis Therapeutics LLC | 80725-387-13 | 80725-387 | NDA022012 | NDA | N/A |
| Carvedilol Phosphate | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (80725-388-13) | Waylis Therapeutics LLC | 80725-388-13 | 80725-388 | NDA022012 | NDA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2098-2) | Jubilant HollisterStier LLC | 65044-2098-2 | 65044-2098 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2098-3) | Jubilant HollisterStier LLC | 65044-2098-3 | 65044-2098 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2098-4) | Jubilant HollisterStier LLC | 65044-2098-4 | 65044-2098 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2099-1) | Jubilant HollisterStier LLC | 65044-2099-1 | 65044-2099 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2101-2) | Jubilant HollisterStier LLC | 65044-2101-2 | 65044-2101 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2101-3) | Jubilant HollisterStier LLC | 65044-2101-3 | 65044-2101 | BLA103888 | BLA | N/A |
| Carya Illinoinensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2101-4) | Jubilant HollisterStier LLC | 65044-2101-4 | 65044-2101 | BLA103888 | BLA | N/A |
| Carya Ovata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1702-2) | Jubilant HollisterStier LLC | 65044-1702-2 | 65044-1702 | BLA103888 | BLA | N/A |
| Carya Ovata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1702-3) | Jubilant HollisterStier LLC | 65044-1702-3 | 65044-1702 | BLA103888 | BLA | N/A |
| Carya Ovata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1702-4) | Jubilant HollisterStier LLC | 65044-1702-4 | 65044-1702 | BLA103888 | BLA | N/A |
| Carya Ovata Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1703-1) | Jubilant HollisterStier LLC | 65044-1703-1 | 65044-1703 | BLA103888 | BLA | N/A |
| Casein | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3380-2) | Jubilant HollisterStier LLC | 65044-3380-2 | 65044-3380 | BLA103888 | BLA | N/A |
| Casein | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3381-1) | Jubilant HollisterStier LLC | 65044-3381-1 | 65044-3381 | BLA103888 | BLA | N/A |
| Cashew | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3134-2) | Jubilant HollisterStier LLC | 65044-3134-2 | 65044-3134 | BLA103888 | BLA | N/A |
| Caspofungin Acetate | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-194-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-194-10 | 25021-194 | ANDA207092 | ANDA | N/A |
| Caspofungin Acetate | Injection, Powder, Lyophilized, For Solution | Intravenous | 7mg/mL | 1 Vial In 1 Carton (25021-195-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-195-10 | 25021-195 | ANDA207092 | ANDA | N/A |
| Cavia Porcellus Dander; Cavia Porcellus Hair | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-4401-2) | Jubilant HollisterStier LLC | 65044-4401-2 | 65044-4401 | BLA103888 | BLA | N/A |
| Cavia Porcellus Dander; Cavia Porcellus Hair | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-4402-1) | Jubilant HollisterStier LLC | 65044-4402-1 | 65044-4402 | BLA103888 | BLA | N/A |
| Cefaclor | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle, Plastic (61442-171-01) | Carlsbad Technology, Inc. | 61442-171-01 | 61442-171 | ANDA065146 | ANDA | N/A |
| Cefaclor | Capsule | Oral | 250mg/1 | 500 Capsule In 1 Bottle, Plastic (61442-171-05) | Carlsbad Technology, Inc. | 61442-171-05 | 61442-171 | ANDA065146 | ANDA | N/A |
| Cefaclor | Capsule | Oral | 250mg/1 | 30 Capsule In 1 Bottle, Plastic (61442-171-30) | Carlsbad Technology, Inc. | 61442-171-30 | 61442-171 | ANDA065146 | ANDA | N/A |
| Cefaclor | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle, Plastic (61442-172-01) | Carlsbad Technology, Inc. | 61442-172-01 | 61442-172 | ANDA065146 | ANDA | N/A |
| Cefaclor | Capsule | Oral | 500mg/1 | 500 Capsule In 1 Bottle, Plastic (61442-172-05) | Carlsbad Technology, Inc. | 61442-172-05 | 61442-172 | ANDA065146 | ANDA | N/A |
| Cefaclor | Capsule | Oral | 500mg/1 | 30 Capsule In 1 Bottle, Plastic (61442-172-30) | Carlsbad Technology, Inc. | 61442-172-30 | 61442-172 | ANDA065146 | ANDA | N/A |
| Cabergoline | Tablet | Oral | .5mg/1 | 8 Tablet In 1 Bottle (50742-118-08) | Ingenus Pharmaceuticals, LLC | 50742-118-08 | 50742-118 | ANDA204735 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .5ug/1 | 30 Capsule In 1 Bottle (65162-576-03) | Amneal Pharmaceuticals LLC | 65162-576-03 | 65162-576 | ANDA203289 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .5ug/1 | 100 Capsule In 1 Bottle (65162-576-10) | Amneal Pharmaceuticals LLC | 65162-576-10 | 65162-576 | ANDA203289 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .5ug/1 | 250 Capsule In 1 Bottle (65162-576-25) | Amneal Pharmaceuticals LLC | 65162-576-25 | 65162-576 | ANDA203289 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .25ug/1 | 30 Capsule In 1 Bottle (65162-519-03) | Amneal Pharmaceuticals LLC | 65162-519-03 | 65162-519 | ANDA203289 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .25ug/1 | 100 Capsule In 1 Bottle (65162-519-10) | Amneal Pharmaceuticals LLC | 65162-519-10 | 65162-519 | ANDA203289 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Bottle In 1 Carton (25021-102-99) / 1 Injection, Powder, For Solution In 1 Bottle | Sagent Pharmaceuticals | 25021-102-99 | 25021-102 | ANDA065306 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/2.2mL | 25 Vial In 1 Carton (25021-100-10) / 2.2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-100-10 | 25021-100 | ANDA065303 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/3mL | 25 Vial In 1 Carton (25021-101-10) / 3 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-101-10 | 25021-101 | ANDA065303 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 3g/1 | 25 Vial, Single-Dose In 1 Carton (60505-6266-5) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (60505-6266-0) | Apotex Corp. | 60505-6266-5 | 60505-6266 | ANDA203661 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial, Single-Dose In 1 Carton (60505-6142-5) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (60505-6142-0) | Apotex Corp. | 60505-6142-5 | 60505-6142 | ANDA203661 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Vial, Pharmacy Bulk Package In 1 Carton (60505-6143-4) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package (60505-6143-0) | Apotex Corp. | 60505-6143-4 | 60505-6143 | ANDA209217 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 25 Vial, Single-Dose In 1 Carton (60505-6231-5) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (60505-6231-0) | Apotex Corp. | 60505-6231-5 | 60505-6231 | ANDA203661 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial, Single-Dose In 1 Carton (60505-6243-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (60505-6243-0) | Apotex Corp. | 60505-6243-4 | 60505-6243 | ANDA203661 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Vial, Pharmacy Bulk Package In 1 Carton (60505-6244-4) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package (60505-6244-0) | Apotex Corp. | 60505-6244-4 | 60505-6244 | ANDA209217 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 225mg/mL | 2.2 Ml In 1 Vial (0143-9923-90) | Hikma Pharmaceuticals USA Inc. | 0143-9923-90 | 0143-9923 | ANDA065047 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 330mg/mL | 3 Ml In 1 Vial (0143-9924-90) | Hikma Pharmaceuticals USA Inc. | 0143-9924-90 | 0143-9924 | ANDA065047 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Vial, Pharmacy Bulk Package In 1 Carton (0143-9261-10) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package (0143-9261-01) | Hikma Pharmaceuticals USA Inc. | 0143-9261-10 | 0143-9261 | ANDA065143 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 330mg/mL | 25 Vial In 1 Carton (0143-9262-25) / 3 Ml In 1 Vial (0143-9262-01) | Hikma Pharmaceuticals USA Inc. | 0143-9262-25 | 0143-9262 | ANDA065047 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 20g/1 | 1 Injection, Powder, For Solution In 1 Vial (0143-9665-10) | Hikma Pharmaceuticals USA Inc. | 0143-9665-10 | 0143-9665 | ANDA065143 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Vial, Pharmacy Bulk Package In 1 Carton (0143-9983-03) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package (0143-9983-91) | Hikma Pharmaceuticals USA Inc. | 0143-9983-03 | 0143-9983 | ANDA065143 | ANDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 2g/1 | 25 Vial In 1 Carton (0143-9139-25) / 1 Injection, Powder, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9139-25 | 0143-9139 | NDA216109 | NDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 3g/1 | 25 Vial In 1 Carton (0143-9140-25) / 1 Injection, Powder, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9140-25 | 0143-9140 | NDA216109 | NDA | N/A |
| Cefazolin Sodium | Injection, Powder, For Solution | Intravenous | 1g/1 | 25 Vial In 1 Carton (0409-2585-01) / 1 Injection, Powder, For Solution In 1 Vial (0409-2585-11) | Hospira, Inc | 0409-2585-01 | 0409-2585 | ANDA065345 | ANDA | N/A |
| Calcitriol | Capsule | Oral | .25ug/1 | 250 Capsule In 1 Bottle (65162-519-25) | Amneal Pharmaceuticals LLC | 65162-519-25 | 65162-519 | ANDA203289 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial In 1 Carton (25021-121-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-121-20 | 25021-121 | ANDA065441 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-122-50) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-122-50 | 25021-122 | ANDA065441 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6144-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6144-4 | 60505-6144 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6145-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6145-4 | 60505-6145 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 1 Vial, Single-Dose In 1 Carton (60505-6146-0) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6146-0 | 60505-6146 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6146-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6146-4 | 60505-6146 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 1 Vial, Single-Dose In 1 Carton (60505-6147-0) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6147-0 | 60505-6147 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6147-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6147-4 | 60505-6147 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6245-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6245-4 | 60505-6245 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial, Single-Dose In 1 Carton (60505-6246-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Apotex Corp. | 60505-6246-4 | 60505-6246 | ANDA203704 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial In 1 Carton (0409-9735-10) / 1 Injection, Powder, For Solution In 1 Vial (0409-9735-01) | Hospira, Inc. | 0409-9735-10 | 0409-9735 | ANDA065441 | ANDA | N/A |
| Cefepime Hydrochloride | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial In 1 Carton (0409-9566-10) / 1 Injection, Powder, For Solution In 1 Vial (0409-9566-01) | Hospira, Inc. | 0409-9566-10 | 0409-9566 | ANDA065441 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 100mg/5mL | 50 Ml In 1 Bottle (62250-663-26) | Belcher Pharmaceuticals,LLC | 62250-663-26 | 62250-663 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 100mg/5mL | 75 Ml In 1 Bottle (62250-663-27) | Belcher Pharmaceuticals,LLC | 62250-663-27 | 62250-663 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 100mg/5mL | 100 Ml In 1 Bottle (62250-663-28) | Belcher Pharmaceuticals,LLC | 62250-663-28 | 62250-663 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 200mg/5mL | 50 Ml In 1 Bottle (62250-664-26) | Belcher Pharmaceuticals,LLC | 62250-664-26 | 62250-664 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 200mg/5mL | 75 Ml In 1 Bottle (62250-664-27) | Belcher Pharmaceuticals,LLC | 62250-664-27 | 62250-664 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (62250-664-28) | Belcher Pharmaceuticals,LLC | 62250-664-28 | 62250-664 | ANDA206938 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 500mg/5mL | 10 Ml In 1 Bottle (62250-668-24) | Belcher Pharmaceuticals,LLC | 62250-668-24 | 62250-668 | ANDA206939 | ANDA | N/A |
| Cefixime | Powder, For Suspension | Oral | 500mg/5mL | 20 Ml In 1 Bottle (62250-668-25) | Belcher Pharmaceuticals,LLC | 62250-668-25 | 62250-668 | ANDA206939 | ANDA | N/A |
| Cefotaxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 10 Vial In 1 Package (0143-9930-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9930-01) | Hikma Pharmaceuticals USA Inc. | 0143-9930-10 | 0143-9930 | ANDA065072 | ANDA | N/A |
| Cefotaxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial In 1 Package (0143-9931-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9931-01) | Hikma Pharmaceuticals USA Inc. | 0143-9931-25 | 0143-9931 | ANDA065072 | ANDA | N/A |
| Cefotaxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 25 Vial In 1 Package (0143-9933-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9933-01) | Hikma Pharmaceuticals USA Inc. | 0143-9933-25 | 0143-9933 | ANDA065072 | ANDA | N/A |
| Cefotaxime Sodium | Injection | Intravenous | 10g/1 | 1 Injection In 1 Package (0143-9935-01) | Hikma Pharmaceuticals USA Inc. | 0143-9935-01 | 0143-9935 | ANDA065071 | ANDA | N/A |
| Cefotetan | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial In 1 Carton (0143-9670-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9670-01) | Hikma Pharmaceuticals USA Inc. | 0143-9670-10 | 0143-9670 | ANDA091031 | ANDA | N/A |
| Cefotetan | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial In 1 Carton (0143-9671-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9671-01) | Hikma Pharmaceuticals USA Inc. | 0143-9671-10 | 0143-9671 | ANDA091031 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 1g/1 | 10 Vial In 1 Carton (25021-109-10) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-109-10 | 25021-109 | ANDA065414 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-110-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-110-20 | 25021-110 | ANDA065414 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Bottle In 1 Carton (25021-111-99) / 1 Injection, Powder, For Solution In 1 Bottle | Sagent Pharmaceuticals | 25021-111-99 | 25021-111 | ANDA065415 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 10 Bottle In 1 Carton (0143-9876-10) / 1 Injection, Powder, For Solution In 1 Bottle (0143-9876-01) | Hikma Pharmaceuticals USA Inc. | 0143-9876-10 | 0143-9876 | ANDA065239 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 2g/1 | 25 Vial In 1 Carton (0143-9877-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9877-01) | Hikma Pharmaceuticals USA Inc. | 0143-9877-25 | 0143-9877 | ANDA065238 | ANDA | N/A |
| Cefoxitin Sodium | Injection, Powder, For Solution | Intravenous | 1g/1 | 25 Vial In 1 Carton (0143-9878-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9878-01) | Hikma Pharmaceuticals USA Inc. | 0143-9878-25 | 0143-9878 | ANDA065238 | ANDA | N/A |
| Cefpodoxime Proxetil | Tablet, Film Coated | Oral | 100mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-083-20) | Golden State Medical Supply, Inc. | 51407-083-20 | 51407-083 | ANDA210568 | ANDA | N/A |
| Cefpodoxime Proxetil | Tablet, Film Coated | Oral | 200mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-084-20) | Golden State Medical Supply, Inc. | 51407-084-20 | 51407-084 | ANDA210568 | ANDA | N/A |
| Calcitriol | Solution | Oral | 1ug/mL | 1 Bottle, Glass In 1 Carton (64980-447-15) / 15 Ml In 1 Bottle, Glass | Rising Pharmaceuticals, Inc. | 64980-447-15 | 64980-447 | ANDA209798 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 100 Capsule In 1 Bottle (65162-590-10) | Amneal Pharmaceuticals LLC | 65162-590-10 | 65162-590 | ANDA201658 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 200 Capsule In 1 Bottle (65162-590-20) | Amneal Pharmaceuticals LLC | 65162-590-20 | 65162-590 | ANDA201658 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 500 Capsule In 1 Bottle (65162-590-50) | Amneal Pharmaceuticals LLC | 65162-590-50 | 65162-590 | ANDA201658 | ANDA | N/A |
| Calcium Acetate | Capsule | Oral | 667mg/1 | 200 Capsule In 1 Bottle, Plastic (16571-813-20) | Rising Pharma Holdings, Inc. | 16571-813-20 | 16571-813 | ANDA211038 | ANDA | N/A |
| Calcium Chloride | Injection, Solution | Intravenous | 100mg/mL | 24 Carton In 1 Carton (70121-2308-4) / 1 Syringe, Glass In 1 Carton (70121-2308-1) / 10 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-2308-4 | 70121-2308 | ANDA217524 | ANDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 4mg/1 | 30 Tablet In 1 Bottle (62559-640-30) | ANI Pharmaceuticals, Inc. | 62559-640-30 | 62559-640 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 8mg/1 | 30 Tablet In 1 Bottle (62559-641-30) | ANI Pharmaceuticals, Inc. | 62559-641-30 | 62559-641 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 16mg/1 | 30 Tablet In 1 Bottle (62559-642-30) | ANI Pharmaceuticals, Inc. | 62559-642-30 | 62559-642 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 16mg/1 | 90 Tablet In 1 Bottle (62559-642-90) | ANI Pharmaceuticals, Inc. | 62559-642-90 | 62559-642 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 32mg/1 | 30 Tablet In 1 Bottle (62559-643-30) | ANI Pharmaceuticals, Inc. | 62559-643-30 | 62559-643 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 32mg/1 | 90 Tablet In 1 Bottle (62559-643-90) | ANI Pharmaceuticals, Inc. | 62559-643-90 | 62559-643 | NDA020838 | NDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 4mg/1 | 50000 Tablet In 1 Box (62559-686-99) | ANI Pharmaceuticals, Inc. | 62559-686-99 | 62559-686 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial In 1 Carton (25021-127-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-127-20 | 25021-127 | ANDA062640 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-128-50) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-128-50 | 25021-128 | ANDA062640 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 6g/30mL | 6 Bottle In 1 Carton (25021-129-99) / 30 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-129-99 | 25021-129 | ANDA062640 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial In 1 Carton (0409-5084-11) / 1 Injection, Powder, For Solution In 1 Vial (0409-5084-13) | Hospira, Inc. | 0409-5084-11 | 0409-5084 | ANDA062662 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 6g/1 | 10 Vial, Pharmacy Bulk Package In 1 Carton (0409-5086-11) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package (0409-5086-13) | Hospira, Inc. | 0409-5086-11 | 0409-5086 | ANDA062662 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 1g/1 | 25 Vial, Patent Delivery System In 1 Tray (0409-5092-16) / 1 Injection, Powder, For Solution In 1 Vial, Patent Delivery System (0409-5092-11) | Hospira, Inc. | 0409-5092-16 | 0409-5092 | ANDA064032 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial, Patent Delivery System In 1 Tray (0409-5093-11) / 1 Injection, Powder, For Solution In 1 Vial, Patent Delivery System (0409-5093-14) | Hospira, Inc. | 0409-5093-11 | 0409-5093 | ANDA064032 | ANDA | N/A |
| Ceftazidime | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial In 1 Carton (0409-5082-16) / 1 Injection, Powder, For Solution In 1 Vial (0409-5082-11) | Hospira, Inc. | 0409-5082-16 | 0409-5082 | ANDA062662 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial In 1 Carton (25021-106-10) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-106-10 | 25021-106 | ANDA065329 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 25 Vial In 1 Carton (25021-107-20) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-107-20 | 25021-107 | ANDA065329 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 1 Vial, Single-Use In 1 Carton (60505-6148-0) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6148-0 | 60505-6148 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Use In 1 Carton (60505-6148-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6148-4 | 60505-6148 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial, Single-Use In 1 Carton (60505-6149-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (60505-6149-0) | Apotex Corp. | 60505-6149-4 | 60505-6149 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 1 Vial, Pharmacy Bulk Package In 1 Carton (60505-6150-5) / 1 Injection, Powder, For Solution In 1 Vial, Pharmacy Bulk Package | Apotex Corp. | 60505-6150-5 | 60505-6150 | ANDA209218 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 250mg/1 | 10 Vial, Single-Use In 1 Carton (60505-6151-1) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6151-1 | 60505-6151 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 250mg/1 | 1 Vial, Single-Use In 1 Carton (60505-6151-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6151-4 | 60505-6151 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 10 Vial, Single-Use In 1 Carton (60505-6152-1) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6152-1 | 60505-6152 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 1 Vial, Single-Use In 1 Carton (60505-6152-4) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use | Apotex Corp. | 60505-6152-4 | 60505-6152 | ANDA203702 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 25 Vial In 1 Box (0143-9857-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9857-01) | Hikma Pharmaceuticals USA Inc. | 0143-9857-25 | 0143-9857 | ANDA065342 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 25 Vial In 1 Box (0143-9858-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9858-01) | Hikma Pharmaceuticals USA Inc. | 0143-9858-25 | 0143-9858 | ANDA065342 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 250mg/1 | 25 Vial In 1 Box (0143-9859-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9859-01) | Hikma Pharmaceuticals USA Inc. | 0143-9859-25 | 0143-9859 | ANDA065342 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 10g/1 | 1 Injection, Powder, For Solution In 1 Carton (0143-9678-01) | Hikma Pharmaceuticals USA Inc. | 0143-9678-01 | 0143-9678 | ANDA090701 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 25 Vial In 1 Box (0143-9856-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9856-01) | Hikma Pharmaceuticals USA Inc. | 0143-9856-25 | 0143-9856 | ANDA065342 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 250mg/1 | 10 Vial, Single-Use In 1 Carton (0409-7337-01) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7337-11) | Hospira, Inc | 0409-7337-01 | 0409-7337 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 10 Vial, Single-Use In 1 Carton (0409-7338-20) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7338-21) | Hospira, Inc | 0409-7338-20 | 0409-7338 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 10 Vial, Single-Use In 1 Carton (0409-7338-01) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7338-11) | Hospira, Inc | 0409-7338-01 | 0409-7338 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Use In 1 Carton (0409-7332-20) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7332-21) | Hospira, Inc | 0409-7332-20 | 0409-7332 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Use In 1 Carton (0409-7332-01) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7332-11) | Hospira, Inc | 0409-7332-01 | 0409-7332 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 1g/1 | 10 Vial, Single-Use In 1 Carton (0409-7333-49) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7333-31) | Hospira, Inc | 0409-7333-49 | 0409-7333 | ANDA065204 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 1g/1 | 10 Vial, Single-Use In 1 Carton (0409-7333-04) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7333-11) | Hospira, Inc | 0409-7333-04 | 0409-7333 | ANDA065204 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 10g/100mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-7334-10) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc | 0409-7334-10 | 0409-7334 | ANDA065168 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 10g/100mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-7334-20) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc | 0409-7334-20 | 0409-7334 | ANDA065168 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial, Single-Use In 1 Carton (0409-7335-20) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7335-21) | Hospira, Inc | 0409-7335-20 | 0409-7335 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial, Single-Use In 1 Carton (0409-7335-03) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7335-13) | Hospira, Inc | 0409-7335-03 | 0409-7335 | ANDA065169 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intravenous | 2g/1 | 10 Vial, Single-Use In 1 Carton (0409-7336-04) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7336-11) | Hospira, Inc | 0409-7336-04 | 0409-7336 | ANDA065204 | ANDA | N/A |
| Ceftriaxone Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 250mg/1 | 10 Vial, Single-Use In 1 Carton (0409-7337-20) / 1 Injection, Powder, For Solution In 1 Vial, Single-Use (0409-7337-21) | Hospira, Inc | 0409-7337-20 | 0409-7337 | ANDA065169 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 250mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-333-20) | Golden State Medical Supply, Inc. | 51407-333-20 | 51407-333 | ANDA065496 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 250mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-333-60) | Golden State Medical Supply, Inc. | 51407-333-60 | 51407-333 | ANDA065496 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 500mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-334-20) | Golden State Medical Supply, Inc. | 51407-334-20 | 51407-334 | ANDA065496 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-334-60) | Golden State Medical Supply, Inc. | 51407-334-60 | 51407-334 | ANDA065496 | ANDA | N/A |
| Candesartan Cilexetil | Tablet | Oral | 8mg/1 | 50000 Tablet In 1 Box (62559-687-99) | ANI Pharmaceuticals, Inc. | 62559-687-99 | 62559-687 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil | Tablet | Oral | 16mg/1 | 50000 Tablet In 1 Box (62559-688-99) | ANI Pharmaceuticals, Inc. | 62559-688-99 | 62559-688 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil | Tablet | Oral | 32mg/1 | 25000 Tablet In 1 Box (62559-689-98) | ANI Pharmaceuticals, Inc. | 62559-689-98 | 62559-689 | NDA020838 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 32mg/1, 25 mg/1 | 90 Tablet In 1 Bottle (62559-652-90) | ANI Pharmaceuticals, Inc. | 62559-652-90 | 62559-652 | NDA021093 | NDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 750mg/1 | 25 Vial In 1 Carton (25021-118-10) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-118-10 | 25021-118 | ANDA064125 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 1.5g/16mL | 25 Vial In 1 Carton (25021-119-20) / 16 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-119-20 | 25021-119 | ANDA064125 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 750mg/1 | 25 Vial In 1 Carton (25021-182-66) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-182-66 | 25021-182 | ANDA064125 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 1.5g/16mL | 25 Vial In 1 Carton (25021-183-67) / 16 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-183-67 | 25021-183 | ANDA064125 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 1.5g/1 | 25 Vial In 1 Carton (0143-9567-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9567-01) | Hikma Pharmaceuticals USA Inc. | 0143-9567-25 | 0143-9567 | ANDA065048 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 750mg/1 | 25 Vial In 1 Carton (0143-9568-25) / 1 Injection, Powder, For Solution In 1 Vial (0143-9568-01) | Hikma Pharmaceuticals USA Inc. | 0143-9568-25 | 0143-9568 | ANDA065048 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 7.5g/1 | 10 Vial In 1 Carton (0143-9569-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9569-01) | Hikma Pharmaceuticals USA Inc. | 0143-9569-10 | 0143-9569 | ANDA065046 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 750mg/8mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (0143-9976-03) / 82.5 Ml In 1 Vial, Pharmacy Bulk Package (0143-9976-91) | Hikma Pharmaceuticals USA Inc. | 0143-9976-03 | 0143-9976 | ANDA065046 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intravenous | 1.5g/1 | 25 Vial In 1 Carton (0143-9977-22) / 1 Injection, Powder, For Solution In 1 Vial (0143-9977-90) | Hikma Pharmaceuticals USA Inc. | 0143-9977-22 | 0143-9977 | ANDA065048 | ANDA | N/A |
| Cefuroxime Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 750mg/1 | 25 Vial In 1 Carton (0143-9979-22) / 1 Injection, Powder, For Solution In 1 Vial (0143-9979-90) | Hikma Pharmaceuticals USA Inc. | 0143-9979-22 | 0143-9979 | ANDA065048 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (75834-236-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-236-05 | 75834-236 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Blister Pack (75834-236-11) | NIVAGEN PHARMACEUTICALS, INC. | 75834-236-11 | 75834-236 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (75834-236-60) | NIVAGEN PHARMACEUTICALS, INC. | 75834-236-60 | 75834-236 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (75834-237-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-237-01 | 75834-237 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (75834-237-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-237-05 | 75834-237 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Blister Pack (75834-237-11) | NIVAGEN PHARMACEUTICALS, INC. | 75834-237-11 | 75834-237 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (75834-238-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-238-01 | 75834-238 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (75834-238-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-238-05 | 75834-238 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Blister Pack (75834-238-11) | NIVAGEN PHARMACEUTICALS, INC. | 75834-238-11 | 75834-238 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (75834-239-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-239-05 | 75834-239 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Blister Pack (75834-239-11) | NIVAGEN PHARMACEUTICALS, INC. | 75834-239-11 | 75834-239 | ANDA210628 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (75834-239-60) | NIVAGEN PHARMACEUTICALS, INC. | 75834-239-60 | 75834-239 | ANDA210628 | ANDA | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 16mg/1, 12.5 mg/1 | 90 Tablet In 1 Bottle (62559-650-90) | ANI Pharmaceuticals, Inc. | 62559-650-90 | 62559-650 | NDA021093 | NDA | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 32mg/1, 12.5 mg/1 | 90 Tablet In 1 Bottle (62559-651-90) | ANI Pharmaceuticals, Inc. | 62559-651-90 | 62559-651 | NDA021093 | NDA | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 16mg/1, 12.5 mg/1 | 90 Tablet In 1 Bottle (62559-660-90) | ANI Pharmaceuticals, Inc. | 62559-660-90 | 62559-660 | NDA021093 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 32mg/1, 12.5 mg/1 | 90 Tablet In 1 Bottle (62559-661-90) | ANI Pharmaceuticals, Inc. | 62559-661-90 | 62559-661 | NDA021093 | NDA AUTHORIZED GENERIC | N/A |
| Candesartan Cilexetil; Hydrochlorothiazide | Tablet | Oral | 32mg/1, 25 mg/1 | 90 Tablet In 1 Bottle (62559-662-90) | ANI Pharmaceuticals, Inc. | 62559-662-90 | 62559-662 | NDA021093 | NDA AUTHORIZED GENERIC | N/A |
| capecitabine | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-774-60) | Camber Pharmaceuticals, Inc. | 31722-774-60 | 31722-774 | ANDA210203 | ANDA | N/A |
| capecitabine | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-775-12) | Camber Pharmaceuticals, Inc. | 31722-775-12 | 31722-775 | ANDA210203 | ANDA | N/A |
| capecitabine | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-775-60) | Camber Pharmaceuticals, Inc. | 31722-775-60 | 31722-775 | ANDA210203 | ANDA | N/A |
| Captopril | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (31722-141-01) | Camber Pharmaceuticals, Inc. | 31722-141-01 | 31722-141 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (31722-141-10) | Camber Pharmaceuticals, Inc. | 31722-141-10 | 31722-141 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (31722-142-01) | Camber Pharmaceuticals, Inc. | 31722-142-01 | 31722-142 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (31722-142-10) | Camber Pharmaceuticals, Inc. | 31722-142-10 | 31722-142 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (31722-143-01) | Camber Pharmaceuticals, Inc. | 31722-143-01 | 31722-143 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (31722-143-10) | Camber Pharmaceuticals, Inc. | 31722-143-10 | 31722-143 | ANDA074737 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 15 Capsule In 1 Bottle, Plastic (60760-742-15) | St Mary's Medical Park Pharmacy | 60760-742-15 | 60760-742 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-742-30) | St Mary's Medical Park Pharmacy | 60760-742-30 | 60760-742 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-742-60) | St Mary's Medical Park Pharmacy | 60760-742-60 | 60760-742 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-649-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-649-30 | 60760-649 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-649-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-649-60 | 60760-649 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-823-30) | St. Mary's Medical Park Pharmacy | 60760-823-30 | 60760-823 | ANDA204590 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-823-60) | St. Mary's Medical Park Pharmacy | 60760-823-60 | 60760-823 | ANDA204590 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 15 Capsule In 1 Bottle, Plastic (60760-824-15) | St. Mary's Medical Park Pharmacy | 60760-824-15 | 60760-824 | ANDA204590 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-824-30) | St. Mary's Medical Park Pharmacy | 60760-824-30 | 60760-824 | ANDA204590 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-824-60) | St. Mary's Medical Park Pharmacy | 60760-824-60 | 60760-824 | ANDA204590 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 100 Blister Pack In 1 Carton (58151-085-88) / 1 Capsule In 1 Blister Pack | Viatris Specialty LLC | 58151-085-88 | 58151-085 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (58151-085-91) | Viatris Specialty LLC | 58151-085-91 | 58151-085 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (58151-082-91) | Viatris Specialty LLC | 58151-082-91 | 58151-082 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (58151-084-01) | Viatris Specialty LLC | 58151-084-01 | 58151-084 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (58151-084-05) | Viatris Specialty LLC | 58151-084-05 | 58151-084 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Blister Pack In 1 Carton (58151-084-88) / 1 Capsule In 1 Blister Pack | Viatris Specialty LLC | 58151-084-88 | 58151-084 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (60505-3847-6) | Apotex Corp. | 60505-3847-6 | 60505-3847 | ANDA204197 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (60505-3848-1) | Apotex Corp. | 60505-3848-1 | 60505-3848 | ANDA204197 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (60505-3848-5) | Apotex Corp. | 60505-3848-5 | 60505-3848 | ANDA204197 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (60505-3849-1) | Apotex Corp. | 60505-3849-1 | 60505-3849 | ANDA204197 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (60505-3849-5) | Apotex Corp. | 60505-3849-5 | 60505-3849 | ANDA204197 | ANDA | N/A |
| Captopril | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (31722-144-01) | Camber Pharmaceuticals, Inc. | 31722-144-01 | 31722-144 | ANDA074737 | ANDA | N/A |
| Captopril | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (31722-144-10) | Camber Pharmaceuticals, Inc. | 31722-144-10 | 31722-144 | ANDA074737 | ANDA | N/A |
| Captopril; Hydrochlorothiazide | Tablet | Oral | 50mg/1, 25 mg/1 | 90 Tablet In 1 Bottle (16571-830-09) | Rising Pharma Holdings, Inc. | 16571-830-09 | 16571-830 | ANDA074896 | ANDA | N/A |
| Captopril; Hydrochlorothiazide | Tablet | Oral | 25mg/1, 15 mg/1 | 90 Tablet In 1 Bottle (16571-827-09) | Rising Pharma Holdings, Inc. | 16571-827-09 | 16571-827 | ANDA074896 | ANDA | N/A |
| Captopril; Hydrochlorothiazide | Tablet | Oral | 25mg/1, 25 mg/1 | 90 Tablet In 1 Bottle (16571-828-09) | Rising Pharma Holdings, Inc. | 16571-828-09 | 16571-828 | ANDA074896 | ANDA | N/A |
| Captopril; Hydrochlorothiazide | Tablet | Oral | 50mg/1, 15 mg/1 | 90 Tablet In 1 Bottle (16571-829-09) | Rising Pharma Holdings, Inc. | 16571-829-09 | 16571-829 | ANDA074896 | ANDA | N/A |
| Carbamazepine | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (70954-240-10) / 450 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 70954-240-10 | 70954-240 | ANDA214277 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-274-01) | Epic Pharma, LLC | 42806-274-01 | 42806-274 | ANDA216235 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-275-01) | Epic Pharma, LLC | 42806-275-01 | 42806-275 | ANDA216235 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-276-01) | Epic Pharma, LLC | 42806-276-01 | 42806-276 | ANDA216235 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-257-01) | Ingenus Pharmaceuticals, LLC | 50742-257-01 | 50742-257 | ANDA216404 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-258-01) | Ingenus Pharmaceuticals, LLC | 50742-258-01 | 50742-258 | ANDA216404 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-259-01) | Ingenus Pharmaceuticals, LLC | 50742-259-01 | 50742-259 | ANDA216404 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-680-01) | Rising Pharma Holdings, Inc. | 16571-680-01 | 16571-680 | ANDA211623 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-681-01) | Rising Pharma Holdings, Inc. | 16571-681-01 | 16571-681 | ANDA211623 | ANDA | N/A |
| Carbamazepine | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-682-01) | Rising Pharma Holdings, Inc. | 16571-682-01 | 16571-682 | ANDA211623 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 12.5mg/1, 200 mg/1, 50 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-689-01) | Rising Pharma Holdings, Inc. | 16571-689-01 | 16571-689 | ANDA213212 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 18.75mg/1, 200 mg/1, 75 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-690-01) | Rising Pharma Holdings, Inc. | 16571-690-01 | 16571-690 | ANDA213212 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 25mg/1, 200 mg/1, 100 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-691-01) | Rising Pharma Holdings, Inc. | 16571-691-01 | 16571-691 | ANDA213212 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 31.25mg/1, 200 mg/1, 125 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-692-01) | Rising Pharma Holdings, Inc. | 16571-692-01 | 16571-692 | ANDA213212 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 37.5mg/1, 200 mg/1, 150 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-693-01) | Rising Pharma Holdings, Inc. | 16571-693-01 | 16571-693 | ANDA213212 | ANDA | N/A |
| Carbidopa; Entacapone; Levodopa | Tablet, Film Coated | Oral | 50mg/1, 200 mg/1, 200 mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-694-01) | Rising Pharma Holdings, Inc. | 16571-694-01 | 16571-694 | ANDA213212 | ANDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 35mg/1, 140 mg/1 | 1 Bottle In 1 Carton (64896-967-16) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-967-16 | 64896-967 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 35mg/1, 140 mg/1 | 1 Bottle In 1 Carton (64896-967-23) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-967-23 | 64896-967 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 52.5mg/1, 210 mg/1 | 1 Bottle In 1 Carton (64896-968-16) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-968-16 | 64896-968 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 52.5mg/1, 210 mg/1 | 1 Bottle In 1 Carton (64896-968-23) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-968-23 | 64896-968 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 70mg/1, 280 mg/1 | 1 Bottle In 1 Carton (64896-969-16) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-969-16 | 64896-969 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 70mg/1, 280 mg/1 | 1 Bottle In 1 Carton (64896-969-23) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-969-23 | 64896-969 | NDA217186 | NDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (0025-1520-31) | PFIZER LABORATORIES DIV PFIZER INC | 0025-1520-31 | 0025-1520 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (0025-1520-34) / 1 Capsule In 1 Blister Pack | PFIZER LABORATORIES DIV PFIZER INC | 0025-1520-34 | 0025-1520 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (0025-1520-51) | PFIZER LABORATORIES DIV PFIZER INC | 0025-1520-51 | 0025-1520 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (0025-1525-31) | PFIZER LABORATORIES DIV PFIZER INC | 0025-1525-31 | 0025-1525 | NDA020998 | NDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (0025-1525-51) | PFIZER LABORATORIES DIV PFIZER INC | 0025-1525-51 | 0025-1525 | NDA020998 | NDA | N/A |
| Celery | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3140-2) | Jubilant HollisterStier LLC | 65044-3140-2 | 65044-3140 | BLA103888 | BLA | N/A |
| Celtis Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1663-2) | Jubilant HollisterStier LLC | 65044-1663-2 | 65044-1663 | BLA103888 | BLA | N/A |
| Celtis Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1663-3) | Jubilant HollisterStier LLC | 65044-1663-3 | 65044-1663 | BLA103888 | BLA | N/A |
| Celtis Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1663-4) | Jubilant HollisterStier LLC | 65044-1663-4 | 65044-1663 | BLA103888 | BLA | N/A |
| Celtis Occidentalis Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1664-1) | Jubilant HollisterStier LLC | 65044-1664-1 | 65044-1664 | BLA103888 | BLA | N/A |
| Cephalexin | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (62250-801-02) | Belcher Pharmaceuticals, LLC | 62250-801-02 | 62250-801 | ANDA062713 | ANDA | N/A |
| Cephalexin | Capsule | Oral | 250mg/1 | 500 Capsule In 1 Bottle (62250-801-08) | Belcher Pharmaceuticals, LLC | 62250-801-08 | 62250-801 | ANDA062713 | ANDA | N/A |
| Cephalexin | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle (62250-802-02) | Belcher Pharmaceuticals, LLC | 62250-802-02 | 62250-802 | ANDA062713 | ANDA | N/A |
| Cephalexin | Capsule | Oral | 500mg/1 | 500 Capsule In 1 Bottle (62250-802-08) | Belcher Pharmaceuticals, LLC | 62250-802-08 | 62250-802 | ANDA062713 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (45802-626-26) / 120 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-626-26 | 45802-626 | ANDA078398 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-919-39) / 30 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-919-39 | 45802-919 | ANDA078336 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-919-87) / 300 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-919-87 | 45802-919 | ANDA078336 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (45802-974-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-974-26 | 45802-974 | ANDA090254 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2106-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2106-1 | 51672-2106 | ANDA201546 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2106-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2106-4 | 51672-2106 | ANDA201546 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2106-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2106-8 | 51672-2106 | ANDA201546 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-4070-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4070-8 | 51672-4070 | ANDA076601 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2102-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2102-1 | 51672-2102 | ANDA090182 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 2 Bottle In 1 Carton (51672-2102-2) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2102-2 | 51672-2102 | ANDA090182 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2102-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2102-4 | 51672-2102 | ANDA090182 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 2 Bottle In 1 Carton (51672-2102-7) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2102-7 | 51672-2102 | ANDA090182 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (51672-2102-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2102-8 | 51672-2102 | ANDA090182 | ANDA | N/A |
| Cetirizine Hydrochloride | Capsule | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Carton (69452-265-15) / 40 Capsule In 1 Bottle, Plastic | Bionpharma Inc. | 69452-265-15 | 69452-265 | NDA022429 | NDA | N/A |
| Cetirizine Hydrochloride | Capsule | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Carton (69452-265-86) / 25 Capsule In 1 Bottle, Plastic | Bionpharma Inc. | 69452-265-86 | 69452-265 | NDA022429 | NDA | N/A |
| Cetirizine Hydrochloride | Capsule | Oral | 10mg/1 | 1 Bottle, Plastic In 1 Carton (69452-265-88) / 65 Capsule In 1 Bottle, Plastic | Bionpharma Inc. | 69452-265-88 | 69452-265 | NDA022429 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 87.5mg/1, 350 mg/1 | 1 Bottle In 1 Carton (64896-970-16) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-970-16 | 64896-970 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 87.5mg/1, 350 mg/1 | 1 Bottle In 1 Carton (64896-970-23) / 120 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-970-23 | 64896-970 | NDA217186 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 36.25mg/1, 145 mg/1 | 100 Capsule, Extended Release In 1 Bottle (64896-662-01) | Amneal Pharmaceuticals LLC | 64896-662-01 | 64896-662 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 36.25mg/1, 145 mg/1 | 25 Capsule, Extended Release In 1 Bottle (64896-662-09) | Amneal Pharmaceuticals LLC | 64896-662-09 | 64896-662 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 36.25mg/1, 145 mg/1 | 240 Capsule, Extended Release In 1 Bottle (64896-662-43) | Amneal Pharmaceuticals LLC | 64896-662-43 | 64896-662 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 36.25mg/1, 145 mg/1 | 100 Capsule, Extended Release In 1 Bottle (64896-662-99) | Amneal Pharmaceuticals LLC | 64896-662-99 | 64896-662 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 48.75mg/1, 195 mg/1 | 100 Capsule, Extended Release In 1 Bottle (64896-663-01) | Amneal Pharmaceuticals LLC | 64896-663-01 | 64896-663 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 48.75mg/1, 195 mg/1 | 25 Capsule, Extended Release In 1 Bottle (64896-663-09) | Amneal Pharmaceuticals LLC | 64896-663-09 | 64896-663 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 48.75mg/1, 195 mg/1 | 240 Capsule, Extended Release In 1 Bottle (64896-663-43) | Amneal Pharmaceuticals LLC | 64896-663-43 | 64896-663 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 48.75mg/1, 195 mg/1 | 100 Capsule, Extended Release In 1 Bottle (64896-663-99) | Amneal Pharmaceuticals LLC | 64896-663-99 | 64896-663 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 61.25mg/1, 245 mg/1 | 100 Capsule, Extended Release In 1 Bottle (64896-664-01) | Amneal Pharmaceuticals LLC | 64896-664-01 | 64896-664 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Capsule, Extended Release | Oral | 61.25mg/1, 245 mg/1 | 240 Capsule, Extended Release In 1 Bottle (64896-664-43) | Amneal Pharmaceuticals LLC | 64896-664-43 | 64896-664 | NDA203312 | NDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (50228-457-01) | ScieGen Pharmaceuticals Inc | 50228-457-01 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 500 Tablet In 1 Bottle (50228-457-05) | ScieGen Pharmaceuticals Inc | 50228-457-05 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 1000 Tablet In 1 Bottle (50228-457-10) | ScieGen Pharmaceuticals Inc | 50228-457-10 | 50228-457 | ANDA214092 | ANDA | N/A |
| Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 120 mg/1 | 12 Blister Pack In 1 Carton (45802-147-53) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-147-53 | 45802-147 | ANDA210719 | ANDA | N/A |
| Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 120 mg/1 | 24 Blister Pack In 1 Carton (45802-147-62) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-147-62 | 45802-147 | ANDA210719 | ANDA | N/A |
| Cetylpyridinium Chloride | Rinse | Dental | .75mg/mL | 400 Ml In 1 Bottle (66923-002-64) | Ranir LLC | 66923-002-64 | 66923-002 | part356 | OTC MONOGRAPH NOT FINAL | N/A |
| Cevimeline Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (69452-316-20) | Bionpharma Inc | 69452-316-20 | 69452-316 | ANDA218290 | ANDA | N/A |
| Cevimeline Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle, Plastic (0713-0937-01) | Cosette Pharmaceuticals, Inc. | 0713-0937-01 | 0713-0937 | NDA020989 | NDA | N/A |
| Cevimeline Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle, Plastic (0713-0883-01) | Cosette Pharmaceuticals, Inc. | 0713-0883-01 | 0713-0883 | NDA020989 | NDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 30 Tablet In 1 Bottle (50228-457-30) | ScieGen Pharmaceuticals Inc | 50228-457-30 | 50228-457 | ANDA214092 | ANDA | N/A |
| Cevimeline Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (0054-0334-25) | Hikma Pharmaceuticals USA Inc. | 0054-0334-25 | 0054-0334 | ANDA091591 | ANDA | N/A |
| Chamomile; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 3[hp_X]/14g, 2 [hp_X]/14g | 1 Tube In 1 Carton (71042-010-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-010-14 | 71042-010 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Chenodiol | Tablet, Film Coated | Oral | 250mg/1 | 1 Tablet, Film Coated In 1 Bottle, Plastic (79739-7121-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7121-1 | 79739-7121 | ANDA091019 | ANDA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1786-2) | Jubilant HollisterStier LLC | 65044-1786-2 | 65044-1786 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1786-3) | Jubilant HollisterStier LLC | 65044-1786-3 | 65044-1786 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1786-4) | Jubilant HollisterStier LLC | 65044-1786-4 | 65044-1786 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1787-1) | Jubilant HollisterStier LLC | 65044-1787-1 | 65044-1787 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1789-2) | Jubilant HollisterStier LLC | 65044-1789-2 | 65044-1789 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1789-3) | Jubilant HollisterStier LLC | 65044-1789-3 | 65044-1789 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1789-4) | Jubilant HollisterStier LLC | 65044-1789-4 | 65044-1789 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 10 Ml In 1 Vial (65044-1790-2) | Jubilant HollisterStier LLC | 65044-1790-2 | 65044-1790 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 30 Ml In 1 Vial (65044-1790-3) | Jubilant HollisterStier LLC | 65044-1790-3 | 65044-1790 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 50 Ml In 1 Vial (65044-1790-4) | Jubilant HollisterStier LLC | 65044-1790-4 | 65044-1790 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 10 Ml In 1 Vial (65044-1791-2) | Jubilant HollisterStier LLC | 65044-1791-2 | 65044-1791 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 30 Ml In 1 Vial (65044-1791-3) | Jubilant HollisterStier LLC | 65044-1791-3 | 65044-1791 | BLA103888 | BLA | N/A |
| Chenopodium Album Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 50 Ml In 1 Vial (65044-1791-4) | Jubilant HollisterStier LLC | 65044-1791-4 | 65044-1791 | BLA103888 | BLA | N/A |
| Chlorambucil | Tablet, Film Coated | Oral | 2mg/1 | 25 Tablet, Film Coated In 1 Bottle (80725-610-25) | Waylis Therapeutics LLC | 80725-610-25 | 80725-610 | NDA010669 | NDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (50228-458-01) | ScieGen Pharmaceuticals Inc | 50228-458-01 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 500 Tablet In 1 Bottle (50228-458-05) | ScieGen Pharmaceuticals Inc | 50228-458-05 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 1000 Tablet In 1 Bottle (50228-458-10) | ScieGen Pharmaceuticals Inc | 50228-458-10 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 30 Tablet In 1 Bottle (50228-458-30) | ScieGen Pharmaceuticals Inc | 50228-458-30 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 100 Tablet In 1 Bottle (50228-459-01) | ScieGen Pharmaceuticals Inc | 50228-459-01 | 50228-459 | ANDA214092 | ANDA | N/A |
| Chlorhexidine Gluconate | Rinse | Buccal | 1.2mg/mL | 50 Cup, Unit-Dose In 1 Case (66689-106-50) / 15 Ml In 1 Cup, Unit-Dose (66689-106-01) | VistaPharm, LLC | 66689-106-50 | 66689-106 | ANDA203212 | ANDA | N/A |
| Chlorhexidine Gluconate | Rinse | Buccal | 1.2mg/mL | 100 Cup, Unit-Dose In 1 Case (66689-106-99) / 15 Ml In 1 Cup, Unit-Dose (66689-106-01) | VistaPharm, LLC | 66689-106-99 | 66689-106 | ANDA203212 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 500 Tablet In 1 Bottle (50228-459-05) | ScieGen Pharmaceuticals Inc | 50228-459-05 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 1000 Tablet In 1 Bottle (50228-459-10) | ScieGen Pharmaceuticals Inc | 50228-459-10 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 30 Tablet In 1 Bottle (50228-459-30) | ScieGen Pharmaceuticals Inc | 50228-459-30 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 100 Tablet, Extended Release In 1 Bottle (50228-460-01) | ScieGen Pharmaceuticals Inc | 50228-460-01 | 50228-460 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50228-460-10) | ScieGen Pharmaceuticals Inc | 50228-460-10 | 50228-460 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-460-30) | ScieGen Pharmaceuticals Inc | 50228-460-30 | 50228-460 | ANDA214091 | ANDA | N/A |
| Chloroprocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 20mg/mL | 10 Vial In 1 Carton (0143-9209-10) / 20 Ml In 1 Vial (0143-9209-01) | Hikma Pharmaceuticals USA Inc. | 0143-9209-10 | 0143-9209 | ANDA040273 | ANDA | N/A |
| Chloroprocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 30mg/mL | 10 Vial In 1 Carton (0143-9210-10) / 20 Ml In 1 Vial (0143-9210-01) | Hikma Pharmaceuticals USA Inc. | 0143-9210-10 | 0143-9210 | ANDA040273 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 100 Tablet, Extended Release In 1 Bottle (50228-461-01) | ScieGen Pharmaceuticals Inc | 50228-461-01 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50228-461-10) | ScieGen Pharmaceuticals Inc | 50228-461-10 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-461-30) | ScieGen Pharmaceuticals Inc | 50228-461-30 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (50228-457-01) | ScieGen Pharmaceuticals Inc | 50228-457-01 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 500 Tablet In 1 Bottle (50228-457-05) | ScieGen Pharmaceuticals Inc | 50228-457-05 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 1000 Tablet In 1 Bottle (50228-457-10) | ScieGen Pharmaceuticals Inc | 50228-457-10 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 10mg/1, 100 mg/1 | 30 Tablet In 1 Bottle (50228-457-30) | ScieGen Pharmaceuticals Inc | 50228-457-30 | 50228-457 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (50228-458-01) | ScieGen Pharmaceuticals Inc | 50228-458-01 | 50228-458 | ANDA214092 | ANDA | N/A |
| Chlorothiazide Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/18mL | 1 Vial In 1 Carton (25021-305-66) / 18 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-305-66 | 25021-305 | ANDA202462 | ANDA | N/A |
| Chlorothiazide Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/18mL | 1 Vial In 1 Carton (25021-305-20) / 18 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-305-20 | 25021-305 | ANDA202462 | ANDA | N/A |
| Chlorothiazide Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/18mL | 1 Vial In 1 Carton (0517-1820-01) / 18 Ml In 1 Vial | American Regent, Inc. | 0517-1820-01 | 0517-1820 | ANDA202561 | ANDA | N/A |
| Chloroxylenol | Soap | Topical | 15g/L | 208.198 L In 1 Drum (71212-103-00) | Chemstation | 71212-103-00 | 71212-103 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 15g/L | 4 Bottle, Plastic In 1 Box (71212-103-01) / 3.79 L In 1 Bottle, Plastic | Chemstation | 71212-103-01 | 71212-103 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 15g/L | 6 Cartridge In 1 Box (71212-103-02) / 1.25 L In 1 Cartridge | Chemstation | 71212-103-02 | 71212-103 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 1200 Ml In 1 Cartridge (43097-876-01) | People's Janitorial Supply | 43097-876-01 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 700 Ml In 1 Bag (43097-876-07) | People's Janitorial Supply | 43097-876-07 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 1000 Ml In 1 Cartridge (43097-876-10) | People's Janitorial Supply | 43097-876-10 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 1000 Ml In 1 Bottle, Plastic (43097-876-11) | People's Janitorial Supply | 43097-876-11 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 1000 Ml In 1 Bag (43097-876-12) | People's Janitorial Supply | 43097-876-12 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 800 Ml In 1 Bag (43097-876-13) | People's Janitorial Supply | 43097-876-13 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 3785 Ml In 1 Bottle, Plastic (43097-876-14) | People's Janitorial Supply | 43097-876-14 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 946 Ml In 1 Bottle, Plastic (43097-876-15) | People's Janitorial Supply | 43097-876-15 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 800 Ml In 1 Cartridge (43097-876-27) | People's Janitorial Supply | 43097-876-27 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3mg/mL | 208200 Ml In 1 Drum (43097-876-55) | People's Janitorial Supply | 43097-876-55 | 43097-876 | part333E | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 3.75mg/mL | 3780 Ml In 1 Jug (57424-708-04) | Economical Janitorial Supplies | 57424-708-04 | 57424-708 | part333A | OTC MONOGRAPH NOT FINAL | N/A |
| Chloroxylenol | Soap | Topical | 1g/L | 3.78 L In 1 Bottle, Plastic (49557-701-41) | Janisource, LLC | 49557-701-41 | 49557-701 | 505G(a)(3) | OTC MONOGRAPH DRUG | N/A |
| Chlorpheniramine Maleate | Tablet, Film Coated, Extended Release | Oral | 12mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (10702-017-01) | KVK-Tech, Inc. | 10702-017-01 | 10702-017 | ANDA040829 | ANDA | N/A |
| Chlorpheniramine Maleate | Tablet, Film Coated, Extended Release | Oral | 12mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (10702-017-06) | KVK-Tech, Inc. | 10702-017-06 | 10702-017 | ANDA040829 | ANDA | N/A |
| Chlorpheniramine Maleate | Tablet, Film Coated, Extended Release | Oral | 12mg/1 | 24 Tablet, Film Coated, Extended Release In 1 Carton (10702-017-24) | KVK-Tech, Inc. | 10702-017-24 | 10702-017 | ANDA040829 | ANDA | N/A |
| Chlorpheniramine Maleate | Tablet, Film Coated, Extended Release | Oral | 12mg/1 | 50 Package In 1 Carton (10702-017-54) / 4 Tablet, Film Coated, Extended Release In 1 Package (10702-017-04) | KVK-Tech, Inc. | 10702-017-54 | 10702-017 | ANDA040829 | ANDA | N/A |
| Chlorpheniramine Maleate; Hydrocodone Bitartrate | Suspension, Extended Release | Oral | 8mg/5mL, 10 mg/5mL | 1 Bottle, Unit-Dose In 1 Carton (27808-086-01) / 115 Ml In 1 Bottle, Unit-Dose | Tris Pharma Inc | 27808-086-01 | 27808-086 | ANDA091632 | ANDA | CII |
| Chlorpheniramine Maleate; Hydrocodone Bitartrate | Suspension, Extended Release | Oral | 8mg/5mL, 10 mg/5mL | 473 Ml In 1 Bottle (27808-086-02) | Tris Pharma Inc | 27808-086-02 | 27808-086 | ANDA091632 | ANDA | CII |
| Chlorpheniramine Maleate; Hydrocodone Bitartrate | Suspension, Extended Release | Oral | 8mg/5mL, 10 mg/5mL | 1 Bottle, Unit-Dose In 1 Carton (27808-086-03) / 70 Ml In 1 Bottle, Unit-Dose | Tris Pharma Inc | 27808-086-03 | 27808-086 | ANDA091632 | ANDA | CII |
| Chlorpromazine Hydrochloride | Tablet, Coated | Oral | 10mg/1 | 100 Tablet, Coated In 1 Bottle (51407-434-01) | Golden State Medical Supply, Inc. | 51407-434-01 | 51407-434 | ANDA212996 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Tablet, Coated | Oral | 25mg/1 | 100 Tablet, Coated In 1 Bottle (51407-435-01) | Golden State Medical Supply, Inc. | 51407-435-01 | 51407-435 | ANDA212996 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Tablet, Coated | Oral | 50mg/1 | 100 Tablet, Coated In 1 Bottle (51407-436-01) | Golden State Medical Supply, Inc. | 51407-436-01 | 51407-436 | ANDA212996 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Tablet, Coated | Oral | 100mg/1 | 100 Tablet, Coated In 1 Bottle (51407-437-01) | Golden State Medical Supply, Inc. | 51407-437-01 | 51407-437 | ANDA212996 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Tablet, Coated | Oral | 200mg/1 | 100 Tablet, Coated In 1 Bottle (51407-438-01) | Golden State Medical Supply, Inc. | 51407-438-01 | 51407-438 | ANDA212996 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Injection | Intramuscular | 25mg/mL | 25 Ampule In 1 Carton (0641-1397-35) / 1 Ml In 1 Ampule (0641-1397-31) | Hikma Pharmaceuticals USA Inc. | 0641-1397-35 | 0641-1397 | ANDA083329 | ANDA | N/A |
| Chlorpromazine Hydrochloride | Injection | Intramuscular | 25mg/mL | 25 Ampule In 1 Carton (0641-1398-35) / 2 Ml In 1 Ampule (0641-1398-31) | Hikma Pharmaceuticals USA Inc. | 0641-1398-35 | 0641-1398 | ANDA083329 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (75834-109-01) | Nivagen Pharmaceuticals, INC. | 75834-109-01 | 75834-109 | ANDA207222 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (75834-109-10) | Nivagen Pharmaceuticals, INC. | 75834-109-10 | 75834-109 | ANDA207222 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (75834-110-01) | Nivagen Pharmaceuticals, INC. | 75834-110-01 | 75834-110 | ANDA207222 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (75834-110-10) | Nivagen Pharmaceuticals, INC. | 75834-110-10 | 75834-110 | ANDA207222 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (59746-761-01) | JUBILANT CADISTA PHARMACEUTICALS,INC. | 59746-761-01 | 59746-761 | ANDA211320 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (59746-760-01) | JUBILANT CADISTA PHARMACEUTICALS,INC. | 59746-760-01 | 59746-760 | ANDA211320 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (59746-760-36) | JUBILANT CADISTA PHARMACEUTICALS,INC. | 59746-760-36 | 59746-760 | ANDA211320 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 500 Tablet In 1 Bottle (50228-458-05) | ScieGen Pharmaceuticals Inc | 50228-458-05 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 1000 Tablet In 1 Bottle (50228-458-10) | ScieGen Pharmaceuticals Inc | 50228-458-10 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 100 mg/1 | 30 Tablet In 1 Bottle (50228-458-30) | ScieGen Pharmaceuticals Inc | 50228-458-30 | 50228-458 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 100 Tablet In 1 Bottle (50228-459-01) | ScieGen Pharmaceuticals Inc | 50228-459-01 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 500 Tablet In 1 Bottle (50228-459-05) | ScieGen Pharmaceuticals Inc | 50228-459-05 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 1000 Tablet In 1 Bottle (50228-459-10) | ScieGen Pharmaceuticals Inc | 50228-459-10 | 50228-459 | ANDA214092 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet | Oral | 25mg/1, 250 mg/1 | 30 Tablet In 1 Bottle (50228-459-30) | ScieGen Pharmaceuticals Inc | 50228-459-30 | 50228-459 | ANDA214092 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (70954-085-10) | Novitium Pharma LLC | 70954-085-10 | 70954-085 | ANDA212254 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (70954-085-20) | Novitium Pharma LLC | 70954-085-20 | 70954-085 | ANDA212254 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 40 Tablet In 1 Bottle, Plastic (60760-619-40) | St Mary's Medical Park Pharmacy | 60760-619-40 | 60760-619 | ANDA212254 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-619-90) | St Mary's Medical Park Pharmacy | 60760-619-90 | 60760-619 | ANDA212254 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 40 Tablet In 1 Bottle, Plastic (60760-479-40) | St. Mary's Medical Park Pharmacy | 60760-479-40 | 60760-479 | ANDA089859 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-479-90) | St. Mary's Medical Park Pharmacy | 60760-479-90 | 60760-479 | ANDA089859 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 375mg/1 | 100 Tablet In 1 Bottle, Plastic (68025-046-10) | Vertical Pharmaceuticals, Inc. | 68025-046-10 | 68025-046 | ANDA040861 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 750mg/1 | 2 Pouch In 1 Box, Unit-Dose (68025-047-02) / 1 Tablet In 1 Pouch (68025-047-01) | Vertical Pharmaceuticals, Inc. | 68025-047-02 | 68025-047 | ANDA040861 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle, Plastic (68025-047-10) | Vertical Pharmaceuticals, Inc. | 68025-047-10 | 68025-047 | ANDA040861 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 100 Tablet, Extended Release In 1 Bottle (50228-460-01) | ScieGen Pharmaceuticals Inc | 50228-460-01 | 50228-460 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50228-460-10) | ScieGen Pharmaceuticals Inc | 50228-460-10 | 50228-460 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 25mg/1, 100 mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-460-30) | ScieGen Pharmaceuticals Inc | 50228-460-30 | 50228-460 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 100 Tablet, Extended Release In 1 Bottle (50228-461-01) | ScieGen Pharmaceuticals Inc | 50228-461-01 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50228-461-10) | ScieGen Pharmaceuticals Inc | 50228-461-10 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carbidopa; Levodopa | Tablet, Extended Release | Oral | 50mg/1, 200 mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-461-30) | ScieGen Pharmaceuticals Inc | 50228-461-30 | 50228-461 | ANDA214091 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 450mg/45mL | 1 Vial, Multi-Dose In 1 Carton (50742-447-45) / 45 Ml In 1 Vial, Multi-Dose | Ingenus Pharmaceuticals, LLC | 50742-447-45 | 50742-447 | ANDA208487 | ANDA | N/A |
| Carboplatin | Injection, Solution | Intravenous | 600mg/60mL | 1 Vial, Multi-Dose In 1 Carton (50742-448-60) / 60 Ml In 1 Vial, Multi-Dose | Ingenus Pharmaceuticals, LLC | 50742-448-60 | 50742-448 | ANDA208487 | ANDA | N/A |
| Carboprost Tromethamine | Injection, Solution | Intramuscular | 250ug/mL | 10 Vial In 1 Carton (70121-1680-7) / 1 Ml In 1 Vial (70121-1680-1) | Amneal Pharmaceuticals LLC | 70121-1680-7 | 70121-1680 | ANDA215337 | ANDA | N/A |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (50742-656-01) | Ingenus Pharmaceuticals, LLC | 50742-656-01 | 50742-656 | ANDA040823 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 500 Tablet In 1 Bottle (50742-656-05) | Ingenus Pharmaceuticals, LLC | 50742-656-05 | 50742-656 | ANDA040823 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (16571-780-01) | Rising Pharma Holdings, Inc. | 16571-780-01 | 16571-780 | ANDA040792 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (16571-781-01) | Rising Pharma Holdings, Inc. | 16571-781-01 | 16571-781 | ANDA040792 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 1000 Tablet In 1 Bottle (16571-781-10) | Rising Pharma Holdings, Inc. | 16571-781-10 | 16571-781 | ANDA040792 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 500 Tablet In 1 Bottle (16571-781-50) | Rising Pharma Holdings, Inc. | 16571-781-50 | 16571-781 | ANDA040792 | ANDA | CIV |
| Chromic Chloride | Injection, Solution | Intravenous | 4ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-4093-10) / 10 Ml In 1 Vial, Single-Dose (0409-4093-09) | Hospira, Inc. | 0409-4093-10 | 0409-4093 | NDA018961 | NDA | N/A |
| Chromic Chloride | Injection, Solution | Intravenous | 4ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-4093-01) / 10 Ml In 1 Vial, Single-Dose (0409-4093-11) | Hospira, Inc. | 0409-4093-01 | 0409-4093 | NDA018961 | NDA | N/A |
| Chromic Chloride; Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate Heptahydrate | Injection, Solution | Intravenous | 20.5ug/mL, 1.57 mg/mL, .308 mg/mL, 32.7 ug/mL, 4.39 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0517-8510-25) / 10 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-8510-25 | 0517-8510 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Chromic Chloride; Cupric Sulfate; Manganese Sulfate; Zinc Sulfate Heptahydrate | Injection, Solution, Concentrate | Intravenous | 5.12ug/mL, .4 mg/mL, 77 ug/mL, 4.39 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-9203-25) / 3 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-9203-25 | 0517-9203 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Chromium; Copper; Folic Acid; Niacinamide; Selenium; Zinc | Tablet | Oral | 100ug/1, 2 mg/1, 850 ug/1, 750 mg/1, 50 ug/1, 27 mg/1 | 60 Tablet In 1 Bottle (42192-374-60) | Acella Pharmaceuticals, LLC | 42192-374-60 | 42192-374 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Ciclopirox | Solution | Topical | 80mg/mL | 1 Bottle, With Applicator In 1 Carton (45802-141-67) / 6.6 Ml In 1 Bottle, With Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-141-67 | 45802-141 | ANDA077623 | ANDA | N/A |
| Ciclopirox | Shampoo | Topical | 1g/100mL | 120 Ml In 1 Bottle (45802-401-09) | Padagis Israel Pharmaceuticals Ltd | 45802-401-09 | 45802-401 | ANDA078594 | ANDA | N/A |
| Ciclopirox | Gel | Topical | 7.7mg/g | 1 Tube In 1 Carton (0574-2061-01) / 100 G In 1 Tube | Padagis US LLC | 0574-2061-01 | 0574-2061 | ANDA078266 | ANDA | N/A |
| Ciclopirox | Gel | Topical | 7.7mg/g | 1 Tube In 1 Carton (0574-2061-30) / 30 G In 1 Tube | Padagis US LLC | 0574-2061-30 | 0574-2061 | ANDA078266 | ANDA | N/A |
| Ciclopirox | Gel | Topical | 7.7mg/g | 1 Tube In 1 Carton (0574-2061-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2061-45 | 0574-2061 | ANDA078266 | ANDA | N/A |
| Ciclopirox | Solution | Topical | 80mg/mL | 1 Bottle, With Applicator In 1 Carton (51672-5302-0) / 6.6 Ml In 1 Bottle, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-5302-0 | 51672-5302 | ANDA078233 | ANDA | N/A |
| Ciclopirox | Shampoo | Topical | 10mg/.96mL | 1 Bottle, Plastic In 1 Carton (51672-1351-8) / 120 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1351-8 | 51672-1351 | ANDA090269 | ANDA | N/A |
| Ciclopirox | Solution | Topical | 80mg/mL | 1 Bottle In 1 Carton (42192-715-06) / 6.6 Ml In 1 Bottle | Acella Pharmaceuticals, LLC | 42192-715-06 | 42192-715 | ANDA078172 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (45802-138-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-138-11 | 45802-138 | ANDA077364 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (45802-138-18) / 90 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-138-18 | 45802-138 | ANDA077364 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (45802-138-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-138-35 | 45802-138 | ANDA077364 | ANDA | N/A |
| Ciclopirox Olamine | Suspension | Topical | 7.7mg/100mL | 1 Bottle In 1 Carton (45802-400-46) / 60 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-400-46 | 45802-400 | ANDA077676 | ANDA | N/A |
| Ciclopirox Olamine | Suspension | Topical | 7.7mg/100mL | 1 Bottle In 1 Carton (45802-400-49) / 30 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-400-49 | 45802-400 | ANDA077676 | ANDA | N/A |
| Ciclopirox Olamine | Suspension | Topical | 7.7mg/mL | 1 Bottle In 1 Carton (51672-1323-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1323-3 | 51672-1323 | ANDA077092 | ANDA | N/A |
| Ciclopirox Olamine | Suspension | Topical | 7.7mg/mL | 1 Bottle In 1 Carton (51672-1323-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1323-4 | 51672-1323 | ANDA077092 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (51672-1318-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1318-1 | 51672-1318 | ANDA076790 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (51672-1318-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1318-2 | 51672-1318 | ANDA076790 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Carton (51672-1318-8) / 90 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1318-8 | 51672-1318 | ANDA076790 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Box (0713-0638-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0638-15 | 0713-0638 | ANDA078463 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Box (0713-0638-18) / 90 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0638-18 | 0713-0638 | ANDA078463 | ANDA | N/A |
| Ciclopirox Olamine | Cream | Topical | 7.7mg/g | 1 Tube In 1 Box (0713-0638-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0638-31 | 0713-0638 | ANDA078463 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (60505-2521-1) | Apotex Corp. | 60505-2521-1 | 60505-2521 | ANDA077030 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (60505-2521-3) | Apotex Corp. | 60505-2521-3 | 60505-2521 | ANDA077030 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (60505-2521-8) | Apotex Corp. | 60505-2521-8 | 60505-2521 | ANDA077030 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (60505-2522-1) | Apotex Corp. | 60505-2522-1 | 60505-2522 | ANDA077030 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (60505-2522-3) | Apotex Corp. | 60505-2522-3 | 60505-2522 | ANDA077030 | ANDA | N/A |
| Cilostazol | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (60505-2522-8) | Apotex Corp. | 60505-2522-8 | 60505-2522 | ANDA077030 | ANDA | N/A |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (50228-109-01) | ScieGen Pharmaceuticals, Inc. | 50228-109-01 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 500 Tablet In 1 Bottle (50228-109-05) | ScieGen Pharmaceuticals, Inc. | 50228-109-05 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 1000 Tablet In 1 Bottle (50228-109-10) | ScieGen Pharmaceuticals, Inc. | 50228-109-10 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 30 Tablet In 1 Bottle (50228-109-30) | ScieGen Pharmaceuticals, Inc. | 50228-109-30 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 100 Tablet In 1 Bottle (50228-109-01) | ScieGen Pharmaceuticals, Inc. | 50228-109-01 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 500 Tablet In 1 Bottle (50228-109-05) | ScieGen Pharmaceuticals, Inc. | 50228-109-05 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 1000 Tablet In 1 Bottle (50228-109-10) | ScieGen Pharmaceuticals, Inc. | 50228-109-10 | 50228-109 | ANDA203374 | ANDA | CIV |
| Carisoprodol | Tablet | Oral | 350mg/1 | 30 Tablet In 1 Bottle (50228-109-30) | ScieGen Pharmaceuticals, Inc. | 50228-109-30 | 50228-109 | ANDA203374 | ANDA | CIV |
| Cefadroxil | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle (57237-096-01) | Rising Pharma Holdings, Inc. | 57237-096-01 | 57237-096 | ANDA065352 | ANDA | N/A |
| Cefadroxil | Capsule | Oral | 500mg/1 | 50 Capsule In 1 Bottle (57237-096-50) | Rising Pharma Holdings, Inc. | 57237-096-50 | 57237-096 | ANDA065352 | ANDA | N/A |
| Cefadroxil | Powder, For Suspension | Oral | 250mg/5mL | 100 Ml In 1 Bottle (57237-097-01) | Rising Pharma Holdings, Inc. | 57237-097-01 | 57237-097 | ANDA065349 | ANDA | N/A |
| Cefadroxil | Powder, For Suspension | Oral | 250mg/5mL | 50 Ml In 1 Bottle (57237-097-50) | Rising Pharma Holdings, Inc. | 57237-097-50 | 57237-097 | ANDA065349 | ANDA | N/A |
| Cinnamon; Ginger; Holy Basil Leaf; Licorice; Litsea Glutinosa Bark | Granule, For Solution | Oral | 420mg/2g, 420 mg/2g, 360 mg/2g, 400 mg/2g, 340 mg/2g | 28 G In 1 Box, Unit-Dose (75360-1145-1) | Hemani International | 75360-1145-1 | 75360-1145 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 2mg/mL | 24 Pouch In 1 Carton (25021-114-82) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-114-82 | 25021-114 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 2mg/mL | 24 Pouch In 1 Carton (25021-114-87) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-114-87 | 25021-114 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 2mg/mL | 24 Pouch In 1 Carton (25021-192-82) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-192-82 | 25021-192 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 2mg/mL | 24 Pouch In 1 Carton (25021-192-87) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-192-87 | 25021-192 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 200mg/100mL | 24 Pouch In 1 Carton (0409-2300-24) / 1 Bag In 1 Pouch (0409-2300-01) / 100 Ml In 1 Bag | Hospira, Inc. | 0409-2300-24 | 0409-2300 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin | Injection, Solution | Intravenous | 400mg/200mL | 24 Pouch In 1 Carton (0409-3300-24) / 1 Bag In 1 Pouch (0409-3300-01) / 200 Ml In 1 Bag | Hospira, Inc. | 0409-3300-24 | 0409-3300 | ANDA078252 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Coated | Oral | 500mg/1 | 10 Tablet, Coated In 1 Bottle, Plastic (60760-074-10) | St Mary's Medical Park Pharmacy | 60760-074-10 | 60760-074 | ANDA208921 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Coated | Oral | 500mg/1 | 20 Tablet, Coated In 1 Bottle, Plastic (60760-074-20) | St Mary's Medical Park Pharmacy | 60760-074-20 | 60760-074 | ANDA208921 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 500mg/1 | 10 Tablet In 1 Bottle, Plastic (60760-815-10) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-815-10 | 60760-815 | ANDA076639 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 500mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-815-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-815-20 | 60760-815 | ANDA076639 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-815-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-815-30 | 60760-815 | ANDA076639 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-165-01) | Golden State Medical Supply, Inc. | 51407-165-01 | 51407-165 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-165-20) | Golden State Medical Supply, Inc. | 51407-165-20 | 51407-165 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 28 Tablet, Film Coated In 1 Bottle (51407-165-28) | Golden State Medical Supply, Inc. | 51407-165-28 | 51407-165 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-775-01) | Golden State Medical Supply, Inc. | 51407-775-01 | 51407-775 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 750mg/1 | 50 Tablet, Film Coated In 1 Bottle (51407-776-50) | Golden State Medical Supply, Inc. | 51407-776-50 | 51407-776 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Plastic In 1 Carton (69315-308-02) / 2.5 Ml In 1 Bottle, Plastic | Leading Pharma, LLC | 69315-308-02 | 69315-308 | ANDA077568 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Plastic In 1 Carton (69315-308-05) / 5 Ml In 1 Bottle, Plastic | Leading Pharma, LLC | 69315-308-05 | 69315-308 | ANDA077568 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Plastic In 1 Carton (69315-308-10) / 10 Ml In 1 Bottle, Plastic | Leading Pharma, LLC | 69315-308-10 | 69315-308 | ANDA077568 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (61442-222-01) | Carlsbad Technology, Inc. | 61442-222-01 | 61442-222 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (61442-223-01) | Carlsbad Technology, Inc. | 61442-223-01 | 61442-223 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (61442-223-05) | Carlsbad Technology, Inc. | 61442-223-05 | 61442-223 | ANDA076126 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 750mg/1 | 50 Tablet, Film Coated In 1 Bottle (61442-224-50) | Carlsbad Technology, Inc. | 61442-224-50 | 61442-224 | ANDA076126 | ANDA | N/A |
| Cefadroxil | Powder, For Suspension | Oral | 500mg/5mL | 100 Ml In 1 Bottle (57237-098-01) | Rising Pharma Holdings, Inc. | 57237-098-01 | 57237-098 | ANDA065349 | ANDA | N/A |
| Cefadroxil | Powder, For Suspension | Oral | 500mg/5mL | 75 Ml In 1 Bottle (57237-098-75) | Rising Pharma Holdings, Inc. | 57237-098-75 | 57237-098 | ANDA065349 | ANDA | N/A |
| Cefdinir | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle (57237-099-60) | Rising Pharma Holdings, Inc. | 57237-099-60 | 57237-099 | ANDA065434 | ANDA | N/A |
| Cefpodoxime Proxetil | Granule, For Suspension | Oral | 50mg/5mL | 1 Bottle In 1 Carton (64980-402-10) / 100 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-402-10 | 64980-402 | ANDA065409 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (0143-9927-01) | Hikma Pharmaceuticals USA Inc. | 0143-9927-01 | 0143-9927 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (0143-9927-05) | Hikma Pharmaceuticals USA Inc. | 0143-9927-05 | 0143-9927 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (0143-9927-30) | Hikma Pharmaceuticals USA Inc. | 0143-9927-30 | 0143-9927 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (0143-9928-01) | Hikma Pharmaceuticals USA Inc. | 0143-9928-01 | 0143-9928 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (0143-9928-05) | Hikma Pharmaceuticals USA Inc. | 0143-9928-05 | 0143-9928 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (0143-9928-30) | Hikma Pharmaceuticals USA Inc. | 0143-9928-30 | 0143-9928 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 750mg/1 | 100 Tablet, Film Coated In 1 Bottle (0143-9929-01) | Hikma Pharmaceuticals USA Inc. | 0143-9929-01 | 0143-9929 | ANDA076558 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet, Film Coated | Oral | 750mg/1 | 50 Tablet, Film Coated In 1 Bottle (0143-9929-50) | Hikma Pharmaceuticals USA Inc. | 0143-9929-50 | 0143-9929 | ANDA076558 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-712-96) / 5 Ml In 1 Vial, Single-Dose (71288-712-95) | Meitheal Pharmaceuticals Inc. | 71288-712-96 | 71288-712 | ANDA211668 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-712-06) / 5 Ml In 1 Vial, Single-Dose (71288-712-05) | Meitheal Pharmaceuticals Inc. | 71288-712-06 | 71288-712 | ANDA211668 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 200mg/20mL | 10 Vial, Single-Dose In 1 Carton (71288-713-96) / 20 Ml In 1 Vial, Single-Dose (71288-713-95) | Meitheal Pharmaceuticals Inc. | 71288-713-96 | 71288-713 | ANDA211668 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 200mg/20mL | 10 Vial, Single-Dose In 1 Carton (71288-713-21) / 20 Ml In 1 Vial, Single-Dose (71288-713-20) | Meitheal Pharmaceuticals Inc. | 71288-713-21 | 71288-713 | ANDA211668 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 20mg/10mL | 10 Vial, Multi-Dose In 1 Carton (71288-714-96) / 10 Ml In 1 Vial, Multi-Dose (71288-714-95) | Meitheal Pharmaceuticals Inc. | 71288-714-96 | 71288-714 | ANDA211669 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 20mg/10mL | 10 Vial, Multi-Dose In 1 Carton (71288-714-11) / 10 Ml In 1 Vial, Multi-Dose (71288-714-10) | Meitheal Pharmaceuticals Inc. | 71288-714-11 | 71288-714 | ANDA211669 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-720-96) / 5 Ml In 1 Vial, Single-Dose (71288-720-95) | Meitheal Pharmaceuticals Inc. | 71288-720-96 | 71288-720 | ANDA211668 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial In 1 Carton (25021-668-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-668-05 | 25021-668 | ANDA201836 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-669-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-669-20 | 25021-669 | ANDA201836 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial In 1 Carton (25021-670-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-670-10 | 25021-670 | ANDA201851 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 1 Vial In 1 Carton (70069-141-01) / 5 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-141-01 | 70069-141 | ANDA206791 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 10 Vial In 1 Carton (70069-141-10) / 5 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-141-10 | 70069-141 | ANDA206791 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 10mg/mL | 1 Vial In 1 Carton (70069-151-01) / 20 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-151-01 | 70069-151 | ANDA206791 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Carton (70069-151-10) / 20 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-151-10 | 70069-151 | ANDA206791 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 1 Vial In 1 Carton (70069-161-01) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-161-01 | 70069-161 | ANDA209132 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 10 Vial, Multi-Dose In 1 Carton (70069-161-10) / 10 Ml In 1 Vial, Multi-Dose | Somerset Therapeutics, LLC | 70069-161-10 | 70069-161 | ANDA209132 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 1 Vial In 1 Carton (0143-9396-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9396-01 | 0143-9396 | ANDA203078 | ANDA | N/A |
| Cisatracurium Besylate | Injection | Intravenous | 2mg/mL | 10 Vial In 1 Carton (0143-9397-10) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9397-10 | 0143-9397 | ANDA203079 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1098-02) / 5 Ml In 1 Vial, Single-Dose (0409-1098-12) | Hospira, Inc. | 0409-1098-02 | 0409-1098 | ANDA203236 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1103-01) / 20 Ml In 1 Vial, Single-Dose (0409-1103-11) | Hospira, Inc. | 0409-1103-01 | 0409-1103 | ANDA203236 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-5547-10) / 5 Ml In 1 Vial, Single-Dose (0409-5547-01) | Hospira, Inc. | 0409-5547-10 | 0409-5547 | ANDA203236 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-3670-10) / 20 Ml In 1 Vial, Single-Dose (0409-3670-01) | Hospira, Inc. | 0409-3670-10 | 0409-3670 | ANDA203236 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-7083-10) / 10 Ml In 1 Vial, Multi-Dose (0409-7083-01) | Hospira, Inc. | 0409-7083-10 | 0409-7083 | ANDA203238 | ANDA | N/A |
| Cisatracurium Besylate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-1208-01) / 10 Ml In 1 Vial, Multi-Dose (0409-1208-11) | Hospira, Inc. | 0409-1208-01 | 0409-1208 | ANDA203238 | ANDA | N/A |
| Cisplatin | Injection, Solution | Intravenous | 1mg/mL | 1 Vial In 1 Carton (25021-253-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-253-50 | 25021-253 | ANDA207323 | ANDA | N/A |
| Cisplatin | Injection, Solution | Intravenous | 1mg/mL | 1 Vial In 1 Carton (25021-253-51) / 100 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-253-51 | 25021-253 | ANDA207323 | ANDA | N/A |
| Cisplatin | Injection, Solution | Intravenous | 50mg/50mL | 1 Vial, Multi-Dose In 1 Carton (60505-6277-0) / 50 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6277-0 | 60505-6277 | N/A | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | N/A |
| Cisplatin | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Multi-Dose In 1 Carton (60505-6279-0) / 50 Ml In 1 Vial, Multi-Dose | Apotex Corp. | 60505-6279-0 | 60505-6279 | ANDA218868 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-009-30) | St Marys Medical Park Pharmacy | 60760-009-30 | 60760-009 | ANDA078216 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-009-90) | St Marys Medical Park Pharmacy | 60760-009-90 | 60760-009 | ANDA078216 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-173-10) | Golden State Medical Supply, Inc. | 60429-173-10 | 60429-173 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-174-10) | Golden State Medical Supply, Inc. | 60429-174-10 | 60429-174 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-175-10) | Golden State Medical Supply, Inc. | 60429-175-10 | 60429-175 | ANDA077045 | ANDA | N/A |
| Cefpodoxime Proxetil | Granule, For Suspension | Oral | 50mg/5mL | 1 Bottle In 1 Carton (64980-402-50) / 50 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-402-50 | 64980-402 | ANDA065409 | ANDA | N/A |
| Cefpodoxime Proxetil | Granule, For Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (64980-403-10) / 100 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-403-10 | 64980-403 | ANDA065409 | ANDA | N/A |
| Cefpodoxime Proxetil | Granule, For Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (64980-403-50) / 50 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-403-50 | 64980-403 | ANDA065409 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 125mg/5mL | 100 Ml In 1 Bottle (57237-034-01) | Rising Pharma Holdings, Inc. | 57237-034-01 | 57237-034 | ANDA065381 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 125mg/5mL | 50 Ml In 1 Bottle (57237-034-50) | Rising Pharma Holdings, Inc. | 57237-034-50 | 57237-034 | ANDA065381 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 125mg/5mL | 75 Ml In 1 Bottle (57237-034-75) | Rising Pharma Holdings, Inc. | 57237-034-75 | 57237-034 | ANDA065381 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 250mg/5mL | 100 Ml In 1 Bottle (57237-035-01) | Rising Pharma Holdings, Inc. | 57237-035-01 | 57237-035 | ANDA065381 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 250mg/5mL | 50 Ml In 1 Bottle (57237-035-50) | Rising Pharma Holdings, Inc. | 57237-035-50 | 57237-035 | ANDA065381 | ANDA | N/A |
| Cefprozil | Powder, For Suspension | Oral | 250mg/5mL | 75 Ml In 1 Bottle (57237-035-75) | Rising Pharma Holdings, Inc. | 57237-035-75 | 57237-035 | ANDA065381 | ANDA | N/A |
| Cefprozil | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-036-01) | Rising Pharma Holdings, Inc. | 57237-036-01 | 57237-036 | ANDA065340 | ANDA | N/A |
| Cefprozil | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-037-01) | Rising Pharma Holdings, Inc. | 57237-037-01 | 57237-037 | ANDA065340 | ANDA | N/A |
| Cefprozil | Tablet, Film Coated | Oral | 500mg/1 | 50 Tablet, Film Coated In 1 Bottle (57237-037-50) | Rising Pharma Holdings, Inc. | 57237-037-50 | 57237-037 | ANDA065340 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 250mg/1 | 20 Tablet, Film Coated In 1 Bottle (57237-058-20) | Rising Pharma Holdings, Inc. | 57237-058-20 | 57237-058 | ANDA065308 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 250mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-058-60) | Rising Pharma Holdings, Inc. | 57237-058-60 | 57237-058 | ANDA065308 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 500mg/1 | 20 Tablet, Film Coated In 1 Bottle (57237-059-20) | Rising Pharma Holdings, Inc. | 57237-059-20 | 57237-059 | ANDA065308 | ANDA | N/A |
| Cefuroxime Axetil | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-059-60) | Rising Pharma Holdings, Inc. | 57237-059-60 | 57237-059 | ANDA065308 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (65162-817-06) | Amneal Pharmaceuticals LLC | 65162-817-06 | 65162-817 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (65162-818-10) | Amneal Pharmaceuticals LLC | 65162-818-10 | 65162-818 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (65162-818-11) | Amneal Pharmaceuticals LLC | 65162-818-11 | 65162-818 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (65162-818-50) | Amneal Pharmaceuticals LLC | 65162-818-50 | 65162-818 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (65162-819-10) | Amneal Pharmaceuticals LLC | 65162-819-10 | 65162-819 | ANDA208833 | ANDA | N/A |
| Citalopram Hydrobromide | Solution | Oral | 10mg/5mL | 1 Bottle, Plastic In 1 Carton (0054-0062-58) / 240 Ml In 1 Bottle, Plastic | Hikma Pharmaceuticals USA Inc. | 0054-0062-58 | 0054-0062 | ANDA077043 | ANDA | N/A |
| Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5128-2) | Jubilant HollisterStier LLC | 65044-5128-2 | 65044-5128 | BLA103888 | BLA | N/A |
| Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5128-3) | Jubilant HollisterStier LLC | 65044-5128-3 | 65044-5128 | BLA103888 | BLA | N/A |
| Cladosporium Cladosporioides | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5128-4) | Jubilant HollisterStier LLC | 65044-5128-4 | 65044-5128 | BLA103888 | BLA | N/A |
| Cladosporium Cladosporioides | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5129-1) | Jubilant HollisterStier LLC | 65044-5129-1 | 65044-5129 | BLA103888 | BLA | N/A |
| Cladribine | Injection | Intravenous | 1mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9871-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9871-01 | 0143-9871 | ANDA075405 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (65162-819-11) | Amneal Pharmaceuticals LLC | 65162-819-11 | 65162-819 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (65162-819-50) | Amneal Pharmaceuticals LLC | 65162-819-50 | 65162-819 | ANDA208833 | ANDA | N/A |
| Clindamycin | Injection, Solution | Intravenous | 6mg/mL | 1 Vial In 1 Carton (0143-9267-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9267-01 | 0143-9267 | ANDA214401 | ANDA | N/A |
| Clindamycin | Injection, Solution | Intravenous | 12mg/mL | 1 Vial In 1 Carton (0143-9268-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9268-01 | 0143-9268 | ANDA214401 | ANDA | N/A |
| Clindamycin | Injection, Solution | Intravenous | 18mg/mL | 1 Vial In 1 Carton (0143-9269-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9269-01 | 0143-9269 | ANDA214401 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 300mg/1 | 10 Capsule In 1 Bottle, Plastic (60760-484-10) | St. Mary's Medical Park Pharmacy | 60760-484-10 | 60760-484 | ANDA065061 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 300mg/1 | 20 Capsule In 1 Bottle, Plastic (60760-484-20) | St. Mary's Medical Park Pharmacy | 60760-484-20 | 60760-484 | ANDA065061 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-484-30) | St. Mary's Medical Park Pharmacy | 60760-484-30 | 60760-484 | ANDA065061 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 150mg/1 | 28 Capsule In 1 Bottle, Plastic (60760-487-28) | St. Mary's Medical Park Pharmacy | 60760-487-28 | 60760-487 | ANDA207402 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-487-60) | St. Mary's Medical Park Pharmacy | 60760-487-60 | 60760-487 | ANDA207402 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (51407-373-01) | Golden State Medical Supply, Inc. | 51407-373-01 | 51407-373 | ANDA065061 | ANDA | N/A |
| Clindamycin Hydrochloride | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (51407-373-05) | Golden State Medical Supply, Inc. | 51407-373-05 | 51407-373 | ANDA065061 | ANDA | N/A |
| Clindamycin Palmitate Hydrochloride | Granule, For Solution | Oral | 75mg/5mL | 1 Bottle, Glass In 1 Carton (0574-0129-01) / 100 Ml In 1 Bottle, Glass | Padagis US LLC | 0574-0129-01 | 0574-0129 | ANDA090902 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (65162-820-06) | Amneal Pharmaceuticals LLC | 65162-820-06 | 65162-820 | ANDA208833 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (42806-720-60) | EPIC PHARMA, LLC | 42806-720-60 | 42806-720 | ANDA207872 | ANDA | N/A |
| Clindamycin Phosphate | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (45802-900-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-900-94 | 45802-900 | ANDA212104 | ANDA | N/A |
| Clindamycin Phosphate | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (45802-900-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-900-96 | 45802-900 | ANDA212104 | ANDA | N/A |
| Clindamycin Phosphate | Solution | Topical | 10mg/mL | 60 Applicator In 1 Jar (45802-263-37) / 1 Ml In 1 Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-263-37 | 45802-263 | ANDA065049 | ANDA | N/A |
| Clindamycin Phosphate | Aerosol, Foam | Topical | 10mg/g | 1 Can In 1 Carton (45802-660-32) / 50 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-660-32 | 45802-660 | ANDA090785 | ANDA | N/A |
| Clindamycin Phosphate | Aerosol, Foam | Topical | 10mg/g | 1 Can In 1 Carton (45802-660-33) / 100 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-660-33 | 45802-660 | ANDA090785 | ANDA | N/A |
| Clindamycin Phosphate | Lotion | Topical | 10mg/mL | 60 Ml In 1 Bottle (45802-128-01) | Padagis Israel Pharmaceuticals Ltd | 45802-128-01 | 45802-128 | ANDA214604 | ANDA | N/A |
| Clindamycin Phosphate | Solution | Topical | 10mg/mL | 1 Bottle, With Applicator In 1 Carton (45802-562-01) / 30 Ml In 1 Bottle, With Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-562-01 | 45802-562 | ANDA064050 | ANDA | N/A |
| Clindamycin Phosphate | Solution | Topical | 10mg/mL | 1 Bottle, With Applicator In 1 Carton (45802-562-02) / 60 Ml In 1 Bottle, With Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-562-02 | 45802-562 | ANDA064050 | ANDA | N/A |
| Clindamycin Phosphate | Cream | Vaginal | 100mg/5g | 1 Applicator In 1 Carton (45802-042-01) / 5 G In 1 Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-042-01 | 45802-042 | NDA050793 | NDA | N/A |
| Clindamycin Phosphate | Cream | Vaginal | 100mg/5g | 1 Applicator In 1 Carton (45802-042-02) / 5 G In 1 Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-042-02 | 45802-042 | NDA050793 | NDA | N/A |
| Clindamycin Phosphate | Injection, Solution | Intramuscular; Intravenous | 150mg/mL | 25 Vial In 1 Carton (25021-115-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-115-02 | 25021-115 | ANDA090108 | ANDA | N/A |
| Clindamycin Phosphate | Injection, Solution | Intramuscular; Intravenous | 150mg/mL | 25 Vial In 1 Carton (25021-115-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-115-04 | 25021-115 | ANDA090108 | ANDA | N/A |
| Clindamycin Phosphate | Injection, Solution | Intramuscular; Intravenous | 150mg/mL | 25 Vial In 1 Carton (25021-115-06) / 6 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-115-06 | 25021-115 | ANDA090108 | ANDA | N/A |
| Clindamycin Phosphate | Injection, Solution | Intravenous | 150mg/mL | 1 Bottle In 1 Carton (25021-115-51) / 60 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-115-51 | 25021-115 | ANDA090109 | ANDA | N/A |
| Clindamycin Phosphate | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1399-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1399-2 | 51672-1399 | ANDA214052 | ANDA | N/A |
| Clindamycin Phosphate | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1399-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1399-3 | 51672-1399 | ANDA214052 | ANDA | N/A |
| Clindamycin Phosphate | Lotion | Topical | 10mg/mL | 1 Bottle In 1 Carton (51672-1400-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1400-4 | 51672-1400 | ANDA214526 | ANDA | N/A |
| Clindamycin Phosphate | Aerosol, Foam | Topical | 10mg/g | 1 Can In 1 Carton (51672-4194-3) / 50 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4194-3 | 51672-4194 | ANDA210004 | ANDA | N/A |
| Clindamycin Phosphate | Aerosol, Foam | Topical | 10mg/g | 1 Can In 1 Carton (51672-4194-7) / 100 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4194-7 | 51672-4194 | ANDA210004 | ANDA | N/A |
| Clindamycin Phosphate | Solution | Topical | 10mg/mL | 1 Bottle, With Applicator In 1 Carton (51672-4081-3) / 30 Ml In 1 Bottle, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-4081-3 | 51672-4081 | ANDA065184 | ANDA | N/A |
| Clindamycin Phosphate | Solution | Topical | 10mg/mL | 1 Bottle, With Applicator In 1 Carton (51672-4081-4) / 60 Ml In 1 Bottle, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-4081-4 | 51672-4081 | ANDA065184 | ANDA | N/A |
| Clindamycin Phosphate; Tretinoin | Gel | Topical | 10mg/g, .25 mg/g | 1 Tube In 1 Carton (66993-959-31) / 30 G In 1 Tube | Prasco Laboratories | 66993-959-31 | 66993-959 | NDA050803 | NDA AUTHORIZED GENERIC | N/A |
| Clindamycin Phosphate; Tretinoin | Gel | Topical | 10mg/g, .25 mg/g | 1 Tube In 1 Carton (66993-959-61) / 60 G In 1 Tube | Prasco Laboratories | 66993-959-61 | 66993-959 | NDA050803 | NDA AUTHORIZED GENERIC | N/A |
| Clobazam | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-585-01) | Golden State Medical Supply, Inc. | 51407-585-01 | 51407-585 | ANDA209687 | ANDA | CIV |
| Clobazam | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (51407-586-01) | Golden State Medical Supply, Inc. | 51407-586-01 | 51407-586 | ANDA209687 | ANDA | CIV |
| Clobazam | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51672-4202-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4202-1 | 51672-4202 | ANDA209440 | ANDA | CIV |
| Clobazam | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (51672-4203-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4203-1 | 51672-4203 | ANDA209440 | ANDA | CIV |
| Clobazam | Suspension | Oral | 2.5mg/mL | 120 Ml In 1 Bottle (51672-4227-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4227-8 | 51672-4227 | ANDA210978 | ANDA | CIV |
| Clobazam | Suspension | Oral | 2.5mg/mL | 1 Bottle, Plastic In 1 Carton (66689-058-04) / 120 Ml In 1 Bottle, Plastic | VistaPharm, LLC | 66689-058-04 | 66689-058 | ANDA210746 | ANDA | CIV |
| Clobazam | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (69452-114-20) | Bionpharma Inc. | 69452-114-20 | 69452-114 | ANDA208825 | ANDA | CIV |
| Clobazam | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (69452-115-20) | Bionpharma Inc. | 69452-115-20 | 69452-115 | ANDA208825 | ANDA | CIV |
| Clobazam | Suspension | Oral | 2.5mg/mL | 1 Bottle In 1 Carton (69452-116-45) / 120 Ml In 1 Bottle | Bionpharma Inc. | 69452-116-45 | 69452-116 | ANDA208819 | ANDA | CIV |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (45802-437-32) / 50 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-437-32 | 45802-437 | ANDA077763 | ANDA | N/A |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (45802-437-33) / 100 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-437-33 | 45802-437 | ANDA077763 | ANDA | N/A |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (45802-637-32) / 50 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-637-32 | 45802-637 | ANDA201402 | ANDA | N/A |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (45802-637-33) / 100 G In 1 Can | Padagis Israel Pharmaceuticals Ltd | 45802-637-33 | 45802-637 | ANDA201402 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (45802-925-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-925-14 | 45802-925 | ANDA075027 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (45802-925-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-925-94 | 45802-925 | ANDA075027 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (45802-925-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-925-96 | 45802-925 | ANDA075027 | ANDA | N/A |
| Clobetasol Propionate | Shampoo | Topical | .05g/100mL | 118 Ml In 1 Bottle (45802-961-26) | Padagis Israel Pharmaceuticals Ltd | 45802-961-26 | 45802-961 | ANDA090974 | ANDA | N/A |
| Clobetasol Propionate | Solution | Topical | .5mg/mL | 1 Bottle In 1 Carton (51407-737-25) / 25 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 51407-737-25 | 51407-737 | ANDA211494 | ANDA | N/A |
| Clobetasol Propionate | Solution | Topical | .5mg/mL | 1 Bottle In 1 Carton (51407-737-50) / 50 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 51407-737-50 | 51407-737 | ANDA211494 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1294-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1294-1 | 51672-1294 | ANDA075279 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1294-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1294-2 | 51672-1294 | ANDA075279 | ANDA | N/A |
| Clobetasol Propionate | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1294-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1294-3 | 51672-1294 | ANDA075279 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1297-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1297-1 | 51672-1297 | ANDA075633 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1297-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1297-2 | 51672-1297 | ANDA075633 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1297-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1297-3 | 51672-1297 | ANDA075633 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1258-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1258-1 | 51672-1258 | ANDA074249 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1258-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1258-2 | 51672-1258 | ANDA074249 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1258-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1258-3 | 51672-1258 | ANDA074249 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1258-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1258-6 | 51672-1258 | ANDA074249 | ANDA | N/A |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (51672-4193-3) / 50 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4193-3 | 51672-4193 | ANDA208779 | ANDA | N/A |
| Clobetasol Propionate | Aerosol, Foam | Topical | .5mg/g | 1 Can In 1 Carton (51672-4193-7) / 100 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-4193-7 | 51672-4193 | ANDA208779 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1259-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1259-1 | 51672-1259 | ANDA074248 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1259-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1259-2 | 51672-1259 | ANDA074248 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1259-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1259-3 | 51672-1259 | ANDA074248 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1259-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1259-6 | 51672-1259 | ANDA074248 | ANDA | N/A |
| Clobetasol Propionate | Spray | Topical | .05g/mL | 1 Bottle, Pump In 1 Carton (51672-1371-4) / 59 Ml In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1371-4 | 51672-1371 | ANDA208842 | ANDA | N/A |
| Clobetasol Propionate | Spray | Topical | .05g/mL | 1 Bottle, Pump In 1 Carton (51672-1371-8) / 125 Ml In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1371-8 | 51672-1371 | ANDA208842 | ANDA | N/A |
| Clobetasol Propionate | Shampoo | Topical | .05g/100mL | 1 Bottle In 1 Carton (51672-1347-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1347-8 | 51672-1347 | ANDA214867 | ANDA | N/A |
| Clobetasol Propionate | Lotion | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-1350-4) / 59 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1350-4 | 51672-1350 | ANDA200302 | ANDA | N/A |
| Clobetasol Propionate | Lotion | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-1350-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1350-8 | 51672-1350 | ANDA200302 | ANDA | N/A |
| Clobetasol Propionate | Solution | Topical | .5mg/mL | 1 Bottle, Plastic In 1 Carton (51672-1293-2) / 25 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1293-2 | 51672-1293 | ANDA075224 | ANDA | N/A |
| Clobetasol Propionate | Solution | Topical | .5mg/mL | 1 Bottle, Plastic In 1 Carton (51672-1293-3) / 50 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1293-3 | 51672-1293 | ANDA075224 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0656-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0656-15 | 0713-0656 | ANDA074089 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0656-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0656-31 | 0713-0656 | ANDA074089 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0656-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0656-37 | 0713-0656 | ANDA074089 | ANDA | N/A |
| Clobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0656-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0656-60 | 0713-0656 | ANDA074089 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (42806-721-01) | EPIC PHARMA, LLC | 42806-721-01 | 42806-721 | ANDA207872 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (42806-721-05) | EPIC PHARMA, LLC | 42806-721-05 | 42806-721 | ANDA207872 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (42806-722-01) | EPIC PHARMA, LLC | 42806-722-01 | 42806-722 | ANDA207872 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (42806-722-05) | EPIC PHARMA, LLC | 42806-722-05 | 42806-722 | ANDA207872 | ANDA | N/A |
| Clocortolone Pivalate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (66993-947-48) / 45 G In 1 Tube | Prasco Laboratories | 66993-947-48 | 66993-947 | NDA017765 | NDA AUTHORIZED GENERIC | N/A |
| Clocortolone Pivalate | Cream | Topical | 1mg/g | 1 Bottle, Pump In 1 Carton (66993-947-79) / 75 G In 1 Bottle, Pump | Prasco Laboratories | 66993-947-79 | 66993-947 | NDA017765 | NDA AUTHORIZED GENERIC | N/A |
| Clocortolone Pivalate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (66993-947-93) / 90 G In 1 Tube | Prasco Laboratories | 66993-947-93 | 66993-947 | NDA017765 | NDA AUTHORIZED GENERIC | N/A |
| Clocortolone Pivalate | Cream | Topical | .001g/g | 1 Tube In 1 Carton (51672-4166-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-4166-6 | 51672-4166 | ANDA206370 | ANDA | N/A |
| Clocortolone Pivalate | Cream | Topical | .001g/g | 1 Tube In 1 Carton (51672-4166-8) / 90 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-4166-8 | 51672-4166 | ANDA206370 | ANDA | N/A |
| Clofarabine | Injection | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-128-20) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-128-20 | 71288-128 | ANDA213461 | ANDA | N/A |
| Clofarabine | Injection | Intravenous | 1mg/mL | 1 Vial, Single-Use In 1 Carton (60505-6166-0) / 20 Ml In 1 Vial, Single-Use | Apotex Corp. | 60505-6166-0 | 60505-6166 | ANDA209775 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (42806-723-60) | EPIC PHARMA, LLC | 42806-723-60 | 42806-723 | ANDA207872 | ANDA | N/A |
| Clomiphene Citrate | Tablet | Oral | 50mg/1 | 1 Blister Pack In 1 Carton (0713-0885-09) / 10 Tablet In 1 Blister Pack | Cosette Pharmaceuticals, Inc. | 0713-0885-09 | 0713-0885 | ANDA075528 | ANDA | N/A |
| Clomiphene Citrate | Tablet | Oral | 50mg/1 | 3 Blister Pack In 1 Carton (0713-0885-30) / 10 Tablet In 1 Blister Pack | Cosette Pharmaceuticals, Inc. | 0713-0885-30 | 0713-0885 | ANDA075528 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (51407-757-01) | Golden State Medical Supply, Inc. | 51407-757-01 | 51407-757 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (51407-758-01) | Golden State Medical Supply, Inc. | 51407-758-01 | 51407-758 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (51407-759-01) | Golden State Medical Supply, Inc. | 51407-759-01 | 51407-759 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (51672-4011-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4011-1 | 51672-4011 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 60 Capsule In 1 Bottle (51672-4011-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4011-4 | 51672-4011 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (51672-4011-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4011-5 | 51672-4011 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (51672-4011-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4011-6 | 51672-4011 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (51672-4012-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4012-1 | 51672-4012 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (51672-4012-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4012-4 | 51672-4012 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (51672-4012-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4012-5 | 51672-4012 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (51672-4012-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4012-6 | 51672-4012 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (51672-4013-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4013-1 | 51672-4013 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle (51672-4013-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4013-4 | 51672-4013 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (51672-4013-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4013-5 | 51672-4013 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (51672-4013-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4013-6 | 51672-4013 | ANDA074694 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (69315-165-01) | Leading Pharma, LLC | 69315-165-01 | 69315-165 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (69315-165-03) | Leading Pharma, LLC | 69315-165-03 | 69315-165 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (69315-166-01) | Leading Pharma, LLC | 69315-166-01 | 69315-166 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (69315-166-03) | Leading Pharma, LLC | 69315-166-03 | 69315-166 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (69315-166-09) | Leading Pharma, LLC | 69315-166-09 | 69315-166 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (69315-167-01) | Leading Pharma, LLC | 69315-167-01 | 69315-167 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (69315-167-03) | Leading Pharma, LLC | 69315-167-03 | 69315-167 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (69315-167-09) | Leading Pharma, LLC | 69315-167-09 | 69315-167 | ANDA211364 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (59746-710-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-710-01 | 59746-710 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (59746-710-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-710-30 | 59746-710 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (59746-710-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-710-90 | 59746-710 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (59746-711-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-711-01 | 59746-711 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (59746-711-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-711-30 | 59746-711 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (59746-711-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-711-90 | 59746-711 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (59746-712-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-712-01 | 59746-712 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (59746-712-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-712-30 | 59746-712 | ANDA212218 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (59746-712-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-712-90 | 59746-712 | ANDA212218 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (50228-159-05) | ScieGen Pharmaceuticals, Inc. | 50228-159-05 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (50228-159-30) | ScieGen Pharmaceuticals, Inc. | 50228-159-30 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (50228-159-60) | ScieGen Pharmaceuticals, Inc. | 50228-159-60 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (50228-156-10) | ScieGen Pharmaceuticals, Inc. | 50228-156-10 | 50228-156 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (50228-156-30) | ScieGen Pharmaceuticals, Inc. | 50228-156-30 | 50228-156 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (50228-156-60) | ScieGen Pharmaceuticals, Inc. | 50228-156-60 | 50228-156 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (50228-157-01) | ScieGen Pharmaceuticals, Inc. | 50228-157-01 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (50228-157-05) | ScieGen Pharmaceuticals, Inc. | 50228-157-05 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-157-10) | ScieGen Pharmaceuticals, Inc. | 50228-157-10 | 50228-157 | ANDA205129 | ANDA | N/A |
| Clonazepam | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (51407-524-01) | Golden State Medical Supply, Inc. | 51407-524-01 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (51407-524-05) | Golden State Medical Supply, Inc. | 51407-524-05 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 120 Tablet In 1 Bottle (51407-524-12) | Golden State Medical Supply, Inc. | 51407-524-12 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 15 Tablet In 1 Bottle (51407-524-15) | Golden State Medical Supply, Inc. | 51407-524-15 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle (51407-524-30) | Golden State Medical Supply, Inc. | 51407-524-30 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 45 Tablet In 1 Bottle (51407-524-45) | Golden State Medical Supply, Inc. | 51407-524-45 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 150 Tablet In 1 Bottle (51407-524-51) | Golden State Medical Supply, Inc. | 51407-524-51 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 60 Tablet In 1 Bottle (51407-524-60) | Golden State Medical Supply, Inc. | 51407-524-60 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonazepam | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (51407-524-90) | Golden State Medical Supply, Inc. | 51407-524-90 | 51407-524 | ANDA074569 | ANDA | CIV |
| Clonidine Hydrochloride | Injection, Solution | Intravenous | 500ug/mL | 10 Ml In 1 Vial, Single-Use (0143-9723-01) | Hikma Pharmaceuticals USA Inc. | 0143-9723-01 | 0143-9723 | ANDA200300 | ANDA | N/A |
| Clonidine Hydrochloride | Injection, Solution | Intravenous | 100ug/mL | 10 Ml In 1 Vial, Single-Use (0143-9724-01) | Hikma Pharmaceuticals USA Inc. | 0143-9724-01 | 0143-9724 | ANDA200300 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-157-30) | ScieGen Pharmaceuticals, Inc. | 50228-157-30 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (50228-158-01) | ScieGen Pharmaceuticals, Inc. | 50228-158-01 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (50228-158-05) | ScieGen Pharmaceuticals, Inc. | 50228-158-05 | 50228-158 | ANDA205129 | ANDA | N/A |
| Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-5168-2) | Jubilant HollisterStier LLC | 65044-5168-2 | 65044-5168 | BLA103888 | BLA | N/A |
| Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-5168-3) | Jubilant HollisterStier LLC | 65044-5168-3 | 65044-5168 | BLA103888 | BLA | N/A |
| Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-5168-4) | Jubilant HollisterStier LLC | 65044-5168-4 | 65044-5168 | BLA103888 | BLA | N/A |
| Clonostachys Rosea F. Rosea; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Digitatum; Penicillium Expansum | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL, .1 g/mL, .2 g/mL | 5 Ml In 1 Vial (65044-5169-1) | Jubilant HollisterStier LLC | 65044-5169-1 | 65044-5169 | BLA103888 | BLA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (50228-158-10) | ScieGen Pharmaceuticals, Inc. | 50228-158-10 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-158-30) | ScieGen Pharmaceuticals, Inc. | 50228-158-30 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (50228-159-05) | ScieGen Pharmaceuticals, Inc. | 50228-159-05 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (50228-159-30) | ScieGen Pharmaceuticals, Inc. | 50228-159-30 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 400mg/1 | 60 Capsule In 1 Bottle (50228-159-60) | ScieGen Pharmaceuticals, Inc. | 50228-159-60 | 50228-159 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (50228-156-10) | ScieGen Pharmaceuticals, Inc. | 50228-156-10 | 50228-156 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (50228-156-30) | ScieGen Pharmaceuticals, Inc. | 50228-156-30 | 50228-156 | ANDA205129 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 1000 Tablet In 1 Bottle, Dispensing (52605-082-10) | POLYGEN PHARMACEUTICALS INC. | 52605-082-10 | 52605-082 | ANDA213351 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (52605-082-13) | POLYGEN PHARMACEUTICALS INC. | 52605-082-13 | 52605-082 | ANDA213351 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle, Dispensing (52605-083-05) | POLYGEN PHARMACEUTICALS INC. | 52605-083-05 | 52605-083 | ANDA213351 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (52605-083-13) | POLYGEN PHARMACEUTICALS INC. | 52605-083-13 | 52605-083 | ANDA213351 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51407-032-10) | Golden State Medical Supply, Inc. | 51407-032-10 | 51407-032 | ANDA076274 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-032-30) | Golden State Medical Supply, Inc. | 51407-032-30 | 51407-032 | ANDA076274 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-032-90) | Golden State Medical Supply, Inc. | 51407-032-90 | 51407-032 | ANDA076274 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-3532-5) | Apotex Corp. | 60505-3532-5 | 60505-3532 | ANDA076274 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-0253-2) | Apotex Corp. | 60505-0253-2 | 60505-0253 | ANDA076274 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0253-3) | Apotex Corp. | 60505-0253-3 | 60505-0253 | ANDA076274 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (50228-156-60) | ScieGen Pharmaceuticals, Inc. | 50228-156-60 | 50228-156 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (50228-157-01) | ScieGen Pharmaceuticals, Inc. | 50228-157-01 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (50228-157-05) | ScieGen Pharmaceuticals, Inc. | 50228-157-05 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-157-10) | ScieGen Pharmaceuticals, Inc. | 50228-157-10 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-157-30) | ScieGen Pharmaceuticals, Inc. | 50228-157-30 | 50228-157 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (50228-158-01) | ScieGen Pharmaceuticals, Inc. | 50228-158-01 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (50228-158-05) | ScieGen Pharmaceuticals, Inc. | 50228-158-05 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (50228-158-10) | ScieGen Pharmaceuticals, Inc. | 50228-158-10 | 50228-158 | ANDA205129 | ANDA | N/A |
| Celecoxib | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-158-30) | ScieGen Pharmaceuticals, Inc. | 50228-158-30 | 50228-158 | ANDA205129 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 5mg/5mL | 118 Ml In 1 Bottle (65162-684-86) | Amneal Pharmaceuticals LLC | 65162-684-86 | 65162-684 | ANDA090766 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle (65162-684-90) | Amneal Pharmaceuticals LLC | 65162-684-90 | 65162-684 | ANDA090766 | ANDA | N/A |
| Clorazepate Dipotassium | Tablet | Oral | 3.75mg/1 | 100 Tablet In 1 Bottle (51672-4042-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4042-1 | 51672-4042 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 3.75mg/1 | 500 Tablet In 1 Bottle (51672-4042-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4042-2 | 51672-4042 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 3.75mg/1 | 1000 Tablet In 1 Bottle (51672-4042-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4042-3 | 51672-4042 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (51672-4043-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4043-1 | 51672-4043 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 7.5mg/1 | 500 Tablet In 1 Bottle (51672-4043-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4043-2 | 51672-4043 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (51672-4043-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4043-3 | 51672-4043 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (51672-4044-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4044-1 | 51672-4044 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (51672-4044-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4044-2 | 51672-4044 | ANDA075731 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (51672-4044-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4044-3 | 51672-4044 | ANDA075731 | ANDA | CIV |
| Cetirizine Hydrochloride | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (65162-145-03) / 30 Tablet In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-145-03 | 65162-145 | ANDA078780 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-145-50) | Amneal Pharmaceuticals LLC | 65162-145-50 | 65162-145 | ANDA078780 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (65162-045-03) / 30 Tablet In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-045-03 | 65162-045 | ANDA078780 | ANDA | N/A |
| Clorazepate Dipotassium | Tablet | Oral | 3.75mg/mg | 100 Mg In 1 Bottle (60505-4754-1) | Apotex Corp. | 60505-4754-1 | 60505-4754 | ANDA215566 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 7.5mg/mg | 100 Mg In 1 Bottle (60505-4755-1) | Apotex Corp. | 60505-4755-1 | 60505-4755 | ANDA215566 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 15mg/mg | 100 Mg In 1 Bottle (60505-4756-1) | Apotex Corp. | 60505-4756-1 | 60505-4756 | ANDA215566 | ANDA | CIV |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (70954-036-20) / 30 Ml In 1 Bottle | Novitium Pharma LLC | 70954-036-20 | 70954-036 | ANDA209815 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-045-50) | Amneal Pharmaceuticals LLC | 65162-045-50 | 65162-045 | ANDA078780 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (65162-046-03) / 30 Tablet In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-046-03 | 65162-046 | ANDA078780 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-046-50) | Amneal Pharmaceuticals LLC | 65162-046-50 | 65162-046 | ANDA078780 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (65162-003-86) / 118 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-003-86 | 65162-003 | ANDA090765 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (45802-434-01) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-434-01 | 45802-434 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (45802-434-11) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-434-11 | 45802-434 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Lozenge | Oral | 10mg/1 | 140 Lozenge In 1 Bottle, Plastic (0574-0107-14) | Padagis US LLC | 0574-0107-14 | 0574-0107 | ANDA076763 | ANDA | N/A |
| Clotrimazole | Lozenge | Oral | 10mg/1 | 70 Lozenge In 1 Bottle, Plastic (0574-0107-70) | Padagis US LLC | 0574-0107-70 | 0574-0107 | ANDA076763 | ANDA | N/A |
| Clotrimazole | Lozenge | Oral | 10mg/1 | 70 Packet In 1 Box (0574-0107-77) / 1 Lozenge In 1 Packet | Padagis US LLC | 0574-0107-77 | 0574-0107 | ANDA076763 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 1g/100g | 28 G In 1 Tube (73715-004-01) | Mohnark Pharmaceuticals Inc. | 73715-004-01 | 73715-004 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Cream | Topical | 10mg/g | 1 Tube In 1 Box (80684-039-01) / 14 G In 1 Tube | FOURSTAR GROUP USA, INC. | 80684-039-01 | 80684-039 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle, Plastic In 1 Carton (51672-1260-3) / 30 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1260-3 | 51672-1260 | ANDA074580 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2002-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2002-1 | 51672-2002 | part333C | OTC MONOGRAPH FINAL | N/A |
| Clotrimazole | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2002-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2002-2 | 51672-2002 | part333C | OTC MONOGRAPH FINAL | N/A |
| Clotrimazole | Cream | Vaginal | 1g/100g | 1 Tube In 1 Carton (51672-2003-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2003-6 | 51672-2003 | ANDA072641 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1275-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1275-1 | 51672-1275 | ANDA072640 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1275-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1275-2 | 51672-1275 | ANDA072640 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1275-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1275-6 | 51672-1275 | ANDA072640 | ANDA | N/A |
| Clotrimazole | Cream | Topical | 10mg/g | 2 Tube In 1 Carton (51672-1275-7) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1275-7 | 51672-1275 | ANDA072640 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 1g/mL | 1 Bottle In 1 Carton (51672-2037-1) / 10 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2037-1 | 51672-2037 | part333C | OTC MONOGRAPH FINAL | N/A |
| Clotrimazole | Cream | Vaginal | 2g/100g | 1 Tube, With Applicator In 1 Carton (51672-2062-0) / 21 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2062-0 | 51672-2062 | NDA021143 | NDA | N/A |
| Clotrimazole | Liquid | Topical | 10mg/mL | 1 Bottle, Spray In 1 Box (52389-600-60) / 60 Ml In 1 Bottle, Spray | Alva-Amco Pharmacal Companies, Inc. | 52389-600-60 | 52389-600 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Gel | Topical | 10mg/g | 1 Tube, With Applicator In 1 Box (52389-733-09) / 9 G In 1 Tube, With Applicator | Alva-Amco Pharmacal Companies, Inc. | 52389-733-09 | 52389-733 | M005 | OTC MONOGRAPH DRUG | N/A |
| Clotrimazole | Gel | Topical | 10mg/g | 1 Tube, With Applicator In 1 Box (52389-647-09) / 9 G In 1 Tube, With Applicator | Alva-Amco Pharmacal Companies, Inc. | 52389-647-09 | 52389-647 | M005 | OTC MONOGRAPH DRUG | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (65162-005-86) / 118 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-005-86 | 65162-005 | ANDA090765 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (16571-401-10) | Rising Pharma Holdings, Inc. | 16571-401-10 | 16571-401 | ANDA077829 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (16571-402-10) | Rising Pharma Holdings, Inc. | 16571-402-10 | 16571-402 | ANDA077829 | ANDA | N/A |
| Cetirizine Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (16571-402-50) | Rising Pharma Holdings, Inc. | 16571-402-50 | 16571-402 | ANDA077829 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 120 Ml In 1 Bottle, Plastic (16571-134-12) | Rising Pharma Holdings, Inc. | 16571-134-12 | 16571-134 | ANDA090191 | ANDA | N/A |
| Cetirizine Hydrochloride | Solution | Oral | 1mg/mL | 480 Ml In 1 Bottle, Plastic (16571-134-48) | Rising Pharma Holdings, Inc. | 16571-134-48 | 16571-134 | ANDA090191 | ANDA | N/A |
| Coal Tar | Ointment | Topical | 20mg/g | 119 G In 1 Tube (52389-752-02) | Alva-Amco Pharmacal Companies, Inc. | 52389-752-02 | 52389-752 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (52389-752-42) / 119 G In 1 Tube | Alva-Amco Pharmacal Companies, Inc. | 52389-752-42 | 52389-752 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Gel | Topical | 12.5mg/g | 1 Tube In 1 Carton (52389-166-01) / 28.35 G In 1 Tube (52389-166-28) | Alva-Amco Pharmacal Companies, Inc. | 52389-166-01 | 52389-166 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Gel | Topical | 12.5mg/g | 2 Tube In 1 Box (52389-166-43) / 21.25 G In 1 Tube | Alva-Amco Pharmacal Companies, Inc. | 52389-166-43 | 52389-166 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Gel | Topical | 12.5mg/g | 2 Tube In 1 Carton (52389-166-56) / 28.35 G In 1 Tube (52389-166-28) | Alva-Amco Pharmacal Companies, Inc. | 52389-166-56 | 52389-166 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Lotion/Shampoo | Topical | 20mg/g | 140 G In 1 Tube (52389-670-05) | Alva-Amco Pharmacal Companies, LLC | 52389-670-05 | 52389-670 | M032 | OTC MONOGRAPH DRUG | N/A |
| Coal Tar | Soap | Topical | 21.3mg/g | 1 Bag In 1 Carton (49758-000-01) / 90 G In 1 Bag | Dermabon de Chihuahua, S.A. de C.V. | 49758-000-01 | 49758-000 | M032 | OTC MONOGRAPH DRUG | N/A |
| Cochliobolus Spicifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5076-2) | Jubilant HollisterStier LLC | 65044-5076-2 | 65044-5076 | BLA103888 | BLA | N/A |
| Cochliobolus Spicifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5076-3) | Jubilant HollisterStier LLC | 65044-5076-3 | 65044-5076 | BLA103888 | BLA | N/A |
| Cochliobolus Spicifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5076-4) | Jubilant HollisterStier LLC | 65044-5076-4 | 65044-5076 | BLA103888 | BLA | N/A |
| Cochliobolus Spicifer | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5077-1) | Jubilant HollisterStier LLC | 65044-5077-1 | 65044-5077 | BLA103888 | BLA | N/A |
| Cod, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3203-2) | Jubilant HollisterStier LLC | 65044-3203-2 | 65044-3203 | BLA103888 | BLA | N/A |
| Cevimeline Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (16571-657-10) | Rising Pharma Holdings, Inc. | 16571-657-10 | 16571-657 | ANDA203775 | ANDA | N/A |
| CHILDRENS ALLERGY RELIEF | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (69230-316-11) / 118 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-316-11 | 69230-316 | ANDA210622 | ANDA | N/A |
| Codeine Phosphate; Promethazine Hydrochloride | Solution | Oral | 10mg/5mL, 6.25 mg/5mL | 118 Ml In 1 Bottle (70408-185-31) | Nostrum Laboratories, Inc. | 70408-185-31 | 70408-185 | ANDA090180 | ANDA | CV |
| Codeine Phosphate; Promethazine Hydrochloride | Solution | Oral | 10mg/5mL, 6.25 mg/5mL | 473 Ml In 1 Bottle (70408-185-34) | Nostrum Laboratories, Inc. | 70408-185-34 | 70408-185 | ANDA090180 | ANDA | CV |
| Codeine Phosphate; Promethazine Hydrochloride | Solution | Oral | 10mg/5mL, 6.25 mg/5mL | 473 Ml In 1 Bottle, Plastic (27808-065-02) | Tris Pharma Inc | 27808-065-02 | 27808-065 | ANDA200386 | ANDA | CV |
| Codeine Sulfate | Tablet | Oral | 15mg/1 | 10 Blister Pack In 1 Box (0054-0243-24) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0243-24 | 0054-0243 | NDA022402 | NDA | CII |
| Codeine Sulfate | Tablet | Oral | 30mg/1 | 10 Blister Pack In 1 Box (0054-0244-24) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0244-24 | 0054-0244 | NDA022402 | NDA | CII |
| Codeine Sulfate | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (0054-0244-25) | Hikma Pharmaceuticals USA Inc. | 0054-0244-25 | 0054-0244 | NDA022402 | NDA | CII |
| Codeine Sulfate | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (0054-0245-25) | Hikma Pharmaceuticals USA Inc. | 0054-0245-25 | 0054-0245 | NDA022402 | NDA | CII |
| Colchicine | Tablet, Film Coated | Oral | .6mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-082-01) | Golden State Medical Supply, Inc. | 51407-082-01 | 51407-082 | ANDA210425 | ANDA | N/A |
| Colchicine | Tablet, Film Coated | Oral | .6mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-082-30) | Golden State Medical Supply, Inc. | 51407-082-30 | 51407-082 | ANDA210425 | ANDA | N/A |
| Chlordiazepoxide Hydrochloride | Capsule, Gelatin Coated | Oral | 10mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (42806-562-01) | Epic Pharma LLC | 42806-562-01 | 42806-562 | ANDA085472 | ANDA | CIV |
| Chlordiazepoxide Hydrochloride | Capsule, Gelatin Coated | Oral | 25mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (42806-563-01) | Epic Pharma LLC | 42806-563-01 | 42806-563 | ANDA085475 | ANDA | CIV |
| Chlordiazepoxide Hydrochloride | Capsule, Gelatin Coated | Oral | 5mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (42806-564-01) | Epic Pharma, LLC | 42806-564-01 | 42806-564 | ANDA085461 | ANDA | CIV |
| Colchicine | Capsule | Oral | .6mg/1 | 100 Capsule In 1 Bottle, Plastic (0143-3018-01) | Hikma Pharmaceuticals USA Inc. | 0143-3018-01 | 0143-3018 | NDA204820 | NDA | N/A |
| Colchicine | Capsule | Oral | .6mg/1 | 1000 Capsule In 1 Bottle, Plastic (0143-3018-10) | Hikma Pharmaceuticals USA Inc. | 0143-3018-10 | 0143-3018 | NDA204820 | NDA | N/A |
| Colchicine | Capsule | Oral | .6mg/1 | 30 Capsule In 1 Bottle, Plastic (0143-3018-30) | Hikma Pharmaceuticals USA Inc. | 0143-3018-30 | 0143-3018 | NDA204820 | NDA | N/A |
| Chlordiazepoxide Hydrochloride | Capsule, Gelatin Coated | Oral | 10mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (42806-565-01) | Epic Pharma, LLC | 42806-565-01 | 42806-565 | ANDA085472 | ANDA | CIV |
| Chlordiazepoxide Hydrochloride | Capsule, Gelatin Coated | Oral | 25mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (42806-566-01) | Epic Pharma, LLC | 42806-566-01 | 42806-566 | ANDA085475 | ANDA | CIV |
| Colesevelam Hydrochloride | Tablet, Coated | Oral | 625mg/1 | 180 Tablet, Coated In 1 Bottle (75834-152-18) | Nivagen Pharmaceuticals, Inc. | 75834-152-18 | 75834-152 | ANDA212050 | ANDA | N/A |
| Colesevelam Hydrochloride | Tablet | Oral | 625mg/1 | 180 Tablet In 1 Bottle (51407-336-18) | Golden State Medical Supply, Inc. | 51407-336-18 | 51407-336 | ANDA209946 | ANDA | N/A |
| Colesevelam Hydrochloride | Tablet | Oral | 625mg/1 | 180 Tablet In 1 Bottle (27808-190-01) | Tris Pharma Inc | 27808-190-01 | 27808-190 | ANDA209946 | ANDA | N/A |
| Colesevelam Hydrochloride | Tablet, Film Coated | Oral | 625mg/1 | 180 Tablet, Film Coated In 1 Bottle (69452-158-25) | Bionpharma Inc. | 69452-158-25 | 69452-158 | ANDA208670 | ANDA | N/A |
| Colesevelam Hydrochloride | For Suspension | Oral | 3.75g/1 | 30 Packet In 1 Carton (0713-0935-30) / 1 For Suspension In 1 Packet | Cosette Pharmaceuticals, Inc. | 0713-0935-30 | 0713-0935 | NDA022362 | NDA | N/A |
| Colesevelam Hydrochloride | Tablet, Film Coated | Oral | 625mg/1 | 180 Tablet, Film Coated In 1 Bottle (0713-0936-81) | Cosette Pharmaceuticals, Inc. | 0713-0936-81 | 0713-0936 | NDA021176 | NDA | N/A |
| Colesevelam Hydrochloride | Tablet, Film Coated | Oral | 625mg/1 | 180 Tablet, Film Coated In 1 Bottle (0713-0879-81) | Cosette Pharmaceuticals, Inc. | 0713-0879-81 | 0713-0879 | NDA021176 | NDA | N/A |
| Chlorhexidine Gluconate | Solution | Topical | 40mg/mL | 118 Ml In 1 Bottle (16571-111-12) | Rising Pharma Holdings, Inc. | 16571-111-12 | 16571-111 | NDA019258 | NDA | N/A |
| Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) | Injection, Powder, For Solution | Intravenous | 250[arb'U]/10mL | 1 Vial In 1 Carton (0008-0423-03) / 10 Ml In 1 Vial (0008-0423-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0423-03 | 0008-0423 | BLA101099 | BLA | N/A |
| Corn | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3212-2) | Jubilant HollisterStier LLC | 65044-3212-2 | 65044-3212 | BLA103888 | BLA | N/A |
| Chlorhexidine Gluconate | Solution | Topical | 40mg/mL | 237 Ml In 1 Bottle (16571-111-24) | Rising Pharma Holdings, Inc. | 16571-111-24 | 16571-111 | NDA019258 | NDA | N/A |
| Chlorhexidine Gluconate | Solution | Topical | 40mg/mL | 473 Ml In 1 Bottle (16571-111-48) | Rising Pharma Holdings, Inc. | 16571-111-48 | 16571-111 | NDA019258 | NDA | N/A |
| Cosyntropin | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0548-5900-00) / 1 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-5900-00 | 0548-5900 | NDA016750 | NDA | N/A |
| Cosyntropin | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | .25mg/mL | 10 Vial In 1 Carton (0548-5900-00) / 1 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-5900-00 | 0548-5900 | NDA016750 | NDA | N/A |
| Cow Milk | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-3389-2) | Jubilant HollisterStier LLC | 65044-3389-2 | 65044-3389 | BLA103888 | BLA | N/A |
| Cow Milk | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-3390-1) | Jubilant HollisterStier LLC | 65044-3390-1 | 65044-3390 | BLA103888 | BLA | N/A |
| Crab Leg, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3215-2) | Jubilant HollisterStier LLC | 65044-3215-2 | 65044-3215 | BLA103888 | BLA | N/A |
| Crisaborole | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (55724-211-11) / 100 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 55724-211-11 | 55724-211 | NDA207695 | NDA | N/A |
| Crisaborole | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (55724-211-21) / 60 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 55724-211-21 | 55724-211 | NDA207695 | NDA | N/A |
| Crisaborole | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (55724-211-23) / 60 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 55724-211-23 | 55724-211 | NDA207695 | NDA | N/A |
| Crisaborole | Ointment | Topical | 20mg/g | 6 Tube In 1 Carton (55724-211-42) / 2.5 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 55724-211-42 | 55724-211 | NDA207695 | NDA | N/A |
| Crizotinib | Capsule, Coated Pellets | Oral | 150mg/1 | 60 Capsule, Coated Pellets In 1 Bottle (0069-1500-60) | Pfizer Laboratories Div Pfizer Inc | 0069-1500-60 | 0069-1500 | NDA217581 | NDA | N/A |
| Crizotinib | Capsule | Oral | 250mg/1 | 60 Capsule In 1 Bottle (0069-8140-20) | Pfizer Laboratories Div Pfizer Inc | 0069-8140-20 | 0069-8140 | NDA202570 | NDA | N/A |
| Crizotinib | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle (0069-8141-20) | Pfizer Laboratories Div Pfizer Inc | 0069-8141-20 | 0069-8141 | NDA202570 | NDA | N/A |
| Crizotinib | Capsule, Coated Pellets | Oral | 20mg/1 | 60 Capsule, Coated Pellets In 1 Bottle (0069-0251-60) | Pfizer Laboratories Div Pfizer Inc | 0069-0251-60 | 0069-0251 | NDA217581 | NDA | N/A |
| Crizotinib | Capsule, Coated Pellets | Oral | 50mg/1 | 60 Capsule, Coated Pellets In 1 Bottle (0069-0507-60) | Pfizer Laboratories Div Pfizer Inc | 0069-0507-60 | 0069-0507 | NDA217581 | NDA | N/A |
| Chlorhexidine Gluconate | Solution | Topical | 40mg/mL | 946 Ml In 1 Bottle (16571-111-95) | Rising Pharma Holdings, Inc. | 16571-111-95 | 16571-111 | NDA019258 | NDA | N/A |
| Cupressus Arizonica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1450-2) | Jubilant HollisterStier LLC | 65044-1450-2 | 65044-1450 | BLA103888 | BLA | N/A |
| Cupressus Arizonica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1450-3) | Jubilant HollisterStier LLC | 65044-1450-3 | 65044-1450 | BLA103888 | BLA | N/A |
| Cupressus Arizonica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1450-4) | Jubilant HollisterStier LLC | 65044-1450-4 | 65044-1450 | BLA103888 | BLA | N/A |
| Cupressus Arizonica Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1451-1) | Jubilant HollisterStier LLC | 65044-1451-1 | 65044-1451 | BLA103888 | BLA | N/A |
| Cupric Chloride | Injection | Intravenous | .4mg/mL | 25 Vial, Plastic In 1 Carton (70069-506-25) / 10 Ml In 1 Vial, Plastic (70069-506-01) | Somerset Therapeutics, LLC | 70069-506-25 | 70069-506 | ANDA216113 | ANDA | N/A |
| Cupric Chloride | Injection, Solution | Intravenous | .4mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4092-01) / 10 Ml In 1 Vial, Single-Dose (0409-4092-11) | Hospira, Inc. | 0409-4092-01 | 0409-4092 | NDA018960 | NDA | N/A |
| Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate | Injection, Solution | Intravenous | 150ug/mL, 8.22 ug/mL, 9.8 ug/mL, 2470 ug/mL | 25 Vial, Single-Dose In 1 Tray (0517-9302-25) / 1 Ml In 1 Vial, Single-Dose (0517-9302-01) | American Regent, Inc. | 0517-9302-25 | 0517-9302 | NDA209376 | NDA | N/A |
| Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate | Injection, Solution | Intravenous | .3mg/mL, 55 ug/mL, 60 ug/mL, 3 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-9305-25) / 1 Ml In 1 Vial, Single-Dose (0517-9305-01) | American Regent, Inc. | 0517-9305-25 | 0517-9305 | NDA209376 | NDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial, Multi-Dose In 1 Carton (71288-303-02) / 1 Ml In 1 Vial, Multi-Dose (71288-303-01) | Meitheal Pharmaceuticals Inc. | 71288-303-02 | 71288-303 | ANDA214390 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial, Multi-Dose In 1 Carton (71288-303-92) / 1 Ml In 1 Vial, Multi-Dose (71288-303-91) | Meitheal Pharmaceuticals Inc. | 71288-303-92 | 71288-303 | ANDA214390 | ANDA | N/A |
| Cyanocobalamin | Spray | Nasal | 500ug/1 | 4 Bottle, Unit-Dose In 1 Carton (45802-491-84) / 1 Spray In 1 Bottle, Unit-Dose | Padagis Israel Pharmaceuticals Ltd | 45802-491-84 | 45802-491 | ANDA212458 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial In 1 Carton (25021-502-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-502-01 | 25021-502 | ANDA215107 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 5 Vial In 1 Carton (70069-171-05) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-171-05 | 70069-171 | ANDA209429 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 10 Vial In 1 Carton (70069-171-10) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-171-10 | 70069-171 | ANDA209429 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 10 Vial In 1 Carton (70069-172-10) / 10 Ml In 1 Vial (70069-172-01) | Somerset Therapeutics, LLC | 70069-172-10 | 70069-172 | ANDA206503 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial In 1 Carton (70069-172-25) / 10 Ml In 1 Vial (70069-172-01) | Somerset Therapeutics, LLC | 70069-172-25 | 70069-172 | ANDA206503 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial In 1 Carton (70069-005-10) / 1 Ml In 1 Vial (70069-005-01) | Somerset Therapeutics, LLC | 70069-005-10 | 70069-005 | ANDA206503 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial, Multi-Dose In 1 Tray (0517-0031-25) / 1 Ml In 1 Vial, Multi-Dose (0517-0031-01) | American Regent, Inc. | 0517-0031-25 | 0517-0031 | ANDA080737 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial, Multi-Dose In 1 Tray (0517-0032-25) / 10 Ml In 1 Vial, Multi-Dose (0517-0032-01) | American Regent, Inc. | 0517-0032-25 | 0517-0032 | ANDA080737 | ANDA | N/A |
| Cyanocobalamin | Injection, Solution | Intramuscular; Subcutaneous | 1000ug/mL | 1 Vial, Multi-Dose In 1 Box (0517-0130-01) / 30 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0130-01 | 0517-0130 | ANDA080737 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 30 Ml In 1 Vial, Multi-Dose (0143-9619-01) | Hikma Pharmaceuticals USA Inc. | 0143-9619-01 | 0143-9619 | ANDA080515 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 10 Vial, Multi-Dose In 1 Box (0143-9619-10) / 30 Ml In 1 Vial, Multi-Dose (0143-9619-01) | Hikma Pharmaceuticals USA Inc. | 0143-9619-10 | 0143-9619 | ANDA080515 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 10 Vial, Multi-Dose In 1 Box (0143-9620-10) / 10 Ml In 1 Vial, Multi-Dose (0143-9620-01) | Hikma Pharmaceuticals USA Inc. | 0143-9620-10 | 0143-9620 | ANDA080515 | ANDA | N/A |
| Cyanocobalamin | Injection | Intramuscular; Subcutaneous | 1000ug/mL | 25 Vial In 1 Box (0143-9621-25) / 1 Ml In 1 Vial (0143-9621-01) | Hikma Pharmaceuticals USA Inc. | 0143-9621-25 | 0143-9621 | ANDA080515 | ANDA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1858-2) | Jubilant HollisterStier LLC | 65044-1858-2 | 65044-1858 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1858-3) | Jubilant HollisterStier LLC | 65044-1858-3 | 65044-1858 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1858-4) | Jubilant HollisterStier LLC | 65044-1858-4 | 65044-1858 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1859-1) | Jubilant HollisterStier LLC | 65044-1859-1 | 65044-1859 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1861-2) | Jubilant HollisterStier LLC | 65044-1861-2 | 65044-1861 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1861-3) | Jubilant HollisterStier LLC | 65044-1861-3 | 65044-1861 | BLA103888 | BLA | N/A |
| Cyclachaena Xanthifolia Pollen; Iva Annua Pollen; Iva Axillaris Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1861-4) | Jubilant HollisterStier LLC | 65044-1861-4 | 65044-1861 | BLA103888 | BLA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 4 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-04) | St Mary's Medical Park Pharmacy | 60760-889-04 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 15 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-15) | St Mary's Medical Park Pharmacy | 60760-889-15 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-20) | St Mary's Medical Park Pharmacy | 60760-889-20 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-30) | St Mary's Medical Park Pharmacy | 60760-889-30 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 40 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-40) | St Mary's Medical Park Pharmacy | 60760-889-40 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-889-90) | St Mary's Medical Park Pharmacy | 60760-889-90 | 60760-889 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 4 Tablet, Film Coated In 1 Bottle, Plastic (60760-536-04) | St Mary's Medical Park Pharmacy | 60760-536-04 | 60760-536 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 15 Tablet, Film Coated In 1 Bottle, Plastic (60760-536-15) | St Mary's Medical Park Pharmacy | 60760-536-15 | 60760-536 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-536-30) | St Mary's Medical Park Pharmacy | 60760-536-30 | 60760-536 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-536-90) | St Mary's Medical Park Pharmacy | 60760-536-90 | 60760-536 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-363-60) | St. Mary's Medical Park Pharmacy | 60760-363-60 | 60760-363 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-363-90) | St. Mary's Medical Park Pharmacy | 60760-363-90 | 60760-363 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 120 Tablet, Film Coated In 1 Bottle, Plastic (60760-363-92) | St. Mary's Medical Park Pharmacy | 60760-363-92 | 60760-363 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 4 Tablet, Film Coated In 1 Bottle, Plastic (60760-365-04) | St. Mary's Medical Park Pharmacy | 60760-365-04 | 60760-365 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 15 Tablet, Film Coated In 1 Bottle, Plastic (60760-365-15) | St. Mary's Medical Park Pharmacy | 60760-365-15 | 60760-365 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-365-30) | St. Mary's Medical Park Pharmacy | 60760-365-30 | 60760-365 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-365-90) | St. Mary's Medical Park Pharmacy | 60760-365-90 | 60760-365 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 4 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-04) | St. Mary's Medical Park Pharmacy | 60760-366-04 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 9 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-09) | St. Mary's Medical Park Pharmacy | 60760-366-09 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 15 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-15) | St. Mary's Medical Park Pharmacy | 60760-366-15 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-20) | St. Mary's Medical Park Pharmacy | 60760-366-20 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-30) | St. Mary's Medical Park Pharmacy | 60760-366-30 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 40 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-40) | St. Mary's Medical Park Pharmacy | 60760-366-40 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-366-90) | St. Mary's Medical Park Pharmacy | 60760-366-90 | 60760-366 | ANDA208170 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (60429-876-01) | Golden State Medical Supply | 60429-876-01 | 60429-876 | ANDA077797 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (60429-876-05) | Golden State Medical Supply | 60429-876-05 | 60429-876 | ANDA077797 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (10702-006-01) | KVK-TECH, Inc. | 10702-006-01 | 10702-006 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (10702-006-10) | KVK-TECH, Inc. | 10702-006-10 | 10702-006 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (10702-006-50) | KVK-TECH, Inc. | 10702-006-50 | 10702-006 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (10702-007-01) | KVK-TECH, Inc. | 10702-007-01 | 10702-007 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (10702-007-03) | KVK-TECH, Inc. | 10702-007-03 | 10702-007 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (10702-007-09) | KVK-TECH, Inc. | 10702-007-09 | 10702-007 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (10702-007-10) | KVK-TECH, Inc. | 10702-007-10 | 10702-007 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (10702-007-50) | KVK-TECH, Inc. | 10702-007-50 | 10702-007 | ANDA078048 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-177-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-177-06 | 59746-177 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-177-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-177-10 | 59746-177 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-211-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-211-06 | 59746-211 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-211-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-211-10 | 59746-211 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-735-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-735-01 | 59746-735 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-735-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-735-10 | 59746-735 | ANDA077563 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-735-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-735-30 | 59746-735 | ANDA077563 | ANDA | N/A |
| Chlorhexidine Gluconate | Solution | Dental | 1.2mg/mL | 473 Ml In 1 Bottle (16571-128-48) | Rising Pharma Holdings, Inc. | 16571-128-48 | 16571-128 | ANDA075561 | ANDA | N/A |
| Chlorhexidine Gluconate | Solution | Dental | 1.2mg/mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (16571-128-52) / 15 Ml In 1 Cup, Unit-Dose (16571-128-15) | Rising Pharma Holdings, Inc. | 16571-128-52 | 16571-128 | ANDA075561 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle, Plastic (64980-177-01) | Rising Pharmaceuticals, Inc. | 64980-177-01 | 64980-177 | ANDA091621 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle, Plastic (64980-177-05) | Rising Pharmaceuticals, Inc. | 64980-177-05 | 64980-177 | ANDA091621 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle, Plastic (64980-177-10) | Rising Pharmaceuticals, Inc. | 64980-177-10 | 64980-177 | ANDA091621 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 250mg/1 | 50 Tablet In 1 Bottle, Plastic (64980-177-50) | Rising Pharmaceuticals, Inc. | 64980-177-50 | 64980-177 | ANDA091621 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle, Plastic (64980-178-01) | Rising Pharmaceuticals, Inc. | 64980-178-01 | 64980-178 | ANDA090612 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 500mg/1 | 25 Tablet In 1 Bottle, Plastic (64980-178-02) | Rising Pharmaceuticals, Inc. | 64980-178-02 | 64980-178 | ANDA090612 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle, Plastic (64980-178-05) | Rising Pharmaceuticals, Inc. | 64980-178-05 | 64980-178 | ANDA090612 | ANDA | N/A |
| Chloroquine Phosphate | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle, Plastic (64980-178-10) | Rising Pharmaceuticals, Inc. | 64980-178-10 | 64980-178 | ANDA090612 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (65162-247-03) | Amneal Pharmaceuticals LLC | 65162-247-03 | 65162-247 | ANDA207204 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (65162-247-09) | Amneal Pharmaceuticals LLC | 65162-247-09 | 65162-247 | ANDA207204 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (65162-250-03) | Amneal Pharmaceuticals LLC | 65162-250-03 | 65162-250 | ANDA207204 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 500mg/25mL | 1 Vial, Single-Dose In 1 Carton (81298-8110-1) / 25 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-8110-1 | 81298-8110 | ANDA215089 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 1g/50mL | 1 Vial, Single-Dose In 1 Carton (81298-8112-1) / 50 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-8112-1 | 81298-8112 | ANDA215089 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 2g/100mL | 1 Vial, Single-Dose In 1 Carton (81298-8114-1) / 100 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-8114-1 | 81298-8114 | ANDA215089 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/25mL | 1 Vial In 1 Carton (25021-247-50) / 25 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-247-50 | 25021-247 | ANDA214529 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/50mL | 1 Vial In 1 Carton (25021-248-51) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-248-51 | 25021-248 | ANDA214529 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, Lyophilized, For Solution | Intravenous | 2g/100mL | 1 Vial In 1 Carton (25021-249-51) / 100 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-249-51 | 25021-249 | ANDA214529 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (65162-250-09) | Amneal Pharmaceuticals LLC | 65162-250-09 | 65162-250 | ANDA207204 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle, Plastic (64980-303-01) | Rising Pharmaceuticals, Inc. | 64980-303-01 | 64980-303 | ANDA206904 | ANDA | N/A |
| Chlorthalidone | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle, Plastic (64980-303-10) | Rising Pharmaceuticals, Inc. | 64980-303-10 | 64980-303 | ANDA206904 | ANDA | N/A |
| Cyclophosphamide | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (0054-0382-25) | Hikma Pharmaceuticals USA Inc. | 0054-0382-25 | 0054-0382 | NDA203856 | NDA | N/A |
| Cyclophosphamide | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (0054-0383-25) | Hikma Pharmaceuticals USA Inc. | 0054-0383-25 | 0054-0383 | NDA203856 | NDA | N/A |
| Chlorthalidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (64980-304-01) | Rising Pharmaceuticals, Inc. | 64980-304-01 | 64980-304 | ANDA206904 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 375mg/1 | 100 Tablet In 1 Bottle (16571-725-01) | Rising Pharma Holdings, Inc. | 16571-725-01 | 16571-725 | ANDA213126 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 375mg/1 | 500 Tablet In 1 Bottle (16571-725-50) | Rising Pharma Holdings, Inc. | 16571-725-50 | 16571-725 | ANDA213126 | ANDA | N/A |
| Cyclosporine | Emulsion | Ophthalmic | .5mg/mL | 30 Vial, Single-Use In 1 Tray (10702-808-03) / .4 Ml In 1 Vial, Single-Use | KVK-TECH, INC. | 10702-808-03 | 10702-808 | NDA050790 | NDA AUTHORIZED GENERIC | N/A |
| Cyclosporine | Emulsion | Ophthalmic | .5mg/mL | 60 Vial, Single-Use In 1 Tray (10702-808-06) / .4 Ml In 1 Vial, Single-Use | KVK-TECH, INC. | 10702-808-06 | 10702-808 | NDA050790 | NDA AUTHORIZED GENERIC | N/A |
| Cyclosporine | Emulsion | Ophthalmic | .5mg/mL | 30 Vial In 1 Tray (60505-6202-1) / .4 Ml In 1 Vial | Apotex Corp | 60505-6202-1 | 60505-6202 | NDA050790 | NDA AUTHORIZED GENERIC | N/A |
| Cyclosporine | Emulsion | Ophthalmic | .5mg/mL | 60 Vial In 1 Tray (60505-6202-2) / .4 Ml In 1 Vial | Apotex Corp | 60505-6202-2 | 60505-6202 | NDA050790 | NDA AUTHORIZED GENERIC | N/A |
| Cyclosporine | Capsule, Gelatin Coated | Oral | 25mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (60505-0133-0) | Apotex Corp. | 60505-0133-0 | 60505-0133 | ANDA065040 | ANDA | N/A |
| Cyclosporine | Capsule, Gelatin Coated | Oral | 100mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (60505-0134-0) | Apotex Corp. | 60505-0134-0 | 60505-0134 | ANDA065040 | ANDA | N/A |
| Cyclosporine | Capsule, Liquid Filled | Oral | 25mg/1 | 30 Blister Pack In 1 Carton (60505-4630-3) / 10 Capsule, Liquid Filled In 1 Blister Pack | Apotex Corp. | 60505-4630-3 | 60505-4630 | ANDA210721 | ANDA | N/A |
| Cyclosporine | Capsule, Liquid Filled | Oral | 50mg/1 | 30 Blister Pack In 1 Carton (60505-4631-3) / 5 Capsule, Liquid Filled In 1 Blister Pack | Apotex Corp. | 60505-4631-3 | 60505-4631 | ANDA210721 | ANDA | N/A |
| Cyclosporine | Capsule, Liquid Filled | Oral | 100mg/1 | 30 Blister Pack In 1 Carton (60505-4632-3) / 6 Capsule, Liquid Filled In 1 Blister Pack | Apotex Corp. | 60505-4632-3 | 60505-4632 | ANDA210721 | ANDA | N/A |
| Cynodon Dactylon Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0537-1) | Jubilant HollisterStier LLC | 65044-0537-1 | 65044-0537 | BLA103872 | BLA | N/A |
| Cynodon Dactylon Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0537-2) | Jubilant HollisterStier LLC | 65044-0537-2 | 65044-0537 | BLA103872 | BLA | N/A |
| Cynodon Dactylon Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0537-3) | Jubilant HollisterStier LLC | 65044-0537-3 | 65044-0537 | BLA103872 | BLA | N/A |
| Cynodon Dactylon Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0537-4) | Jubilant HollisterStier LLC | 65044-0537-4 | 65044-0537 | BLA103872 | BLA | N/A |
| Cyproheptadine | Solution | Oral | 2mg/5mL | 473 Ml In 1 Bottle, Glass (39328-544-16) | Patrin Pharma, Inc. | 39328-544-16 | 39328-544 | ANDA209108 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-272-10) | Golden State Medical Supply | 51407-272-10 | 51407-272 | ANDA205087 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Syrup | Oral | 2mg/5mL | 473 Ml In 1 Bottle, Plastic (27808-099-01) | Tris Pharma Inc | 27808-099-01 | 27808-099 | ANDA205431 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (16571-726-01) | Rising Pharma Holdings, Inc. | 16571-726-01 | 16571-726 | ANDA213126 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (16571-726-50) | Rising Pharma Holdings, Inc. | 16571-726-50 | 16571-726 | ANDA213126 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle (16571-727-01) | Rising Pharma Holdings, Inc. | 16571-727-01 | 16571-727 | ANDA213126 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (16571-727-50) | Rising Pharma Holdings, Inc. | 16571-727-50 | 16571-727 | ANDA213126 | ANDA | N/A |
| Chlorzoxazone | Tablet | Oral | 250mg/1 | 60 Tablet In 1 Bottle (64980-582-06) | Rising Pharma Holdings, Inc. | 64980-582-06 | 64980-582 | ANDA216925 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intravenous; Subcutaneous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-168-50) / 50 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc. | 71288-168-50 | 71288-168 | ANDA206190 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intravenous; Subcutaneous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-169-25) / 25 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc. | 71288-169-25 | 71288-169 | ANDA208485 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 20mg/mL | 5 Vial, Single-Dose In 1 Carton (71288-108-06) / 5 Ml In 1 Vial, Single-Dose (71288-108-05) | Meitheal Pharmaceuticals Inc. | 71288-108-06 | 71288-108 | ANDA206189 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 2g/20mL | 1 Vial, Single-Dose In 1 Carton (71288-109-20) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-109-20 | 71288-109 | ANDA205696 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 100mg/mL | 1 Vial In 1 Carton (25021-223-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-223-20 | 25021-223 | ANDA211938 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 20mg/mL | 5 Vial In 1 Carton (25021-229-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-229-05 | 25021-229 | ANDA211937 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (61703-303-46) / 50 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc. | 61703-303-46 | 61703-303 | ANDA072168 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intravenous; Subcutaneous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-304-36) / 25 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-304-36 | 61703-304 | ANDA072945 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 20mg/mL | 5 Vial, Single-Dose In 1 Carton (61703-305-38) / 5 Ml In 1 Vial, Single-Dose (61703-305-58) | Hospira, Inc. | 61703-305-38 | 61703-305 | ANDA071868 | ANDA | N/A |
| Cytarabine | Injection, Solution | Intrathecal; Intravenous; Subcutaneous | 100mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-319-22) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-319-22 | 61703-319 | ANDA075383 | ANDA | N/A |
| Cytisus Scoparius Flowering Top | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2486-1) | Jubilant HollisterStier LLC | 65044-2486-1 | 65044-2486 | BLA103888 | BLA | N/A |
| Cytisus Scoparius Flowering Top | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2487-2) | Jubilant HollisterStier LLC | 65044-2487-2 | 65044-2487 | BLA103888 | BLA | N/A |
| Cytisus Scoparius Flowering Top | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2487-3) | Jubilant HollisterStier LLC | 65044-2487-3 | 65044-2487 | BLA103888 | BLA | N/A |
| Cytisus Scoparius Flowering Top | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2487-4) | Jubilant HollisterStier LLC | 65044-2487-4 | 65044-2487 | BLA103888 | BLA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/9g | 9 G In 1 Pouch (42806-265-98) | EPIC PHARMA, LLC | 42806-265-98 | 42806-265 | ANDA074557 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/9g | 60 Pouch In 1 Carton (42806-266-95) / 9 G In 1 Pouch (42806-266-98) | EPIC PHARMA, LLC | 42806-266-95 | 42806-266 | ANDA074557 | ANDA | N/A |
| Dabigatran Etexilate Mesylate | Capsule | Oral | 75mg/1 | 10 Blister Pack In 1 Carton (60505-4347-2) / 6 Capsule In 1 Blister Pack | Apotex Corp. | 60505-4347-2 | 60505-4347 | ANDA208070 | ANDA | N/A |
| Dabigatran Etexilate Mesylate | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle (60505-4347-6) | Apotex Corp. | 60505-4347-6 | 60505-4347 | ANDA208070 | ANDA | N/A |
| Dabigatran Etexilate Mesylate | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle (60505-4348-6) | Apotex Corp. | 60505-4348-6 | 60505-4348 | ANDA208070 | ANDA | N/A |
| Dabigatran Etexilate Mesylate | Capsule | Oral | 110mg/1 | 60 Capsule In 1 Bottle (60505-4349-6) | Apotex Corp. | 60505-4349-6 | 60505-4349 | ANDA208070 | ANDA | N/A |
| Dacarbazine | Injection, Powder, For Solution | Intravenous | 200mg/20mL | 10 Vial, Single-Use In 1 Carton (71288-174-21) / 20 Ml In 1 Vial, Single-Use (71288-174-20) | Meitheal Pharmaceuticals Inc. | 71288-174-21 | 71288-174 | ANDA075259 | ANDA | N/A |
| Dacarbazine | Injection, Powder, Lyophilized, For Solution | Intravenous | 10mg/mL | 10 Vial In 1 Carton (0143-9245-10) / 20 Ml In 1 Vial (0143-9245-01) | Hikma Pharmaceuticals USA Inc. | 0143-9245-10 | 0143-9245 | ANDA075812 | ANDA | N/A |
| Dacomitinib | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0069-0197-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0197-30 | 0069-0197 | NDA211288 | NDA | N/A |
| Dacomitinib | Tablet, Film Coated | Oral | 45mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0069-2299-30) | Pfizer Laboratories Div Pfizer Inc | 0069-2299-30 | 0069-2299 | NDA211288 | NDA | N/A |
| Dacomitinib | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0069-1198-30) | Pfizer Laboratories Div Pfizer Inc | 0069-1198-30 | 0069-1198 | NDA211288 | NDA | N/A |
| Dactinomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | .5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-129-02) / 1 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-129-02 | 71288-129 | ANDA213463 | ANDA | N/A |
| Dactinomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | .5mg/mL | 12 Carton In 1 Carton (66993-489-35) / 1 Vial, Single-Dose In 1 Carton (66993-489-83) / 1 Ml In 1 Vial, Single-Dose | Prasco Laboratories | 66993-489-35 | 66993-489 | NDA050682 | NDA AUTHORIZED GENERIC | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0718-1) | Jubilant HollisterStier LLC | 65044-0718-1 | 65044-0718 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0718-2) | Jubilant HollisterStier LLC | 65044-0718-2 | 65044-0718 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0718-3) | Jubilant HollisterStier LLC | 65044-0718-3 | 65044-0718 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0718-4) | Jubilant HollisterStier LLC | 65044-0718-4 | 65044-0718 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0719-1) | Jubilant HollisterStier LLC | 65044-0719-1 | 65044-0719 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0719-2) | Jubilant HollisterStier LLC | 65044-0719-2 | 65044-0719 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0719-3) | Jubilant HollisterStier LLC | 65044-0719-3 | 65044-0719 | BLA103875 | BLA | N/A |
| Dactylis Glomerata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0719-4) | Jubilant HollisterStier LLC | 65044-0719-4 | 65044-0719 | BLA103875 | BLA | N/A |
| Dalfampridine | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-876-60) | Golden State Medical Supply, Inc. | 51407-876-60 | 51407-876 | ANDA206765 | ANDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 2500[iU]/.2mL | 10 Syringe In 1 Carton (0069-0195-02) / .2 Ml In 1 Syringe (0069-0195-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0195-02 | 0069-0195 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 5000[iU]/.2mL | 10 Syringe In 1 Carton (0069-0196-02) / .2 Ml In 1 Syringe (0069-0196-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0196-02 | 0069-0196 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 7500[iU]/.3mL | 10 Syringe In 1 Carton (0069-0206-02) / .3 Ml In 1 Syringe (0069-0206-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0206-02 | 0069-0206 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 10000[iU]/mL | 10 Syringe In 1 Carton (0069-0217-02) / 1 Ml In 1 Syringe (0069-0217-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0217-02 | 0069-0217 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 12500[iU]/.5mL | 10 Syringe In 1 Carton (0069-0220-02) / .5 Ml In 1 Syringe (0069-0220-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0220-02 | 0069-0220 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 15000[iU]/.6mL | 10 Syringe In 1 Carton (0069-0223-02) / .6 Ml In 1 Syringe (0069-0223-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0223-02 | 0069-0223 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 18000[iU]/.72mL | 10 Syringe In 1 Carton (0069-0228-02) / .72 Ml In 1 Syringe (0069-0228-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0228-02 | 0069-0228 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 25000[iU]/mL | 1 Vial, Multi-Dose In 1 Carton (0069-0232-01) / 3.8 Ml In 1 Vial, Multi-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-0232-01 | 0069-0232 | NDA020287 | NDA | N/A |
| Dalteparin Sodium | Injection | Subcutaneous | 2500[iU]/mL | 10 Vial, Single-Dose In 1 Carton (0069-0253-10) / 4 Ml In 1 Vial, Single-Dose (0069-0253-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0253-10 | 0069-0253 | NDA020287 | NDA | N/A |
| Dantrolene Sodium | Injection, Powder, For Solution | Intravenous | 20mg/1 | 1 Injection, Powder, For Solution In 1 Vial (0143-9297-01) | Hikma Pharmaceuticals USA Inc. | 0143-9297-01 | 0143-9297 | ANDA204762 | ANDA | N/A |
| Dapagliflozin Propanediol | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (66993-456-30) | PRASCO, LLC | 66993-456-30 | 66993-456 | NDA202293 | NDA AUTHORIZED GENERIC | N/A |
| Dapagliflozin Propanediol | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (66993-457-30) | PRASCO, LLC | 66993-457-30 | 66993-457 | NDA202293 | NDA AUTHORIZED GENERIC | N/A |
| Dapagliflozin Propanediol; Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 1000 mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (66993-361-60) | PRASCO, LLC | 66993-361-60 | 66993-361 | NDA205649 | NDA AUTHORIZED GENERIC | N/A |
| Dapagliflozin Propanediol; Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1, 1000 mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (66993-362-30) | PRASCO, LLC | 66993-362-30 | 66993-362 | NDA205649 | NDA AUTHORIZED GENERIC | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (29033-036-01) | Nostrum Laboratories, Inc. | 29033-036-01 | 29033-036 | ANDA203887 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (29033-036-30) | Nostrum Laboratories, Inc. | 29033-036-30 | 29033-036 | ANDA203887 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (29033-037-30) | Nostrum Laboratories, Inc. | 29033-037-30 | 29033-037 | ANDA203887 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 2 Blister Pack In 1 Carton (51672-4197-2) / 15 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4197-2 | 51672-4197 | ANDA209430 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (51672-4197-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4197-6 | 51672-4197 | ANDA209430 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 2 Blister Pack In 1 Carton (51672-4198-2) / 15 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4198-2 | 51672-4198 | ANDA209430 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51672-4198-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4198-6 | 51672-4198 | ANDA209430 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1387-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1387-2 | 51672-1387 | ANDA209506 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1387-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1387-3 | 51672-1387 | ANDA209506 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (51672-1387-8) / 90 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1387-8 | 51672-1387 | ANDA209506 | ANDA | N/A |
| Dapsone | Gel | Topical | 75mg/g | 1 Bottle, Pump In 1 Carton (51672-1388-2) / 30 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1388-2 | 51672-1388 | ANDA210191 | ANDA | N/A |
| Dapsone | Gel | Topical | 75mg/g | 1 Bottle, Pump In 1 Carton (51672-1388-3) / 60 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1388-3 | 51672-1388 | ANDA210191 | ANDA | N/A |
| Dapsone | Gel | Topical | 75mg/g | 1 Bottle, Pump In 1 Carton (51672-1388-8) / 90 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1388-8 | 51672-1388 | ANDA210191 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/9g | 378 G In 1 Jar (42806-267-93) | EPIC PHARMA, LLC | 42806-267-93 | 42806-267 | ANDA074557 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/9g | 378 G In 1 Can (42806-267-97) | EPIC PHARMA, LLC | 42806-267-97 | 42806-267 | ANDA074557 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/5.7g | 5.7 G In 1 Pouch (42806-269-98) | EPIC PHARMA, LLC | 42806-269-98 | 42806-269 | ANDA074558 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/5.7g | 60 Pouch In 1 Carton (42806-270-95) / 5.7 G In 1 Pouch (42806-270-98) | EPIC PHARMA, LLC | 42806-270-95 | 42806-270 | ANDA074558 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (0713-0886-18) / 90 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0886-18 | 0713-0886 | ANDA210178 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (0713-0886-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0886-60 | 0713-0886 | ANDA210178 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/5.7g | 239.6 G In 1 Jar (42806-271-93) | EPIC PHARMA, LLC | 42806-271-93 | 42806-271 | ANDA074558 | ANDA | N/A |
| Cholestyramine | Powder, For Suspension | Oral | 4g/5.7g | 239.6 G In 1 Can (42806-271-97) | EPIC PHARMA, LLC | 42806-271-97 | 42806-271 | ANDA074558 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-103-30) | Camber Pharmaceuticals, Inc. | 31722-103-30 | 31722-103 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 30mg/1 | 3 Blister Pack In 1 Carton (31722-103-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-103-31 | 31722-103 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-104-30) | Camber Pharmaceuticals, Inc. | 31722-104-30 | 31722-104 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 60mg/1 | 3 Blister Pack In 1 Carton (31722-104-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-104-31 | 31722-104 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 90mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-105-30) | Camber Pharmaceuticals, Inc. | 31722-105-30 | 31722-105 | ANDA209403 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-016-95) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-016-95 | 71288-016 | ANDA213623 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-016-91) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-016-91 | 71288-016 | ANDA213623 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial, Single-Dose In 1 Carton (71288-017-91) / 7 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-017-91 | 71288-017 | ANDA213786 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial, Single-Dose In 1 Carton (71288-017-15) / 7 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-017-15 | 71288-017 | ANDA213786 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-016-15) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-016-15 | 71288-016 | ANDA213623 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/mL | 1 Vial In 1 Carton (25021-174-15) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-174-15 | 25021-174 | ANDA207104 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/mL | 10 Vial In 1 Carton (25021-174-16) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-174-16 | 25021-174 | ANDA207104 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial In 1 Carton (25021-179-15) / 7 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-179-15 | 25021-179 | NDA208385 | NDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 10 Vial In 1 Carton (25021-179-16) / 7 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-179-16 | 25021-179 | NDA208385 | NDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial In 1 Carton (25021-179-66) / 7 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-179-66 | 25021-179 | NDA208385 | NDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 10 Vial In 1 Carton (25021-179-67) / 7 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-179-67 | 25021-179 | NDA208385 | NDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Use In 1 Carton (60505-6229-4) / 10 Ml In 1 Vial, Single-Use | APOTEX CORP. | 60505-6229-4 | 60505-6229 | ANDA215316 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (0143-9378-01) / 10 Ml In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9378-01 | 0143-9378 | ANDA212022 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial, Single-Dose In 1 Carton (0409-0120-01) / 7 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0120-01 | 0409-0120 | NDA210282 | NDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (0409-0122-01) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0122-01 | 0409-0122 | NDA210282 | NDA | N/A |
| Darifenacin Hydrobromide | Tablet, Extended Release | Oral | 7.5mg/1 | 1000 Tablet, Extended Release In 1 Bottle (52605-067-10) | POLYGEN PHARMACEUTICALS INC. | 52605-067-10 | 52605-067 | ANDA211045 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Extended Release | Oral | 7.5mg/1 | 90 Tablet, Extended Release In 1 Bottle (52605-067-19) | POLYGEN PHARMACEUTICALS INC. | 52605-067-19 | 52605-067 | ANDA211045 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Extended Release | Oral | 15mg/1 | 1000 Tablet, Extended Release In 1 Bottle (52605-068-10) | POLYGEN PHARMACEUTICALS INC. | 52605-068-10 | 52605-068 | ANDA211045 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Extended Release | Oral | 15mg/1 | 30 Tablet, Extended Release In 1 Bottle (52605-068-13) | POLYGEN PHARMACEUTICALS INC. | 52605-068-13 | 52605-068 | ANDA211045 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Extended Release | Oral | 15mg/1 | 90 Tablet, Extended Release In 1 Bottle (52605-068-19) | POLYGEN PHARMACEUTICALS INC. | 52605-068-19 | 52605-068 | ANDA211045 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 90mg/1 | 3 Blister Pack In 1 Carton (31722-105-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-105-31 | 31722-105 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-150-30) | XLCare Pharmaceuticals Inc. | 72865-150-30 | 72865-150 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 30mg/1 | 3 Blister Pack In 1 Carton (72865-150-31) / 10 Tablet, Film Coated In 1 Blister Pack | XLCare Pharmaceuticals Inc. | 72865-150-31 | 72865-150 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-151-30) | XLCare Pharmaceuticals Inc. | 72865-151-30 | 72865-151 | ANDA209403 | ANDA | N/A |
| Dasatinib | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (66993-233-60) / 60 Tablet In 1 Bottle | Prasco Laboratories | 66993-233-60 | 66993-233 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet | Oral | 50mg/1 | 1 Bottle In 1 Carton (66993-234-60) / 60 Tablet In 1 Bottle | Prasco Laboratories | 66993-234-60 | 66993-234 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet | Oral | 70mg/1 | 1 Bottle In 1 Carton (66993-235-60) / 60 Tablet In 1 Bottle | Prasco Laboratories | 66993-235-60 | 66993-235 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet | Oral | 80mg/1 | 1 Bottle In 1 Carton (66993-236-30) / 30 Tablet In 1 Bottle | Prasco Laboratories | 66993-236-30 | 66993-236 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet | Oral | 100mg/1 | 1 Bottle In 1 Carton (66993-237-30) / 30 Tablet In 1 Bottle | Prasco Laboratories | 66993-237-30 | 66993-237 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet | Oral | 140mg/1 | 1 Bottle In 1 Carton (66993-238-30) / 30 Tablet In 1 Bottle | Prasco Laboratories | 66993-238-30 | 66993-238 | NDA021986 | NDA AUTHORIZED GENERIC | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 20mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-3628-6) | Apotex Corp. | 60505-3628-6 | 60505-3628 | ANDA202103 | ANDA | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-3629-6) | Apotex Corp. | 60505-3629-6 | 60505-3629 | ANDA202103 | ANDA | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 70mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-3630-6) | Apotex Corp. | 60505-3630-6 | 60505-3630 | ANDA202103 | ANDA | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3631-3) | Apotex Corp. | 60505-3631-3 | 60505-3631 | ANDA202103 | ANDA | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 80mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3816-3) | Apotex Corp. | 60505-3816-3 | 60505-3816 | ANDA203180 | ANDA | N/A |
| Dasatinib | Tablet, Film Coated | Oral | 140mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3817-3) | Apotex Corp. | 60505-3817-3 | 60505-3817 | ANDA203180 | ANDA | N/A |
| Daunorubicin Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Box (0143-9551-10) / 4 Ml In 1 Vial (0143-9551-01) | Hikma Pharmaceuticals USA Inc. | 0143-9551-10 | 0143-9551 | NDA050731 | NDA | N/A |
| Daunorubicin Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial In 1 Carton (0143-9550-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9550-01 | 0143-9550 | NDA050731 | NDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/20mL | 1 Vial, Single-Dose In 1 Carton (71288-119-20) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-119-20 | 71288-119 | ANDA212959 | ANDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/20mL | 1 Vial In 1 Carton (75834-190-01) / 20 Ml In 1 Vial | Nivagen Pharmaceuticals, Inc. | 75834-190-01 | 75834-190 | ANDA212117 | ANDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/10mL | 1 Vial In 1 Carton (25021-231-20) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-231-20 | 25021-231 | ANDA205539 | ANDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/20mL | 1 Vial In 1 Carton (25021-219-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-219-20 | 25021-219 | ANDA212826 | ANDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/1 | 1 Vial, Single-Dose In 1 Carton (0143-9385-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9385-01 | 0143-9385 | ANDA213472 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 60mg/1 | 3 Blister Pack In 1 Carton (72865-151-31) / 10 Tablet, Film Coated In 1 Blister Pack | XLCare Pharmaceuticals Inc. | 72865-151-31 | 72865-151 | ANDA209403 | ANDA | N/A |
| Deferasirox | Tablet, For Suspension | Oral | 250mg/1 | 30 Tablet, For Suspension In 1 Bottle (69452-160-13) | Bionpharma Inc. | 69452-160-13 | 69452-160 | ANDA210920 | ANDA | N/A |
| Deferasirox | Tablet, For Suspension | Oral | 500mg/1 | 30 Tablet, For Suspension In 1 Bottle (69452-161-13) | Bionpharma Inc. | 69452-161-13 | 69452-161 | ANDA210920 | ANDA | N/A |
| Deferasirox | Tablet, For Suspension | Oral | 125mg/1 | 30 Tablet, For Suspension In 1 Bottle (69452-159-13) | Bionpharma Inc. | 69452-159-13 | 69452-159 | ANDA210920 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 90mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-152-30) | XLCare Pharmaceuticals Inc. | 72865-152-30 | 72865-152 | ANDA209403 | ANDA | N/A |
| Cinacalcet | Tablet, Film Coated | Oral | 90mg/1 | 3 Blister Pack In 1 Carton (72865-152-31) / 10 Tablet, Film Coated In 1 Blister Pack | XLCare Pharmaceuticals Inc. | 72865-152-31 | 72865-152 | ANDA209403 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (65162-155-03) | Amneal Pharmaceuticals LLC | 65162-155-03 | 65162-155 | ANDA204364 | ANDA | N/A |
| Deferiprone | Tablet | Oral | 1000mg/1 | 50 Tablet In 1 Bottle (51672-4237-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4237-4 | 51672-4237 | ANDA208800 | ANDA | N/A |
| Deferiprone | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (51672-4196-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4196-1 | 51672-4196 | ANDA208800 | ANDA | N/A |
| Deferiprone | Tablet, Coated | Oral | 1000mg/1 | 50 Tablet, Coated In 1 Bottle (0054-0711-19) | Hikma Pharmaceuticals USA Inc. | 0054-0711-19 | 0054-0711 | ANDA213239 | ANDA | N/A |
| Deferiprone | Tablet, Coated | Oral | 1000mg/1 | 150 Tablet, Coated In 1 Bottle (0054-0711-23) | Hikma Pharmaceuticals USA Inc. | 0054-0711-23 | 0054-0711 | ANDA213239 | ANDA | N/A |
| Deferiprone | Tablet, Coated | Oral | 1000mg/1 | 300 Tablet, Coated In 1 Bottle (0054-0711-28) | Hikma Pharmaceuticals USA Inc. | 0054-0711-28 | 0054-0711 | ANDA213239 | ANDA | N/A |
| Deferiprone | Tablet, Coated | Oral | 500mg/1 | 100 Tablet, Coated In 1 Bottle (0054-0576-25) | Hikma Pharmaceuticals USA Inc. | 0054-0576-25 | 0054-0576 | ANDA213239 | ANDA | N/A |
| Deferoxamine Mesylate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous; Subcutaneous | 500mg/1 | 4 Injection, Powder, Lyophilized, For Solution In 1 Carton (60505-6236-6) | Apotex Corp. | 60505-6236-6 | 60505-6236 | ANDA207384 | ANDA | N/A |
| Deferoxamine Mesylate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 2g/1 | 4 Injection, Powder, Lyophilized, For Solution In 1 Carton (60505-6237-6) | Apotex Corp. | 60505-6237-6 | 60505-6237 | ANDA207384 | ANDA | N/A |
| Deferoxamine Mesylate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous; Subcutaneous | 500mg/1 | 4 Injection, Powder, Lyophilized, For Solution In 1 Carton (60505-6238-6) | Apotex Corp. | 60505-6238-6 | 60505-6238 | ANDA207384 | ANDA | N/A |
| Deferoxamine Mesylate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous; Subcutaneous | 2g/1 | 1 Vial In 1 Carton (47781-624-07) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Alvogen Inc. | 47781-624-07 | 47781-624 | ANDA207384 | ANDA | N/A |
| Deferoxamine Mesylate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous; Subcutaneous | 2g/1 | 4 Vial, Single-Use In 1 Carton (0409-2337-25) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Use (0409-2337-15) | Hospira, Inc. | 0409-2337-25 | 0409-2337 | ANDA076019 | ANDA | N/A |
| Deflazacort | Suspension | Oral | 22.75mg/mL | 13 Ml In 1 Bottle (27808-249-01) | Tris Pharma Inc | 27808-249-01 | 27808-249 | ANDA217813 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (65162-155-10) | Amneal Pharmaceuticals LLC | 65162-155-10 | 65162-155 | ANDA204364 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 30mg/1 | 250 Tablet In 1 Bottle (65162-155-25) | Amneal Pharmaceuticals LLC | 65162-155-25 | 65162-155 | ANDA204364 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (65162-157-03) | Amneal Pharmaceuticals LLC | 65162-157-03 | 65162-157 | ANDA204364 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (65162-157-10) | Amneal Pharmaceuticals LLC | 65162-157-10 | 65162-157 | ANDA204364 | ANDA | N/A |
| Cinacalcet Hydrochloride | Tablet | Oral | 60mg/1 | 250 Tablet In 1 Bottle (65162-157-25) | Amneal Pharmaceuticals LLC | 65162-157-25 | 65162-157 | ANDA204364 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (16571-411-10) | Rising Pharma Holdings, Inc. | 16571-411-10 | 16571-411 | ANDA076639 | ANDA | N/A |
| Dendryphiella Vinosa | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5124-2) | Jubilant HollisterStier LLC | 65044-5124-2 | 65044-5124 | BLA103888 | BLA | N/A |
| Dendryphiella Vinosa | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5124-3) | Jubilant HollisterStier LLC | 65044-5124-3 | 65044-5124 | BLA103888 | BLA | N/A |
| Dendryphiella Vinosa | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5124-4) | Jubilant HollisterStier LLC | 65044-5124-4 | 65044-5124 | BLA103888 | BLA | N/A |
| Dendryphiella Vinosa | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5125-1) | Jubilant HollisterStier LLC | 65044-5125-1 | 65044-5125 | BLA103888 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Subcutaneous | 10000[AU]/mL | 10 Ml In 1 Vial (65044-6723-2) | Jubilant HollisterStier LLC | 65044-6723-2 | 65044-6723 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Subcutaneous | 10000[AU]/mL | 30 Ml In 1 Vial (65044-6723-3) | Jubilant HollisterStier LLC | 65044-6723-3 | 65044-6723 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Subcutaneous | 10000[AU]/mL | 50 Ml In 1 Vial (65044-6723-4) | Jubilant HollisterStier LLC | 65044-6723-4 | 65044-6723 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 5 Ml In 1 Vial (65044-6720-1) | Jubilant HollisterStier LLC | 65044-6720-1 | 65044-6720 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 10 Ml In 1 Vial (65044-6720-2) | Jubilant HollisterStier LLC | 65044-6720-2 | 65044-6720 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 30 Ml In 1 Vial (65044-6720-3) | Jubilant HollisterStier LLC | 65044-6720-3 | 65044-6720 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae; Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 5000[AU]/mL, 5000 [AU]/mL | 10 Ml In 1 Vial (65044-6691-2) | Jubilant HollisterStier LLC | 65044-6691-2 | 65044-6691 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae; Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 5000[AU]/mL, 5000 [AU]/mL | 30 Ml In 1 Vial (65044-6691-3) | Jubilant HollisterStier LLC | 65044-6691-3 | 65044-6691 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae; Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 5000[AU]/mL, 5000 [AU]/mL | 50 Ml In 1 Vial (65044-6691-4) | Jubilant HollisterStier LLC | 65044-6691-4 | 65044-6691 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae; Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 15000[AU]/mL, 15000 [AU]/mL | 10 Ml In 1 Vial (65044-6690-2) | Jubilant HollisterStier LLC | 65044-6690-2 | 65044-6690 | BLA103870 | BLA | N/A |
| Dermatophagoides Farinae; Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 15000[AU]/mL, 15000 [AU]/mL | 30 Ml In 1 Vial (65044-6690-3) | Jubilant HollisterStier LLC | 65044-6690-3 | 65044-6690 | BLA103870 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 10000[AU]/mL | 10 Ml In 1 Vial (65044-6695-2) | Jubilant HollisterStier LLC | 65044-6695-2 | 65044-6695 | BLA103871 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 10000[AU]/mL | 30 Ml In 1 Vial (65044-6695-3) | Jubilant HollisterStier LLC | 65044-6695-3 | 65044-6695 | BLA103871 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Subcutaneous | 10000[AU]/mL | 50 Ml In 1 Vial (65044-6695-4) | Jubilant HollisterStier LLC | 65044-6695-4 | 65044-6695 | BLA103871 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 5 Ml In 1 Vial (65044-6692-1) | Jubilant HollisterStier LLC | 65044-6692-1 | 65044-6692 | BLA103871 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 10 Ml In 1 Vial (65044-6692-2) | Jubilant HollisterStier LLC | 65044-6692-2 | 65044-6692 | BLA103871 | BLA | N/A |
| Dermatophagoides Pteronyssinus | Injection, Solution | Percutaneous; Subcutaneous | 30000[AU]/mL | 30 Ml In 1 Vial (65044-6692-3) | Jubilant HollisterStier LLC | 65044-6692-3 | 65044-6692 | BLA103871 | BLA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 10mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (30698-007-01) | Validus Pharmaceuticals LLC | 30698-007-01 | 30698-007 | NDA014399 | NDA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 25mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (30698-011-01) | Validus Pharmaceuticals LLC | 30698-011-01 | 30698-011 | NDA014399 | NDA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 50mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (30698-015-01) | Validus Pharmaceuticals LLC | 30698-015-01 | 30698-015 | NDA014399 | NDA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 75mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (30698-019-01) | Validus Pharmaceuticals LLC | 30698-019-01 | 30698-019 | NDA014399 | NDA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 100mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (30698-020-01) | Validus Pharmaceuticals LLC | 30698-020-01 | 30698-020 | NDA014399 | NDA | N/A |
| Desipramine Hydrochloride | Tablet, Sugar Coated | Oral | 150mg/1 | 50 Tablet, Sugar Coated In 1 Bottle (30698-021-50) | Validus Pharmaceuticals LLC | 30698-021-50 | 30698-021 | NDA014399 | NDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (16571-412-10) | Rising Pharma Holdings, Inc. | 16571-412-10 | 16571-412 | ANDA076639 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (16571-412-50) | Rising Pharma Holdings, Inc. | 16571-412-50 | 16571-412 | ANDA076639 | ANDA | N/A |
| Ciprofloxacin Hydrochloride | Tablet | Oral | 750mg/1 | 50 Tablet In 1 Bottle (16571-413-05) | Rising Pharma Holdings, Inc. | 16571-413-05 | 16571-413 | ANDA076639 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (65162-052-03) | Amneal Pharmaceuticals LLC | 65162-052-03 | 65162-052 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (65162-052-10) | Amneal Pharmaceuticals LLC | 65162-052-10 | 65162-052 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-052-11) | Amneal Pharmaceuticals LLC | 65162-052-11 | 65162-052 | ANDA077289 | ANDA | N/A |
| Desloratadine | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (62250-619-01) | Belcher Pharmaceuticals,LLC | 62250-619-01 | 62250-619 | ANDA078355 | ANDA | N/A |
| Desloratadine | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (62250-619-02) | Belcher Pharmaceuticals,LLC | 62250-619-02 | 62250-619 | ANDA078355 | ANDA | N/A |
| Desloratadine | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (62250-619-08) | Belcher Pharmaceuticals,LLC | 62250-619-08 | 62250-619 | ANDA078355 | ANDA | N/A |
| Desloratadine | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-363-20) | Bionpharma Inc. | 69452-363-20 | 69452-363 | ANDA078357 | ANDA | N/A |
| Desloratadine | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (69452-363-30) | Bionpharma Inc. | 69452-363-30 | 69452-363 | ANDA078357 | ANDA | N/A |
| Desmopressin Acetate | Injection | Intravenous; Subcutaneous | 4ug/mL | 10 Vial In 1 Carton (71288-440-02) / 1 Ml In 1 Vial (71288-440-01) | Meitheal Pharmaceuticals Inc. | 71288-440-02 | 71288-440 | ANDA074888 | ANDA | N/A |
| Desmopressin Acetate | Injection | Intravenous; Subcutaneous | 4ug/mL | 1 Vial In 1 Carton (71288-441-10) / 10 Ml In 1 Vial | Meitheal Pharmaceuticals Inc. | 71288-441-10 | 71288-441 | ANDA074888 | ANDA | N/A |
| Desmopressin Acetate | Injection, Solution | Intravenous; Subcutaneous | 4ug/mL | 10 Vial In 1 Carton (25021-460-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-460-01 | 25021-460 | ANDA204695 | ANDA | N/A |
| Desmopressin Acetate | Injection, Solution | Intravenous; Subcutaneous | 40ug/10mL | 1 Vial In 1 Carton (25021-461-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-461-10 | 25021-461 | ANDA204751 | ANDA | N/A |
| Desmopressin Acetate | Tablet | Oral | .1mg/1 | 100 Tablet In 1 Bottle (10702-169-01) | KVK-TECH, INC. | 10702-169-01 | 10702-169 | ANDA210371 | ANDA | N/A |
| Desmopressin Acetate | Tablet | Oral | .2mg/1 | 100 Tablet In 1 Bottle (10702-170-01) | KVK-TECH, INC. | 10702-170-01 | 10702-170 | ANDA210371 | ANDA | N/A |
| Desmopressin Acetate | Tablet | Oral | .1mg/1 | 100 Tablet In 1 Bottle (60505-0257-1) | Apotex Corp. | 60505-0257-1 | 60505-0257 | ANDA077414 | ANDA | N/A |
| Desmopressin Acetate | Tablet | Oral | .2mg/1 | 100 Tablet In 1 Bottle (60505-0258-1) | Apotex Corp. | 60505-0258-1 | 60505-0258 | ANDA077414 | ANDA | N/A |
| Desmopressin Acetate | Spray | Nasal | 10ug/1 | 1 Bottle, Spray In 1 Carton (60505-0815-0) / 50 Spray In 1 Bottle, Spray | Apotex Corp. | 60505-0815-0 | 60505-0815 | ANDA076703 | ANDA | N/A |
| Desonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-423-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-423-35 | 45802-423 | NDA017426 | NDA | N/A |
| Desonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-423-37) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-423-37 | 45802-423 | NDA017426 | NDA | N/A |
| Desonide | Lotion | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-4079-4) / 59 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4079-4 | 51672-4079 | ANDA202161 | ANDA | N/A |
| Desonide | Lotion | Topical | .5mg/mL | 1 Bottle In 1 Carton (51672-4079-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4079-8 | 51672-4079 | ANDA202161 | ANDA | N/A |
| Desonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1280-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1280-1 | 51672-1280 | ANDA073548 | ANDA | N/A |
| Desonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1280-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1280-3 | 51672-1280 | ANDA073548 | ANDA | N/A |
| Desonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1281-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1281-1 | 51672-1281 | ANDA074254 | ANDA | N/A |
| Desonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1281-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1281-3 | 51672-1281 | ANDA074254 | ANDA | N/A |
| Desonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0661-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0661-15 | 0713-0661 | ANDA074027 | ANDA | N/A |
| Desonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0661-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0661-60 | 0713-0661 | ANDA074027 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (45802-495-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-495-35 | 45802-495 | ANDA076510 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (45802-495-37) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-495-37 | 45802-495 | ANDA076510 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (45802-496-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-496-14 | 45802-496 | ANDA077770 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (45802-496-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-496-96 | 45802-496 | ANDA077770 | ANDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle, Spray In 1 Carton (45802-807-98) / 100 Ml In 1 Bottle, Spray | Padagis Israel Pharmaceuticals Ltd | 45802-807-98 | 45802-807 | ANDA206441 | ANDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle, Spray In 1 Carton (51672-1396-3) / 30 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-1396-3 | 51672-1396 | NDA204141 | NDA AUTHORIZED GENERIC | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle, Spray In 1 Carton (51672-1396-4) / 50 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-1396-4 | 51672-1396 | NDA204141 | NDA AUTHORIZED GENERIC | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 2 Bottle, Spray In 1 Carton (51672-1396-6) / 50 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-1396-6 | 51672-1396 | NDA204141 | NDA AUTHORIZED GENERIC | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle, Spray In 1 Carton (51672-1396-7) / 100 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-1396-7 | 51672-1396 | NDA204141 | NDA AUTHORIZED GENERIC | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1261-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1261-1 | 51672-1261 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1261-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1261-2 | 51672-1261 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1261-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1261-3 | 51672-1261 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1262-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1262-1 | 51672-1262 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1262-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1262-2 | 51672-1262 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1262-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1262-3 | 51672-1262 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1262-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1262-7 | 51672-1262 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1270-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1270-1 | 51672-1270 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1270-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1270-2 | 51672-1270 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1270-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1270-3 | 51672-1270 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-1270-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1270-7 | 51672-1270 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1271-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1271-1 | 51672-1271 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1271-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1271-2 | 51672-1271 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1271-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1271-3 | 51672-1271 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1271-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1271-7 | 51672-1271 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1352-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1352-1 | 51672-1352 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1352-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1352-2 | 51672-1352 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1352-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1352-3 | 51672-1352 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1352-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1352-7 | 51672-1352 | NDA018594 | NDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5202-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5202-1 | 51672-5202 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5202-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5202-2 | 51672-5202 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5202-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5202-3 | 51672-5202 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Gel | Topical | .5mg/g | 5 G In 1 Tube (51672-5202-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5202-5 | 51672-5202 | ANDA074904 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5203-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5203-1 | 51672-5203 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5203-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5203-3 | 51672-5203 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 5 G In 1 Tube (51672-5203-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5203-5 | 51672-5203 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5203-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5203-7 | 51672-5203 | ANDA074286 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5204-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5204-1 | 51672-5204 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5204-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5204-3 | 51672-5204 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 5 G In 1 Tube (51672-5204-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5204-5 | 51672-5204 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | 2.5mg/g | 1 Tube In 1 Carton (51672-5204-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5204-7 | 51672-5204 | ANDA073193 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5205-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5205-1 | 51672-5205 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5205-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5205-3 | 51672-5205 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 5 G In 1 Tube (51672-5205-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5205-5 | 51672-5205 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5205-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5205-7 | 51672-5205 | ANDA073210 | ANDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5263-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5263-1 | 51672-5263 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5263-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5263-2 | 51672-5263 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5263-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5263-3 | 51672-5263 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 10 Tube In 1 Carton (51672-5263-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5263-5 | 51672-5263 | NDA018594 | NDA | N/A |
| Desoximetasone | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5263-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5263-7 | 51672-5263 | NDA018594 | NDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle In 1 Carton (51672-5281-0) / 6 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5281-0 | 51672-5281 | NDA204141 | NDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle In 1 Carton (51672-5281-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5281-3 | 51672-5281 | NDA204141 | NDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle In 1 Carton (51672-5281-4) / 50 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5281-4 | 51672-5281 | NDA204141 | NDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 2 Bottle In 1 Carton (51672-5281-6) / 50 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5281-6 | 51672-5281 | NDA204141 | NDA | N/A |
| Desoximetasone | Spray | Topical | 2.5mg/mL | 1 Bottle In 1 Carton (51672-5281-7) / 100 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5281-7 | 51672-5281 | NDA204141 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0054-0400-13) | Hikma Pharmaceuticals USA Inc. | 0054-0400-13 | 0054-0400 | ANDA204082 | ANDA | N/A |
| Desvenlafaxine Succinate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (0054-0400-22) | Hikma Pharmaceuticals USA Inc. | 0054-0400-22 | 0054-0400 | ANDA204082 | ANDA | N/A |
| Desvenlafaxine Succinate | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0054-0401-13) | Hikma Pharmaceuticals USA Inc. | 0054-0401-13 | 0054-0401 | ANDA204083 | ANDA | N/A |
| Desvenlafaxine Succinate | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (0054-0401-22) | Hikma Pharmaceuticals USA Inc. | 0054-0401-22 | 0054-0401 | ANDA204083 | ANDA | N/A |
| Desvenlafaxine Succinate | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0054-0603-13) | Hikma Pharmaceuticals USA Inc. | 0054-0603-13 | 0054-0603 | ANDA204082 | ANDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 25mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (0008-1210-30) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1210-30 | 0008-1210 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 50mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (0008-1211-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211-01 | 0008-1211 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 50mg/1 | 14 Tablet, Extended Release In 1 Bottle, Plastic (0008-1211-14) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211-14 | 0008-1211 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 50mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (0008-1211-30) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211-30 | 0008-1211 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 50mg/1 | 100 Blister Pack In 1 Carton (0008-1211-50) / 1 Tablet, Extended Release In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211-50 | 0008-1211 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 100mg/1 | 90 Tablet, Extended Release In 1 Bottle, Plastic (0008-1222-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1222-01 | 0008-1222 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 100mg/1 | 14 Tablet, Extended Release In 1 Bottle, Plastic (0008-1222-14) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1222-14 | 0008-1222 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 100mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (0008-1222-30) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1222-30 | 0008-1222 | NDA021992 | NDA | N/A |
| Desvenlafaxine Succinate | Tablet, Extended Release | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (0008-1222-50) / 1 Tablet, Extended Release In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1222-50 | 0008-1222 | NDA021992 | NDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (66993-730-02) | Prasco Laboratories | 66993-730-02 | 66993-730 | ANDA080399 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 10 Blister Pack In 1 Carton (66993-730-80) / 10 Tablet In 1 Blister Pack (66993-730-51) | Prasco Laboratories | 66993-730-80 | 66993-730 | ANDA080399 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-361-01) | Golden State Medical Supply, Inc. | 51407-361-01 | 51407-361 | ANDA084612 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-052-50) | Amneal Pharmaceuticals LLC | 65162-052-50 | 65162-052 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (65162-053-03) | Amneal Pharmaceuticals LLC | 65162-053-03 | 65162-053 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (65162-053-10) | Amneal Pharmaceuticals LLC | 65162-053-10 | 65162-053 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (65162-053-11) | Amneal Pharmaceuticals LLC | 65162-053-11 | 65162-053 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (65162-053-50) | Amneal Pharmaceuticals LLC | 65162-053-50 | 65162-053 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (65162-054-03) | Amneal Pharmaceuticals LLC | 65162-054-03 | 65162-054 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (65162-054-10) | Amneal Pharmaceuticals LLC | 65162-054-10 | 65162-054 | ANDA077289 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .75mg/1 | 100 Tablet In 1 Bottle (60505-6250-1) | Apotex Corp. | 60505-6250-1 | 60505-6250 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (60505-6251-1) | Apotex Corp. | 60505-6251-1 | 60505-6251 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1.5mg/1 | 100 Tablet In 1 Bottle (60505-6252-1) | Apotex Corp. | 60505-6252-1 | 60505-6252 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (60505-6253-1) | Apotex Corp. | 60505-6253-1 | 60505-6253 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (60505-6254-1) | Apotex Corp. | 60505-6254-1 | 60505-6254 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (60505-6255-1) | Apotex Corp. | 60505-6255-1 | 60505-6255 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (60505-6249-1) | Apotex Corp. | 60505-6249-1 | 60505-6249 | ANDA217695 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (69452-276-20) | Bionpharma Inc., | 69452-276-20 | 69452-276 | ANDA217538 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (69452-277-20) | Bionpharma Inc., | 69452-277-20 | 69452-277 | ANDA217001 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (69452-278-20) | Bionpharma Inc., | 69452-278-20 | 69452-278 | ANDA217001 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (47781-914-01) | Alvogen Inc. | 47781-914-01 | 47781-914 | ANDA088481 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 10 Blister Pack In 1 Carton (47781-914-51) / 10 Tablet In 1 Blister Pack (47781-914-13) | Alvogen Inc. | 47781-914-51 | 47781-914 | ANDA088481 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (47781-916-01) | Alvogen Inc. | 47781-916-01 | 47781-916 | ANDA088481 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (65162-054-11) | Amneal Pharmaceuticals LLC | 65162-054-11 | 65162-054 | ANDA077289 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1.5mg/1 | 10 Blister Pack In 1 Carton (0054-8181-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8181-25 | 0054-8181 | ANDA084610 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 10 Blister Pack In 1 Carton (0054-8183-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8183-25 | 0054-8183 | ANDA088316 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4179-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4179-25 | 0054-4179 | ANDA084611 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .75mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4180-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4180-25 | 0054-4180 | ANDA084613 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4181-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4181-25 | 0054-4181 | ANDA088306 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1.5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4182-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4182-25 | 0054-4182 | ANDA084610 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4183-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4183-25 | 0054-4183 | ANDA087916 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4184-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4184-25 | 0054-4184 | ANDA084612 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4186-25) | Hikma Pharmaceuticals USA, Inc. | 0054-4186-25 | 0054-4186 | ANDA088316 | ANDA | N/A |
| Dexamethasone | Solution | Oral | .5mg/5mL | 240 Ml In 1 Bottle, Plastic (0054-3177-57) | Hikma Pharmaceuticals USA, Inc. | 0054-3177-57 | 0054-3177 | ANDA088248 | ANDA | N/A |
| Dexamethasone | Solution | Oral | .5mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3177-63) | Hikma Pharmaceuticals USA, Inc. | 0054-3177-63 | 0054-3177 | ANDA088248 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1mg/1 | 10 Blister Pack In 1 Can (0054-8174-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8174-25 | 0054-8174 | ANDA088306 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 10 Blister Pack In 1 Carton (0054-8175-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8175-25 | 0054-8175 | ANDA084612 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 2mg/1 | 10 Blister Pack In 1 Carton (0054-8176-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8176-25 | 0054-8176 | ANDA087916 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .5mg/1 | 10 Blister Pack In 1 Carton (0054-8179-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8179-25 | 0054-8179 | ANDA084611 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .75mg/1 | 10 Blister Pack In 1 Carton (0054-8180-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA, Inc. | 0054-8180-25 | 0054-8180 | ANDA084613 | ANDA | N/A |
| Dexamethasone | Solution, Concentrate | Oral | 1mg/mL | 30 Ml In 1 Bottle, Glass (0054-3176-44) | Hikma Pharmaceuticals USA, Inc. | 0054-3176-44 | 0054-3176 | ANDA088252 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (70069-021-25) / 1 Ml In 1 Vial (70069-021-01) | Somerset Therapeutics, LLC | 70069-021-25 | 70069-021 | ANDA207442 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial, Single-Dose In 1 Carton (70069-022-25) / 1 Ml In 1 Vial, Single-Dose (70069-022-01) | Somerset Therapeutics, LLC | 70069-022-25 | 70069-022 | ANDA207521 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial, Multi-Dose In 1 Carton (70069-023-25) / 5 Ml In 1 Vial, Multi-Dose (70069-023-01) | Somerset Therapeutics, LLC | 70069-023-25 | 70069-023 | ANDA207521 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial, Multi-Dose In 1 Carton (70069-024-25) / 30 Ml In 1 Vial, Multi-Dose (70069-024-01) | Somerset Therapeutics, LLC | 70069-024-25 | 70069-024 | ANDA207521 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 10 Vial In 1 Carton (70069-025-10) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-025-10 | 70069-025 | ANDA211036 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (65162-054-50) | Amneal Pharmaceuticals LLC | 65162-054-50 | 65162-054 | ANDA077289 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-019-01) | Epic Pharma, LLC | 42806-019-01 | 42806-019 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-019-10) | Epic Pharma, LLC | 42806-019-10 | 42806-019 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-019-30) | Epic Pharma, LLC | 42806-019-30 | 42806-019 | ANDA077045 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (0641-0367-25) / 1 Ml In 1 Vial (0641-0367-21) | Hikma Pharmaceuticals USA Inc. | 0641-0367-25 | 0641-0367 | ANDA087702 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial In 1 Carton (0641-6145-25) / 1 Ml In 1 Vial (0641-6145-01) | Hikma Pharmaceuticals USA Inc. | 0641-6145-25 | 0641-6145 | ANDA084282 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 10 Vial In 1 Carton (0641-6146-10) / 5 Ml In 1 Vial (0641-6146-01) | Hikma Pharmaceuticals USA Inc. | 0641-6146-10 | 0641-6146 | ANDA084282 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial In 1 Carton (0641-6146-25) / 5 Ml In 1 Vial (0641-6146-01) | Hikma Pharmaceuticals USA Inc. | 0641-6146-25 | 0641-6146 | ANDA084282 | ANDA | N/A |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | Ointment | Ophthalmic | 1mg/g, 3.5 mg/g, 10000 [USP'U]/g | 1 Tube In 1 Carton (0574-4160-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4160-35 | 0574-4160 | ANDA062938 | ANDA | N/A |
| Dexamethasone; Tobramycin | Suspension/ Drops | Ophthalmic | 1mg/mL, 3 mg/mL | 5 Ml In 1 Bottle, Plastic (0574-4031-05) | Padagis US LLC | 0574-4031-05 | 0574-4031 | ANDA212715 | ANDA | N/A |
| Dexamethasone; Tobramycin | Suspension/ Drops | Ophthalmic | 1mg/mL, 3 mg/mL | 10 Ml In 1 Bottle, Plastic (0574-4031-10) | Padagis US LLC | 0574-4031-10 | 0574-4031 | ANDA212715 | ANDA | N/A |
| Dexamethasone; Tobramycin | Suspension/ Drops | Ophthalmic | 1mg/mL, 3 mg/mL | 2.5 Ml In 1 Bottle, Plastic (0574-4031-25) | Padagis US LLC | 0574-4031-25 | 0574-4031 | ANDA212715 | ANDA | N/A |
| Dexbrompheniramine Maleate; Pseudoephedrine Sulfate | Tablet, Extended Release | Oral | 6mg/1, 120 mg/1 | 30 Tablet, Extended Release In 1 Bottle (10702-005-03) | KVK-TECH, INC. | 10702-005-03 | 10702-005 | ANDA078648 | ANDA | N/A |
| Dexbrompheniramine Maleate; Pseudoephedrine Sulfate | Tablet, Extended Release | Oral | 6mg/1, 120 mg/1 | 2 Blister Pack In 1 Carton (10702-005-21) / 10 Tablet, Extended Release In 1 Blister Pack | KVK-TECH, INC. | 10702-005-21 | 10702-005 | ANDA078648 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 100ug/mL | 25 Vial, Single-Dose In 1 Carton (71288-505-03) / 2 Ml In 1 Vial, Single-Dose (71288-505-02) | Meitheal Pharmaceuticals Inc. | 71288-505-03 | 71288-505 | ANDA204843 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle In 1 Carton (25021-615-50) / 50 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-615-50 | 25021-615 | ANDA217308 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle In 1 Carton (25021-615-51) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-615-51 | 25021-615 | ANDA217308 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-020-01) | Epic Pharma, LLC | 42806-020-01 | 42806-020 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-020-10) | Epic Pharma, LLC | 42806-020-10 | 42806-020 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-020-30) | Epic Pharma, LLC | 42806-020-30 | 42806-020 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-021-01) | Epic Pharma, LLC | 42806-021-01 | 42806-021 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-021-10) | Epic Pharma, LLC | 42806-021-10 | 42806-021 | ANDA077045 | ANDA | N/A |
| Citalopram Hydrobromide | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-021-30) | Epic Pharma, LLC | 42806-021-30 | 42806-021 | ANDA077045 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection | Intravenous | 100ug/mL | 25 Vial In 1 Carton (0143-9532-25) / 2 Ml In 1 Vial (0143-9532-01) | Hikma Pharmaceuticals USA Inc. | 0143-9532-25 | 0143-9532 | ANDA205046 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Pouch In 1 Bag (0143-9525-10) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9525-10 | 0143-9525 | ANDA206407 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Pouch In 1 Case (0143-9526-10) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9526-10 | 0143-9526 | ANDA206407 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Carton In 1 Case (0409-1596-10) / 1 Bottle In 1 Carton (0409-1596-01) / 100 Ml In 1 Bottle | Hospira, Inc. | 0409-1596-10 | 0409-1596 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 1 Bottle In 1 Carton (0409-2815-01) / 250 Ml In 1 Bottle | Hospira, Inc. | 0409-2815-01 | 0409-2815 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 100ug/mL | 25 Vial In 1 Tray (0409-1638-02) / 2 Ml In 1 Vial (0409-1638-32) | Hospira, Inc. | 0409-1638-02 | 0409-1638 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle In 1 Tray (0409-1660-10) / 100 Ml In 1 Bottle (0409-1660-35) | Hospira, Inc. | 0409-1660-10 | 0409-1660 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Vial In 1 Carton (0409-1660-20) / 20 Ml In 1 Vial (0409-1660-22) | Hospira, Inc. | 0409-1660-20 | 0409-1660 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 20 Bottle In 1 Tray (0409-1660-50) / 50 Ml In 1 Bottle (0409-1660-55) | Hospira, Inc. | 0409-1660-50 | 0409-1660 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle In 1 Tray (0409-0155-02) / 100 Ml In 1 Bottle (0409-0155-01) | Hospira, Inc. | 0409-0155-02 | 0409-0155 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 20 Bottle In 1 Tray (0409-4596-20) / 50 Ml In 1 Bottle (0409-4596-01) | Hospira, Inc. | 0409-4596-20 | 0409-4596 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 1 Bottle In 1 Carton (0409-1434-01) / 250 Ml In 1 Bottle | Hospira, Inc. | 0409-1434-01 | 0409-1434 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 20 Bottle In 1 Tray (0409-1454-20) / 50 Ml In 1 Bottle (0409-1454-01) | Hospira, Inc. | 0409-1454-20 | 0409-1454 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Vial In 1 Carton (0409-3301-10) / 20 Ml In 1 Vial (0409-3301-01) | Hospira, Inc. | 0409-3301-10 | 0409-3301 | NDA021038 | NDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle In 1 Tray (0409-1174-10) / 100 Ml In 1 Bottle (0409-1174-01) | Hospira, Inc. | 0409-1174-10 | 0409-1174 | NDA021038 | NDA | N/A |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (75834-327-01) | Nivagen Pharmaceuticals, Inc. | 75834-327-01 | 75834-327 | ANDA209211 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (75834-328-01) | Nivagen Pharmaceuticals, Inc. | 75834-328-01 | 75834-328 | ANDA209211 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-091-01) | Tris Pharma Inc | 27808-091-01 | 27808-091 | ANDA207901 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (27808-092-01) | Tris Pharma Inc | 27808-092-01 | 27808-092 | ANDA207901 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (27808-093-01) | Tris Pharma Inc | 27808-093-01 | 27808-093 | ANDA207901 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (10702-106-01) | KVK-TECH, INC | 10702-106-01 | 10702-106 | ANDA206931 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (10702-107-01) | KVK-TECH, INC | 10702-107-01 | 10702-107 | ANDA206931 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-108-01) | KVK-TECH, INC | 10702-108-01 | 10702-108 | ANDA206931 | ANDA | CII |
| Clarithromycin | Tablet, Film Coated | Oral | 250mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-044-60) | Rising Pharma Holdings, Inc. | 57237-044-60 | 57237-044 | ANDA065489 | ANDA | N/A |
| Clarithromycin | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-045-60) | Rising Pharma Holdings, Inc. | 57237-045-60 | 57237-045 | ANDA065489 | ANDA | N/A |
| Clindamycin Palmitate Hydrochloride | Powder, For Solution | Oral | 75mg/5mL | 1 Bottle In 1 Carton (65162-468-19) / 100 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-468-19 | 65162-468 | ANDA203513 | ANDA | N/A |
| Clindamycin Palmitate Hydrochloride | Granule, For Solution | Oral | 75mg/5mL | 100 Ml In 1 Bottle (64980-511-10) | Rising Pharma Holdings, Inc. | 64980-511-10 | 64980-511 | ANDA201821 | ANDA | N/A |
| Clobazam | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-639-01) | Camber Pharmaceuticals, Inc. | 31722-639-01 | 31722-639 | ANDA209795 | ANDA | CIV |
| Clobazam | Tablet | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (31722-639-31) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-639-31 | 31722-639 | ANDA209795 | ANDA | CIV |
| Clobazam | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-640-01) | Camber Pharmaceuticals, Inc. | 31722-640-01 | 31722-640 | ANDA209795 | ANDA | CIV |
| Clobazam | Tablet | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (31722-640-31) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-640-31 | 31722-640 | ANDA209795 | ANDA | CIV |
| Clobazam | Suspension | Oral | 2.5mg/mL | 1 Bottle, Glass In 1 Carton (31722-641-12) / 120 Ml In 1 Bottle, Glass | Camber Pharmaceuticals, Inc. | 31722-641-12 | 31722-641 | ANDA209796 | ANDA | CIV |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (64980-441-03) / 30 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-441-03 | 64980-441 | ANDA211401 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (64980-441-15) / 15 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-441-15 | 64980-441 | ANDA211401 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (64980-441-45) / 45 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-441-45 | 64980-441 | ANDA211401 | ANDA | N/A |
| Clobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (64980-441-60) / 60 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-441-60 | 64980-441 | ANDA211401 | ANDA | N/A |
| Clofarabine | Injection | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Box (70121-1236-1) / 20 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1236-1 | 70121-1236 | ANDA208857 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (16571-683-01) | Rising Pharma Holdings, Inc. | 16571-683-01 | 16571-683 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (16571-683-03) | Rising Pharma Holdings, Inc. | 16571-683-03 | 16571-683 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (16571-683-09) | Rising Pharma Holdings, Inc. | 16571-683-09 | 16571-683 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (16571-684-01) | Rising Pharma Holdings, Inc. | 16571-684-01 | 16571-684 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (16571-684-03) | Rising Pharma Holdings, Inc. | 16571-684-03 | 16571-684 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (16571-684-09) | Rising Pharma Holdings, Inc. | 16571-684-09 | 16571-684 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (16571-685-01) | Rising Pharma Holdings, Inc. | 16571-685-01 | 16571-685 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (16571-685-03) | Rising Pharma Holdings, Inc. | 16571-685-03 | 16571-685 | ANDA212285 | ANDA | N/A |
| Clomipramine Hydrochloride | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (16571-685-09) | Rising Pharma Holdings, Inc. | 16571-685-09 | 16571-685 | ANDA212285 | ANDA | N/A |
| Clonidine Hydrochloride | Tablet, Extended Release | Oral | .1mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-247-05) | Ingenus Pharmaceuticals, LLC | 50742-247-05 | 50742-247 | ANDA209675 | ANDA | N/A |
| Clonidine Hydrochloride | Tablet, Extended Release | Oral | .1mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-247-30) | Ingenus Pharmaceuticals, LLC | 50742-247-30 | 50742-247 | ANDA209675 | ANDA | N/A |
| Clonidine Hydrochloride | Tablet, Extended Release | Oral | .1mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-247-60) | Ingenus Pharmaceuticals, LLC | 50742-247-60 | 50742-247 | ANDA209675 | ANDA | N/A |
| CLOPIDOGREL | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (31722-758-05) | Camber Pharmaceuticals, Inc. | 31722-758-05 | 31722-758 | ANDA205345 | ANDA | N/A |
| CLOPIDOGREL | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (31722-758-30) | Camber Pharmaceuticals, Inc. | 31722-758-30 | 31722-758 | ANDA205345 | ANDA | N/A |
| CLOPIDOGREL | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (31722-758-90) | Camber Pharmaceuticals, Inc. | 31722-758-90 | 31722-758 | ANDA205345 | ANDA | N/A |
| CLOPIDOGREL | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (31722-759-05) | Camber Pharmaceuticals, Inc. | 31722-759-05 | 31722-759 | ANDA205345 | ANDA | N/A |
| CLOPIDOGREL | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (31722-759-30) | Camber Pharmaceuticals, Inc. | 31722-759-30 | 31722-759 | ANDA205345 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (65162-414-03) | Amneal Pharmaceuticals LLC | 65162-414-03 | 65162-414 | ANDA203751 | ANDA | N/A |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | Capsule | Oral | 10.4mg/1, 52.3 mg/1 | 100 Capsule In 1 Bottle, Plastic (65038-561-99) | Corium, LLC. | 65038-561-99 | 65038-561 | NDA212994 | NDA | CII |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | Capsule | Oral | 5.2mg/1, 26.1 mg/1 | 100 Capsule In 1 Bottle, Plastic (65038-286-99) | Corium, LLC. | 65038-286-99 | 65038-286 | NDA212994 | NDA | CII |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | Capsule | Oral | 7.8mg/1, 39.2 mg/1 | 100 Capsule In 1 Bottle, Plastic (65038-429-99) | Corium, LLC. | 65038-429-99 | 65038-429 | NDA212994 | NDA | CII |
| Dexrazoxane Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 10mg/mL | 1 Vial In 1 Box (0143-9247-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9247-01 | 0143-9247 | ANDA076068 | ANDA | N/A |
| Dexrazoxane Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 10mg/mL | 1 Vial In 1 Box (0143-9248-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9248-01 | 0143-9248 | ANDA076068 | ANDA | N/A |
| Dextran 40 | Injection, Solution | Intravenous | 10g/100mL | 12 Pouch In 1 Case (0409-7418-03) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-7418-13) | Hospira, Inc. | 0409-7418-03 | 0409-7418 | BA720563 | ANDA | N/A |
| Dextran 40 | Injection, Solution | Intravenous | 10g/100mL | 12 Pouch In 1 Case (0409-7419-03) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-7419-14) | Hospira, Inc. | 0409-7419-03 | 0409-7419 | BA720562 | ANDA | N/A |
| Dextroamphetamine Sulfate | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle, Plastic (66993-359-57) | Prasco Laboratories | 66993-359-57 | 66993-359 | ANDA040776 | ANDA | CII |
| Dextroamphetamine Sulfate | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle, Plastic (27808-085-01) | Tris Pharma Inc | 27808-085-01 | 27808-085 | ANDA203644 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-089-01) | Tris Pharma Inc | 27808-089-01 | 27808-089 | ANDA206095 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (27808-090-01) | Tris Pharma Inc | 27808-090-01 | 27808-090 | ANDA206095 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (52536-520-03) | Wilshire Pharmaceuticals, Inc. | 52536-520-03 | 52536-520 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (52536-530-03) | Wilshire Pharmaceuticals, Inc. | 52536-530-03 | 52536-530 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (52536-500-01) | Wilshire Pharmaceuticals, Inc. | 52536-500-01 | 52536-500 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (52536-500-03) | Wilshire Pharmaceuticals, Inc. | 52536-500-03 | 52536-500 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (52536-510-01) | Wilshire Pharmaceuticals, Inc. | 52536-510-01 | 52536-510 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (52536-510-03) | Wilshire Pharmaceuticals, Inc. | 52536-510-03 | 52536-510 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (52536-515-03) | Wilshire Pharmaceuticals, Inc. | 52536-515-03 | 52536-515 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (10702-065-01) | KVK-Tech, Inc. | 10702-065-01 | 10702-065 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (10702-065-03) | KVK-Tech, Inc. | 10702-065-03 | 10702-065 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 60 Tablet In 1 Bottle (10702-065-06) | KVK-Tech, Inc. | 10702-065-06 | 10702-065 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-066-01) | KVK-Tech, Inc. | 10702-066-01 | 10702-066 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (10702-066-03) | KVK-Tech, Inc. | 10702-066-03 | 10702-066 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 60 Tablet In 1 Bottle (10702-066-06) | KVK-Tech, Inc. | 10702-066-06 | 10702-066 | ANDA203548 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (24338-850-03) | AZURITY PHARMACEUTICALS, INC. | 24338-850-03 | 24338-850 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (24338-851-03) | AZURITY PHARMACEUTICALS, INC. | 24338-851-03 | 24338-851 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (24338-852-03) | AZURITY PHARMACEUTICALS, INC. | 24338-852-03 | 24338-852 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (24338-853-03) | AZURITY PHARMACEUTICALS, INC. | 24338-853-03 | 24338-853 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (24338-854-03) | AZURITY PHARMACEUTICALS, INC. | 24338-854-03 | 24338-854 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (24338-855-03) | AZURITY PHARMACEUTICALS, INC. | 24338-855-03 | 24338-855 | ANDA090533 | ANDA | CII |
| Dextroamphetamine Sulfate | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (24338-856-03) | AZURITY PHARMACEUTICALS, INC. | 24338-856-03 | 24338-856 | ANDA090533 | ANDA | CII |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (65162-414-09) | Amneal Pharmaceuticals LLC | 65162-414-09 | 65162-414 | ANDA203751 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 1000 Tablet In 1 Bottle (65162-414-11) | Amneal Pharmaceuticals LLC | 65162-414-11 | 65162-414 | ANDA203751 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (65162-414-50) | Amneal Pharmaceuticals LLC | 65162-414-50 | 65162-414 | ANDA203751 | ANDA | N/A |
| Dextromethorphan Hydrobromide | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (45802-433-21) / 89 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-433-21 | 45802-433 | ANDA091135 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-121-05) | ScieGen Pharmaceuticals Inc | 50228-121-05 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-121-30) | ScieGen Pharmaceuticals Inc | 50228-121-30 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-121-90) | ScieGen Pharmaceuticals Inc | 50228-121-90 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-124-05) | ScieGen Pharmaceuticals Inc | 50228-124-05 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-124-10) | ScieGen Pharmaceuticals Inc | 50228-124-10 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-124-30) | ScieGen Pharmaceuticals Inc | 50228-124-30 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-124-90) | ScieGen Pharmaceuticals Inc | 50228-124-90 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-121-05) | ScieGen Pharmaceuticals Inc | 50228-121-05 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-121-30) | ScieGen Pharmaceuticals Inc | 50228-121-30 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 300mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-121-90) | ScieGen Pharmaceuticals Inc | 50228-121-90 | 50228-121 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-124-05) | ScieGen Pharmaceuticals Inc | 50228-124-05 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-124-10) | ScieGen Pharmaceuticals Inc | 50228-124-10 | 50228-124 | ANDA204165 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Promethazine Hydrochloride | Solution | Oral | 15mg/5mL, 6.25 mg/5mL | 473 Ml In 1 Bottle, Plastic (27808-057-01) | Tris Pharma Inc | 27808-057-01 | 27808-057 | ANDA091687 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Quinidine Sulfate | Capsule, Gelatin Coated | Oral | 20mg/1, 10 mg/1 | 1 Bottle In 1 Carton (64597-301-13) / 13 Capsule, Gelatin Coated In 1 Bottle | Avanir Pharmaceuticals, Inc. | 64597-301-13 | 64597-301 | NDA021879 | NDA | N/A |
| Dextromethorphan Hydrobromide; Quinidine Sulfate | Capsule, Gelatin Coated | Oral | 20mg/1, 10 mg/1 | 60 Capsule, Gelatin Coated In 1 Bottle (64597-301-60) | Avanir Pharmaceuticals, Inc. | 64597-301-60 | 64597-301 | NDA021879 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 25g/50mL | 25 Vial, Single-Dose In 1 Tray (0409-6648-02) / 50 Ml In 1 Vial, Single-Dose (0409-6648-16) | Hospira, Inc. | 0409-6648-02 | 0409-6648 | NDA019445 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 25g/50mL | 10 Carton In 1 Container (0409-7517-16) / 1 Syringe, Plastic In 1 Carton / 50 Ml In 1 Syringe, Plastic (0409-7517-66) | Hospira, Inc. | 0409-7517-16 | 0409-7517 | NDA019445 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 50mg/mL | 12 Pouch In 1 Case (0409-7100-02) / 2 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-7100-04) | Hospira, Inc. | 0409-7100-02 | 0409-7100 | NDA019466 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 50mg/mL | 10 Pouch In 1 Case (0409-7100-66) / 5 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-7100-68) | Hospira, Inc. | 0409-7100-66 | 0409-7100 | NDA019466 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 50mg/mL | 10 Pouch In 1 Case (0409-7100-67) / 5 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-7100-69) | Hospira, Inc. | 0409-7100-67 | 0409-7100 | NDA019466 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 250mg/mL | 10 Carton In 1 Package (0409-1775-10) / 1 Syringe, Plastic In 1 Carton / 10 Ml In 1 Syringe, Plastic (0409-1775-40) | Hospira, Inc. | 0409-1775-10 | 0409-1775 | NDA019445 | NDA | N/A |
| Dextrose Monohydrate | Injection, Solution | Intravenous | 25g/50mL | 10 Carton In 1 Container (0409-4902-34) / 1 Syringe In 1 Carton / 50 Ml In 1 Syringe (0409-4902-64) | Hospira, Inc. | 0409-4902-34 | 0409-4902 | NDA019445 | NDA | N/A |
| Diazepam | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (80725-006-01) | Waylis Therapuetics LLC | 80725-006-01 | 80725-006 | NDA013263 | NDA | CIV |
| Diazepam | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (80725-004-01) | Waylis Therapuetics LLC | 80725-004-01 | 80725-004 | NDA013263 | NDA | CIV |
| Diazepam | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6243-10) / 10 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0641-6243-10 | 0641-6243 | ANDA070311 | ANDA | CIV |
| Diazepam | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Syringe In 1 Carton (0641-6244-10) / 2 Ml In 1 Syringe | Hikma Pharmaceuticals USA Inc. | 0641-6244-10 | 0641-6244 | ANDA070313 | ANDA | CIV |
| Diazepam | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3188-63) | Hikma Pharmaceuticals USA Inc. | 0054-3188-63 | 0054-3188 | ANDA070928 | ANDA | CIV |
| Diazepam | Solution, Concentrate | Oral | 5mg/mL | 1 Bottle In 1 Carton (0054-3185-44) / 30 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-3185-44 | 0054-3185 | ANDA071415 | ANDA | CIV |
| Diazepam | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Cartridge In 1 Carton (0409-1273-32) / 2 Ml In 1 Cartridge (0409-1273-03) | Hospira, Inc. | 0409-1273-32 | 0409-1273 | ANDA072079 | ANDA | CIV |
| Diazepam | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-3213-12) / 10 Ml In 1 Vial, Multi-Dose (0409-3213-11) | Hospira, Inc. | 0409-3213-12 | 0409-3213 | ANDA071583 | ANDA | CIV |
| Dibasic Potassium Phosphate; Monobasic Potassium Phosphate | Injection, Solution | Intravenous | 236mg/mL, 224 mg/mL | 25 Bottle In 1 Carton (70069-746-25) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-746-25 | 70069-746 | ANDA217726 | ANDA | N/A |
| Dibasic Potassium Phosphate; Monobasic Potassium Phosphate | Injection, Solution | Intravenous | 236mg/mL, 224 mg/mL | 25 Bottle In 1 Carton (70069-747-25) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-747-25 | 70069-747 | ANDA217726 | ANDA | N/A |
| Dibasic Potassium Phosphate; Monobasic Potassium Phosphate | Injection, Solution, Concentrate | Intravenous | 236mg/mL, 224 mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-7295-01) / 15 Ml In 1 Vial, Single-Dose (0409-7295-11) | Hospira, Inc. | 0409-7295-01 | 0409-7295 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Diclofenac Potassium | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-443-01) | Golden State Medical Supply, Inc. | 51407-443-01 | 51407-443 | ANDA076561 | ANDA | N/A |
| Diclofenac Potassium | Powder, For Solution | Oral | 50mg/1 | 9 Packet In 1 Carton (51672-4240-6) / 1 Powder, For Solution In 1 Packet (51672-4240-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4240-6 | 51672-4240 | ANDA218011 | ANDA | N/A |
| Diclofenac Potassium | Powder, For Solution | Oral | 50mg/1 | 9 Packet In 1 Carton (69315-506-09) / 1 Powder, For Solution In 1 Packet | Leading Pharma, LLC | 69315-506-09 | 69315-506 | NDA022165 | NDA AUTHORIZED GENERIC | N/A |
| Diclofenac Potassium | Capsule, Liquid Filled | Oral | 25mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (69315-275-20) | Leading Pharma, LLC | 69315-275-20 | 69315-275 | NDA022202 | NDA AUTHORIZED GENERIC | N/A |
| Diclofenac Potassium | Powder, For Solution | Oral | 50mg/1 | 9 Packet In 1 Carton (13913-011-19) / 1 Powder, For Solution In 1 Packet (13913-011-01) | Assertio Therapeutics, Inc. | 13913-011-19 | 13913-011 | NDA022165 | NDA | N/A |
| Diclofenac Potassium | Powder, For Solution | Oral | 50mg/1 | 9 Packet In 1 Carton (13913-012-02) / 1 Powder, For Solution In 1 Packet | Assertio Therapeutics, Inc. | 13913-012-02 | 13913-012 | NDA022165 | NDA | N/A |
| Diclofenac Potassium | Powder, For Solution | Oral | 50mg/1 | 9 Packet In 1 Carton (13913-012-03) / 1 Powder, For Solution In 1 Packet (13913-012-01) | Assertio Therapeutics, Inc. | 13913-012-03 | 13913-012 | NDA022165 | NDA | N/A |
| Diclofenac Potassium | Capsule, Liquid Filled | Oral | 25mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (13913-008-11) | Assertio Therapeutics, Inc. | 13913-008-11 | 13913-008 | NDA022202 | NDA | N/A |
| Diclofenac Potassium | Capsule, Liquid Filled | Oral | 25mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (13913-008-12) | Assertio Therapeutics, Inc. | 13913-008-12 | 13913-008 | NDA022202 | NDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-124-30) | ScieGen Pharmaceuticals Inc | 50228-124-30 | 50228-124 | ANDA204165 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 30mg/g | 1 Tube In 1 Carton (45802-111-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-111-01 | 45802-111 | ANDA210893 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (45802-953-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-953-01 | 45802-953 | ANDA211253 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (45802-160-00) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-160-00 | 45802-160 | ANDA211253 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 20mg/g | 1 Bottle In 1 Carton (0574-0167-12) / 112 G In 1 Bottle | Padagis US LLC | 0574-0167-12 | 0574-0167 | NDA204623 | NDA AUTHORIZED GENERIC | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 15 Tablet, Delayed Release In 1 Bottle, Plastic (60760-090-15) | St. Mary's Medical Park Pharmacy | 60760-090-15 | 60760-090 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 20 Tablet, Delayed Release In 1 Bottle, Plastic (60760-090-20) | St. Mary's Medical Park Pharmacy | 60760-090-20 | 60760-090 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (60760-090-60) | St. Mary's Medical Park Pharmacy | 60760-090-60 | 60760-090 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 16.05mg/mL | 1 Bottle In 1 Carton (60760-112-95) / 150 Ml In 1 Bottle | St. Mary's Medical Park Pharmacy | 60760-112-95 | 60760-112 | ANDA202769 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (60760-264-30) | St. Mary's Medical Park Pharmacy | 60760-264-30 | 60760-264 | ANDA075492 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 15 Tablet, Delayed Release In 1 Bottle, Plastic (60760-153-15) | St. Mary's Medical Park Pharmacy | 60760-153-15 | 60760-153 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 20 Tablet, Delayed Release In 1 Bottle, Plastic (60760-153-20) | St. Mary's Medical Park Pharmacy | 60760-153-20 | 60760-153 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (60760-153-60) | St. Mary's Medical Park Pharmacy | 60760-153-60 | 60760-153 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 1g/100g | 50 G In 1 Carton (73715-005-01) | Mohnark Pharmaceuticals Inc. | 73715-005-01 | 73715-005 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 100 Tablet, Delayed Release In 1 Bottle (60429-421-01) | Golden State Medical Supply, Inc. | 60429-421-01 | 60429-421 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (60429-421-10) | Golden State Medical Supply, Inc. | 60429-421-10 | 60429-421 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 180 Tablet, Delayed Release In 1 Bottle (60429-421-18) | Golden State Medical Supply, Inc. | 60429-421-18 | 60429-421 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 100 Tablet, Delayed Release In 1 Bottle (60429-422-01) | Golden State Medical Supply, Inc. | 60429-422-01 | 60429-422 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (60429-422-10) | Golden State Medical Supply, Inc. | 60429-422-10 | 60429-422 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 180 Tablet, Delayed Release In 1 Bottle (60429-422-18) | Golden State Medical Supply, Inc. | 60429-422-18 | 60429-422 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 60 Tablet, Delayed Release In 1 Bottle (60429-422-60) | Golden State Medical Supply, Inc. | 60429-422-60 | 60429-422 | ANDA074514 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 16.05mg/mL | 1 Bottle, Dropper In 1 Carton (51672-1358-2) / 150 Ml In 1 Bottle, Dropper | Taro Pharmaceuticals U.S.A., Inc. | 51672-1358-2 | 51672-1358 | ANDA203818 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 16.05mg/mL | 1 Bottle, Dropper In 1 Carton (51672-1358-4) / 60 Ml In 1 Bottle, Dropper | Taro Pharmaceuticals U.S.A., Inc. | 51672-1358-4 | 51672-1358 | ANDA203818 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 30mg/g | 1 Tube In 1 Carton (51672-1363-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1363-3 | 51672-1363 | ANDA206298 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 30mg/g | 1 Tube In 1 Carton (51672-1363-7) / 100 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1363-7 | 51672-1363 | ANDA206298 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 20mg/g | 1 Bottle, Pump In 1 Carton (51672-1369-8) / 112 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1369-8 | 51672-1369 | ANDA208098 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 20mg/g | 1 Bottle In 1 Carton (60505-0406-3) / 112 G In 1 Bottle | Apotex Corp. | 60505-0406-3 | 60505-0406 | ANDA207714 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 25mg/1 | 24 Bottle, Plastic In 1 Box (61442-101-01) / 100 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-101-01 | 61442-101 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 25mg/1 | 12 Bottle, Plastic In 1 Box (61442-101-10) / 1000 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-101-10 | 61442-101 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 25mg/1 | 24 Bottle, Plastic In 1 Box (61442-101-60) / 60 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-101-60 | 61442-101 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 24 Bottle, Plastic In 1 Box (61442-102-01) / 100 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-102-01 | 61442-102 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 12 Bottle, Plastic In 1 Box (61442-102-10) / 1000 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-102-10 | 61442-102 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 24 Bottle, Plastic In 1 Box (61442-102-60) / 60 Tablet, Delayed Release In 1 Bottle, Plastic | Carlsbad Technology, Inc. | 61442-102-60 | 61442-102 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 100 Tablet, Delayed Release In 1 Bottle, Plastic (61442-103-01) | Carlsbad Technology, Inc. | 61442-103-01 | 61442-103 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 500 Tablet, Delayed Release In 1 Bottle, Plastic (61442-103-05) | Carlsbad Technology, Inc. | 61442-103-05 | 61442-103 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 1000 Tablet, Delayed Release In 1 Bottle, Plastic (61442-103-10) | Carlsbad Technology, Inc. | 61442-103-10 | 61442-103 | ANDA075185 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (61442-103-60) | Carlsbad Technology, Inc. | 61442-103-60 | 61442-103 | ANDA075185 | ANDA | N/A |
| Clopidogrel Bisulfate | Tablet, Film Coated | Oral | 75mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-124-90) | ScieGen Pharmaceuticals Inc | 50228-124-90 | 50228-124 | ANDA204165 | ANDA | N/A |
| Clorazepate Dipotassium | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (70954-157-20) | ANI Pharmaceuticals, Inc. | 70954-157-20 | 70954-157 | ANDA213730 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (70954-158-30) | ANI Pharmaceuticals, Inc. | 70954-158-30 | 70954-158 | ANDA213730 | ANDA | CIV |
| Clorazepate Dipotassium | Tablet | Oral | 3.75mg/1 | 30 Tablet In 1 Bottle (70954-159-30) | ANI Pharmaceuticals, Inc. | 70954-159-30 | 70954-159 | ANDA213730 | ANDA | CIV |
| Clotrimazole | Lozenge | Oral | 10mg/1 | 70 Lozenge In 1 Bottle (16571-686-07) | Rising Pharma Holdings, Inc. | 16571-686-07 | 16571-686 | ANDA215641 | ANDA | N/A |
| Clotrimazole | Lozenge | Oral | 10mg/1 | 140 Lozenge In 1 Bottle (16571-686-14) | Rising Pharma Holdings, Inc. | 16571-686-14 | 16571-686 | ANDA215641 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-08) / 10 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-08 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-30) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-30 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-31) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-31 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 2 Bottle In 1 Carton (50228-502-61) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-61 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-08) / 10 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-08 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-30) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-30 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 1 Bottle In 1 Carton (50228-502-31) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-31 | 50228-502 | ANDA216569 | ANDA | N/A |
| Clotrimazole | Solution | Topical | 10mg/mL | 2 Bottle In 1 Carton (50228-502-61) / 30 Ml In 1 Bottle | ScieGen Pharmaceuticals, Inc | 50228-502-61 | 50228-502 | ANDA216569 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 60 Tablet, Delayed Release In 1 Bottle (75834-264-60) | Nivagen Pharmaceuticals, Inc. | 75834-264-60 | 75834-264 | ANDA205143 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 90 Tablet, Delayed Release In 1 Bottle (75834-264-90) | Nivagen Pharmaceuticals, Inc. | 75834-264-90 | 75834-264 | ANDA205143 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 75mg/1, 200 ug/1 | 60 Tablet, Delayed Release In 1 Bottle (75834-265-60) | Nivagen Pharmaceuticals, Inc. | 75834-265-60 | 75834-265 | ANDA205143 | ANDA | N/A |
| Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup | Oral | 10mg/5mL, 5 mg/5mL, 6.25 mg/5mL | 118 Ml In 1 Bottle (65162-694-86) | Amneal Pharmaceuticals LLC | 65162-694-86 | 65162-694 | ANDA200963 | ANDA | CV |
| Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup | Oral | 10mg/5mL, 5 mg/5mL, 6.25 mg/5mL | 473 Ml In 1 Bottle (65162-694-90) | Amneal Pharmaceuticals LLC | 65162-694-90 | 65162-694 | ANDA200963 | ANDA | CV |
| Colchicine | Tablet | Oral | .6mg/1 | 30 Tablet In 1 Bottle (65162-710-03) | Amneal Pharmaceuticals LLC | 65162-710-03 | 65162-710 | ANDA204711 | ANDA | N/A |
| Colchicine | Tablet | Oral | .6mg/1 | 90 Tablet In 1 Bottle (65162-710-09) | Amneal Pharmaceuticals LLC | 65162-710-09 | 65162-710 | ANDA204711 | ANDA | N/A |
| Colchicine | Tablet | Oral | .6mg/1 | 1000 Tablet In 1 Bottle (65162-710-11) | Amneal Pharmaceuticals LLC | 65162-710-11 | 65162-710 | ANDA204711 | ANDA | N/A |
| Colchicine | Tablet, Film Coated | Oral | .6mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-899-01) | Camber Pharmaceuticals, Inc. | 31722-899-01 | 31722-899 | ANDA208993 | ANDA | N/A |
| Colchicine | Tablet, Film Coated | Oral | .6mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-899-30) | Camber Pharmaceuticals, Inc. | 31722-899-30 | 31722-899 | ANDA208993 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Film Coated | Oral | 50mg/1, 200 ug/1 | 60 Tablet, Film Coated In 1 Bottle (0025-1411-60) | Pfizer Laboratories Div Pfizer Inc | 0025-1411-60 | 0025-1411 | NDA020607 | NDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Film Coated | Oral | 50mg/1, 200 ug/1 | 90 Tablet, Film Coated In 1 Bottle (0025-1411-90) | Pfizer Laboratories Div Pfizer Inc | 0025-1411-90 | 0025-1411 | NDA020607 | NDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Film Coated | Oral | 75mg/1, 200 ug/1 | 60 Tablet, Film Coated In 1 Bottle (0025-1421-60) | Pfizer Laboratories Div Pfizer Inc | 0025-1421-60 | 0025-1421 | NDA020607 | NDA | N/A |
| Dicyclomine Hydrochloride | Injection | Intramuscular | 10mg/mL | 5 Vial, Single-Dose In 1 Carton (14789-010-02) / 2 Ml In 1 Vial, Single-Dose (14789-010-07) | Nexus Pharmaceuticals LLC | 14789-010-02 | 14789-010 | ANDA206468 | ANDA | N/A |
| Dicyclomine Hydrochloride | Solution | Oral | 10mg/5mL | 473 Ml In 1 Bottle (70954-261-10) | Novitium Pharma LLC | 70954-261-10 | 70954-261 | ANDA214721 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-638-30) | St Mary's Medical Park Pharmacy | 60760-638-30 | 60760-638 | ANDA040230 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 120 Tablet In 1 Bottle, Plastic (51407-821-12) | Golden State Medical Supply, Inc. | 51407-821-12 | 51407-821 | ANDA216782 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (51407-783-01) | Golden State Medical Supply, Inc. | 51407-783-01 | 51407-783 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle, Plastic (51407-783-10) | Golden State Medical Supply, Inc. | 51407-783-10 | 51407-783 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (51407-365-01) | Golden State Medical Supply, Inc. | 51407-365-01 | 51407-365 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle, Plastic (51407-365-10) | Golden State Medical Supply, Inc. | 51407-365-10 | 51407-365 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (69452-311-20) | Bionpharma Inc. | 69452-311-20 | 69452-311 | ANDA217916 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (69452-311-32) | Bionpharma Inc. | 69452-311-32 | 69452-311 | ANDA217916 | ANDA | N/A |
| Dicyclomine Hydrochloride | Injection, Solution | Intramuscular | 20mg/2mL | 5 Vial, Single-Dose In 1 Carton (0517-1980-05) / 2 Ml In 1 Vial, Single-Dose (0517-1980-01) | American Regent, Inc. | 0517-1980-05 | 0517-1980 | ANDA208353 | ANDA | N/A |
| Dicyclomine Hydrochloride | Injection, Solution | Intramuscular | 20mg/2mL | 10 Vial, Single-Dose In 1 Carton (0517-1980-10) / 2 Ml In 1 Vial, Single-Dose (0517-1980-01) | American Regent, Inc. | 0517-1980-10 | 0517-1980 | ANDA208353 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (0143-1227-01) | Hikma Pharmaceuticals USA Inc. | 0143-1227-01 | 0143-1227 | ANDA040161 | ANDA | N/A |
| Dicyclomine Hydrochloride | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1227-10) | Hikma Pharmaceuticals USA Inc. | 0143-1227-10 | 0143-1227 | ANDA040161 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (0143-3126-01) | Hikma Pharmaceuticals USA Inc. | 0143-3126-01 | 0143-3126 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle, Plastic (0143-3126-10) | Hikma Pharmaceuticals USA Inc. | 0143-3126-10 | 0143-3126 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (0054-0748-25) | Hikma Pharmaceuticals USA Inc. | 0054-0748-25 | 0054-0748 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle, Plastic (0054-0748-31) | Hikma Pharmaceuticals USA Inc. | 0054-0748-31 | 0054-0748 | ANDA040204 | ANDA | N/A |
| Dicyclomine Hydrochloride | Injection | Intramuscular | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0641-6173-10) / 2 Ml In 1 Vial, Single-Dose (0641-6173-01) | Hikma Pharmaceuticals USA Inc. | 0641-6173-10 | 0641-6173 | ANDA040465 | ANDA | N/A |
| Dicyclomine Hydrochloride | Solution | Oral | 10mg/5mL | 473 Ml In 1 Bottle (0054-0622-63) | Hikma Pharmaceuticals USA Inc. | 0054-0622-63 | 0054-0622 | ANDA212286 | ANDA | N/A |
| Diethylpropion Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (10702-044-01) | KVK-TECH, INC | 10702-044-01 | 10702-044 | ANDA201212 | ANDA | CIV |
| Diethylpropion Hydrochloride | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (10702-044-03) | KVK-TECH, INC | 10702-044-03 | 10702-044 | ANDA201212 | ANDA | CIV |
| Diethylpropion Hydrochloride | Tablet | Oral | 25mg/1 | 60 Tablet In 1 Bottle (10702-044-06) | KVK-TECH, INC | 10702-044-06 | 10702-044 | ANDA201212 | ANDA | CIV |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1295-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1295-1 | 51672-1295 | ANDA075331 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1295-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1295-2 | 51672-1295 | ANDA075331 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1295-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1295-3 | 51672-1295 | ANDA075331 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1296-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1296-1 | 51672-1296 | ANDA075508 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1296-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1296-2 | 51672-1296 | ANDA075508 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1296-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1296-3 | 51672-1296 | ANDA075508 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | 5mg/g | 1 Tube In 1 Carton (51672-5292-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5292-3 | 51672-5292 | ANDA075508 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | 5mg/g | 1 Tube In 1 Carton (51672-5292-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5292-5 | 51672-5292 | ANDA075508 | ANDA | N/A |
| COLCHICINE | Capsule | Oral | .6mg/1 | 100 Capsule In 1 Bottle (31722-099-01) | Camber Pharmaceuticals, Inc. | 31722-099-01 | 31722-099 | ANDA217620 | ANDA | N/A |
| COLCHICINE | Capsule | Oral | .6mg/1 | 1000 Capsule In 1 Bottle (31722-099-10) | Camber Pharmaceuticals, Inc. | 31722-099-10 | 31722-099 | ANDA217620 | ANDA | N/A |
| COLCHICINE | Capsule | Oral | .6mg/1 | 30 Capsule In 1 Bottle (31722-099-30) | Camber Pharmaceuticals, Inc. | 31722-099-30 | 31722-099 | ANDA217620 | ANDA | N/A |
| Colchicine; Probenecid | Tablet | Oral | .5mg/1, 500 mg/1 | 100 Tablet In 1 Bottle (50742-263-01) | Ingenus Pharmaceuticals, LLC | 50742-263-01 | 50742-263 | ANDA040618 | ANDA | N/A |
| Colchicine; Probenecid | Tablet | Oral | .5mg/1, 500 mg/1 | 100 Tablet In 1 Container (16571-832-01) | Rising Pharma Holdings, Inc. | 16571-832-01 | 16571-832 | ANDA217030 | ANDA | N/A |
| Colestipol Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 120 Tablet, Film Coated In 1 Bottle (62559-395-12) | ANI Pharmaceuticals, Inc. | 62559-395-12 | 62559-395 | ANDA216517 | ANDA | N/A |
| Corticotropin | Injection | Intramuscular; Subcutaneous | 80[USP'U]/mL | 1 Vial, Multi-Dose In 1 Carton (62559-860-11) / 1 Ml In 1 Vial, Multi-Dose | ANI Pharmaceuticals, Inc. | 62559-860-11 | 62559-860 | NDA008975 | NDA | N/A |
| Digoxin | Tablet | Oral | 125ug/1 | 100 Tablet In 1 Bottle, Plastic (60429-099-01) | Golden State Medical Supply, Inc. | 60429-099-01 | 60429-099 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 125ug/1 | 1000 Tablet In 1 Bottle, Plastic (60429-099-10) | Golden State Medical Supply, Inc. | 60429-099-10 | 60429-099 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 250ug/1 | 100 Tablet In 1 Bottle, Plastic (60429-100-01) | Golden State Medical Supply, Inc. | 60429-100-01 | 60429-100 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 250ug/1 | 1000 Tablet In 1 Bottle, Plastic (60429-100-10) | Golden State Medical Supply, Inc. | 60429-100-10 | 60429-100 | ANDA077002 | ANDA | N/A |
| Digoxin | Solution | Oral | .05mg/mL | 1 Bottle, Glass In 1 Carton (66689-327-02) / 60 Ml In 1 Bottle, Glass | VistaPharm, LLC | 66689-327-02 | 66689-327 | ANDA213000 | ANDA | N/A |
| Corticotropin | Injection | Intramuscular; Subcutaneous | 80[USP'U]/mL | 1 Vial, Multi-Dose In 1 Carton (62559-860-15) / 5 Ml In 1 Vial, Multi-Dose | ANI Pharmaceuticals, Inc. | 62559-860-15 | 62559-860 | NDA008975 | NDA | N/A |
| Cromolyn Sodium | Solution, Concentrate | Oral | 100mg/5mL | 12 Pouch In 1 Carton (16571-600-96) / 8 Ampule In 1 Pouch / 5 Ml In 1 Ampule | Rising Pharma Holdings, Inc. | 16571-600-96 | 16571-600 | ANDA202583 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-540-10) | Amneal Pharmaceuticals LLC | 65162-540-10 | 65162-540 | ANDA078218 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-540-11) | Amneal Pharmaceuticals LLC | 65162-540-11 | 65162-540 | ANDA078218 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-540-50) | Amneal Pharmaceuticals LLC | 65162-540-50 | 65162-540 | ANDA078218 | ANDA | N/A |
| Digoxin | Solution | Oral | .05mg/mL | 60 Ml In 1 Bottle (0054-0057-46) | Hikma Pharmaceuticals USA Inc. | 0054-0057-46 | 0054-0057 | NDA021648 | NDA | N/A |
| Digoxin | Injection | Intramuscular; Intravenous | .25mg/mL | 25 Ampule In 1 Carton (0641-1410-35) / 2 Ml In 1 Ampule (0641-1410-31) | Hikma Pharmaceuticals USA Inc. | 0641-1410-35 | 0641-1410 | ANDA083391 | ANDA | N/A |
| Digoxin | Injection | Intramuscular; Intravenous | .25mg/mL | 25 Ampule In 1 Carton (0641-6184-25) / 2 Ml In 1 Ampule (0641-6184-01) | Hikma Pharmaceuticals USA Inc. | 0641-6184-25 | 0641-6184 | ANDA083391 | ANDA | N/A |
| Digoxin | Tablet | Oral | 125ug/1 | 100 Tablet In 1 Bottle, Plastic (0143-1240-01) | Hikma Pharmaceuticals USA Inc. | 0143-1240-01 | 0143-1240 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 125ug/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1240-10) | Hikma Pharmaceuticals USA Inc. | 0143-1240-10 | 0143-1240 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 250ug/1 | 100 Tablet In 1 Bottle, Plastic (0143-1241-01) | Hikma Pharmaceuticals USA Inc. | 0143-1241-01 | 0143-1241 | ANDA077002 | ANDA | N/A |
| Digoxin | Tablet | Oral | 250ug/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1241-10) | Hikma Pharmaceuticals USA Inc. | 0143-1241-10 | 0143-1241 | ANDA077002 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 5 Ampule In 1 Carton (0574-0850-05) / 1 Ml In 1 Ampule | Padagis US LLC | 0574-0850-05 | 0574-0850 | ANDA040475 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Ampule In 1 Carton (0574-0850-10) / 1 Ml In 1 Ampule | Padagis US LLC | 0574-0850-10 | 0574-0850 | ANDA040475 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 5 Vial In 1 Carton (25021-609-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-609-01 | 25021-609 | ANDA207264 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Vial In 1 Carton (25021-609-02) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-609-02 | 25021-609 | ANDA207264 | ANDA | N/A |
| Dihydroergotamine Mesylate | Spray | Nasal | 4mg/mL | 1 Vial In 1 Kit (24201-463-01) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 24201-463-01 | 24201-463 | ANDA211393 | ANDA | N/A |
| Dihydroergotamine Mesylate | Spray | Nasal | 4mg/mL | 8 Vial In 1 Kit (24201-463-08) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 24201-463-08 | 24201-463 | ANDA211393 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Ampule In 1 Carton (0143-9273-10) / 1 Ml In 1 Ampule (0143-9273-01) | Hikma Pharmaceuticals USA Inc. | 0143-9273-10 | 0143-9273 | ANDA206621 | ANDA | N/A |
| Dihydroergotamine Mesylate | Injection | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Vial In 1 Carton (0143-9151-10) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9151-10 | 0143-9151 | ANDA040453 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-541-10) | Amneal Pharmaceuticals LLC | 65162-541-10 | 65162-541 | ANDA078218 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-541-11) | Amneal Pharmaceuticals LLC | 65162-541-11 | 65162-541 | ANDA078218 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-541-50) | Amneal Pharmaceuticals LLC | 65162-541-50 | 65162-541 | ANDA078218 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-266-01) | Rising Health, LLC | 57237-266-01 | 57237-266 | ANDA071611 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-782-01) | Rising Pharma Holdings, Inc. | 16571-782-01 | 16571-782 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-782-10) | Rising Pharma Holdings, Inc. | 16571-782-10 | 16571-782 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-782-50) | Rising Pharma Holdings, Inc. | 16571-782-50 | 16571-782 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-783-01) | Rising Pharma Holdings, Inc. | 16571-783-01 | 16571-783 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-783-10) | Rising Pharma Holdings, Inc. | 16571-783-10 | 16571-783 | ANDA078643 | ANDA | N/A |
| Cyclobenzaprine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-783-50) | Rising Pharma Holdings, Inc. | 16571-783-50 | 16571-783 | ANDA078643 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 500mg/25mL | 1 Vial, Single-Dose In 1 Carton (70121-1238-1) / 25 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1238-1 | 70121-1238 | ANDA210046 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 1g/50mL | 1 Vial, Single-Dose In 1 Carton (70121-1239-1) / 50 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1239-1 | 70121-1239 | ANDA210046 | ANDA | N/A |
| Cyclophosphamide | Injection, Powder, For Solution | Intravenous; Oral | 2g/100mL | 1 Vial, Single-Dose In 1 Carton (70121-1240-1) / 100 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1240-1 | 70121-1240 | ANDA210046 | ANDA | N/A |
| Cyclophosphamide Anhydrous | Injection, Solution | Intravenous | 200mg/mL | 1 Vial In 1 Carton (50742-519-02) / 2.5 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-519-02 | 50742-519 | NDA212501 | NDA | N/A |
| Cyclophosphamide Anhydrous | Injection, Solution | Intravenous | 200mg/mL | 1 Vial In 1 Carton (50742-520-05) / 5 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-520-05 | 50742-520 | NDA212501 | NDA | N/A |
| Cyclophosphamide Anhydrous | Injection, Solution | Intravenous | 200mg/mL | 1 Vial In 1 Carton (50742-521-10) / 10 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-521-10 | 50742-521 | NDA212501 | NDA | N/A |
| Cyproheptadine Hydrochloride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle, Plastic (50742-190-01) | Ingenus Pharmaceuticals LLC | 50742-190-01 | 50742-190 | ANDA205087 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle, Plastic (50742-190-10) | Ingenus Pharmaceuticals LLC | 50742-190-10 | 50742-190 | ANDA205087 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (16571-805-01) | Rising Pharma Holdings, Inc. | 16571-805-01 | 16571-805 | ANDA207555 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (16571-805-10) | Rising Pharma Holdings, Inc. | 16571-805-10 | 16571-805 | ANDA207555 | ANDA | N/A |
| Cyproheptadine Hydrochloride | Syrup | Oral | 2mg/5mL | 473 Ml In 1 Bottle (64980-504-48) | Rising Pharmaceuticals, Inc. | 64980-504-48 | 64980-504 | ANDA040668 | ANDA | N/A |
| Dabigatran Etexilate | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle (72865-272-60) | XLCare Pharmaceuticals, Inc. | 72865-272-60 | 72865-272 | ANDA207961 | ANDA | N/A |
| Dabigatran Etexilate | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle (72865-273-60) | XLCare Pharmaceuticals, Inc. | 72865-273-60 | 72865-273 | ANDA207961 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (65162-339-63) / 30 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-339-63 | 65162-339 | ANDA209890 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (65162-339-85) / 60 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-339-85 | 65162-339 | ANDA209890 | ANDA | N/A |
| Dapsone | Gel | Topical | 50mg/g | 1 Tube In 1 Carton (65162-339-91) / 90 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-339-91 | 65162-339 | ANDA209890 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (70954-136-10) | ANI Pharmaceuticals, Inc. | 70954-136-10 | 70954-136 | ANDA206505 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 10 Vial In 1 Carton (25021-319-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-319-05 | 25021-319 | ANDA074617 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 10 Vial In 1 Carton (25021-319-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-319-10 | 25021-319 | ANDA074617 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 10 Vial In 1 Carton (25021-319-25) / 25 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-319-25 | 25021-319 | ANDA074617 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-473-90) | Golden State Medical Supply, Inc. | 51407-473-90 | 51407-473 | ANDA205231 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-474-90) | Golden State Medical Supply, Inc. | 51407-474-90 | 51407-474 | ANDA205231 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-475-90) | Golden State Medical Supply, Inc. | 51407-475-90 | 51407-475 | ANDA205231 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-476-90) | Golden State Medical Supply, Inc. | 51407-476-90 | 51407-476 | ANDA205231 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 100 Capsule, Extended Release In 1 Bottle (60505-0016-6) | Apotex Corp. | 60505-0016-6 | 60505-0016 | ANDA074943 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 500 Capsule, Extended Release In 1 Bottle (60505-0016-8) | Apotex Corp. | 60505-0016-8 | 60505-0016 | ANDA074943 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 100 Capsule, Extended Release In 1 Bottle (60505-0014-6) | Apotex Corp. | 60505-0014-6 | 60505-0014 | ANDA074943 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 500 Capsule, Extended Release In 1 Bottle (60505-0014-8) | Apotex Corp. | 60505-0014-8 | 60505-0014 | ANDA074943 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 100 Capsule, Extended Release In 1 Bottle (60505-0015-6) | Apotex Corp. | 60505-0015-6 | 60505-0015 | ANDA074943 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 500 Capsule, Extended Release In 1 Bottle (60505-0015-8) | Apotex Corp. | 60505-0015-8 | 60505-0015 | ANDA074943 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (70954-136-20) | ANI Pharmaceuticals, Inc. | 70954-136-20 | 70954-136 | ANDA206505 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (70954-135-10) | ANI Pharmaceuticals, Inc. | 70954-135-10 | 70954-135 | ANDA206505 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (70954-135-20) | ANI Pharmaceuticals, Inc. | 70954-135-20 | 70954-135 | ANDA206505 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (64980-566-01) | Rising Pharma Holdings, Inc. | 64980-566-01 | 64980-566 | ANDA207165 | ANDA | N/A |
| Dapsone | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (64980-566-03) | Rising Pharma Holdings, Inc. | 64980-566-03 | 64980-566 | ANDA207165 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (64980-567-01) | Rising Pharma Holdings, Inc. | 64980-567-01 | 64980-567 | ANDA207165 | ANDA | N/A |
| Dapsone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (64980-567-03) | Rising Pharma Holdings, Inc. | 64980-567-03 | 64980-567 | ANDA207165 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (31722-102-10) / 10 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals Inc. | 31722-102-10 | 31722-102 | ANDA212513 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 1 Vial, Single-Dose In 1 Carton (31722-215-01) / 7 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals, Inc. | 31722-215-01 | 31722-215 | ANDA216445 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 350mg/7mL | 10 Vial, Single-Dose In 1 Carton (31722-215-10) / 7 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals, Inc. | 31722-215-10 | 31722-215 | ANDA216445 | ANDA | N/A |
| Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Single-Dose In 1 Carton (31722-216-01) / 10 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals, Inc. | 31722-216-01 | 31722-216 | ANDA216413 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (16571-767-03) | Rising Pharma Holdings, Inc. | 16571-767-03 | 16571-767 | ANDA206743 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (16571-767-09) | Rising Pharma Holdings, Inc. | 16571-767-09 | 16571-767 | ANDA206743 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (16571-768-03) | Rising Pharma Holdings, Inc. | 16571-768-03 | 16571-768 | ANDA206743 | ANDA | N/A |
| Darifenacin Hydrobromide | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (16571-768-09) | Rising Pharma Holdings, Inc. | 16571-768-09 | 16571-768 | ANDA206743 | ANDA | N/A |
| Decitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/1 | 1 Vial In 1 Carton (50742-430-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-430-01 | 50742-430 | ANDA210984 | ANDA | N/A |
| Deferasirox | Tablet, Film Coated | Oral | 90mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-011-30) | Camber Pharmaceuticals, Inc. | 31722-011-30 | 31722-011 | ANDA214341 | ANDA | N/A |
| Deferasirox | Tablet, Film Coated | Oral | 180mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-012-30) | Camber Pharmaceuticals, Inc. | 31722-012-30 | 31722-012 | ANDA214341 | ANDA | N/A |
| Deferasirox | Tablet, Film Coated | Oral | 360mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-013-30) | Camber Pharmaceuticals, Inc. | 31722-013-30 | 31722-013 | ANDA214341 | ANDA | N/A |
| DEFERASIROX | Granule | Oral | 90mg/1 | 30 Packet In 1 Carton (31722-029-32) / 1 Granule In 1 Packet | Camber Pharmaceuticals, Inc. | 31722-029-32 | 31722-029 | ANDA216229 | ANDA | N/A |
| DEFERASIROX | Granule | Oral | 180mg/1 | 30 Packet In 1 Carton (31722-030-32) / 1 Granule In 1 Packet | Camber Pharmaceuticals, Inc. | 31722-030-32 | 31722-030 | ANDA216229 | ANDA | N/A |
| DEFERASIROX | Granule | Oral | 360mg/1 | 30 Packet In 1 Carton (31722-031-32) / 1 Granule In 1 Packet | Camber Pharmaceuticals, Inc. | 31722-031-32 | 31722-031 | ANDA216229 | ANDA | N/A |
| Deferasirox | Granule | Oral | 90mg/1 | 30 Packet In 1 Carton (42806-371-30) / 1 Granule In 1 Packet | EPIC PHARMA, LLC | 42806-371-30 | 42806-371 | ANDA214559 | ANDA | N/A |
| Deferasirox | Granule | Oral | 180mg/1 | 30 Packet In 1 Carton (42806-372-30) / 1 Granule In 1 Packet | EPIC PHARMA, LLC | 42806-372-30 | 42806-372 | ANDA214559 | ANDA | N/A |
| Deferasirox | Granule | Oral | 360mg/1 | 30 Packet In 1 Carton (42806-373-30) / 1 Granule In 1 Packet | EPIC PHARMA, LLC | 42806-373-30 | 42806-373 | ANDA214559 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-143-01) | Epic Pharma, LLC | 42806-143-01 | 42806-143 | ANDA065447 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 150mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-143-05) | Epic Pharma, LLC | 42806-143-05 | 42806-143 | ANDA065447 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-9217-10) / 5 Ml In 1 Vial (0641-9217-01) | Hikma Pharmaceuticals USA Inc. | 0641-9217-10 | 0641-9217 | ANDA078538 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-9218-10) / 10 Ml In 1 Vial (0641-9218-01) | Hikma Pharmaceuticals USA Inc. | 0641-9218-10 | 0641-9218 | ANDA078538 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-9219-10) / 25 Ml In 1 Vial (0641-9219-01) | Hikma Pharmaceuticals USA Inc. | 0641-9219-10 | 0641-9219 | ANDA078538 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6013-10) / 5 Ml In 1 Vial (0641-6013-01) | Hikma Pharmaceuticals USA Inc. | 0641-6013-10 | 0641-6013 | ANDA078538 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6014-10) / 10 Ml In 1 Vial (0641-6014-01) | Hikma Pharmaceuticals USA Inc. | 0641-6014-10 | 0641-6014 | ANDA078538 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6015-10) / 25 Ml In 1 Vial (0641-6015-01) | Hikma Pharmaceuticals USA Inc. | 0641-6015-10 | 0641-6015 | ANDA078538 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 150mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-143-30) | Epic Pharma, LLC | 42806-143-30 | 42806-143 | ANDA065447 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-144-01) | Epic Pharma, LLC | 42806-144-01 | 42806-144 | ANDA065447 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-144-30) | Epic Pharma, LLC | 42806-144-30 | 42806-144 | ANDA065447 | ANDA | N/A |
| Demeclocycline Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 48 Tablet, Film Coated In 1 Bottle (42806-144-48) | Epic Pharma, LLC | 42806-144-48 | 42806-144 | ANDA065447 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (50742-112-01) | Ingenus Pharmaceuticals, LLC | 50742-112-01 | 50742-112 | ANDA204963 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (50742-113-01) | Ingenus Pharmaceuticals, LLC | 50742-113-01 | 50742-113 | ANDA204963 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (50742-114-01) | Ingenus Pharmaceuticals, LLC | 50742-114-01 | 50742-114 | ANDA204963 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 75mg/1 | 100 Tablet In 1 Bottle (50742-115-01) | Ingenus Pharmaceuticals, LLC | 50742-115-01 | 50742-115 | ANDA204963 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (50742-116-01) | Ingenus Pharmaceuticals, LLC | 50742-116-01 | 50742-116 | ANDA204963 | ANDA | N/A |
| Desipramine Hydrochloride | Tablet | Oral | 150mg/1 | 50 Tablet In 1 Bottle (50742-117-50) | Ingenus Pharmaceuticals, LLC | 50742-117-50 | 50742-117 | ANDA204963 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (70954-398-10) | ANI Pharmaceuticals, Inc. | 70954-398-10 | 70954-398 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | .75mg/1 | 100 Tablet In 1 Bottle (70954-399-10) | ANI Pharmaceuticals, Inc. | 70954-399-10 | 70954-399 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 1.5mg/1 | 100 Tablet In 1 Bottle (70954-401-10) | ANI Pharmaceuticals, Inc. | 70954-401-10 | 70954-401 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (70954-402-10) | ANI Pharmaceuticals, Inc. | 70954-402-10 | 70954-402 | ANDA217696 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (70954-403-10) | ANI Pharmaceuticals, Inc. | 70954-403-10 | 70954-403 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 4mg/1 | 100 Blister Pack In 1 Carton (70954-403-30) / 1 Tablet In 1 Blister Pack (70954-403-20) | ANI Pharmaceuticals, Inc. | 70954-403-30 | 70954-403 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (70954-404-10) | ANI Pharmaceuticals, Inc. | 70954-404-10 | 70954-404 | ANDA215604 | ANDA | N/A |
| Dexamethasone | Elixir | Oral | .5mg/5mL | 237 Ml In 1 Bottle, Plastic (64980-509-24) | Rising Pharma Holdings, Inc. | 64980-509-24 | 64980-509 | ANDA090891 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (70121-1399-5) / 1 Ml In 1 Vial (70121-1399-1) | Amneal Pharmaceuticals LLC | 70121-1399-5 | 70121-1399 | ANDA208690 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection, Solution | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial, Single-Dose In 1 Carton (70121-1450-5) / 1 Ml In 1 Vial, Single-Dose (70121-1450-1) | Amneal Pharmaceuticals LLC | 70121-1450-5 | 70121-1450 | ANDA208689 | ANDA | N/A |
| Diltiazem Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/1 | 10 Vial, Patent Delivery System In 1 Tray (0409-4350-03) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Patent Delivery System (0409-4350-13) | Hospira, Inc. | 0409-4350-03 | 0409-4350 | ANDA075853 | ANDA | N/A |
| Dimethicone; Loperamide Hydrochloride | Tablet | Oral | 125mg/1, 2 mg/1 | 1 Blister Pack In 1 Carton (69452-210-04) / 6 Tablet In 1 Blister Pack | Bionpharma Inc. | 69452-210-04 | 69452-210 | ANDA213484 | ANDA | N/A |
| Dimethicone; Loperamide Hydrochloride | Tablet | Oral | 125mg/1, 2 mg/1 | 4 Blister Pack In 1 Carton (69452-210-12) / 6 Tablet In 1 Blister Pack | Bionpharma Inc. | 69452-210-12 | 69452-210 | ANDA213484 | ANDA | N/A |
| Dimethyl Fumarate | Capsule, Delayed Release | Oral | 240mg/1 | 60 Capsule, Delayed Release In 1 Bottle, Plastic (51407-441-60) | Golden State Medical Supply, Inc. | 51407-441-60 | 51407-441 | ANDA210382 | ANDA | N/A |
| Dimethyl Fumarate | Capsule, Delayed Release | Oral | 120mg/1 | 14 Capsule, Delayed Release In 1 Bottle, Plastic (51407-442-14) | Golden State Medical Supply, Inc. | 51407-442-14 | 51407-442 | ANDA210382 | ANDA | N/A |
| Diphenhydramine Hydrochloride | Gel | Topical | 2mg/100mL | 118 Ml In 1 Container (69452-376-55) | Bionpharma, Inc. | 69452-376-55 | 69452-376 | M017 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Capsule, Liquid Filled | Oral | 50mg/1 | 32 Capsule, Liquid Filled In 1 Bottle (69452-427-10) | BIONPHARMA INC. | 69452-427-10 | 69452-427 | M010 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Capsule, Liquid Filled | Oral | 50mg/1 | 60 Capsule, Liquid Filled In 1 Bottle (69452-427-17) | BIONPHARMA INC. | 69452-427-17 | 69452-427 | M010 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Capsule, Liquid Filled | Oral | 50mg/1 | 160 Capsule, Liquid Filled In 1 Bottle (69452-427-79) | BIONPHARMA INC. | 69452-427-79 | 69452-427 | M010 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Capsule, Liquid Filled | Oral | 50mg/1 | 160 Capsule, Liquid Filled In 1 Bottle (69452-322-79) | Bionpharma Inc. | 69452-322-79 | 69452-322 | M010 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Capsule | Oral | 50mg/1 | 2 Blister Pack In 1 Carton (50486-616-16) / 8 Capsule In 1 Blister Pack | Blairex Laboratories, Inc. | 50486-616-16 | 50486-616 | part338 | OTC MONOGRAPH FINAL | N/A |
| Diphenhydramine Hydrochloride | Capsule | Oral | 50mg/1 | 4 Blister Pack In 1 Carton (50486-616-32) / 8 Capsule In 1 Blister Pack | Blairex Laboratories, Inc. | 50486-616-32 | 50486-616 | part338 | OTC MONOGRAPH FINAL | N/A |
| Dexamethasone Sodium Phosphate | Injection, Solution | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 25 Vial, Multi-Dose In 1 Carton (70121-1451-5) / 5 Ml In 1 Vial, Multi-Dose (70121-1451-1) | Amneal Pharmaceuticals LLC | 70121-1451-5 | 70121-1451 | ANDA208689 | ANDA | N/A |
| Dexamethasone Sodium Phosphate | Injection, Solution | Intra-Articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | 4mg/mL | 1 Vial, Multi-Dose In 1 Carton (70121-1452-1) / 30 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1452-1 | 70121-1452 | ANDA208689 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 20 Bottle, Glass In 1 Carton (70121-1388-8) / 50 Ml In 1 Bottle, Glass (70121-1388-1) | Amneal Pharmaceuticals LLC | 70121-1388-8 | 70121-1388 | ANDA207551 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection, Solution | Intravenous | 4ug/mL | 10 Bottle, Glass In 1 Carton (70121-1389-7) / 100 Ml In 1 Bottle, Glass (70121-1389-1) | Amneal Pharmaceuticals LLC | 70121-1389-7 | 70121-1389 | ANDA207551 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection | Intravenous | 4ug/mL | 15 Pouch In 1 Carton (70121-1711-2) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1711-2 | 70121-1711 | ANDA216604 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection | Intravenous | 4ug/mL | 24 Pouch In 1 Carton (70121-1711-9) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1711-9 | 70121-1711 | ANDA216604 | ANDA | N/A |
| Diphenhydramine Hydrochloride | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Package (0641-0376-25) / 1 Ml In 1 Vial (0641-0376-21) | Hikma Pharmaceuticals USA Inc. | 0641-0376-25 | 0641-0376 | ANDA080817 | ANDA | N/A |
| Diphenhydramine Hydrochloride | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Package (0641-6282-25) / 1 Ml In 1 Vial (0641-6282-21) | Hikma Pharmaceuticals USA Inc. | 0641-6282-25 | 0641-6282 | ANDA080817 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 1 Blister Pack In 1 Carton (69452-205-04) / 6 Capsule, Liquid Filled In 1 Blister Pack | Bionpharma Inc. | 69452-205-04 | 69452-205 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 20 Capsule, Liquid Filled In 1 Bottle (69452-205-11) | Bionpharma Inc. | 69452-205-11 | 69452-205 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 40 Capsule, Liquid Filled In 1 Bottle (69452-205-15) | Bionpharma Inc. | 69452-205-15 | 69452-205 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (69452-205-20) | Bionpharma Inc. | 69452-205-20 | 69452-205 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 80 Capsule, Liquid Filled In 1 Bottle (69452-205-78) | Bionpharma Inc. | 69452-205-78 | 69452-205 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Ibuprofen | Capsule, Liquid Filled | Oral | 25mg/1, 200 mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (69452-264-22) | Bionpharma Inc. | 69452-264-22 | 69452-264 | ANDA090397 | ANDA | N/A |
| Diphenhydramine Hydrochloride; Zinc Acetate | Cream | Topical | 2g/100g, .1 g/100g | 1 Tube In 1 Carton (45802-358-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-358-03 | 45802-358 | M017 | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride; Zinc Acetate | Cream | Topical | 20mg/g, 1 mg/g | 1 Tube In 1 Carton (51672-2089-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2089-2 | 51672-2089 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Diphenhydramine Hydrochloride; Zinc Acetate | Cream | Topical | 20mg/g, 1 mg/g | 1 Tube In 1 Carton (69452-449-37) / 35.4 G In 1 Tube | Bionpharma Inc. | 69452-449-37 | 69452-449 | M017 | OTC MONOGRAPH DRUG | N/A |
| Dexmedetomidine Hydrochloride | Injection | Intravenous | 4ug/mL | 10 Pouch In 1 Carton (70121-1712-2) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1712-2 | 70121-1712 | ANDA216604 | ANDA | N/A |
| Dexmedetomidine Hydrochloride | Injection | Intravenous | 4ug/mL | 12 Pouch In 1 Carton (70121-1712-3) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1712-3 | 70121-1712 | ANDA216604 | ANDA | N/A |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 5mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-327-05) | Ascent Pharmaceuticals, Inc. | 43602-327-05 | 43602-327 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 5mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-327-30) | Ascent Pharmaceuticals, Inc. | 43602-327-30 | 43602-327 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 10mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-328-05) | Ascent Pharmaceuticals, Inc. | 43602-328-05 | 43602-328 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 10mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-328-30) | Ascent Pharmaceuticals, Inc. | 43602-328-30 | 43602-328 | ANDA215523 | ANDA | CII |
| Dipyridamole | Injection | Intravenous | 5mg/mL | 5 Vial In 1 Carton (0641-2569-44) / 10 Ml In 1 Vial (0641-2569-41) | Hikma Pharmaceuticals USA Inc. | 0641-2569-44 | 0641-2569 | ANDA074521 | ANDA | N/A |
| Disopyramide Phosphate | Capsule, Gelatin Coated | Oral | 100mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (0025-2752-31) | Pfizer Laboratories Div Pfizer Inc | 0025-2752-31 | 0025-2752 | NDA017447 | NDA | N/A |
| Disopyramide Phosphate | Capsule, Gelatin Coated | Oral | 150mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (0025-2762-31) | Pfizer Laboratories Div Pfizer Inc | 0025-2762-31 | 0025-2762 | NDA017447 | NDA | N/A |
| Disopyramide Phosphate | Capsule, Extended Release | Oral | 100mg/1 | 100 Capsule, Extended Release In 1 Bottle (0025-2732-31) | Pfizer Laboratories Div Pfizer Inc | 0025-2732-31 | 0025-2732 | NDA018655 | NDA | N/A |
| Disopyramide Phosphate | Capsule, Extended Release | Oral | 150mg/1 | 100 Capsule, Extended Release In 1 Bottle (0025-2742-31) | Pfizer Laboratories Div Pfizer Inc | 0025-2742-31 | 0025-2742 | NDA018655 | NDA | N/A |
| Disulfiram | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle, Plastic (47781-607-30) | Alvogen Inc. | 47781-607-30 | 47781-607 | ANDA091681 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 125mg/1 | 30 Tablet, Delayed Release In 1 Bottle (69452-433-13) | Bionpharma Inc. | 69452-433-13 | 69452-433 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 125mg/1 | 100 Tablet, Delayed Release In 1 Bottle (69452-433-20) | Bionpharma Inc. | 69452-433-20 | 69452-433 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 125mg/1 | 500 Tablet, Delayed Release In 1 Bottle (69452-433-30) | Bionpharma Inc. | 69452-433-30 | 69452-433 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 250mg/1 | 30 Tablet, Delayed Release In 1 Bottle (69452-434-13) | Bionpharma Inc. | 69452-434-13 | 69452-434 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 250mg/1 | 100 Tablet, Delayed Release In 1 Bottle (69452-434-20) | Bionpharma Inc. | 69452-434-20 | 69452-434 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 250mg/1 | 500 Tablet, Delayed Release In 1 Bottle (69452-434-30) | Bionpharma Inc. | 69452-434-30 | 69452-434 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 500mg/1 | 30 Tablet, Delayed Release In 1 Bottle (69452-435-13) | Bionpharma Inc. | 69452-435-13 | 69452-435 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 500mg/1 | 100 Tablet, Delayed Release In 1 Bottle (69452-435-20) | Bionpharma Inc. | 69452-435-20 | 69452-435 | ANDA078853 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 500mg/1 | 500 Tablet, Delayed Release In 1 Bottle (69452-435-30) | Bionpharma Inc. | 69452-435-30 | 69452-435 | ANDA078853 | ANDA | N/A |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 15mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-329-05) | Ascent Pharmaceuticals, Inc. | 43602-329-05 | 43602-329 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 15mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-329-30) | Ascent Pharmaceuticals, Inc. | 43602-329-30 | 43602-329 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 20mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-330-05) | Ascent Pharmaceuticals, Inc. | 43602-330-05 | 43602-330 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 20mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-330-30) | Ascent Pharmaceuticals, Inc. | 43602-330-30 | 43602-330 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 25mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-331-05) | Ascent Pharmaceuticals, Inc. | 43602-331-05 | 43602-331 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 25mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-331-30) | Ascent Pharmaceuticals, Inc. | 43602-331-30 | 43602-331 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 30mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-332-05) | Ascent Pharmaceuticals, Inc. | 43602-332-05 | 43602-332 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 30mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-332-30) | Ascent Pharmaceuticals, Inc. | 43602-332-30 | 43602-332 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 35mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-333-05) | Ascent Pharmaceuticals, Inc. | 43602-333-05 | 43602-333 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 35mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-333-30) | Ascent Pharmaceuticals, Inc. | 43602-333-30 | 43602-333 | ANDA215523 | ANDA | CII |
| Dobutamine Hydrochloride | Injection, Solution | Intravenous | 12.5mg/mL | 10 Vial In 1 Carton (0143-9141-10) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9141-10 | 0143-9141 | ANDA074277 | ANDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 12.5mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-2344-88) / 20 Ml In 1 Vial, Single-Dose (0409-2344-68) | Hospira, Inc. | 0409-2344-88 | 0409-2344 | ANDA074086 | ANDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 12.5mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-2344-01) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-2344-01 | 0409-2344 | ANDA074086 | ANDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 12.5mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-2344-02) / 20 Ml In 1 Vial, Single-Dose (0409-2344-62) | Hospira, Inc. | 0409-2344-02 | 0409-2344 | ANDA074086 | ANDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution | Intravenous | 400mg/100mL | 12 Pouch In 1 Case (0409-3724-32) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-3724-11) | Hospira, Inc. | 0409-3724-32 | 0409-3724 | NDA020201 | NDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution | Intravenous | 100mg/100mL | 12 Pouch In 1 Case (0409-2346-32) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-2346-31) | Hospira, Inc. | 0409-2346-32 | 0409-2346 | NDA020201 | NDA | N/A |
| Dobutamine Hydrochloride | Injection, Solution | Intravenous | 200mg/100mL | 12 Pouch In 1 Case (0409-2347-32) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-2347-31) | Hospira, Inc. | 0409-2347-32 | 0409-2347 | NDA020201 | NDA | N/A |
| Docetaxel | Injection, Solution, Concentrate | Intravenous | 20mg/mL | 1 Vial, Glass In 1 Carton (0143-9204-01) / 1 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9204-01 | 0143-9204 | ANDA204490 | ANDA | N/A |
| Docetaxel | Injection, Solution, Concentrate | Intravenous | 20mg/mL | 1 Vial, Glass In 1 Carton (0143-9205-01) / 4 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9205-01 | 0143-9205 | ANDA204490 | ANDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0365-01) / 8 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0365-01 | 0409-0365 | NDA022234 | NDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0366-01) / 1 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0366-01 | 0409-0366 | NDA022234 | NDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0367-01) / 4 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0367-01 | 0409-0367 | NDA022234 | NDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-4235-01) / 1 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-4235-01 | 0409-4235 | NDA022234 | NDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0368-01) / 8 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0368-01 | 0409-0368 | NDA022234 | NDA | N/A |
| Docetaxel | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-5068-01) / 4 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-5068-01 | 0409-5068 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-144-08) / 8 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc | 71288-144-08 | 71288-144 | ANDA209634 | ANDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-144-16) / 16 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc | 71288-144-16 | 71288-144 | ANDA209634 | ANDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 20mg/mL | 1 Vial In 1 Carton (25021-245-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-245-01 | 25021-245 | ANDA207252 | ANDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 20mg/mL | 1 Vial In 1 Carton (25021-245-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-245-04 | 25021-245 | ANDA207252 | ANDA | N/A |
| Docetaxel Anhydrous | Injection | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-254-08) / 8 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-254-08 | 25021-254 | ANDA213510 | ANDA | N/A |
| Docetaxel Anhydrous | Injection | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-254-16) / 16 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-254-16 | 25021-254 | ANDA213510 | ANDA | N/A |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 40mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-334-05) | Ascent Pharmaceuticals, Inc. | 43602-334-05 | 43602-334 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 40mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-334-30) | Ascent Pharmaceuticals, Inc. | 43602-334-30 | 43602-334 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 20mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-330-05) | Ascent Pharmaceuticals, Inc. | 43602-330-05 | 43602-330 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 20mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-330-30) | Ascent Pharmaceuticals, Inc. | 43602-330-30 | 43602-330 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 25mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-331-05) | Ascent Pharmaceuticals, Inc. | 43602-331-05 | 43602-331 | ANDA215523 | ANDA | CII |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-2026-01) / 2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-2026-01 | 0409-2026 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1732-01) / 16 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1732-01 | 0409-1732 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-7870-01) / 8 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-7870-01 | 0409-7870 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0201-02) / 2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0201-02 | 0409-0201 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0201-10) / 8 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0201-10 | 0409-0201 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0201-20) / 16 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0201-20 | 0409-0201 | NDA022234 | NDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-0016-01) / 16 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-0016-01 | 0409-0016 | NDA022234 | NDA | N/A |
| Docosanol | Cream | Topical | 100mg/g | 2 Tube In 1 Package (51672-1406-2) / 2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1406-2 | 51672-1406 | ANDA214454 | ANDA | N/A |
| Docosanol | Cream | Topical | 100mg/g | 1 Tube In 1 Package (51672-1406-3) / 2 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1406-3 | 51672-1406 | ANDA214454 | ANDA | N/A |
| Docosanol | Cream | Topical | 100mg/g | 1 Tube In 1 Carton (0713-0353-02) / 2 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0353-02 | 0713-0353 | ANDA215839 | ANDA | N/A |
| Docosanol | Cream | Topical | 100mg/g | 1 Bottle, Pump In 1 Carton (0713-0353-62) / 2 G In 1 Bottle, Pump | Cosette Pharmaceuticals, Inc. | 0713-0353-62 | 0713-0353 | ANDA215839 | ANDA | N/A |
| Docusate Sodium | Capsule, Liquid Filled | Oral | 100mg/1 | 100 Capsule, Liquid Filled In 1 Bottle (45802-486-78) | Padagis Israel Pharmaceuticals Ltd | 45802-486-78 | 45802-486 | M007 | OTC MONOGRAPH DRUG | N/A |
| Dofetilide | Capsule | Oral | .125mg/1 | 60 Capsule In 1 Bottle (51407-541-60) | Golden State Medical Supply, Inc. | 51407-541-60 | 51407-541 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .25mg/1 | 60 Capsule In 1 Bottle (51407-542-60) | Golden State Medical Supply, Inc. | 51407-542-60 | 51407-542 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .5mg/1 | 60 Capsule In 1 Bottle (51407-543-60) | Golden State Medical Supply, Inc. | 51407-543-60 | 51407-543 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .125mg/1 | 60 Capsule In 1 Bottle (69452-131-17) | Bionpharma Inc. | 69452-131-17 | 69452-131 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .25mg/1 | 60 Capsule In 1 Bottle (69452-132-17) | Bionpharma Inc. | 69452-132-17 | 69452-132 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .5mg/1 | 60 Capsule In 1 Bottle (69452-133-17) | Bionpharma Inc. | 69452-133-17 | 69452-133 | ANDA208625 | ANDA | N/A |
| Dofetilide | Capsule | Oral | .125mg/1 | 40 Blister Pack In 1 Carton (0069-5800-43) / 1 Capsule In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-5800-43 | 0069-5800 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .125mg/1 | 60 Capsule In 1 Bottle (0069-5800-60) | Pfizer Laboratories Div Pfizer Inc | 0069-5800-60 | 0069-5800 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .125mg/1 | 14 Capsule In 1 Bottle (0069-5800-61) | Pfizer Laboratories Div Pfizer Inc | 0069-5800-61 | 0069-5800 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .25mg/1 | 40 Blister Pack In 1 Carton (0069-5810-43) / 1 Capsule In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-5810-43 | 0069-5810 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .25mg/1 | 60 Capsule In 1 Bottle (0069-5810-60) | Pfizer Laboratories Div Pfizer Inc | 0069-5810-60 | 0069-5810 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .25mg/1 | 14 Capsule In 1 Bottle (0069-5810-61) | Pfizer Laboratories Div Pfizer Inc | 0069-5810-61 | 0069-5810 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .5mg/1 | 40 Blister Pack In 1 Carton (0069-5820-43) / 1 Capsule In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-5820-43 | 0069-5820 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .5mg/1 | 60 Capsule In 1 Bottle (0069-5820-60) | Pfizer Laboratories Div Pfizer Inc | 0069-5820-60 | 0069-5820 | NDA020931 | NDA | N/A |
| Dofetilide | Capsule | Oral | .5mg/1 | 14 Capsule In 1 Bottle (0069-5820-61) | Pfizer Laboratories Div Pfizer Inc | 0069-5820-61 | 0069-5820 | NDA020931 | NDA | N/A |
| Dolasetron Mesylate | Tablet, Film Coated | Oral | 50mg/1 | 10 Tablet, Film Coated In 1 Bottle (30698-220-10) | Validus Pharmaceuticals LLC | 30698-220-10 | 30698-220 | NDA020623 | NDA | N/A |
| Dolichovespula Arenaria Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 5.5 Ml In 1 Vial (65044-9942-5) | Jubilant HollisterStier LLC | 65044-9942-5 | 65044-9942 | BLA103886 | BLA | N/A |
| Dolichovespula Arenaria Venom Protein; Dolichovespula Maculata Venom Protein; Vespula Germanica Venom Protein; Vespula Maculifrons Venom Protein; Vespula Pensylvanica Venom Protein; Vespula Squamosa Venom Protein; Vespula Vulgaris Venom Protein | Injection, Powder, Lyophilized, For Solution | Subcutaneous | 100ug/mL, 100 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL | 13 Ml In 1 Vial (65044-9955-6) | Jubilant HollisterStier LLC | 65044-9955-6 | 65044-9955 | BLA103883 | BLA | N/A |
| Dolichovespula Arenaria Venom Protein; Dolichovespula Maculata Venom Protein; Vespula Germanica Venom Protein; Vespula Maculifrons Venom Protein; Vespula Pensylvanica Venom Protein; Vespula Squamosa Venom Protein; Vespula Vulgaris Venom Protein | Injection, Powder, Lyophilized, For Solution | Subcutaneous | 100ug/mL, 100 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL | 5.5 Ml In 1 Vial (65044-9945-5) | Jubilant HollisterStier LLC | 65044-9945-5 | 65044-9945 | BLA103883 | BLA | N/A |
| Dolichovespula Maculata Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 5.5 Ml In 1 Vial (65044-9941-5) | Jubilant HollisterStier LLC | 65044-9941-5 | 65044-9941 | BLA103885 | BLA | N/A |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 25mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-331-30) | Ascent Pharmaceuticals, Inc. | 43602-331-30 | 43602-331 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 30mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-332-05) | Ascent Pharmaceuticals, Inc. | 43602-332-05 | 43602-332 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 30mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-332-30) | Ascent Pharmaceuticals, Inc. | 43602-332-30 | 43602-332 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 35mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-333-05) | Ascent Pharmaceuticals, Inc. | 43602-333-05 | 43602-333 | ANDA215523 | ANDA | CII |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-321-10) | Golden State Medical Supply, Inc. | 60429-321-10 | 60429-321 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-321-30) | Golden State Medical Supply, Inc. | 60429-321-30 | 60429-321 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-321-90) | Golden State Medical Supply, Inc. | 60429-321-90 | 60429-321 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-322-10) | Golden State Medical Supply, Inc. | 60429-322-10 | 60429-322 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-322-30) | Golden State Medical Supply, Inc. | 60429-322-30 | 60429-322 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-322-90) | Golden State Medical Supply, Inc. | 60429-322-90 | 60429-322 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 5mg/1 | 1 Patch In 1 Pouch (65038-055-01) | Corium, LLC. | 65038-055-01 | 65038-055 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 5mg/1 | 4 Pouch In 1 Carton (65038-055-03) / 1 Patch In 1 Pouch (65038-055-01) | Corium, LLC. | 65038-055-03 | 65038-055 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 5mg/1 | 1 Pouch In 1 Carton (65038-055-04) / 1 Patch In 1 Pouch (65038-055-10) | Corium, LLC. | 65038-055-04 | 65038-055 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 5mg/1 | 1 Patch In 1 Pouch (65038-055-10) | Corium, LLC. | 65038-055-10 | 65038-055 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 10mg/1 | 1 Patch In 1 Pouch (65038-056-01) | Corium, LLC. | 65038-056-01 | 65038-056 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 10mg/1 | 4 Pouch In 1 Carton (65038-056-03) / 1 Patch In 1 Pouch (65038-056-01) | Corium, LLC. | 65038-056-03 | 65038-056 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 10mg/1 | 1 Pouch In 1 Carton (65038-056-04) / 1 Patch In 1 Pouch (65038-056-10) | Corium, LLC. | 65038-056-04 | 65038-056 | NDA212304 | NDA | N/A |
| Donepezil Hydrochloride | Patch | Transdermal | 10mg/1 | 1 Patch In 1 Pouch (65038-056-10) | Corium, LLC. | 65038-056-10 | 65038-056 | NDA212304 | NDA | N/A |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 35mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-333-30) | Ascent Pharmaceuticals, Inc. | 43602-333-30 | 43602-333 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 40mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-334-05) | Ascent Pharmaceuticals, Inc. | 43602-334-05 | 43602-334 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 40mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-334-30) | Ascent Pharmaceuticals, Inc. | 43602-334-30 | 43602-334 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 5mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-327-05) | Ascent Pharmaceuticals, Inc. | 43602-327-05 | 43602-327 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 5mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-327-30) | Ascent Pharmaceuticals, Inc. | 43602-327-30 | 43602-327 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 10mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-328-05) | Ascent Pharmaceuticals, Inc. | 43602-328-05 | 43602-328 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 10mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-328-30) | Ascent Pharmaceuticals, Inc. | 43602-328-30 | 43602-328 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 15mg/1 | 500 Capsule, Extended Release In 1 Bottle (43602-329-05) | Ascent Pharmaceuticals, Inc. | 43602-329-05 | 43602-329 | ANDA215523 | ANDA | CII |
| Dexmethylphenidate Hydrochloride | Capsule, Extended Release | Oral | 15mg/1 | 30 Capsule, Extended Release In 1 Bottle (43602-329-30) | Ascent Pharmaceuticals, Inc. | 43602-329-30 | 43602-329 | ANDA215523 | ANDA | CII |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 5mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-229-01) | Camber Pharmaceuticals, Inc. | 31722-229-01 | 31722-229 | ANDA215523 | ANDA | CII |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 10mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-230-01) | Camber Pharmaceuticals, Inc. | 31722-230-01 | 31722-230 | ANDA215523 | ANDA | CII |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 15mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-231-01) | Camber Pharmaceuticals, Inc. | 31722-231-01 | 31722-231 | ANDA215523 | ANDA | CII |
| Dopamine Hydrochloride | Injection | Intravenous | 40mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9252-25) / 5 Ml In 1 Vial, Single-Dose (0143-9252-01) | Hikma Pharmaceuticals USA Inc. | 0143-9252-25 | 0143-9252 | ANDA207707 | ANDA | N/A |
| Dopamine Hydrochloride | Injection | Intravenous | 80mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9253-25) / 5 Ml In 1 Vial, Single-Dose (0143-9253-01) | Hikma Pharmaceuticals USA Inc. | 0143-9253-25 | 0143-9253 | ANDA207707 | ANDA | N/A |
| Dopamine Hydrochloride | Injection | Intravenous | 40mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9254-25) / 10 Ml In 1 Vial, Single-Dose (0143-9254-01) | Hikma Pharmaceuticals USA Inc. | 0143-9254-25 | 0143-9254 | ANDA207707 | ANDA | N/A |
| Dopamine Hydrochloride | Injection | Intravenous | 80mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9255-25) / 10 Ml In 1 Vial, Single-Dose (0143-9255-01) | Hikma Pharmaceuticals USA Inc. | 0143-9255-25 | 0143-9255 | ANDA207707 | ANDA | N/A |
| Dopamine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 40mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-5820-01) / 5 Ml In 1 Vial, Single-Dose (0409-5820-11) | Hospira, Inc. | 0409-5820-01 | 0409-5820 | NDA018132 | NDA | N/A |
| Dopamine Hydrochloride | Injection, Solution, Concentrate | Intravenous | 40mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-9104-20) / 10 Ml In 1 Vial, Single-Dose (0409-9104-21) | Hospira, Inc. | 0409-9104-20 | 0409-9104 | NDA018132 | NDA | N/A |
| Dopamine Hydrochloride | Injection, Solution | Intravenous | 1.6mg/mL | 12 Bag In 1 Carton (0409-7809-22) / 250 Ml In 1 Bag (0409-7809-11) | Hospira, Inc. | 0409-7809-22 | 0409-7809 | NDA018826 | NDA | N/A |
| Dopamine Hydrochloride | Injection, Solution | Intravenous | 1.6mg/mL | 12 Bag In 1 Carton (0409-7809-24) / 500 Ml In 1 Bag (0409-7809-31) | Hospira, Inc. | 0409-7809-24 | 0409-7809 | NDA018826 | NDA | N/A |
| Dopamine Hydrochloride | Injection, Solution | Intravenous | 3.2mg/mL | 12 Bag In 1 Carton (0409-7810-22) / 250 Ml In 1 Bag (0409-7810-11) | Hospira, Inc. | 0409-7810-22 | 0409-7810 | NDA018826 | NDA | N/A |
| Dorzolamide Hydrochloride | Solution/ Drops | Ophthalmic | 20mg/mL | 1 Bottle In 1 Carton (60429-114-10) / 10 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 60429-114-10 | 60429-114 | ANDA077846 | ANDA | N/A |
| Dorzolamide Hydrochloride | Solution | Ophthalmic | 20mg/mL | 1 Bottle In 1 Carton (69315-304-05) / 5 Ml In 1 Bottle | Leading Pharma, LLC | 69315-304-05 | 69315-304 | ANDA205294 | ANDA | N/A |
| Dorzolamide Hydrochloride | Solution | Ophthalmic | 20mg/mL | 1 Bottle In 1 Carton (69315-304-10) / 10 Ml In 1 Bottle | Leading Pharma, LLC | 69315-304-10 | 69315-304 | ANDA205294 | ANDA | N/A |
| Dorzolamide Hydrochloride; Timolol Maleate | Solution | Ophthalmic | 20mg/mL, 5 mg/mL | 1 Bottle In 1 Carton (70069-051-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-051-01 | 70069-051 | ANDA207523 | ANDA | N/A |
| Dorzolamide Hydrochloride; Timolol Maleate | Solution/ Drops | Ophthalmic | 20mg/mL, 5 mg/mL | 1 Bottle, Dropper In 1 Box (60429-115-10) / 10 Ml In 1 Bottle, Dropper | Golden State Medical Supply, Inc. | 60429-115-10 | 60429-115 | ANDA077847 | ANDA | N/A |
| Dorzolamide Hydrochloride; Timolol Maleate | Solution | Ophthalmic | 20mg/mL, 5 mg/mL | 1 Bottle, Plastic In 1 Carton (69315-305-05) / 5 Ml In 1 Bottle, Plastic | Leading Pharma, LLC | 69315-305-05 | 69315-305 | ANDA205295 | ANDA | N/A |
| Dorzolamide Hydrochloride; Timolol Maleate | Solution | Ophthalmic | 20mg/mL, 5 mg/mL | 1 Bottle, Plastic In 1 Carton (69315-305-10) / 10 Ml In 1 Bottle, Plastic | Leading Pharma, LLC | 69315-305-10 | 69315-305 | ANDA205295 | ANDA | N/A |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 20mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-232-01) | Camber Pharmaceuticals, Inc. | 31722-232-01 | 31722-232 | ANDA215523 | ANDA | CII |
| Doxapram Hydrochloride | Injection | Intravenous | 20mg/mL | 20 Ml In 1 Vial (0641-6018-01) | Hikma Pharmaceuticals USA Inc. | 0641-6018-01 | 0641-6018 | NDA014879 | NDA | N/A |
| Doxapram Hydrochloride | Injection | Intravenous | 20mg/mL | 6 Vial In 1 Carton (0641-6018-06) / 20 Ml In 1 Vial (0641-6018-01) | Hikma Pharmaceuticals USA Inc. | 0641-6018-06 | 0641-6018 | NDA014879 | NDA | N/A |
| Doxazosin Mesylate | Tablet, Film Coated, Extended Release | Oral | 4mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (58151-078-93) | Viatris Specialty LLC | 58151-078-93 | 58151-078 | NDA021269 | NDA | N/A |
| Doxazosin Mesylate | Tablet, Film Coated, Extended Release | Oral | 8mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (58151-079-93) | Viatris Specialty LLC | 58151-079-93 | 58151-079 | NDA021269 | NDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (60505-0093-0) | Apotex Corp. | 60505-0093-0 | 60505-0093 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (60505-0093-1) | Apotex Corp. | 60505-0093-1 | 60505-0093 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (60505-0094-0) | Apotex Corp. | 60505-0094-0 | 60505-0094 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (60505-0094-1) | Apotex Corp. | 60505-0094-1 | 60505-0094 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (60505-0095-0) | Apotex Corp. | 60505-0095-0 | 60505-0095 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (60505-0095-1) | Apotex Corp. | 60505-0095-1 | 60505-0095 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 8mg/1 | 100 Tablet In 1 Bottle (60505-0096-0) | Apotex Corp. | 60505-0096-0 | 60505-0096 | ANDA075580 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 8mg/1 | 1000 Tablet In 1 Bottle (60505-0096-1) | Apotex Corp. | 60505-0096-1 | 60505-0096 | ANDA075580 | ANDA | N/A |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 25mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-233-01) | Camber Pharmaceuticals, Inc. | 31722-233-01 | 31722-233 | ANDA215523 | ANDA | CII |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | Capsule, Extended Release | Oral | 30mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-234-01) | Camber Pharmaceuticals, Inc. | 31722-234-01 | 31722-234 | ANDA215523 | ANDA | CII |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Capsule, Extended Release | Oral | 3.75mg/1, 3.75 mg/1, 3.75 mg/1, 3.75 mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-187-01) | Camber Pharmaceuticals, Inc. | 31722-187-01 | 31722-187 | ANDA214959 | ANDA | CII |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Capsule, Extended Release | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-188-01) | Camber Pharmaceuticals, Inc. | 31722-188-01 | 31722-188 | ANDA214959 | ANDA | CII |
| Doxepin Hydrochloride | Tablet | Oral | 3mg/1 | 30 Tablet In 1 Bottle (51407-811-30) | Golden State Medical Supply, Inc. | 51407-811-30 | 51407-811 | ANDA214823 | ANDA | N/A |
| Doxepin Hydrochloride | Tablet | Oral | 6mg/1 | 30 Tablet In 1 Bottle (51407-812-30) | Golden State Medical Supply, Inc. | 51407-812-30 | 51407-812 | ANDA214823 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-966-01) | Golden State Medical Supply, Inc. | 60429-966-01 | 60429-966 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle, Plastic (60429-966-10) | Golden State Medical Supply, Inc. | 60429-966-10 | 60429-966 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-967-01) | Golden State Medical Supply, Inc. | 60429-967-01 | 60429-967 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle, Plastic (60429-967-10) | Golden State Medical Supply, Inc. | 60429-967-10 | 60429-967 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-968-01) | Golden State Medical Supply, Inc. | 60429-968-01 | 60429-968 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle, Plastic (60429-968-10) | Golden State Medical Supply, Inc. | 60429-968-10 | 60429-968 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-969-01) | Golden State Medical Supply, Inc. | 60429-969-01 | 60429-969 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Bottle, Plastic (60429-969-10) | Golden State Medical Supply, Inc. | 60429-969-10 | 60429-969 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-970-01) | Golden State Medical Supply, Inc. | 60429-970-01 | 60429-970 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle, Plastic (60429-970-10) | Golden State Medical Supply, Inc. | 60429-970-10 | 60429-970 | ANDA070791 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (51672-4217-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4217-1 | 51672-4217 | ANDA213063 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (51672-4218-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4218-1 | 51672-4218 | ANDA213063 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (51672-4219-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4219-1 | 51672-4219 | ANDA213063 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (51672-4220-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4220-1 | 51672-4220 | ANDA213063 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (51672-4221-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4221-1 | 51672-4221 | ANDA213063 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Package (69315-158-01) | Leading Pharma, LLC | 69315-158-01 | 69315-158 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Package (69315-158-10) | Leading Pharma, LLC | 69315-158-10 | 69315-158 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Package (69315-159-01) | Leading Pharma, LLC | 69315-159-01 | 69315-159 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Package (69315-159-10) | Leading Pharma, LLC | 69315-159-10 | 69315-159 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Package (69315-160-01) | Leading Pharma, LLC | 69315-160-01 | 69315-160 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Package (69315-160-10) | Leading Pharma, LLC | 69315-160-10 | 69315-160 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Package (69315-161-01) | Leading Pharma, LLC | 69315-161-01 | 69315-161 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Package (69315-161-10) | Leading Pharma, LLC | 69315-161-10 | 69315-161 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Package (69315-162-01) | Leading Pharma, LLC | 69315-162-01 | 69315-162 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Package (69315-162-10) | Leading Pharma, LLC | 69315-162-10 | 69315-162 | ANDA211619 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Package (69315-163-01) | Leading Pharma, LLC | 69315-163-01 | 69315-163 | ANDA211618 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Package (69315-163-05) | Leading Pharma, LLC | 69315-163-05 | 69315-163 | ANDA211618 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 150mg/1 | 50 Capsule In 1 Package (69315-163-50) | Leading Pharma, LLC | 69315-163-50 | 69315-163 | ANDA211618 | ANDA | N/A |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Capsule, Extended Release | Oral | 6.25mg/1, 6.25 mg/1, 6.25 mg/1, 6.25 mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-189-01) | Camber Pharmaceuticals, Inc. | 31722-189-01 | 31722-189 | ANDA214959 | ANDA | CII |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Capsule, Extended Release | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Capsule, Extended Release In 1 Bottle (31722-195-01) | Camber Pharmaceuticals, Inc. | 31722-195-01 | 31722-195 | ANDA214959 | ANDA | CII |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Tablet | Oral | 5mg/1, 5 mg/1, 5 mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (31722-163-01) | Camber Pharmaceuticals, Inc. | 31722-163-01 | 31722-163 | ANDA213709 | ANDA | CII |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Tablet | Oral | 7.5mg/1, 7.5 mg/1, 7.5 mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (31722-164-01) | Camber Pharmaceuticals, Inc. | 31722-164-01 | 31722-164 | ANDA213709 | ANDA | CII |
| Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 5mg/1 | 1 Bottle In 1 Carton (64896-673-10) / 90 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-673-10 | 64896-673 | NDA017078 | NDA | CII |
| Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 10mg/1 | 1 Bottle In 1 Carton (64896-674-10) / 90 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-674-10 | 64896-674 | NDA017078 | NDA | CII |
| Dextroamphetamine Sulfate | Capsule, Extended Release | Oral | 15mg/1 | 1 Bottle In 1 Carton (64896-675-10) / 90 Capsule, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 64896-675-10 | 64896-675 | NDA017078 | NDA | CII |
| Dextromethorphan Hydrobromide | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (65162-700-76) / 89 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-700-76 | 65162-700 | ANDA203133 | ANDA | N/A |
| Dextromethorphan Hydrobromide | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (65162-700-77) / 148 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-700-77 | 65162-700 | ANDA203133 | ANDA | N/A |
| Dextromethorphan Hydrobromide | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (65162-799-76) / 89 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-799-76 | 65162-799 | ANDA203133 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (59746-700-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-700-01 | 59746-700 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle, Plastic (59746-700-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-700-05 | 59746-700 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 90 Capsule In 1 Bottle, Plastic (59746-700-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-700-90 | 59746-700 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle, Plastic (59746-701-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-701-01 | 59746-701 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 500 Capsule In 1 Bottle, Plastic (59746-701-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-701-05 | 59746-701 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle, Plastic (59746-701-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-701-90 | 59746-701 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle, Plastic (59746-702-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-702-01 | 59746-702 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle, Plastic (59746-702-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-702-05 | 59746-702 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle, Plastic (59746-702-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-702-90 | 59746-702 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle, Plastic (59746-703-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-703-01 | 59746-703 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 500 Capsule In 1 Bottle, Plastic (59746-703-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-703-05 | 59746-703 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle, Plastic (59746-703-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-703-90 | 59746-703 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (59746-704-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-704-01 | 59746-704 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (59746-704-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-704-05 | 59746-704 | ANDA215483 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle, Plastic (59746-704-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-704-90 | 59746-704 | ANDA215483 | ANDA | N/A |
| Dextromethorphan Hydrobromide | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (65162-799-77) / 148 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-799-77 | 65162-799 | ANDA203133 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 30mg/1, 600 mg/1 | 1 Bottle In 1 Carton (65162-038-03) / 30 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-038-03 | 65162-038 | ANDA209692 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 30mg/1, 600 mg/1 | 1 Bottle In 1 Carton (65162-038-06) / 60 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-038-06 | 65162-038 | ANDA209692 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 30mg/1, 600 mg/1 | 2 Blister Pack In 1 Carton (65162-038-17) / 10 Tablet, Extended Release In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-038-17 | 65162-038 | ANDA209692 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 60mg/1, 1200 mg/1 | 1 Bottle In 1 Carton (65162-039-03) / 30 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-039-03 | 65162-039 | ANDA209692 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 4ug/2mL | 25 Vial, Multi-Dose In 1 Carton (71288-802-04) / 2 Ml In 1 Vial, Multi-Dose (71288-802-02) | Meitheal Pharmaceuticals Inc. | 71288-802-04 | 71288-802 | ANDA211670 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 60mg/1, 1200 mg/1 | 1 Bottle In 1 Carton (65162-039-06) / 60 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-039-06 | 65162-039 | ANDA209692 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release | Oral | 60mg/1, 1200 mg/1 | 2 Blister Pack In 1 Carton (65162-039-17) / 10 Tablet, Extended Release In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-039-17 | 65162-039 | ANDA209692 | ANDA | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Solution | Oral | 10mg/5mL, 100 mg/5mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-312-51) / 5 Ml In 1 Cup, Unit-Dose (57237-312-05) | Rising Pharma Holdings, Inc. | 57237-312-51 | 57237-312 | part341 | OTC MONOGRAPH FINAL | N/A |
| Dextromethorphan Hydrobromide; Guaifenesin | Solution | Oral | 20mg/10mL, 200 mg/10mL | 80 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-313-18) / 10 Ml In 1 Cup, Unit-Dose (57237-313-01) | Rising Pharma Holdings, Inc. | 57237-313-18 | 57237-313 | part341 | OTC MONOGRAPH FINAL | N/A |
| Diatrizoate Meglumine and Diatrizoate Sodium | Solution | Oral; Rectal | 660mg/mL, 100 mg/mL | 24 Bottle In 1 Box (31722-019-31) / 30 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-019-31 | 31722-019 | ANDA215049 | ANDA | N/A |
| Doxercalciferol | Injection | Intravenous | 2ug/mL | 25 Ampule In 1 Box (0641-6154-25) / 2 Ml In 1 Ampule (0641-6154-01) | Hikma Pharmaceuticals USA Inc. | 0641-6154-25 | 0641-6154 | ANDA091101 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Carton (25021-207-25) / 25 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-207-25 | 25021-207 | ANDA209825 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Carton (25021-207-51) / 100 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-207-51 | 25021-207 | ANDA209825 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9369-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9369-01 | 0143-9369 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9370-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9370-01 | 0143-9370 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9371-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9371-01 | 0143-9371 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Box (0143-9372-01) / 100 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9372-01 | 0143-9372 | ANDA064097 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9275-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9275-01 | 0143-9275 | ANDA062921 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9277-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9277-01 | 0143-9277 | ANDA062921 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Box (0143-9546-01) / 100 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9546-01 | 0143-9546 | ANDA064097 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9547-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9547-01 | 0143-9547 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9548-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9548-01 | 0143-9548 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 10 Vial In 1 Box (0143-9548-10) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9548-10 | 0143-9548 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9549-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9549-01 | 0143-9549 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 10 Vial In 1 Box (0143-9549-10) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9549-10 | 0143-9549 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9084-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9084-01 | 0143-9084 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9085-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9085-01 | 0143-9085 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9086-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9086-01 | 0143-9086 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Box (0143-9087-01) / 100 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9087-01 | 0143-9087 | ANDA064097 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9088-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9088-01 | 0143-9088 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9089-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9089-01 | 0143-9089 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9090-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9090-01 | 0143-9090 | ANDA062975 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Box (0143-9091-01) / 100 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9091-01 | 0143-9091 | ANDA064097 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9092-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9092-01 | 0143-9092 | ANDA062921 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9093-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9093-01 | 0143-9093 | ANDA062921 | ANDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (0069-3034-20) / 100 Ml In 1 Vial, Multi-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-3034-20 | 0069-3034 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (0069-1542-20) / 100 Ml In 1 Vial, Multi-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-1542-20 | 0069-1542 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-4004-05) / 5 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-4004-05 | 0069-4004 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-4015-10) / 10 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-4015-10 | 0069-4015 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-4026-25) / 25 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-4026-25 | 0069-4026 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (0069-4037-01) / 100 Ml In 1 Vial, Multi-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-4037-01 | 0069-4037 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-0358-20) / 5 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-0358-20 | 0069-0358 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-0277-02) / 10 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-0277-02 | 0069-0277 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-3030-20) / 5 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-3030-20 | 0069-3030 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-3031-20) / 10 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-3031-20 | 0069-3031 | NDA050629 | NDA | N/A |
| Doxorubicin Hydrochloride | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0069-3032-20) / 25 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-3032-20 | 0069-3032 | NDA050629 | NDA | N/A |
| Doxycycline | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (66993-815-30) | Prasco Laboratories | 66993-815-30 | 66993-815 | NDA050805 | NDA AUTHORIZED GENERIC | N/A |
| Doxycycline | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (51407-387-01) | Golden State Medical Supply, Inc. | 51407-387-01 | 51407-387 | ANDA065055 | ANDA | N/A |
| Doxycycline | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (0713-0570-01) | Cosette Pharmaceuticals, Inc. | 0713-0570-01 | 0713-0570 | ANDA204446 | ANDA | N/A |
| Doxycycline | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (0713-0571-01) | Cosette Pharmaceuticals, Inc. | 0713-0571-01 | 0713-0571 | ANDA204446 | ANDA | N/A |
| Doxycycline | Capsule | Oral | 100mg/1 | 50 Capsule In 1 Bottle (0713-0572-50) | Cosette Pharmaceuticals, Inc. | 0713-0572-50 | 0713-0572 | ANDA204446 | ANDA | N/A |
| Doxycycline | Capsule | Oral | 100mg/1 | 250 Capsule In 1 Bottle (0713-0572-93) | Cosette Pharmaceuticals, Inc. | 0713-0572-93 | 0713-0572 | ANDA204446 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 20 Tablet, Coated In 1 Bottle, Plastic (60760-215-20) | St Marys Medical Park Pharmacy | 60760-215-20 | 60760-215 | ANDA065095 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 20 Capsule In 1 Bottle, Plastic (60760-721-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-721-20 | 60760-721 | ANDA209402 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-723-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-723-20 | 60760-723 | ANDA211343 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-723-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-723-60 | 60760-723 | ANDA211343 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-651-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-651-20 | 60760-651 | ANDA207773 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-651-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-651-60 | 60760-651 | ANDA207773 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 20 Tablet, Coated In 1 Bottle (60429-069-20) | Golden State Medical Supply, Inc. | 60429-069-20 | 60429-069 | ANDA065095 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Film Coated | Oral | 100mg/1 | 20 Tablet, Film Coated In 1 Bottle (51407-298-20) | Golden State Medical Supply, Inc. | 51407-298-20 | 51407-298 | ANDA062505 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 50 Capsule In 1 Bottle (27808-233-01) | Tris Pharma Inc | 27808-233-01 | 27808-233 | ANDA209402 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (27808-233-02) | Tris Pharma Inc | 27808-233-02 | 27808-233 | ANDA209402 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 50 Tablet In 1 Bottle (27808-234-01) | Tris Pharma Inc | 27808-234-01 | 27808-234 | ANDA211343 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (27808-234-02) | Tris Pharma Inc | 27808-234-02 | 27808-234 | ANDA211343 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 75mg/1 | 60 Tablet, Coated In 1 Bottle (60505-4382-6) | Apotex Corp. | 60505-4382-6 | 60505-4382 | ANDA209243 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 150mg/1 | 60 Tablet, Coated In 1 Bottle (60505-4384-6) | Apotex Corp. | 60505-4384-6 | 60505-4384 | ANDA209243 | ANDA | N/A |
| Diatrizoate Meglumine and Diatrizoate Sodium | Solution | Oral; Rectal | 660mg/mL, 100 mg/mL | 12 Bottle In 1 Box (31722-019-32) / 120 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-019-32 | 31722-019 | ANDA215049 | ANDA | N/A |
| Diclofenac potassium | Powder, For Solution | Oral | 50mg/1 | 1 Powder, For Solution In 1 Packet (31722-046-31) | Camber Pharmaceuticals, Inc. | 31722-046-31 | 31722-046 | ANDA215375 | ANDA | N/A |
| Diclofenac potassium | Powder, For Solution | Oral | 50mg/1 | 9 Powder, For Solution In 1 Carton (31722-046-32) | Camber Pharmaceuticals, Inc. | 31722-046-32 | 31722-046 | ANDA215375 | ANDA | N/A |
| Diclofenac Potassium | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (50742-279-01) | Ingenus Pharmaceuticals, LLC | 50742-279-01 | 50742-279 | ANDA215585 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 20mg/g | 1 Bottle In 1 Carton (65162-683-12) / 112 G In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-683-12 | 65162-683 | ANDA208198 | ANDA | N/A |
| Diclofenac Sodium | Solution | Topical | 16.05mg/mL | 1 Bottle In 1 Carton (65162-911-74) / 150 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-911-74 | 65162-911 | ANDA206116 | ANDA | N/A |
| Diclofenac Sodium | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (65162-833-66) / 100 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-833-66 | 65162-833 | ANDA208077 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (50742-278-01) | Ingenus Pharmaceuticals, LLC | 50742-278-01 | 50742-278 | ANDA216275 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (16571-201-06) | Rising Pharma Holdings, Inc. | 16571-201-06 | 16571-201 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 100 Tablet, Delayed Release In 1 Bottle (16571-201-10) | Rising Pharma Holdings, Inc. | 16571-201-10 | 16571-201 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (16571-201-11) | Rising Pharma Holdings, Inc. | 16571-201-11 | 16571-201 | ANDA077863 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 500 Tablet, Coated In 1 Bottle (42192-501-05) | Acella Pharmaceuticals, LLC | 42192-501-05 | 42192-501 | ANDA210664 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 50 Tablet, Coated In 1 Bottle (42192-501-50) | Acella Pharmaceuticals, LLC | 42192-501-50 | 42192-501 | ANDA210664 | ANDA | N/A |
| Doxycycline Hyclate | Injection, Powder, For Solution | Intravenous | 100mg/1 | 10 Vial In 1 Carton (0143-9381-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9381-01) | Hikma Pharmaceuticals USA Inc. | 0143-9381-10 | 0143-9381 | ANDA062992 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 500 Tablet, Coated In 1 Bottle (0143-2112-05) | Hikma Pharmaceuticals USA Inc. | 0143-2112-05 | 0143-2112 | ANDA065095 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 100mg/1 | 50 Tablet, Coated In 1 Bottle (0143-2112-50) | Hikma Pharmaceuticals USA Inc. | 0143-2112-50 | 0143-2112 | ANDA065095 | ANDA | N/A |
| Doxycycline Hyclate | Capsule, Gelatin Coated | Oral | 50mg/1 | 50 Capsule, Gelatin Coated In 1 Bottle (0143-3141-50) | Hikma Pharmaceuticals USA Inc. | 0143-3141-50 | 0143-3141 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule, Gelatin Coated | Oral | 100mg/1 | 500 Capsule, Gelatin Coated In 1 Bottle, Plastic (0143-3142-05) | Hikma Pharmaceuticals USA Inc. | 0143-3142-05 | 0143-3142 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule, Gelatin Coated | Oral | 100mg/1 | 50 Capsule, Gelatin Coated In 1 Bottle, Plastic (0143-3142-50) | Hikma Pharmaceuticals USA Inc. | 0143-3142-50 | 0143-3142 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 50mg/1 | 50 Capsule In 1 Bottle, Plastic (0143-9802-50) | Hikma Pharmaceuticals USA Inc. | 0143-9802-50 | 0143-9802 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (0143-9803-05) | Hikma Pharmaceuticals USA Inc. | 0143-9803-05 | 0143-9803 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 50 Capsule In 1 Bottle, Plastic (0143-9803-50) | Hikma Pharmaceuticals USA Inc. | 0143-9803-50 | 0143-9803 | ANDA062396 | ANDA | N/A |
| Doxycycline Hyclate | Capsule | Oral | 100mg/1 | 50 Capsule In 1 Bottle (0069-0950-50) | Pfizer Laboratories Div Pfizer Inc | 0069-0950-50 | 0069-0950 | NDA050007 | NDA | N/A |
| Doxylamine Succinate; Pyridoxine Hydrochloride | Tablet, Delayed Release | Oral | 10mg/1, 10 mg/1 | 100 Tablet, Delayed Release In 1 Bottle (69452-206-20) | Bionpharma Inc., | 69452-206-20 | 69452-206 | ANDA217000 | ANDA | N/A |
| Droperidol | Injection, Solution | Intramuscular; Intravenous | 2.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-9702-25) / 2 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-9702-25 | 0517-9702 | ANDA072123 | ANDA | N/A |
| Droperidol | Injection, Solution | Intramuscular; Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (0143-9514-25) / 2 Ml In 1 Vial (0143-9514-01) | Hikma Pharmaceuticals USA Inc. | 0143-9514-25 | 0143-9514 | ANDA208197 | ANDA | N/A |
| Droperidol | Injection, Solution | Intramuscular; Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (0143-9515-25) / 1 Ml In 1 Vial (0143-9515-01) | Hikma Pharmaceuticals USA Inc. | 0143-9515-25 | 0143-9515 | ANDA208197 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 75mg/1 | 500 Tablet, Delayed Release In 1 Bottle (16571-201-50) | Rising Pharma Holdings, Inc. | 16571-201-50 | 16571-201 | ANDA077863 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 60 Tablet, Delayed Release In 1 Bottle (16571-202-06) | Rising Pharma Holdings, Inc. | 16571-202-06 | 16571-202 | ANDA090066 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 100 Tablet, Delayed Release In 1 Bottle (16571-202-10) | Rising Pharma Holdings, Inc. | 16571-202-10 | 16571-202 | ANDA090066 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 50mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (16571-202-11) | Rising Pharma Holdings, Inc. | 16571-202-11 | 16571-202 | ANDA090066 | ANDA | N/A |
| Diclofenac Sodium | Tablet, Delayed Release | Oral | 25mg/1 | 100 Tablet, Delayed Release In 1 Bottle (16571-203-10) | Rising Pharma Holdings, Inc. | 16571-203-10 | 16571-203 | ANDA090066 | ANDA | N/A |
| Diclofenac Sodium | Solution/ Drops | Ophthalmic | 1mg/mL | 48 Bottle In 1 Case (16571-101-25) / 2.5 Ml In 1 Bottle | Rising Pharmaceuticals, Inc. | 16571-101-25 | 16571-101 | ANDA078553 | ANDA | N/A |
| Diclofenac Sodium | Solution/ Drops | Ophthalmic | 1mg/mL | 48 Bottle In 1 Case (16571-101-50) / 5 Ml In 1 Bottle | Rising Pharmaceuticals, Inc. | 16571-101-50 | 16571-101 | ANDA078553 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 30 Tablet, Delayed Release In 1 Bottle (65162-436-03) | Amneal Pharmaceuticals LLC | 65162-436-03 | 65162-436 | ANDA203995 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 60 Tablet, Delayed Release In 1 Bottle (65162-436-06) | Amneal Pharmaceuticals LLC | 65162-436-06 | 65162-436 | ANDA203995 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (51407-765-90) | Golden State Medical Supply, Inc. | 51407-765-90 | 51407-765 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (51407-766-90) | Golden State Medical Supply, Inc. | 51407-766-90 | 51407-766 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (51407-767-90) | Golden State Medical Supply, Inc. | 51407-767-90 | 51407-767 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle, Plastic (69452-258-19) | Bionpharma Inc. | 69452-258-19 | 69452-258 | ANDA213033 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle, Plastic (69452-256-19) | Bionpharma Inc. | 69452-256-19 | 69452-256 | ANDA213033 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle, Plastic (69452-257-19) | Bionpharma Inc. | 69452-257-19 | 69452-257 | ANDA213033 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 90 Tablet, Delayed Release In 1 Bottle (65162-436-09) | Amneal Pharmaceuticals LLC | 65162-436-09 | 65162-436 | ANDA203995 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 50mg/1, 200 ug/1 | 100 Tablet, Delayed Release In 1 Bottle (65162-436-10) | Amneal Pharmaceuticals LLC | 65162-436-10 | 65162-436 | ANDA203995 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 75mg/1, 200 ug/1 | 30 Tablet, Delayed Release In 1 Bottle (65162-438-03) | Amneal Pharmaceuticals LLC | 65162-438-03 | 65162-438 | ANDA203995 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 75mg/1, 200 ug/1 | 60 Tablet, Delayed Release In 1 Bottle (65162-438-06) | Amneal Pharmaceuticals LLC | 65162-438-06 | 65162-438 | ANDA203995 | ANDA | N/A |
| Diclofenac Sodium; Misoprostol | Tablet, Delayed Release | Oral | 75mg/1, 200 ug/1 | 100 Tablet, Delayed Release In 1 Bottle (65162-438-10) | Amneal Pharmaceuticals LLC | 65162-438-10 | 65162-438 | ANDA203995 | ANDA | N/A |
| Dicyclomine hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (31722-052-01) | Camber Pharmaceuticals, Inc. | 31722-052-01 | 31722-052 | ANDA218018 | ANDA | N/A |
| Dicyclomine hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (31722-052-05) | Camber Pharmaceuticals, Inc. | 31722-052-05 | 31722-052 | ANDA218018 | ANDA | N/A |
| Dicyclomine hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (31722-052-10) | Camber Pharmaceuticals, Inc. | 31722-052-10 | 31722-052 | ANDA218018 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 6 Tube In 1 Carton (62559-365-26) / 2 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-365-26 | 62559-365 | ANDA076263 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 30 Capsule, Delayed Release In 1 Bottle, Plastic (60760-461-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-461-30 | 60760-461 | ANDA208706 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 60 Capsule, Delayed Release In 1 Bottle, Plastic (60760-461-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-461-60 | 60760-461 | ANDA208706 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 60mg/1 | 30 Capsule, Delayed Release In 1 Bottle, Plastic (60760-462-30) | St. Mary's Medical Park Pharmacy | 60760-462-30 | 60760-462 | ANDA208706 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 60 Capsule, Delayed Release In 1 Bottle, Plastic (60760-951-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-951-60 | 60760-951 | ANDA090778 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 60mg/1 | 30 Capsule, Delayed Release In 1 Bottle, Plastic (60760-559-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-559-30 | 60760-559 | ANDA206653 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 60 Capsule, Delayed Release Pellets In 1 Bottle (51407-817-60) | Golden State Medical Supply, Inc. | 51407-817-60 | 51407-817 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 30mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (51407-818-30) | Golden State Medical Supply, Inc. | 51407-818-30 | 51407-818 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 30mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (51407-818-90) | Golden State Medical Supply, Inc. | 51407-818-90 | 51407-818 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 60mg/1 | 1000 Capsule, Delayed Release Pellets In 1 Bottle (51407-819-10) | Golden State Medical Supply, Inc. | 51407-819-10 | 51407-819 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 60mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (51407-819-30) | Golden State Medical Supply, Inc. | 51407-819-30 | 51407-819 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 60 Capsule, Delayed Release Pellets In 1 Bottle (60429-164-60) | Golden State Medical Supply, Inc. | 60429-164-60 | 60429-164 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 30mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (60429-165-30) | Golden State Medical Supply, Inc. | 60429-165-30 | 60429-165 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 30mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (60429-165-90) | Golden State Medical Supply, Inc. | 60429-165-90 | 60429-165 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 60mg/1 | 1000 Capsule, Delayed Release Pellets In 1 Bottle (60429-166-10) | Golden State Medical Supply, Inc. | 60429-166-10 | 60429-166 | ANDA203088 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release Pellets | Oral | 60mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (60429-166-30) | Golden State Medical Supply, Inc. | 60429-166-30 | 60429-166 | ANDA203088 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (62559-365-30) / 30 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-365-30 | 62559-365 | ANDA076263 | ANDA | N/A |
| Diflorasone Diacetate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (62559-365-60) / 60 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-365-60 | 62559-365 | ANDA076263 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (64980-124-03) / 30 G In 1 Tube | Rising Pharma Holdings, Inc. | 64980-124-03 | 64980-124 | ANDA207440 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (64980-124-15) / 15 G In 1 Tube | Rising Pharma Holdings, Inc. | 64980-124-15 | 64980-124 | ANDA207440 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (64980-124-45) / 45 G In 1 Tube | Rising Pharma Holdings, Inc. | 64980-124-45 | 64980-124 | ANDA207440 | ANDA | N/A |
| Diflorasone Diacetate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (64980-124-60) / 60 G In 1 Tube | Rising Pharma Holdings, Inc. | 64980-124-60 | 64980-124 | ANDA207440 | ANDA | N/A |
| Digoxin | Tablet | Oral | .0625mg/1 | 100 Tablet In 1 Bottle (70954-200-10) | ANI Pharmaceuticals, Inc. | 70954-200-10 | 70954-200 | ANDA215307 | ANDA | N/A |
| Digoxin | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (70954-201-10) | ANI Pharmaceuticals, Inc. | 70954-201-10 | 70954-201 | ANDA215307 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 90 Capsule, Liquid Filled In 1 Bottle (80725-712-04) | Waylis Therapeutics LLC | 80725-712-04 | 80725-712 | NDA021319 | NDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (80725-712-15) | Waylis Therapeutics LLC | 80725-712-15 | 80725-712 | NDA021319 | NDA | N/A |
| Digoxin | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (70954-201-20) | ANI Pharmaceuticals, Inc. | 70954-201-20 | 70954-201 | ANDA215307 | ANDA | N/A |
| Digoxin | Tablet | Oral | .25mg/1 | 100 Tablet In 1 Bottle (70954-202-10) | ANI Pharmaceuticals, Inc. | 70954-202-10 | 70954-202 | ANDA215307 | ANDA | N/A |
| Digoxin | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (70954-202-20) | ANI Pharmaceuticals, Inc. | 70954-202-20 | 70954-202 | ANDA215307 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 500 Capsule, Extended Release In 1 Bottle (50742-248-05) | Ingenus Pharmaceuticals, LLC | 50742-248-05 | 50742-248 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 1000 Capsule, Extended Release In 1 Bottle (50742-248-10) | Ingenus Pharmaceuticals, LLC | 50742-248-10 | 50742-248 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 30 Capsule, Extended Release In 1 Bottle (50742-248-30) | Ingenus Pharmaceuticals, LLC | 50742-248-30 | 50742-248 | ANDA208783 | ANDA | N/A |
| Dutasteride; Tamsulosin Hydrochloride | Capsule | Oral | .5mg/1, .4 mg/1 | 30 Capsule In 1 Bottle, Plastic (80725-809-13) | Waylis Therapeutics | 80725-809-13 | 80725-809 | NDA022460 | NDA | N/A |
| Dutasteride; Tamsulosin Hydrochloride | Capsule | Oral | .5mg/1, .4 mg/1 | 90 Capsule In 1 Bottle, Plastic (80725-809-59) | Waylis Therapeutics | 80725-809-59 | 80725-809 | NDA022460 | NDA | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-021-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-021-14 | 71042-021 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil; Willow Bark | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-020-08) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-020-08 | 71042-020 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil; Willow Bark | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-020-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-020-14 | 71042-020 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil; Willow Bark | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-022-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-022-14 | 71042-022 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil; Willow Bark | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-024-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-024-14 | 71042-024 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| East Indian Lemongrass Oil; Olea Europaea Fruit Volatile Oil; Willow Bark | Ointment | Topical | 2[hp_X]/100g, 3 [hp_X]/100g, 3 [hp_X]/100g | 1 Tube In 1 Carton (71042-023-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-023-14 | 71042-023 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (45802-466-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-466-11 | 45802-466 | ANDA076479 | ANDA | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (45802-466-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-466-35 | 45802-466 | ANDA076479 | ANDA | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (45802-466-53) / 85 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-466-53 | 45802-466 | ANDA076479 | ANDA | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1303-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1303-1 | 51672-1303 | ANDA076005 | ANDA | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1303-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1303-2 | 51672-1303 | ANDA076005 | ANDA | N/A |
| Econazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1303-8) / 85 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1303-8 | 51672-1303 | ANDA076005 | ANDA | N/A |
| Edaravone | Solution | Intravenous | 30mg/100mL | 2 Bag In 1 Carton (81298-7050-3) / 100 Ml In 1 Bag (81298-7050-1) | Long Grove Pharmaceuticals, LLC | 81298-7050-3 | 81298-7050 | ANDA218354 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 90 Capsule, Extended Release In 1 Bottle (50742-248-90) | Ingenus Pharmaceuticals, LLC | 50742-248-90 | 50742-248 | ANDA208783 | ANDA | N/A |
| Efavirenz | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (51407-382-30) | Golden State Medical Supply, Inc. | 51407-382-30 | 51407-382 | ANDA204869 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 500 Capsule, Extended Release In 1 Bottle (50742-249-05) | Ingenus Pharmaceuticals, LLC | 50742-249-05 | 50742-249 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 1000 Capsule, Extended Release In 1 Bottle (50742-249-10) | Ingenus Pharmaceuticals, LLC | 50742-249-10 | 50742-249 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 30 Capsule, Extended Release In 1 Bottle (50742-249-30) | Ingenus Pharmaceuticals, LLC | 50742-249-30 | 50742-249 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 180mg/1 | 90 Capsule, Extended Release In 1 Bottle (50742-249-90) | Ingenus Pharmaceuticals, LLC | 50742-249-90 | 50742-249 | ANDA208783 | ANDA | N/A |
| Egg White | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-3248-2) | Jubilant HollisterStier LLC | 65044-3248-2 | 65044-3248 | BLA103888 | BLA | N/A |
| Egg White | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-3249-1) | Jubilant HollisterStier LLC | 65044-3249-1 | 65044-3249 | BLA103888 | BLA | N/A |
| Egg Yolk | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-3254-2) | Jubilant HollisterStier LLC | 65044-3254-2 | 65044-3254 | BLA103888 | BLA | N/A |
| Egg Yolk | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-3255-1) | Jubilant HollisterStier LLC | 65044-3255-1 | 65044-3255 | BLA103888 | BLA | N/A |
| Elaeagnus Angustifolia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2360-1) | Jubilant HollisterStier LLC | 65044-2360-1 | 65044-2360 | BLA103888 | BLA | N/A |
| Elaeagnus Angustifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2359-2) | Jubilant HollisterStier LLC | 65044-2359-2 | 65044-2359 | BLA103888 | BLA | N/A |
| Elaeagnus Angustifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2359-3) | Jubilant HollisterStier LLC | 65044-2359-3 | 65044-2359 | BLA103888 | BLA | N/A |
| Elaeagnus Angustifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2359-4) | Jubilant HollisterStier LLC | 65044-2359-4 | 65044-2359 | BLA103888 | BLA | N/A |
| Eletriptan Hydrobromide | Tablet | Oral | 40mg/1 | 6 Blister Pack In 1 Carton (58151-368-56) / 1 Tablet In 1 Blister Pack | Viatris Specialty LLC | 58151-368-56 | 58151-368 | NDA021016 | NDA | N/A |
| Elranatamab | Injection, Solution | Subcutaneous | 76mg/1.9mL | 1 Vial, Single-Dose In 1 Carton (0069-4494-02) / 1.9 Ml In 1 Vial, Single-Dose (0069-4494-01) | Pfizer Laboratories Div Pfizer Inc | 0069-4494-02 | 0069-4494 | BLA761345 | BLA | N/A |
| Elranatamab | Injection, Solution | Subcutaneous | 44mg/1.1mL | 1 Vial, Single-Dose In 1 Carton (0069-2522-02) / 1.1 Ml In 1 Vial, Single-Dose (0069-2522-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2522-02 | 0069-2522 | BLA761345 | BLA | N/A |
| Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet | Oral | 200mg/1, 300 mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-112-30) | Golden State Medical Supply, Inc. | 51407-112-30 | 51407-112 | ANDA091055 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-688-30) | St Mary's Medical Park Pharmacy | 60760-688-30 | 60760-688 | ANDA213273 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-226-30) | St Marys Medical Park Pharmacy | 60760-226-30 | 60760-226 | ANDA075483 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-587-30) | St. Mary's Medical Park Pharmacy | 60760-587-30 | 60760-587 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (51407-828-10) | Golden State Medical Supply, Inc. | 51407-828-10 | 51407-828 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (51407-828-90) | Golden State Medical Supply, Inc. | 51407-828-90 | 51407-828 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51672-4245-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4245-1 | 51672-4245 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (51672-4245-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4245-3 | 51672-4245 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (51672-4037-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4037-1 | 51672-4037 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (51672-4037-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4037-3 | 51672-4037 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51672-4038-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4038-1 | 51672-4038 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (51672-4038-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4038-3 | 51672-4038 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51672-4039-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4039-1 | 51672-4039 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (51672-4039-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4039-3 | 51672-4039 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (51672-4040-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4040-1 | 51672-4040 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (51672-4040-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4040-3 | 51672-4040 | ANDA075657 | ANDA | N/A |
| Enalapril Maleate | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (52536-401-01) / 150 Ml In 1 Bottle | Wilshire Pharmaceuticals, Inc. | 52536-401-01 | 52536-401 | NDA208686 | NDA | N/A |
| Enalapril Maleate | Solution | Oral | 1mg/mL | 150 Ml In 1 Bottle (52652-4001-1) | Azurity Pharmaceuticals, Inc. | 52652-4001-1 | 52652-4001 | NDA208686 | NDA | N/A |
| Enalapril Maleate | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (69452-237-46) / 150 Ml In 1 Bottle | Bionpharma Inc. | 69452-237-46 | 69452-237 | ANDA212408 | ANDA | N/A |
| Enalapril Maleate; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 12.5 mg/1 | 100 Tablet In 1 Bottle (51672-4045-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4045-1 | 51672-4045 | ANDA075788 | ANDA | N/A |
| Enalapril Maleate; Hydrochlorothiazide | Tablet | Oral | 5mg/1, 12.5 mg/1 | 1000 Tablet In 1 Bottle (51672-4045-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4045-3 | 51672-4045 | ANDA075788 | ANDA | N/A |
| Enalapril Maleate; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 25 mg/1 | 100 Tablet In 1 Bottle (51672-4046-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4046-1 | 51672-4046 | ANDA075788 | ANDA | N/A |
| Enalapril Maleate; Hydrochlorothiazide | Tablet | Oral | 10mg/1, 25 mg/1 | 1000 Tablet In 1 Bottle (51672-4046-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4046-3 | 51672-4046 | ANDA075788 | ANDA | N/A |
| Enalaprilat Dihydrate | Injection | Intravenous | 2.5mg/2mL | 10 Vial In 1 Carton (0143-9786-10) / 2 Ml In 1 Vial (0143-9786-01) | Hikma Pharmaceuticals USA Inc. | 0143-9786-10 | 0143-9786 | ANDA078687 | ANDA | N/A |
| Enalaprilat Dihydrate | Injection | Intravenous | 1.25mg/mL | 10 Vial In 1 Carton (0143-9787-10) / 1 Ml In 1 Vial (0143-9787-01) | Hikma Pharmaceuticals USA Inc. | 0143-9787-10 | 0143-9787 | ANDA078687 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Intravenous; Subcutaneous | 300mg/3mL | 1 Vial, Multi-Dose In 1 Carton (71288-426-91) / 3 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc. | 71288-426-91 | 71288-426 | ANDA214856 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Intravenous; Subcutaneous | 300mg/3mL | 1 Vial, Multi-Dose In 1 Carton (71288-426-03) / 3 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc. | 71288-426-03 | 71288-426 | ANDA214856 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-432-81) / .3 Ml In 1 Syringe (71288-432-80) | Meitheal Pharmaceuticals Inc. | 71288-432-81 | 71288-432 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-432-92) / .3 Ml In 1 Syringe (71288-432-91) | Meitheal Pharmaceuticals Inc. | 71288-432-92 | 71288-432 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-433-83) / .4 Ml In 1 Syringe (71288-433-82) | Meitheal Pharmaceuticals Inc. | 71288-433-83 | 71288-433 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-433-92) / .4 Ml In 1 Syringe (71288-433-91) | Meitheal Pharmaceuticals Inc. | 71288-433-92 | 71288-433 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-434-85) / .6 Ml In 1 Syringe (71288-434-84) | Meitheal Pharmaceuticals Inc. | 71288-434-85 | 71288-434 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-434-92) / .6 Ml In 1 Syringe (71288-434-91) | Meitheal Pharmaceuticals Inc. | 71288-434-92 | 71288-434 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-435-87) / .8 Ml In 1 Syringe (71288-435-86) | Meitheal Pharmaceuticals Inc. | 71288-435-87 | 71288-435 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-435-92) / .8 Ml In 1 Syringe (71288-435-91) | Meitheal Pharmaceuticals Inc. | 71288-435-92 | 71288-435 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-436-89) / 1 Ml In 1 Syringe (71288-436-88) | Meitheal Pharmaceuticals Inc. | 71288-436-89 | 71288-436 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-436-92) / 1 Ml In 1 Syringe (71288-436-91) | Meitheal Pharmaceuticals Inc. | 71288-436-92 | 71288-436 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-437-92) / .8 Ml In 1 Syringe (71288-437-91) | Meitheal Pharmaceuticals Inc. | 71288-437-92 | 71288-437 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-437-94) / .8 Ml In 1 Syringe (71288-437-93) | Meitheal Pharmaceuticals Inc. | 71288-437-94 | 71288-437 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-438-94) / 1 Ml In 1 Syringe (71288-438-93) | Meitheal Pharmaceuticals Inc. | 71288-438-94 | 71288-438 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-438-96) / 1 Ml In 1 Syringe (71288-438-95) | Meitheal Pharmaceuticals Inc. | 71288-438-96 | 71288-438 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-410-81) / .3 Ml In 1 Syringe (71288-410-80) | Meitheal Pharmaceuticals Inc. | 71288-410-81 | 71288-410 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-410-83) / .4 Ml In 1 Syringe (71288-410-82) | Meitheal Pharmaceuticals Inc. | 71288-410-83 | 71288-410 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-410-85) / .6 Ml In 1 Syringe (71288-410-84) | Meitheal Pharmaceuticals Inc. | 71288-410-85 | 71288-410 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-410-87) / .8 Ml In 1 Syringe (71288-410-86) | Meitheal Pharmaceuticals Inc. | 71288-410-87 | 71288-410 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (71288-410-89) / 1 Ml In 1 Syringe (71288-410-88) | Meitheal Pharmaceuticals Inc. | 71288-410-89 | 71288-410 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-411-81) / .8 Ml In 1 Syringe (71288-411-80) | Meitheal Pharmaceuticals Inc. | 71288-411-81 | 71288-411 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (71288-411-83) / 1 Ml In 1 Syringe (71288-411-82) | Meitheal Pharmaceuticals Inc. | 71288-411-83 | 71288-411 | ANDA206834 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (25021-410-70) / .3 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-410-70 | 25021-410 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (25021-410-71) / 1 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-410-71 | 25021-410 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (25021-410-76) / .4 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-410-76 | 25021-410 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (25021-410-77) / .6 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-410-77 | 25021-410 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (25021-410-78) / .8 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-410-78 | 25021-410 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (25021-411-70) / .8 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-411-70 | 25021-411 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (25021-411-71) / 1 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-411-71 | 25021-411 | ANDA078990 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5604-00) / .8 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5604-00 | 0548-5604 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5605-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5605-00 | 0548-5605 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (0548-5606-00) / .8 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5606-00 | 0548-5606 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (0548-5607-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5607-00 | 0548-5607 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Intravenous; Subcutaneous | 300mg/3mL | 1 Vial In 1 Carton (0548-5608-00) / 3 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-5608-00 | 0548-5608 | ANDA208600 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5601-00) / .3 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5601-00 | 0548-5601 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5602-00) / .4 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5602-00 | 0548-5602 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5603-00) / .6 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5603-00 | 0548-5603 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5601-00) / .3 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5601-00 | 0548-5601 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5602-00) / .4 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5602-00 | 0548-5602 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5603-00) / .6 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5603-00 | 0548-5603 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5604-00) / .8 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5604-00 | 0548-5604 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 100mg/mL | 10 Syringe In 1 Carton (0548-5605-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5605-00 | 0548-5605 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (0548-5606-00) / .8 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5606-00 | 0548-5606 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Subcutaneous | 150mg/mL | 10 Syringe In 1 Carton (0548-5607-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5607-00 | 0548-5607 | ANDA076684 | ANDA | N/A |
| Enoxaparin Sodium | Injection | Intravenous; Subcutaneous | 300mg/3mL | 1 Vial In 1 Carton (0548-5608-00) / 3 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-5608-00 | 0548-5608 | ANDA208600 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle, Plastic (51407-589-30) | Golden State Medical Supply, Inc. | 51407-589-30 | 51407-589 | ANDA208195 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle, Plastic (61442-311-30) | Carlsbad Technology, Inc. | 61442-311-30 | 61442-311 | ANDA208195 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 500 Capsule, Extended Release In 1 Bottle (50742-250-05) | Ingenus Pharmaceuticals, LLC | 50742-250-05 | 50742-250 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 1000 Capsule, Extended Release In 1 Bottle (50742-250-10) | Ingenus Pharmaceuticals, LLC | 50742-250-10 | 50742-250 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 30 Capsule, Extended Release In 1 Bottle (50742-250-30) | Ingenus Pharmaceuticals, LLC | 50742-250-30 | 50742-250 | ANDA208783 | ANDA | N/A |
| Ephedrine Sulfate | Injection | Intravenous | 5mg/mL | 10 Vial In 1 Carton (14789-250-10) / 10 Ml In 1 Vial (14789-250-07) | Nexus Pharamaceuticals Inc. | 14789-250-10 | 14789-250 | NDA213407 | NDA | N/A |
| Ephedrine Sulfate | Injection | Intravenous | 5mg/mL | 10 Syringe In 1 Carton (14789-251-10) / 5 Ml In 1 Syringe (14789-251-09) | Nexus Pharmaceuticals, LLC | 14789-251-10 | 14789-251 | NDA213407 | NDA | N/A |
| Ephedrine Sulfate | Injection | Intravenous | 5mg/mL | 10 Syringe In 1 Carton (14789-252-10) / 10 Ml In 1 Syringe (14789-252-09) | Nexus Pharmaceuticals, LLC | 14789-252-10 | 14789-252 | NDA213407 | NDA | N/A |
| Ephedrine Sulfate | Injection, Solution | Intravenous | 50mg/mL | 25 Vial In 1 Carton (25021-836-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-836-01 | 25021-836 | ANDA214528 | ANDA | N/A |
| Ephedrine Sulfate | Injection | Intravenous | 50mg/mL | 25 Vial, Single-Dose In 1 Carton (0641-6238-25) / 1 Ml In 1 Vial, Single-Dose (0641-6238-01) | Hikma Pharmaceuticals USA Inc. | 0641-6238-25 | 0641-6238 | ANDA214334 | ANDA | N/A |
| Epicoccum Nigrum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5100-2) | Jubilant HollisterStier LLC | 65044-5100-2 | 65044-5100 | BLA103888 | BLA | N/A |
| Epicoccum Nigrum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5100-3) | Jubilant HollisterStier LLC | 65044-5100-3 | 65044-5100 | BLA103888 | BLA | N/A |
| Epicoccum Nigrum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5100-4) | Jubilant HollisterStier LLC | 65044-5100-4 | 65044-5100 | BLA103888 | BLA | N/A |
| Epicoccum Nigrum | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5101-1) | Jubilant HollisterStier LLC | 65044-5101-1 | 65044-5101 | BLA103888 | BLA | N/A |
| Epidermophyton Floccosum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5104-2) | Jubilant HollisterStier LLC | 65044-5104-2 | 65044-5104 | BLA103888 | BLA | N/A |
| Epidermophyton Floccosum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5104-3) | Jubilant HollisterStier LLC | 65044-5104-3 | 65044-5104 | BLA103888 | BLA | N/A |
| Epidermophyton Floccosum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5104-4) | Jubilant HollisterStier LLC | 65044-5104-4 | 65044-5104 | BLA103888 | BLA | N/A |
| Epidermophyton Floccosum | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5105-1) | Jubilant HollisterStier LLC | 65044-5105-1 | 65044-5105 | BLA103888 | BLA | N/A |
| Epinastine Hydrochloride | Solution/ Drops | Ophthalmic | .5mg/mL | 10 Carton In 1 Carton (70069-008-10) / 1 Bottle In 1 Carton (70069-008-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-008-10 | 70069-008 | ANDA090951 | ANDA | N/A |
| Epinephrine | Injection, Solution | Intramuscular; Subcutaneous | 1mg/mL | 10 Ampule In 1 Box (0517-1171-10) / 1 Ml In 1 Ampule (0517-1171-01) | American Regent, Inc. | 0517-1171-10 | 0517-1171 | ANDA207568 | ANDA | N/A |
| Epinephrine | Injection | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 1 Vial In 1 Carton (0517-3030-01) / 1 Ml In 1 Vial | American Regent, Inc. | 0517-3030-01 | 0517-3030 | ANDA217192 | ANDA | N/A |
| Epinephrine | Injection, Solution | Intravenous | .1mg/mL | 10 Carton In 1 Package (0409-4933-01) / 1 Syringe, Glass In 1 Carton / 10 Ml In 1 Syringe, Glass (0409-4933-11) | Hospira, Inc. | 0409-4933-01 | 0409-4933 | NDA209359 | NDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 5ug/mL, 5 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3177-01) / 50 Ml In 1 Vial, Multi-Dose (0409-3177-16) | Hospira, Inc. | 0409-3177-01 | 0409-3177 | ANDA089635 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 10 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3178-01) / 20 Ml In 1 Vial, Multi-Dose (0409-3178-16) | Hospira, Inc. | 0409-3178-01 | 0409-3178 | ANDA089644 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 10 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3178-02) / 30 Ml In 1 Vial, Multi-Dose (0409-3178-17) | Hospira, Inc. | 0409-3178-02 | 0409-3178 | ANDA089644 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 10 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3178-03) / 50 Ml In 1 Vial, Multi-Dose (0409-3178-18) | Hospira, Inc. | 0409-3178-03 | 0409-3178 | ANDA089644 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 5ug/mL, 15 mg/mL | 5 Vial, Single-Dose In 1 Carton (0409-3181-01) / 30 Ml In 1 Vial, Single-Dose (0409-3181-11) | Hospira, Inc. | 0409-3181-01 | 0409-3181 | ANDA089645 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 20 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3182-01) / 20 Ml In 1 Vial, Multi-Dose (0409-3182-11) | Hospira, Inc. | 0409-3182-01 | 0409-3182 | ANDA089646 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 20 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3182-02) / 30 Ml In 1 Vial, Multi-Dose (0409-3182-21) | Hospira, Inc. | 0409-3182-02 | 0409-3182 | ANDA089646 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10ug/mL, 20 mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3182-03) / 50 Ml In 1 Vial, Multi-Dose (0409-3182-31) | Hospira, Inc. | 0409-3182-03 | 0409-3182 | ANDA089646 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 5ug/mL, 20 mg/mL | 5 Vial, Single-Dose In 1 Carton (0409-3183-01) / 20 Ml In 1 Vial, Single-Dose (0409-3183-11) | Hospira, Inc. | 0409-3183-01 | 0409-3183 | ANDA089651 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Epidural | 5ug/mL, 15 mg/mL | 10 Ampule In 1 Tray (0409-1209-01) / 5 Ml In 1 Ampule (0409-1209-10) | Hospira, Inc. | 0409-1209-01 | 0409-1209 | ANDA088571 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Epidural | 5ug/mL, 15 mg/mL | 400 Ampule In 1 Case (0409-1209-05) / 5 Ml In 1 Ampule | Hospira, Inc. | 0409-1209-05 | 0409-1209 | ANDA088571 | ANDA | N/A |
| Epinephrine; Lidocaine Hydrochloride | Injection, Solution | Epidural | 5ug/mL, 15 mg/mL | 800 Ampule In 1 Case (0409-1209-65) / 5 Ml In 1 Ampule (0409-1209-70) | Hospira, Inc. | 0409-1209-65 | 0409-1209 | ANDA088571 | ANDA | N/A |
| Epirubicin Hydrochloride | Injection | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9202-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9202-01 | 0143-9202 | ANDA065289 | ANDA | N/A |
| Epirubicin Hydrochloride | Injection | Intravenous | 2mg/mL | 1 Vial In 1 Box (0143-9203-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9203-01 | 0143-9203 | ANDA065289 | ANDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (66993-343-30) | Prasco Laboratories | 66993-343-30 | 66993-343 | ANDA203896 | ANDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (66993-343-85) | Prasco Laboratories | 66993-343-85 | 66993-343 | ANDA203896 | ANDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (66993-344-30) | Prasco Laboratories | 66993-344-30 | 66993-344 | ANDA203896 | ANDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (66993-344-85) | Prasco Laboratories | 66993-344-85 | 66993-344 | ANDA203896 | ANDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (58151-142-93) | Viatris Specialty LLC | 58151-142-93 | 58151-142 | NDA021437 | NDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (0025-1710-01) | Pfizer Laboratories Div Pfizer Inc | 0025-1710-01 | 0025-1710 | NDA021437 | NDA | N/A |
| Eplerenone | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (0025-1720-03) | Pfizer Laboratories Div Pfizer Inc | 0025-1720-03 | 0025-1720 | NDA021437 | NDA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 2000[iU]/mL | 10 Vial, Single-Dose In 1 Carton (0069-1305-10) / 1 Ml In 1 Vial, Single-Dose (0069-1305-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1305-10 | 0069-1305 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 3000[iU]/mL | 10 Vial, Single-Dose In 1 Carton (0069-1306-10) / 1 Ml In 1 Vial, Single-Dose (0069-1306-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1306-10 | 0069-1306 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 4000[iU]/mL | 10 Vial, Single-Dose In 1 Carton (0069-1307-10) / 1 Ml In 1 Vial, Single-Dose (0069-1307-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1307-10 | 0069-1307 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 10000[iU]/mL | 10 Vial, Single-Dose In 1 Carton (0069-1308-10) / 1 Ml In 1 Vial, Single-Dose (0069-1308-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1308-10 | 0069-1308 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 40000[iU]/mL | 4 Vial, Single-Dose In 1 Carton (0069-1309-04) / 1 Ml In 1 Vial, Single-Dose (0069-1309-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1309-04 | 0069-1309 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 20000[iU]/mL | 10 Vial, Multi-Dose In 1 Carton (0069-1311-10) / 1 Ml In 1 Vial, Multi-Dose (0069-1311-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1311-10 | 0069-1311 | BLA125545 | BLA | N/A |
| Epoetin | Injection, Solution | Intravenous; Subcutaneous | 10000[iU]/mL | 10 Vial, Multi-Dose In 1 Carton (0069-1318-10) / 2 Ml In 1 Vial, Multi-Dose (0069-1318-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1318-10 | 0069-1318 | BLA125545 | BLA | N/A |
| Eptifibatide | Injection, Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-412-10) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-412-10 | 71288-412 | ANDA213599 | ANDA | N/A |
| Eptifibatide | Injection, Solution | Intravenous | .75mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-413-51) / 100 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-413-51 | 71288-413 | ANDA213599 | ANDA | N/A |
| Eptifibatide | Injection, Solution | Intravenous | .75mg/mL | 1 Vial In 1 Carton (25021-408-51) / 100 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-408-51 | 25021-408 | ANDA204693 | ANDA | N/A |
| Eptifibatide | Injection, Solution | Intravenous | 2mg/mL | 1 Vial In 1 Carton (25021-409-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-409-10 | 25021-409 | ANDA204693 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 240mg/1 | 90 Capsule, Extended Release In 1 Bottle (50742-250-90) | Ingenus Pharmaceuticals, LLC | 50742-250-90 | 50742-250 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 500 Capsule, Extended Release In 1 Bottle (50742-251-05) | Ingenus Pharmaceuticals, LLC | 50742-251-05 | 50742-251 | ANDA208783 | ANDA | N/A |
| Equus Caballus Dander; Equus Caballus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 10 Ml In 1 Vial (65044-4855-2) | Jubilant HollisterStier LLC | 65044-4855-2 | 65044-4855 | BLA103888 | BLA | N/A |
| Equus Caballus Dander; Equus Caballus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 30 Ml In 1 Vial (65044-4855-3) | Jubilant HollisterStier LLC | 65044-4855-3 | 65044-4855 | BLA103888 | BLA | N/A |
| Equus Caballus Dander; Equus Caballus Hair | Injection, Solution | Percutaneous; Subcutaneous | .01g/mL, .01 g/mL | 50 Ml In 1 Vial (65044-4855-4) | Jubilant HollisterStier LLC | 65044-4855-4 | 65044-4855 | BLA103888 | BLA | N/A |
| Equus Caballus Dander; Equus Caballus Hair | Injection, Solution | Percutaneous | .01g/mL, .01 g/mL | 5 Ml In 1 Vial (65044-4856-1) | Jubilant HollisterStier LLC | 65044-4856-1 | 65044-4856 | BLA103888 | BLA | N/A |
| Ergocalciferol | Capsule, Liquid Filled | Oral | 1.25mg/1 | 12 Capsule, Liquid Filled In 1 Bottle, Plastic (60760-152-12) | St. Mary's Medical Park Pharmacy | 60760-152-12 | 60760-152 | ANDA080704 | ANDA | N/A |
| Ergocalciferol | Capsule | Oral | 1.25mg/1 | 12 Capsule In 1 Bottle, Plastic (60760-275-12) | St. Mary's Medical Park Pharmacy | 60760-275-12 | 60760-275 | ANDA204276 | ANDA | N/A |
| Ergocalciferol | Capsule, Liquid Filled | Oral | 1.25mg/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (30698-493-01) | Validus Pharmaceuticals LLC | 30698-493-01 | 30698-493 | NDA003444 | NDA | N/A |
| Ergocalciferol | Capsule, Liquid Filled | Oral | 1.25mg/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-151-20) | Bionpharma Inc. | 69452-151-20 | 69452-151 | ANDA080704 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 1000 Capsule, Extended Release In 1 Bottle (50742-251-10) | Ingenus Pharmaceuticals, LLC | 50742-251-10 | 50742-251 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 30 Capsule, Extended Release In 1 Bottle (50742-251-30) | Ingenus Pharmaceuticals, LLC | 50742-251-30 | 50742-251 | ANDA208783 | ANDA | N/A |
| Eribulin Mesylate | Solution | Intravenous | .5mg/mL | 1 Vial, Single-Dose In 1 Carton (81298-3890-1) / 2 Ml In 1 Vial, Single-Dose | Long Grove Pharmaceuticals, LLC | 81298-3890-1 | 81298-3890 | ANDA214850 | ANDA | N/A |
| Eribulin Mesylate | Injection | Intravenous | .5mg/mL | 1 Vial, Single-Dose In 1 Carton (60505-6289-0) / 2 Ml In 1 Vial, Single-Dose | Apotex Corp. | 60505-6289-0 | 60505-6289 | ANDA218047 | ANDA | N/A |
| Eribulin Mesylate | Injection | Intravenous | .5mg/mL | 1 Vial, Single-Dose In 1 Carton (0143-9167-01) / 2 Ml In 1 Vial, Single-Dose | HIKMA PHARMACEUTICALS USA INC. | 0143-9167-01 | 0143-9167 | ANDA218281 | ANDA | N/A |
| Ertapenem Sodium | Injection | Intramuscular; Intravenous | 1g/20mL | 10 Vial In 1 Carton (60505-6196-4) / 20 Ml In 1 Vial (60505-6196-0) | Apotex Corp | 60505-6196-4 | 60505-6196 | ANDA207647 | ANDA | N/A |
| Ertapenem Sodium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (0143-9398-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0143-9398-01) | Hikma Pharmaceuticals USA, Inc. | 0143-9398-10 | 0143-9398 | ANDA208790 | ANDA | N/A |
| Ertapenem Sodium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Carton (0409-3510-22) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-3510-21) | Hospira, Inc. | 0409-3510-22 | 0409-3510 | ANDA208790 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (75834-242-01) | Nivagen Pharmaceuticals, Inc. | 75834-242-01 | 75834-242 | ANDA213628 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-242-30) | Nivagen Pharmaceuticals, Inc. | 75834-242-30 | 75834-242 | ANDA213628 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (75834-243-01) | Nivagen Pharmaceuticals, Inc. | 75834-243-01 | 75834-243 | ANDA213628 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-243-30) | Nivagen Pharmaceuticals, Inc. | 75834-243-30 | 75834-243 | ANDA213628 | ANDA | N/A |
| Erythromycin | Swab | Topical | 20mg/mL | 60 Applicator In 1 Jar (45802-962-72) / .8 Ml In 1 Applicator | Padagis Israel Pharmaceuticals Ltd | 45802-962-72 | 45802-962 | ANDA064126 | ANDA | N/A |
| Erythromycin | Solution | Topical | 20mg/mL | 1 Bottle In 1 Carton (45802-038-46) / 60 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-038-46 | 45802-038 | ANDA063038 | ANDA | N/A |
| Erythromycin | Gel | Topical | 20mg/g | 1 Tube In 1 Carton (45802-966-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-966-94 | 45802-966 | ANDA063211 | ANDA | N/A |
| Erythromycin | Gel | Topical | 20mg/g | 1 Tube In 1 Carton (45802-966-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-966-96 | 45802-966 | ANDA063211 | ANDA | N/A |
| Erythromycin | Ointment | Ophthalmic | 5mg/g | 1 Tube In 1 Carton (0574-4024-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4024-35 | 0574-4024 | ANDA062447 | ANDA | N/A |
| Erythromycin | Ointment | Ophthalmic | 5mg/g | 24 Tube In 1 Carton (0574-4024-39) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4024-39 | 0574-4024 | ANDA062447 | ANDA | N/A |
| Erythromycin | Ointment | Ophthalmic | 5mg/g | 50 Tube In 1 Carton (0574-4024-50) / 1 G In 1 Tube | Padagis US LLC | 0574-4024-50 | 0574-4024 | ANDA062447 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 250mg/1 | 30 Tablet, Delayed Release In 1 Bottle (51407-853-30) | Golden State Medical Supply, Inc. | 51407-853-30 | 51407-853 | ANDA211975 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 500mg/1 | 30 Tablet, Delayed Release In 1 Bottle (51407-854-30) | Golden State Medical Supply, Inc. | 51407-854-30 | 51407-854 | ANDA211975 | ANDA | N/A |
| Erythromycin | Tablet, Coated | Oral | 250mg/1 | 30 Tablet, Coated In 1 Bottle (51407-855-30) | Golden State Medical Supply, Inc. | 51407-855-30 | 51407-855 | ANDA212015 | ANDA | N/A |
| Erythromycin | Tablet, Coated | Oral | 500mg/1 | 30 Tablet, Coated In 1 Bottle (51407-856-30) | Golden State Medical Supply, Inc. | 51407-856-30 | 51407-856 | ANDA212015 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (52536-103-03) | Wilshire Pharmaceuticals | 52536-103-03 | 52536-103 | ANDA061621 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-103-13) | Wilshire Pharmaceuticals | 52536-103-13 | 52536-103 | ANDA061621 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (52536-105-03) | Wilshire Pharmaceuticals | 52536-105-03 | 52536-105 | ANDA061621 | ANDA | N/A |
| Erythromycin | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-105-13) | Wilshire Pharmaceuticals | 52536-105-13 | 52536-105 | ANDA061621 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 250mg/1 | 30 Tablet, Delayed Release In 1 Bottle (52536-180-03) | Wilshire Pharmaceuticals | 52536-180-03 | 52536-180 | ANDA062298 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 250mg/1 | 100 Tablet, Delayed Release In 1 Bottle (52536-180-10) | Wilshire Pharmaceuticals | 52536-180-10 | 52536-180 | ANDA062298 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 333mg/1 | 30 Tablet, Delayed Release In 1 Bottle (52536-183-03) | Wilshire Pharmaceuticals | 52536-183-03 | 52536-183 | ANDA062298 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 333mg/1 | 100 Tablet, Delayed Release In 1 Bottle (52536-183-10) | Wilshire Pharmaceuticals | 52536-183-10 | 52536-183 | ANDA062298 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 500mg/1 | 30 Tablet, Delayed Release In 1 Bottle (52536-186-03) | Wilshire Pharmaceuticals | 52536-186-03 | 52536-186 | ANDA062298 | ANDA | N/A |
| Erythromycin | Tablet, Delayed Release | Oral | 500mg/1 | 100 Tablet, Delayed Release In 1 Bottle (52536-186-10) | Wilshire Pharmaceuticals | 52536-186-10 | 52536-186 | ANDA062298 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (75834-294-01) | Nivagen Pharmaceuticals, Inc. | 75834-294-01 | 75834-294 | ANDA216212 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (75834-295-01) | Nivagen Pharmaceuticals, Inc. | 75834-295-01 | 75834-295 | ANDA216212 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (52536-130-13) | Wilshire Pharmaceuticals | 52536-130-13 | 52536-130 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (52536-132-13) | Wilshire Pharmaceuticals | 52536-132-13 | 52536-132 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (52536-134-13) | Wilshire Pharmaceuticals Inc. | 52536-134-13 | 52536-134 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 200 Ml In 1 Bottle (52536-136-13) | Wilshire Pharmaceuticals Inc. | 52536-136-13 | 52536-136 | NDA050207 | NDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 90 Capsule, Extended Release In 1 Bottle (50742-251-90) | Ingenus Pharmaceuticals, LLC | 50742-251-90 | 50742-251 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 360mg/1 | 500 Capsule, Extended Release In 1 Bottle (50742-252-05) | Ingenus Pharmaceuticals, LLC | 50742-252-05 | 50742-252 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 360mg/1 | 1000 Capsule, Extended Release In 1 Bottle (50742-252-10) | Ingenus Pharmaceuticals, LLC | 50742-252-10 | 50742-252 | ANDA208783 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (24338-100-03) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-100-03 | 24338-100 | ANDA061905 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (24338-134-02) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-134-02 | 24338-134 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 200 Ml In 1 Bottle (24338-136-10) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-136-10 | 24338-136 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (24338-130-13) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-130-13 | 24338-130 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (24338-132-13) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-132-13 | 24338-132 | NDA050207 | NDA | N/A |
| Erythromycin Ethylsuccinate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (24338-110-03) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-110-03 | 24338-110 | ANDA061904 | ANDA | N/A |
| Erythromycin Lactobionate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 5 Vial, Glass In 1 Box (14789-116-05) / 10 Ml In 1 Vial, Glass (14789-116-07) | Nexus Pharmaceuticals Inc. | 14789-116-05 | 14789-116 | ANDA215290 | ANDA | N/A |
| Erythromycin Lactobionate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/100mL | 10 Vial, Patent Delivery System In 1 Tray (0409-6476-44) / 100 Ml In 1 Vial, Patent Delivery System (0409-6476-54) | Hospira, Inc. | 0409-6476-44 | 0409-6476 | ANDA062638 | ANDA | N/A |
| Erythromycin Lactobionate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 10 Vial In 1 Tray (0409-6482-01) / 10 Ml In 1 Vial (0409-6482-11) | Hospira, Inc. | 0409-6482-01 | 0409-6482 | NDA050609 | NDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-895-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-895-90 | 60760-895 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-590-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-590-90 | 60760-590 | ANDA090432 | ANDA | N/A |
| Escitalopram Oxalate | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-1348-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1348-1 | 51672-1348 | ANDA079121 | ANDA | N/A |
| Escitalopram Oxalate | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-1348-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1348-8 | 51672-1348 | ANDA079121 | ANDA | N/A |
| Escitalopram Oxalate | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-1348-9) / 480 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1348-9 | 51672-1348 | ANDA079121 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-281-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-281-01 | 59746-281 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-281-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-281-05 | 59746-281 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-281-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-281-10 | 59746-281 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-281-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-281-30 | 59746-281 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-279-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-279-01 | 59746-279 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-279-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-279-05 | 59746-279 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-279-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-279-10 | 59746-279 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-279-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-279-30 | 59746-279 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-280-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-280-01 | 59746-280 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-280-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-280-05 | 59746-280 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-280-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-280-10 | 59746-280 | ANDA202280 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-280-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-280-30 | 59746-280 | ANDA202280 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 360mg/1 | 30 Capsule, Extended Release In 1 Bottle (50742-252-30) | Ingenus Pharmaceuticals, LLC | 50742-252-30 | 50742-252 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Capsule, Extended Release | Oral | 360mg/1 | 90 Capsule, Extended Release In 1 Bottle (50742-252-90) | Ingenus Pharmaceuticals, LLC | 50742-252-90 | 50742-252 | ANDA208783 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (50228-481-01) | ScieGen Pharmaceuticals, Inc | 50228-481-01 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (50228-481-05) | ScieGen Pharmaceuticals, Inc | 50228-481-05 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-481-10) | ScieGen Pharmaceuticals, Inc | 50228-481-10 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-481-30) | ScieGen Pharmaceuticals, Inc | 50228-481-30 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (50228-482-01) | ScieGen Pharmaceuticals, Inc | 50228-482-01 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 500 Tablet In 1 Bottle (50228-482-05) | ScieGen Pharmaceuticals, Inc | 50228-482-05 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle (50228-482-10) | ScieGen Pharmaceuticals, Inc | 50228-482-10 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (50228-482-30) | ScieGen Pharmaceuticals, Inc | 50228-482-30 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 100 Tablet In 1 Bottle (50228-483-01) | ScieGen Pharmaceuticals, Inc | 50228-483-01 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 500 Tablet In 1 Bottle (50228-483-05) | ScieGen Pharmaceuticals, Inc | 50228-483-05 | 50228-483 | ANDA216521 | ANDA | N/A |
| Esmolol Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 10 Bag In 1 Carton (25021-308-84) / 250 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-308-84 | 25021-308 | ANDA207107 | ANDA | N/A |
| Esmolol Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 10 Bag In 1 Carton (25021-309-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-309-82 | 25021-309 | ANDA207107 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 1000 Tablet In 1 Bottle (50228-483-10) | ScieGen Pharmaceuticals, Inc | 50228-483-10 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 30 Tablet In 1 Bottle (50228-483-30) | ScieGen Pharmaceuticals, Inc | 50228-483-30 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (50228-484-01) | ScieGen Pharmaceuticals, Inc | 50228-484-01 | 50228-484 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 500 Tablet In 1 Bottle (50228-484-05) | ScieGen Pharmaceuticals, Inc | 50228-484-05 | 50228-484 | ANDA216521 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (70069-814-10) | Somerset Therapeutics, LLC | 70069-814-10 | 70069-814 | ANDA213859 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (70069-814-30) | Somerset Therapeutics, LLC | 70069-814-30 | 70069-814 | ANDA213859 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (70069-814-90) | Somerset Therapeutics, LLC | 70069-814-90 | 70069-814 | ANDA213859 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (70069-815-10) | Somerset Therapeutics, LLC | 70069-815-10 | 70069-815 | ANDA213859 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (70069-815-30) | Somerset Therapeutics, LLC | 70069-815-30 | 70069-815 | ANDA213859 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 90 Capsule, Delayed Release In 1 Bottle (70069-815-90) | Somerset Therapeutics, LLC | 70069-815-90 | 70069-815 | ANDA213859 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 30 Tablet In 1 Bottle (50228-484-30) | ScieGen Pharmaceuticals, Inc | 50228-484-30 | 50228-484 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (50228-481-01) | ScieGen Pharmaceuticals, Inc | 50228-481-01 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (50228-481-05) | ScieGen Pharmaceuticals, Inc | 50228-481-05 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (50228-481-10) | ScieGen Pharmaceuticals, Inc | 50228-481-10 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (50228-481-30) | ScieGen Pharmaceuticals, Inc | 50228-481-30 | 50228-481 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (50228-482-01) | ScieGen Pharmaceuticals, Inc | 50228-482-01 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 500 Tablet In 1 Bottle (50228-482-05) | ScieGen Pharmaceuticals, Inc | 50228-482-05 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle (50228-482-10) | ScieGen Pharmaceuticals, Inc | 50228-482-10 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (50228-482-30) | ScieGen Pharmaceuticals, Inc | 50228-482-30 | 50228-482 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 100 Tablet In 1 Bottle (50228-483-01) | ScieGen Pharmaceuticals, Inc | 50228-483-01 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 500 Tablet In 1 Bottle (50228-483-05) | ScieGen Pharmaceuticals, Inc | 50228-483-05 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 1000 Tablet In 1 Bottle (50228-483-10) | ScieGen Pharmaceuticals, Inc | 50228-483-10 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 90mg/1 | 30 Tablet In 1 Bottle (50228-483-30) | ScieGen Pharmaceuticals, Inc | 50228-483-30 | 50228-483 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (50228-484-01) | ScieGen Pharmaceuticals, Inc | 50228-484-01 | 50228-484 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 500 Tablet In 1 Bottle (50228-484-05) | ScieGen Pharmaceuticals, Inc | 50228-484-05 | 50228-484 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet | Oral | 120mg/1 | 30 Tablet In 1 Bottle (50228-484-30) | ScieGen Pharmaceuticals, Inc | 50228-484-30 | 50228-484 | ANDA216521 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 120mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-495-05) | ScieGen Pharmaceuticals, Inc. | 50228-495-05 | 50228-495 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 120mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-495-30) | ScieGen Pharmaceuticals, Inc. | 50228-495-30 | 50228-495 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 180mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-496-05) | ScieGen Pharmaceuticals, Inc. | 50228-496-05 | 50228-496 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 180mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-496-30) | ScieGen Pharmaceuticals, Inc. | 50228-496-30 | 50228-496 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 240mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-497-05) | ScieGen Pharmaceuticals, Inc. | 50228-497-05 | 50228-497 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 240mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-497-30) | ScieGen Pharmaceuticals, Inc. | 50228-497-30 | 50228-497 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-498-05) | ScieGen Pharmaceuticals, Inc. | 50228-498-05 | 50228-498 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-498-30) | ScieGen Pharmaceuticals, Inc. | 50228-498-30 | 50228-498 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 360mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-499-05) | ScieGen Pharmaceuticals, Inc. | 50228-499-05 | 50228-499 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 360mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-499-30) | ScieGen Pharmaceuticals, Inc. | 50228-499-30 | 50228-499 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 420mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-500-05) | ScieGen Pharmaceuticals, Inc. | 50228-500-05 | 50228-500 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 420mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-500-30) | ScieGen Pharmaceuticals, Inc. | 50228-500-30 | 50228-500 | ANDA216327 | ANDA | N/A |
| Estazolam | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (70954-480-10) | Novitium Pharma LLC | 70954-480-10 | 70954-480 | ANDA074826 | ANDA | CIV |
| Estazolam | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (70954-481-10) | Novitium Pharma LLC | 70954-481-10 | 70954-481 | ANDA074826 | ANDA | CIV |
| Estradiol | Gel | Topical | .5mg/.5g | 30 Packet In 1 Carton (45802-202-30) / .5 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-202-30 | 45802-202 | ANDA216524 | ANDA | N/A |
| Estradiol | Gel | Topical | 1.25mg/1.25g | 30 Packet In 1 Carton (45802-573-30) / 1.25 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-573-30 | 45802-573 | ANDA216524 | ANDA | N/A |
| Estradiol | Gel | Topical | 1mg/g | 30 Packet In 1 Carton (45802-452-30) / 1 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-452-30 | 45802-452 | ANDA216524 | ANDA | N/A |
| Estradiol | Gel | Topical | .25mg/.25g | 30 Packet In 1 Carton (45802-134-30) / .25 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-134-30 | 45802-134 | ANDA216524 | ANDA | N/A |
| Estradiol | Gel | Topical | .75mg/.75g | 30 Packet In 1 Carton (45802-310-30) / .75 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-310-30 | 45802-310 | ANDA216524 | ANDA | N/A |
| Estradiol | Cream | Vaginal | .1mg/g | 1 Tube In 1 Carton (45802-097-35) / 42.5 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-097-35 | 45802-097 | ANDA210194 | ANDA | N/A |
| Estradiol | Spray | Transdermal | 1.53mg/1 | 56 Spray In 1 Vial, Multi-Dose (0574-2067-00) | Padagis US LLC | 0574-2067-00 | 0574-2067 | NDA022014 | NDA | N/A |
| Estradiol | Spray | Transdermal | 1.53mg/1 | 56 Spray In 1 Vial, Multi-Dose (0574-2067-27) | Padagis US LLC | 0574-2067-27 | 0574-2067 | NDA022014 | NDA | N/A |
| Estradiol | Cream | Vaginal | .1mg/g | 1 Tube In 1 Carton (66993-002-10) / 42.5 G In 1 Tube | Prasco Laboratories | 66993-002-10 | 66993-002 | ANDA212313 | ANDA | N/A |
| Estradiol | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (60429-834-05) | Golden State Medical Supply, Inc. | 60429-834-05 | 60429-834 | ANDA040197 | ANDA | N/A |
| Estradiol | Gel | Topical | .25mg/.25g | 7 Packet In 1 Carton (68025-065-07) / .25 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-065-07 | 68025-065 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | .25mg/.25g | 30 Packet In 1 Carton (68025-065-30) / .25 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-065-30 | 68025-065 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | .5mg/.5g | 7 Packet In 1 Carton (68025-066-07) / .5 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-066-07 | 68025-066 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | .5mg/.5g | 30 Packet In 1 Carton (68025-066-30) / .5 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-066-30 | 68025-066 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | 1mg/g | 7 Packet In 1 Carton (68025-067-07) / 1 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-067-07 | 68025-067 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | 1mg/g | 30 Packet In 1 Carton (68025-067-30) / 1 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-067-30 | 68025-067 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | .75mg/.75g | 7 Packet In 1 Carton (68025-083-07) / .75 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-083-07 | 68025-083 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | .75mg/.75g | 30 Packet In 1 Carton (68025-083-30) / .75 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-083-30 | 68025-083 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | 1.25mg/1.25g | 7 Packet In 1 Carton (68025-086-07) / 1.25 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-086-07 | 68025-086 | NDA022038 | NDA | N/A |
| Estradiol | Gel | Topical | 1.25mg/1.25g | 30 Packet In 1 Carton (68025-086-30) / 1.25 G In 1 Packet | Vertical Pharmaceuticals, LLC | 68025-086-30 | 68025-086 | NDA022038 | NDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 120mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-495-05) | ScieGen Pharmaceuticals, Inc. | 50228-495-05 | 50228-495 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 120mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-495-30) | ScieGen Pharmaceuticals, Inc. | 50228-495-30 | 50228-495 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 180mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-496-05) | ScieGen Pharmaceuticals, Inc. | 50228-496-05 | 50228-496 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 180mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-496-30) | ScieGen Pharmaceuticals, Inc. | 50228-496-30 | 50228-496 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 240mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-497-05) | ScieGen Pharmaceuticals, Inc. | 50228-497-05 | 50228-497 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 240mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-497-30) | ScieGen Pharmaceuticals, Inc. | 50228-497-30 | 50228-497 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-498-05) | ScieGen Pharmaceuticals, Inc. | 50228-498-05 | 50228-498 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-498-30) | ScieGen Pharmaceuticals, Inc. | 50228-498-30 | 50228-498 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 360mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-499-05) | ScieGen Pharmaceuticals, Inc. | 50228-499-05 | 50228-499 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 360mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-499-30) | ScieGen Pharmaceuticals, Inc. | 50228-499-30 | 50228-499 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 420mg/1 | 500 Tablet, Extended Release In 1 Bottle (50228-500-05) | ScieGen Pharmaceuticals, Inc. | 50228-500-05 | 50228-500 | ANDA216327 | ANDA | N/A |
| Diltiazem Hydrochloride | Tablet, Extended Release | Oral | 420mg/1 | 30 Tablet, Extended Release In 1 Bottle (50228-500-30) | ScieGen Pharmaceuticals, Inc. | 50228-500-30 | 50228-500 | ANDA216327 | ANDA | N/A |
| DIMETHYL FUMARATE | Capsule, Delayed Release | Oral | 120mg/1 | 1 Bottle In 1 Carton (31722-657-31) / 14 Capsule, Delayed Release In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-657-31 | 31722-657 | ANDA210500 | ANDA | N/A |
| DIMETHYL FUMARATE | Capsule, Delayed Release | Oral | 120mg/1 | 10 Blister Pack In 1 Carton (31722-657-32) / 10 Capsule, Delayed Release In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-657-32 | 31722-657 | ANDA210500 | ANDA | N/A |
| DIMETHYL FUMARATE | Capsule, Delayed Release | Oral | 240mg/1 | 1 Bottle In 1 Carton (31722-658-31) / 46 Capsule, Delayed Release In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-658-31 | 31722-658 | ANDA210500 | ANDA | N/A |
| DIMETHYL FUMARATE | Capsule, Delayed Release | Oral | 240mg/1 | 1 Bottle In 1 Carton (31722-658-32) / 60 Capsule, Delayed Release In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-658-32 | 31722-658 | ANDA210500 | ANDA | N/A |
| DIMETHYL FUMARATE | Capsule, Delayed Release | Oral | 240mg/1 | 10 Blister Pack In 1 Carton (31722-658-33) / 10 Capsule, Delayed Release In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-658-33 | 31722-658 | ANDA210500 | ANDA | N/A |
| Diphenhydramine Hydrochloride | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (42806-648-10) | Epic Pharma, LLC | 42806-648-10 | 42806-648 | part341 | OTC MONOGRAPH FINAL | N/A |
| Diphenhydramine Hydrochloride | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (42806-649-10) | Epic Pharma, LLC | 42806-649-10 | 42806-649 | part341 | OTC MONOGRAPH FINAL | N/A |
| Diphenhydramine Hydrochloride | Liquid | Oral | 12.5mg/5mL | 118 Ml In 1 Bottle (57237-305-12) | Rising Health, LLC | 57237-305-12 | 57237-305 | part341 | OTC MONOGRAPH FINAL | N/A |
| Diphenhydramine Hydrochloride | Liquid | Oral | 12.5mg/5mL | 473 Ml In 1 Bottle (57237-305-16) | Rising Health, LLC | 57237-305-16 | 57237-305 | part341 | OTC MONOGRAPH FINAL | N/A |
| Diphenhydramine Hydrochloride | Solution | Oral | 12.5mg/5mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-317-51) / 5 Ml In 1 Cup, Unit-Dose (57237-317-05) | Rising Pharma Holdings, Inc. | 57237-317-51 | 57237-317 | M | OTC MONOGRAPH DRUG | N/A |
| Diphenhydramine Hydrochloride | Solution | Oral | 25mg/10mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-318-11) / 10 Ml In 1 Cup, Unit-Dose (57237-318-01) | Rising Pharma Holdings, Inc. | 57237-318-11 | 57237-318 | M | OTC MONOGRAPH DRUG | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-133-01) | Rising Pharmaceuticals, Inc. | 64980-133-01 | 64980-133 | ANDA040733 | ANDA | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (64980-133-10) | Rising Pharmaceuticals, Inc. | 64980-133-10 | 64980-133 | ANDA040733 | ANDA | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-134-01) | Rising Pharmaceuticals, Inc. | 64980-134-01 | 64980-134 | ANDA040733 | ANDA | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (64980-134-10) | Rising Pharmaceuticals, Inc. | 64980-134-10 | 64980-134 | ANDA040733 | ANDA | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 75mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-135-01) | Rising Pharmaceuticals, Inc. | 64980-135-01 | 64980-135 | ANDA040733 | ANDA | N/A |
| Dipyridamole | Tablet, Film Coated | Oral | 75mg/1 | 1000 Tablet, Film Coated In 1 Bottle (64980-135-10) | Rising Pharmaceuticals, Inc. | 64980-135-10 | 64980-135 | ANDA040733 | ANDA | N/A |
| Estradiol | System | Vaginal | 2mg/1 | 1 Pouch In 1 Carton (0013-1042-01) / 1 System In 1 Pouch | Pfizer Laboratories Div Pfizer Inc | 0013-1042-01 | 0013-1042 | NDA020472 | NDA | N/A |
| Estradiol | Ring | Vaginal | 2mg/1 | 1 Pouch In 1 Carton (0013-2150-36) / 1 Ring In 1 Pouch | Pfizer Laboratories Div Pfizer Inc | 0013-2150-36 | 0013-2150 | NDA020472 | NDA | N/A |
| Estradiol Hemihydrate | Cream | Vaginal | .1mg/g | 1 Tube, With Applicator In 1 Carton (47781-104-44) / 42.5 G In 1 Tube, With Applicator | Alvogen Inc. | 47781-104-44 | 47781-104 | ANDA209767 | ANDA | N/A |
| Estradiol Valerate | Injection, Solution | Intramuscular | 20mg/mL | 1 Vial, Multi-Dose In 1 Carton (0517-0420-01) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0420-01 | 0517-0420 | ANDA090920 | ANDA | N/A |
| Estradiol Valerate | Injection, Solution | Intramuscular | 40mg/mL | 1 Vial, Multi-Dose In 1 Carton (0517-0440-01) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-0440-01 | 0517-0440 | ANDA090920 | ANDA | N/A |
| Estradiol Valerate | Injection | Intramuscular | 10mg/mL | 1 Vial In 1 Carton (0143-9289-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9289-01 | 0143-9289 | ANDA203723 | ANDA | N/A |
| Estradiol Valerate | Injection | Intramuscular | 20mg/mL | 1 Vial In 1 Carton (0143-9290-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9290-01 | 0143-9290 | ANDA203723 | ANDA | N/A |
| Estradiol Valerate | Injection | Intramuscular | 40mg/mL | 1 Vial In 1 Carton (0143-9291-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9291-01 | 0143-9291 | ANDA203723 | ANDA | N/A |
| Divalproex Sodium | Tablet, Extended Release | Oral | 250mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-755-10) | Amneal Pharmaceuticals LLC | 65162-755-10 | 65162-755 | ANDA203730 | ANDA | N/A |
| Divalproex Sodium | Tablet, Extended Release | Oral | 250mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-755-50) | Amneal Pharmaceuticals LLC | 65162-755-50 | 65162-755 | ANDA203730 | ANDA | N/A |
| Divalproex Sodium | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-757-10) | Amneal Pharmaceuticals LLC | 65162-757-10 | 65162-757 | ANDA203730 | ANDA | N/A |
| Divalproex Sodium | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-757-50) | Amneal Pharmaceuticals LLC | 65162-757-50 | 65162-757 | ANDA203730 | ANDA | N/A |
| Divalproex sodium | Tablet, Film Coated, Extended Release | Oral | 250mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-021-01) | Camber Pharmaceuticals, Inc. | 31722-021-01 | 31722-021 | ANDA215527 | ANDA | N/A |
| Divalproex sodium | Tablet, Film Coated, Extended Release | Oral | 250mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-021-05) | Camber Pharmaceuticals, Inc. | 31722-021-05 | 31722-021 | ANDA215527 | ANDA | N/A |
| Divalproex sodium | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-022-01) | Camber Pharmaceuticals, Inc. | 31722-022-01 | 31722-022 | ANDA215527 | ANDA | N/A |
| Divalproex sodium | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-022-05) | Camber Pharmaceuticals, Inc. | 31722-022-05 | 31722-022 | ANDA215527 | ANDA | N/A |
| Estramustine Phosphate Sodium | Capsule | Oral | 140mg/1 | 1 Bottle In 1 Carton (0013-0132-02) / 100 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0013-0132-02 | 0013-0132 | NDA018045 | NDA | N/A |
| Estrogens, Conjugated | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 25mg/5mL | 1 Vial In 1 Carton (0046-0749-05) / 5 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-0749-05 | 0046-0749 | NDA010402 | NDA | N/A |
| Estrogens, Conjugated | Cream | Vaginal | .625mg/g | 1 Tube, With Applicator In 1 Carton (0046-0872-04) / 4 G In 1 Tube, With Applicator | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-0872-04 | 0046-0872 | NDA020216 | NDA | N/A |
| Estrogens, Conjugated | Cream | Vaginal | .625mg/g | 1 Tube, With Applicator In 1 Carton (0046-0872-21) / 30 G In 1 Tube, With Applicator | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-0872-21 | 0046-0872 | NDA020216 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .3mg/1 | 1 Blister Pack In 1 Carton (0046-1100-52) / 5 Tablet, Film Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1100-52 | 0046-1100 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .3mg/1 | 100 Tablet, Film Coated In 1 Bottle (0046-1100-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1100-81 | 0046-1100 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .3mg/1 | 1 Bottle In 1 Carton (0046-1100-91) / 1000 Tablet, Film Coated In 1 Bottle | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1100-91 | 0046-1100 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .45mg/1 | 100 Tablet, Film Coated In 1 Bottle (0046-1101-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1101-81 | 0046-1101 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .625mg/1 | 1 Blister Pack In 1 Carton (0046-1102-52) / 5 Tablet, Film Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1102-52 | 0046-1102 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .625mg/1 | 100 Tablet, Film Coated In 1 Bottle (0046-1102-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1102-81 | 0046-1102 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .625mg/1 | 1 Bottle In 1 Carton (0046-1102-91) / 1000 Tablet, Film Coated In 1 Bottle | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1102-91 | 0046-1102 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | .9mg/1 | 100 Tablet, Film Coated In 1 Bottle (0046-1103-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1103-81 | 0046-1103 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | 1.25mg/1 | 100 Tablet, Film Coated In 1 Bottle (0046-1104-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1104-81 | 0046-1104 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated | Tablet, Film Coated | Oral | 1.25mg/1 | 1 Bottle In 1 Carton (0046-1104-91) / 1000 Tablet, Film Coated In 1 Bottle | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1104-91 | 0046-1104 | NDA004782 | NDA | N/A |
| Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet, Sugar Coated | Oral | .3mg/1, 1.5 mg/1 | 1 Blister Pack In 1 Carton (0046-1105-11) / 28 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1105-11 | 0046-1105 | NDA020527 | NDA | N/A |
| Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet, Sugar Coated | Oral | .45mg/1, 1.5 mg/1 | 1 Blister Pack In 1 Carton (0046-1106-11) / 28 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1106-11 | 0046-1106 | NDA020527 | NDA | N/A |
| Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet, Sugar Coated | Oral | .625mg/1, 2.5 mg/1 | 1 Blister Pack In 1 Carton (0046-1107-11) / 28 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1107-11 | 0046-1107 | NDA020527 | NDA | N/A |
| Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet, Sugar Coated | Oral | .625mg/1, 5 mg/1 | 1 Blister Pack In 1 Carton (0046-1108-11) / 28 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1108-11 | 0046-1108 | NDA020527 | NDA | N/A |
| Estrogens, Esterified | Tablet, Film Coated | Oral | .3mg/1 | 100 Tablet, Film Coated In 1 Bottle (61570-072-01) | Pfizer Laboratories Div Pfizer Inc | 61570-072-01 | 61570-072 | ANDA084951 | ANDA | N/A |
| Estrogens, Esterified | Tablet, Film Coated | Oral | .625mg/1 | 100 Tablet, Film Coated In 1 Bottle (61570-073-01) | Pfizer Laboratories Div Pfizer Inc | 61570-073-01 | 61570-073 | ANDA084948 | ANDA | N/A |
| Estrogens, Esterified | Tablet, Film Coated | Oral | 1.25mg/1 | 100 Tablet, Film Coated In 1 Bottle (61570-074-01) | Pfizer Laboratories Div Pfizer Inc | 61570-074-01 | 61570-074 | ANDA084950 | ANDA | N/A |
| Estrogens, Esterified | Tablet, Film Coated | Oral | 2.5mg/1 | 50 Tablet, Film Coated In 1 Bottle (61570-075-50) | Pfizer Laboratories Div Pfizer Inc | 61570-075-50 | 61570-075 | ANDA084949 | ANDA | N/A |
| Estrogens, Esterified; Methyltestosterone | Tablet | Oral | .625mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle (69315-283-01) | Leading Pharmaceuticals, LLC | 69315-283-01 | 69315-283 | N/A | UNAPPROVED DRUG OTHER | CIII |
| Estrogens, Esterified; Methyltestosterone | Tablet | Oral | 1.25mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (69315-284-01) | Leading Pharmaceuticals, LLC | 69315-284-01 | 69315-284 | N/A | UNAPPROVED DRUG OTHER | CIII |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 125mg/1 | 100 Tablet, Delayed Release In 1 Bottle (57237-106-01) | Rising Pharma Holdings, Inc. | 57237-106-01 | 57237-106 | ANDA090554 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 125mg/1 | 500 Tablet, Delayed Release In 1 Bottle (57237-106-05) | Rising Pharma Holdings, Inc. | 57237-106-05 | 57237-106 | ANDA090554 | ANDA | N/A |
| Eszopiclone | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60429-632-30) | Golden State Medical Supply, Inc. | 60429-632-30 | 60429-632 | ANDA091151 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 2mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60429-633-30) | Golden State Medical Supply, Inc. | 60429-633-30 | 60429-633 | ANDA091151 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 3mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60429-634-30) | Golden State Medical Supply, Inc. | 60429-634-30 | 60429-634 | ANDA091151 | ANDA | CIV |
| Eszopiclone | Tablet, Coated | Oral | 1mg/1 | 30 Tablet, Coated In 1 Bottle (80725-010-30) | Waylis Therapeutics LLC | 80725-010-30 | 80725-010 | NDA021476 | NDA | CIV |
| Eszopiclone | Tablet, Coated | Oral | 2mg/1 | 30 Tablet, Coated In 1 Bottle (80725-011-30) | Waylis Therapeutics LLC | 80725-011-30 | 80725-011 | NDA021476 | NDA | CIV |
| Eszopiclone | Tablet, Coated | Oral | 3mg/1 | 30 Tablet, Coated In 1 Bottle (80725-012-30) | Waylis Therapeutics LLC | 80725-012-30 | 80725-012 | NDA021476 | NDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (69452-347-13) | Bionpharma Inc. | 69452-347-13 | 69452-347 | ANDA091113 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 1mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-347-20) | Bionpharma Inc. | 69452-347-20 | 69452-347 | ANDA091113 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-348-20) | Bionpharma Inc. | 69452-348-20 | 69452-348 | ANDA091113 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 3mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-349-20) | Bionpharma Inc. | 69452-349-20 | 69452-349 | ANDA091113 | ANDA | CIV |
| Ethacrynate Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/50mL | 1 Vial, Single-Dose In 1 Carton (69315-701-50) / 50 Ml In 1 Vial, Single-Dose | Leading Pharma, LLC | 69315-701-50 | 69315-701 | ANDA208663 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 250mg/1 | 100 Tablet, Delayed Release In 1 Bottle (57237-047-01) | Rising Pharma Holdings, Inc. | 57237-047-01 | 57237-047 | ANDA090554 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 250mg/1 | 500 Tablet, Delayed Release In 1 Bottle (57237-047-05) | Rising Pharma Holdings, Inc. | 57237-047-05 | 57237-047 | ANDA090554 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 500mg/1 | 100 Tablet, Delayed Release In 1 Bottle (57237-048-01) | Rising Pharma Holdings, Inc. | 57237-048-01 | 57237-048 | ANDA090554 | ANDA | N/A |
| Divalproex Sodium | Tablet, Delayed Release | Oral | 500mg/1 | 500 Tablet, Delayed Release In 1 Bottle (57237-048-05) | Rising Pharma Holdings, Inc. | 57237-048-05 | 57237-048 | ANDA090554 | ANDA | N/A |
| Docetaxel Anhydrous | Injection | Intravenous | 20mg/mL | 1 Vial, Glass In 1 Carton (70121-1221-1) / 1 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1221-1 | 70121-1221 | ANDA209640 | ANDA | N/A |
| Docetaxel Anhydrous | Injection | Intravenous | 80mg/4mL | 1 Vial, Glass In 1 Carton (70121-1222-1) / 4 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1222-1 | 70121-1222 | ANDA209640 | ANDA | N/A |
| Docetaxel Anhydrous | Injection | Intravenous | 160mg/8mL | 1 Vial, Glass In 1 Carton (70121-1223-1) / 8 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1223-1 | 70121-1223 | ANDA209640 | ANDA | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (50742-431-08) / 8 Ml In 1 Vial, Multi-Dose | Ingenus Pharmaceuticals, LLC | 50742-431-08 | 50742-431 | ANDA207563 | ANDA | N/A |
| Ethinyl Estradiol; Etonogestrel | Insert, Extended Release | Vaginal | .015mg/d, .12 mg/d | 3 Pouch In 1 Box (66993-605-36) / 21 D In 1 Pouch (66993-605-81) | Prasco Laboratories | 66993-605-36 | 66993-605 | NDA021187 | NDA AUTHORIZED GENERIC | N/A |
| Docetaxel Anhydrous | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Multi-Dose In 1 Carton (50742-463-16) / 16 Ml In 1 Vial, Multi-Dose | Ingenus Pharmaceuticals, LLC | 50742-463-16 | 50742-463 | ANDA207563 | ANDA | N/A |
| Donepezil | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-737-01) | Camber Pharmaceuticals, Inc. | 31722-737-01 | 31722-737 | ANDA203034 | ANDA | N/A |
| Donepezil | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (31722-737-05) | Camber Pharmaceuticals, Inc. | 31722-737-05 | 31722-737 | ANDA203034 | ANDA | N/A |
| Donepezil | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (31722-737-30) | Camber Pharmaceuticals, Inc. | 31722-737-30 | 31722-737 | ANDA203034 | ANDA | N/A |
| Donepezil | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Blister Pack (31722-737-31) | Camber Pharmaceuticals, Inc. | 31722-737-31 | 31722-737 | ANDA203034 | ANDA | N/A |
| Ethinyl Estradiol; Norethindrone Acetate | Tablet | Oral | .0025mg/1, .5 mg/1 | 3 Blister Pack In 1 Carton (75834-129-29) / 28 Tablet In 1 Blister Pack (75834-129-84) | Nivagen Pharmaceuticals, Inc. | 75834-129-29 | 75834-129 | ANDA203435 | ANDA | N/A |
| Ethinyl Estradiol; Norethindrone Acetate | Tablet | Oral | .0025mg/1, .5 mg/1 | 90 Tablet In 1 Bottle (75834-129-90) | Nivagen Pharmaceuticals, Inc. | 75834-129-90 | 75834-129 | ANDA203435 | ANDA | N/A |
| Ethinyl Estradiol; Norethindrone Acetate | Tablet | Oral | .005mg/1, 1 mg/1 | 3 Blister Pack In 1 Carton (75834-130-29) / 28 Tablet In 1 Blister Pack (75834-130-84) | Nivagen Pharmaceuticals, Inc. | 75834-130-29 | 75834-130 | ANDA203435 | ANDA | N/A |
| Ethinyl Estradiol; Norethindrone Acetate | Tablet | Oral | .005mg/1, 1 mg/1 | 90 Tablet In 1 Bottle (75834-130-90) | Nivagen Pharmaceuticals, Inc. | 75834-130-90 | 75834-130 | ANDA203435 | ANDA | N/A |
| Ethionamide | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (0008-4117-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4117-01 | 0008-4117 | NDA013026 | NDA | N/A |
| Ethosuximide | Capsule, Liquid Filled | Oral | 250mg/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-152-20) | Bionpharma Inc. | 69452-152-20 | 69452-152 | ANDA040430 | ANDA | N/A |
| Donepezil | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (31722-737-90) | Camber Pharmaceuticals, Inc. | 31722-737-90 | 31722-737 | ANDA203034 | ANDA | N/A |
| Donepezil | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-738-01) | Camber Pharmaceuticals, Inc. | 31722-738-01 | 31722-738 | ANDA203034 | ANDA | N/A |
| Ethosuximide | Solution | Oral | 250mg/5mL | 1 Bottle, Plastic In 1 Carton (0071-2418-19) / 474 Ml In 1 Bottle, Plastic | Parke-Davis Div of Pfizer Inc | 0071-2418-19 | 0071-2418 | ANDA080258 | ANDA | N/A |
| Ethosuximide | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (0071-0237-24) | Parke-Davis Div of Pfizer Inc | 0071-0237-24 | 0071-0237 | NDA012380 | NDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 15 Tablet, Extended Release In 1 Bottle, Plastic (60760-378-15) | St. Mary's Medical Park Pharmacy | 60760-378-15 | 60760-378 | ANDA076174 | ANDA | N/A |
| Etodolac | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (60429-243-01) | Golden State Medical Supply, Inc. | 60429-243-01 | 60429-243 | ANDA075078 | ANDA | N/A |
| Etodolac | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (60429-244-01) | Golden State Medical Supply, Inc. | 60429-244-01 | 60429-244 | ANDA075078 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-311-01) | Golden State Medical Supply, Inc. | 60429-311-01 | 60429-311 | ANDA075074 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-312-01) | Golden State Medical Supply, Inc. | 60429-312-01 | 60429-312 | ANDA075074 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-313-01) | Golden State Medical Supply, Inc. | 60429-313-01 | 60429-313 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-314-01) | Golden State Medical Supply, Inc. | 60429-314-01 | 60429-314 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4051-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-1 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 500 Tablet, Extended Release In 1 Bottle (51672-4051-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-2 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4051-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-3 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 60 Tablet, Extended Release In 1 Bottle (51672-4051-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-4 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4051-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-6 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 400mg/1 | 10 Blister Pack In 1 Carton (51672-4051-9) / 6 Tablet, Extended Release In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4051-9 | 51672-4051 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4052-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-1 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (51672-4052-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-2 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4052-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-3 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 60 Tablet, Extended Release In 1 Bottle (51672-4052-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-4 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4052-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-6 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 500mg/1 | 10 Blister Pack In 1 Carton (51672-4052-9) / 6 Tablet, Extended Release In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4052-9 | 51672-4052 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 100 Tablet, Extended Release In 1 Bottle (51672-4053-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-1 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 500 Tablet, Extended Release In 1 Bottle (51672-4053-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-2 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51672-4053-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-3 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 60 Tablet, Extended Release In 1 Bottle (51672-4053-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-4 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 30 Tablet, Extended Release In 1 Bottle (51672-4053-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-6 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Tablet, Extended Release | Oral | 600mg/1 | 10 Blister Pack In 1 Carton (51672-4053-9) / 6 Tablet, Extended Release In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4053-9 | 51672-4053 | ANDA076174 | ANDA | N/A |
| Etodolac | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (51672-4016-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4016-1 | 51672-4016 | ANDA075078 | ANDA | N/A |
| Etodolac | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (51672-4017-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4017-1 | 51672-4017 | ANDA075078 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (51672-4018-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4018-1 | 51672-4018 | ANDA075074 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (51672-4036-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4036-1 | 51672-4036 | ANDA075074 | ANDA | N/A |
| Donepezil | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (31722-738-05) | Camber Pharmaceuticals, Inc. | 31722-738-05 | 31722-738 | ANDA203034 | ANDA | N/A |
| Donepezil | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (31722-738-30) | Camber Pharmaceuticals, Inc. | 31722-738-30 | 31722-738 | ANDA203034 | ANDA | N/A |
| Etodolac | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (60505-0039-1) | Apotex Corp. | 60505-0039-1 | 60505-0039 | ANDA075419 | ANDA | N/A |
| Etodolac | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (60505-0040-1) | Apotex Corp. | 60505-0040-1 | 60505-0040 | ANDA075419 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0041-1) | Apotex Corp. | 60505-0041-1 | 60505-0041 | ANDA076004 | ANDA | N/A |
| Etodolac | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0102-1) | Apotex Corp. | 60505-0102-1 | 60505-0102 | ANDA076004 | ANDA | N/A |
| Etomidate | Injection | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9506-10) / 10 Ml In 1 Vial, Single-Dose (0143-9506-01) | Hikma Pharmaceuticals USA Inc. | 0143-9506-10 | 0143-9506 | ANDA202354 | ANDA | N/A |
| Etomidate | Injection | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9507-10) / 20 Ml In 1 Vial, Single-Dose (0143-9507-01) | Hikma Pharmaceuticals USA Inc. | 0143-9507-10 | 0143-9507 | ANDA202354 | ANDA | N/A |
| Etomidate | Injection | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9310-10) / 10 Ml In 1 Vial, Single-Dose (0143-9310-01) | Hikma Pharmaceuticals USA Inc. | 0143-9310-10 | 0143-9310 | ANDA202354 | ANDA | N/A |
| Etomidate | Injection | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9311-10) / 20 Ml In 1 Vial, Single-Dose (0143-9311-01) | Hikma Pharmaceuticals USA Inc. | 0143-9311-10 | 0143-9311 | ANDA202354 | ANDA | N/A |
| Etomidate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-6695-01) / 10 Ml In 1 Vial, Single-Dose (0409-6695-11) | Hospira, Inc. | 0409-6695-01 | 0409-6695 | NDA018227 | NDA | N/A |
| Etomidate | Injection, Solution | Intravenous | 2mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-6695-02) / 20 Ml In 1 Vial, Single-Dose (0409-6695-12) | Hospira, Inc. | 0409-6695-02 | 0409-6695 | NDA018227 | NDA | N/A |
| Etoposide | Injection | Intravenous | 20mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9510-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9510-01 | 0143-9510 | ANDA074290 | ANDA | N/A |
| Etoposide | Injection | Intravenous | 20mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9511-01) / 25 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9511-01 | 0143-9511 | ANDA074290 | ANDA | N/A |
| Etoposide | Injection | Intravenous | 20mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9512-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9512-01 | 0143-9512 | ANDA074290 | ANDA | N/A |
| Etoposide | Injection | Intravenous | 20mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9376-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9376-01 | 0143-9376 | ANDA074290 | ANDA | N/A |
| Etrasimod Arginine | Tablet, Film Coated | Oral | 2mg/1 | 1 Bottle In 1 Carton (0069-0274-30) / 30 Tablet, Film Coated In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-0274-30 | 0069-0274 | NDA216956 | NDA | N/A |
| Etravirine | Tablet | Oral | 100mg/1 | 120 Tablet In 1 Bottle (69315-285-20) | Leading Pharma, LLC | 69315-285-20 | 69315-285 | ANDA215402 | ANDA | N/A |
| Etravirine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (69315-286-06) | Leading Pharma, LLC | 69315-286-06 | 69315-286 | ANDA215402 | ANDA | N/A |
| Etravirine | Tablet | Oral | 100mg/1 | 120 Tablet In 1 Bottle (80005-112-12) | Carnegie Pharmaceuticals LLC | 80005-112-12 | 80005-112 | ANDA215402 | ANDA | N/A |
| Etravirine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (80005-113-09) | Carnegie Pharmaceuticals LLC | 80005-113-09 | 80005-113 | ANDA215402 | ANDA | N/A |
| Eucalyptol; Menthol; Methyl Salicylate; Thymol | Mouthwash | Oral | .92mg/mL, .42 mg/mL, .6 mg/mL, .64 mg/mL | 1500 Ml In 1 Bottle, Plastic (71569-664-12) | Jubilant, LLC | 71569-664-12 | 71569-664 | part356 | OTC MONOGRAPH NOT FINAL | N/A |
| Eucalyptol; Menthol; Methyl Salicylate; Thymol | Mouthwash | Oral | .92mg/mL, .42 mg/mL, .6 mg/mL, .64 mg/mL | 1000 Ml In 1 Bottle, Plastic (71569-664-86) | Jubilant, LLC | 71569-664-86 | 71569-664 | part356 | OTC MONOGRAPH NOT FINAL | N/A |
| Eucalyptus Globulus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1564-2) | Jubilant HollisterStier LLC | 65044-1564-2 | 65044-1564 | BLA103888 | BLA | N/A |
| Eucalyptus Globulus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1564-3) | Jubilant HollisterStier LLC | 65044-1564-3 | 65044-1564 | BLA103888 | BLA | N/A |
| Eucalyptus Globulus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1564-4) | Jubilant HollisterStier LLC | 65044-1564-4 | 65044-1564 | BLA103888 | BLA | N/A |
| Eucalyptus Globulus Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1565-1) | Jubilant HollisterStier LLC | 65044-1565-1 | 65044-1565 | BLA103888 | BLA | N/A |
| Eupatorium Capillifolium Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2058-1) | Jubilant HollisterStier LLC | 65044-2058-1 | 65044-2058 | BLA103888 | BLA | N/A |
| Eupatorium Capillifolium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2057-2) | Jubilant HollisterStier LLC | 65044-2057-2 | 65044-2057 | BLA103888 | BLA | N/A |
| Eupatorium Capillifolium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2057-3) | Jubilant HollisterStier LLC | 65044-2057-3 | 65044-2057 | BLA103888 | BLA | N/A |
| Eupatorium Capillifolium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2057-4) | Jubilant HollisterStier LLC | 65044-2057-4 | 65044-2057 | BLA103888 | BLA | N/A |
| Everolimus | Tablet | Oral | .25mg/1 | 60 Tablet In 1 Bottle (0054-0470-21) | Hikma Pharmaceuticals USA Inc. | 0054-0470-21 | 0054-0470 | ANDA206133 | ANDA | N/A |
| Everolimus | Tablet | Oral | .5mg/1 | 60 Tablet In 1 Bottle (0054-0471-21) | Hikma Pharmaceuticals USA Inc. | 0054-0471-21 | 0054-0471 | ANDA206133 | ANDA | N/A |
| Everolimus | Tablet | Oral | .75mg/1 | 60 Tablet In 1 Bottle (0054-0472-21) | Hikma Pharmaceuticals USA Inc. | 0054-0472-21 | 0054-0472 | ANDA206133 | ANDA | N/A |
| Everolimus | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (0054-0480-13) | Hikma Pharmaceuticals USA Inc. | 0054-0480-13 | 0054-0480 | ANDA207486 | ANDA | N/A |
| Everolimus | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (0054-0481-13) | Hikma Pharmaceuticals USA Inc. | 0054-0481-13 | 0054-0481 | ANDA207486 | ANDA | N/A |
| Everolimus | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (0054-0482-13) | Hikma Pharmaceuticals USA Inc. | 0054-0482-13 | 0054-0482 | ANDA207486 | ANDA | N/A |
| Everolimus | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (0054-0497-13) | Hikma Pharmaceuticals USA Inc. | 0054-0497-13 | 0054-0497 | ANDA207486 | ANDA | N/A |
| Everolimus | Tablet | Oral | 1mg/1 | 60 Tablet In 1 Bottle (0054-0604-21) | Hikma Pharmaceuticals USA Inc. | 0054-0604-21 | 0054-0604 | ANDA206133 | ANDA | N/A |
| Donepezil | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Blister Pack (31722-738-31) | Camber Pharmaceuticals, Inc. | 31722-738-31 | 31722-738 | ANDA203034 | ANDA | N/A |
| Exemestane | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (0054-0080-13) | Hikma Pharmaceuticals USA Inc | 0054-0080-13 | 0054-0080 | ANDA077431 | ANDA | N/A |
| Donepezil | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (31722-738-90) | Camber Pharmaceuticals, Inc. | 31722-738-90 | 31722-738 | ANDA203034 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (16571-778-03) | Rising Pharma Holdings, Inc. | 16571-778-03 | 16571-778 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (16571-778-09) | Rising Pharma Holdings, Inc. | 16571-778-09 | 16571-778 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-778-10) | Rising Pharma Holdings, Inc. | 16571-778-10 | 16571-778 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-778-50) | Rising Pharma Holdings, Inc. | 16571-778-50 | 16571-778 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (16571-779-03) | Rising Pharma Holdings, Inc. | 16571-779-03 | 16571-779 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (16571-779-09) | Rising Pharma Holdings, Inc. | 16571-779-09 | 16571-779 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-779-10) | Rising Pharma Holdings, Inc. | 16571-779-10 | 16571-779 | ANDA090056 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 10 mg/1 | 1000 Tablet In 1 Bottle (51407-190-10) | Golden State Medical Supply | 51407-190-10 | 51407-190 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 10 mg/1 | 30 Tablet In 1 Bottle (51407-190-30) | Golden State Medical Supply | 51407-190-30 | 51407-190 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 10 mg/1 | 90 Tablet In 1 Bottle (51407-190-90) | Golden State Medical Supply | 51407-190-90 | 51407-190 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 20 mg/1 | 1000 Tablet In 1 Bottle (51407-191-10) | Golden State Medical Supply | 51407-191-10 | 51407-191 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 20 mg/1 | 30 Tablet In 1 Bottle (51407-191-30) | Golden State Medical Supply | 51407-191-30 | 51407-191 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 20 mg/1 | 90 Tablet In 1 Bottle (51407-191-90) | Golden State Medical Supply | 51407-191-90 | 51407-191 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 40 mg/1 | 500 Tablet In 1 Bottle (51407-192-05) | Golden State Medical Supply | 51407-192-05 | 51407-192 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 40 mg/1 | 30 Tablet In 1 Bottle (51407-192-30) | Golden State Medical Supply | 51407-192-30 | 51407-192 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 40 mg/1 | 90 Tablet In 1 Bottle (51407-192-90) | Golden State Medical Supply | 51407-192-90 | 51407-192 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 80 mg/1 | 500 Tablet In 1 Bottle (51407-193-05) | Golden State Medical Supply | 51407-193-05 | 51407-193 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 80 mg/1 | 30 Tablet In 1 Bottle (51407-193-30) | Golden State Medical Supply | 51407-193-30 | 51407-193 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 80 mg/1 | 90 Tablet In 1 Bottle (51407-193-90) | Golden State Medical Supply | 51407-193-90 | 51407-193 | ANDA200909 | ANDA | N/A |
| Ezetimibe; Simvastatin | Tablet | Oral | 10mg/1, 20 mg/1 | 90 Tablet In 1 Bottle (60429-880-90) | Golden State Medical Supply, Inc. | 60429-880-90 | 60429-880 | ANDA200909 | ANDA | N/A |
| Fagus Grandifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1120-2) | Jubilant HollisterStier LLC | 65044-1120-2 | 65044-1120 | BLA103888 | BLA | N/A |
| Fagus Grandifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1120-3) | Jubilant HollisterStier LLC | 65044-1120-3 | 65044-1120 | BLA103888 | BLA | N/A |
| Fagus Grandifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1120-4) | Jubilant HollisterStier LLC | 65044-1120-4 | 65044-1120 | BLA103888 | BLA | N/A |
| Fagus Grandifolia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1121-1) | Jubilant HollisterStier LLC | 65044-1121-1 | 65044-1121 | BLA103888 | BLA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3245-3) | Apotex Corp. | 60505-3245-3 | 60505-3245 | ANDA091480 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3246-3) | Apotex Corp. | 60505-3246-3 | 60505-3246 | ANDA091480 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3247-3) | Apotex Corp. | 60505-3247-3 | 60505-3247 | ANDA091480 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-779-50) | Rising Pharma Holdings, Inc. | 16571-779-50 | 16571-779 | ANDA090056 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-139-10) | ScieGen Pharmaceuticals, Inc. | 50228-139-10 | 50228-139 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-139-30) | ScieGen Pharmaceuticals, Inc. | 50228-139-30 | 50228-139 | ANDA203907 | ANDA | N/A |
| Famotidine | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle, Plastic (68475-400-01) | Navinta LLC | 68475-400-01 | 68475-400 | ANDA091020 | ANDA | N/A |
| Famotidine | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle (0574-0147-04) | Padagis US LLC | 0574-0147-04 | 0574-0147 | NDA019527 | NDA AUTHORIZED GENERIC | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 7 Tablet, Film Coated In 1 Bottle, Plastic (60760-736-07) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-736-07 | 60760-736 | ANDA216441 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-736-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-736-60 | 60760-736 | ANDA216441 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-10) / 1000 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-10 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-18) / 180 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-18 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-25) / 25 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-25 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-30) / 30 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-30 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-50) / 50 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-50 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 36 Bottle In 1 Box (51407-683-90) / 90 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-683-90 | 51407-683 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 36 Bottle In 1 Box (51407-684-01) / 100 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-684-01 | 51407-684 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 24 Bottle In 1 Box (51407-684-10) / 1000 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-684-10 | 51407-684 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 36 Bottle In 1 Box (51407-684-18) / 180 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 51407-684-18 | 51407-684 | ANDA075805 | ANDA | N/A |
| Famotidine | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle (51407-452-50) | Golden State Medical Supply, Inc. | 51407-452-50 | 51407-452 | ANDA215043 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (60429-721-01) | Golden State Medical Supply, Inc. | 60429-721-01 | 60429-721 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (21130-022-30) / 30 Tablet In 1 Bottle | Albertsons Companies | 21130-022-30 | 21130-022 | ANDA077367 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (21130-023-25) / 25 Tablet In 1 Bottle | Albertsons Companies | 21130-023-25 | 21130-023 | ANDA077367 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-140-10) | ScieGen Pharmaceuticals, Inc. | 50228-140-10 | 50228-140 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-140-30) | ScieGen Pharmaceuticals, Inc. | 50228-140-30 | 50228-140 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-139-10) | ScieGen Pharmaceuticals, Inc. | 50228-139-10 | 50228-139 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-139-30) | ScieGen Pharmaceuticals, Inc. | 50228-139-30 | 50228-139 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-140-10) | ScieGen Pharmaceuticals, Inc. | 50228-140-10 | 50228-140 | ANDA203907 | ANDA | N/A |
| Donepezil Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-140-30) | ScieGen Pharmaceuticals, Inc. | 50228-140-30 | 50228-140 | ANDA203907 | ANDA | N/A |
| Dorzolamide Hydrochloride; Timolol Maleate | Solution/ Drops | Ophthalmic | 20mg/mL, 5 mg/mL | 12 Pouch In 1 Carton (50742-323-60) / 5 Vial In 1 Pouch (50742-323-05) / .2 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-323-60 | 50742-323 | ANDA217260 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (16571-167-01) | Rising Pharma Holdings, Inc. | 16571-167-01 | 16571-167 | ANDA212727 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 8mg/1 | 100 Tablet In 1 Bottle (16571-168-01) | Rising Pharma Holdings, Inc. | 16571-168-01 | 16571-168 | ANDA212727 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 24 Bottle In 1 Box (61442-121-01) / 100 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-121-01 | 61442-121 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 24 Bottle In 1 Box (61442-121-05) / 500 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-121-05 | 61442-121 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 12 Bottle In 1 Box (61442-121-10) / 1000 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-121-10 | 61442-121 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 24 Bottle In 1 Box (61442-121-30) / 30 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-121-30 | 61442-121 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 24 Bottle In 1 Box (61442-122-01) / 100 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-122-01 | 61442-122 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 24 Bottle In 1 Box (61442-122-05) / 500 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-122-05 | 61442-122 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 12 Bottle In 1 Box (61442-122-10) / 1000 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-122-10 | 61442-122 | ANDA075805 | ANDA | N/A |
| Famotidine | Tablet | Oral | 40mg/1 | 24 Bottle In 1 Box (61442-122-30) / 30 Tablet In 1 Bottle | Carlsbad Technology, Inc | 61442-122-30 | 61442-122 | ANDA075805 | ANDA | N/A |
| Famotidine | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle (80005-119-16) | Carnegie Pharmaceuticals LLC | 80005-119-16 | 80005-119 | ANDA217137 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (16571-165-01) | Rising Pharma Holdings, Inc. | 16571-165-01 | 16571-165 | ANDA212727 | ANDA | N/A |
| Doxazosin Mesylate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (16571-166-01) | Rising Pharma Holdings, Inc. | 16571-166-01 | 16571-166 | ANDA212727 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 10mg/1 | 100 CAPSULE in 1 BOTTLE (55801-527-01) | Appco Pharma LLC | 55801-527-01 | 55801-527 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 10mg/1 | 500 CAPSULE in 1 BOTTLE (55801-527-02) | Appco Pharma LLC | 55801-527-02 | 55801-527 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 25mg/1 | 100 CAPSULE in 1 BOTTLE (55801-528-01) | Appco Pharma LLC | 55801-528-01 | 55801-528 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 25mg/1 | 500 CAPSULE in 1 BOTTLE (55801-528-02) | Appco Pharma LLC | 55801-528-02 | 55801-528 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 50mg/1 | 100 CAPSULE in 1 BOTTLE (55801-529-01) | Appco Pharma LLC | 55801-529-01 | 55801-529 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 50mg/1 | 500 CAPSULE in 1 BOTTLE (55801-529-02) | Appco Pharma LLC | 55801-529-02 | 55801-529 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 75mg/1 | 100 CAPSULE in 1 BOTTLE (55801-530-01) | Appco Pharma LLC | 55801-530-01 | 55801-530 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 75mg/1 | 500 CAPSULE in 1 BOTTLE (55801-530-02) | Appco Pharma LLC | 55801-530-02 | 55801-530 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 100mg/1 | 100 CAPSULE in 1 BOTTLE (55801-531-01) | Appco Pharma LLC | 55801-531-01 | 55801-531 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | CAPSULE | ORAL | 100mg/1 | 500 CAPSULE in 1 BOTTLE (55801-531-02) | Appco Pharma LLC | 55801-531-02 | 55801-531 | ANDA214908 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (42806-530-01) | Epic Pharma, LLC | 42806-530-01 | 42806-530 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (42806-530-10) | Epic Pharma, LLC | 42806-530-10 | 42806-530 | ANDA210675 | ANDA | N/A |
| Famotidine | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Carton (0641-6021-10) / 20 Ml In 1 Vial (0641-6021-01) | Hikma Pharmaceuticals USA Inc. | 0641-6021-10 | 0641-6021 | ANDA075488 | ANDA | N/A |
| Famotidine | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (0641-6022-25) / 2 Ml In 1 Vial (0641-6022-01) | Hikma Pharmaceuticals USA Inc. | 0641-6022-25 | 0641-6022 | ANDA075486 | ANDA | N/A |
| Famotidine | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Carton (0641-6023-10) / 4 Ml In 1 Vial (0641-6023-01) | Hikma Pharmaceuticals USA Inc. | 0641-6023-10 | 0641-6023 | ANDA075488 | ANDA | N/A |
| Famotidine | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (0641-6023-25) / 4 Ml In 1 Vial (0641-6023-01) | Hikma Pharmaceuticals USA Inc. | 0641-6023-25 | 0641-6023 | ANDA075488 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (42806-531-01) | Epic Pharma, LLC | 42806-531-01 | 42806-531 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (42806-531-10) | Epic Pharma, LLC | 42806-531-10 | 42806-531 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (42806-532-01) | Epic Pharma, LLC | 42806-532-01 | 42806-532 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Bottle (42806-532-10) | Epic Pharma, LLC | 42806-532-10 | 42806-532 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (42806-533-01) | Epic Pharma, LLC | 42806-533-01 | 42806-533 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (42806-533-10) | Epic Pharma, LLC | 42806-533-10 | 42806-533 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (42806-529-01) | Epic Pharma, LLC | 42806-529-01 | 42806-529 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (42806-529-10) | Epic Pharma, LLC | 42806-529-10 | 42806-529 | ANDA210675 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (64980-594-01) | Rising Pharma Holdings, Inc. | 64980-594-01 | 64980-594 | ANDA217975 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (64980-595-01) | Rising Pharma Holdings, Inc. | 64980-595-01 | 64980-595 | ANDA217975 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (64980-596-01) | Rising Pharma Holdings, Inc. | 64980-596-01 | 64980-596 | ANDA217975 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (64980-597-01) | Rising Pharma Holdings, Inc. | 64980-597-01 | 64980-597 | ANDA217975 | ANDA | N/A |
| Doxepin Hydrochloride | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (64980-598-01) | Rising Pharma Holdings, Inc. | 64980-598-01 | 64980-598 | ANDA217975 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 4ug/2mL | 50 Vial, Single-Dose In 1 Carton (70121-1392-5) / 2 Ml In 1 Vial, Single-Dose (70121-1392-1) | Amneal Pharmaceuticals LLC | 70121-1392-5 | 70121-1392 | ANDA208974 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (51407-293-30) | Golden State Medical Supply, Inc. | 51407-293-30 | 51407-293 | ANDA205414 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (51407-294-30) | Golden State Medical Supply, Inc. | 51407-294-30 | 51407-294 | ANDA205414 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (27808-206-01) | Tris Pharma Inc | 27808-206-01 | 27808-206 | ANDA210292 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (27808-207-01) | Tris Pharma Inc | 27808-207-01 | 27808-207 | ANDA210292 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (0054-0413-13) | Hikma Pharmaceuticals USA Inc | 0054-0413-13 | 0054-0413 | ANDA205414 | ANDA | N/A |
| Febuxostat | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (0054-0414-13) | Hikma Pharmaceuticals USA Inc | 0054-0414-13 | 0054-0414 | ANDA205414 | ANDA | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 237 Ml In 1 Bottle (70954-051-10) | Novitium Pharma LLC | 70954-051-10 | 70954-051 | ANDA211333 | ANDA | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 473 Ml In 1 Bottle (70954-051-20) | Novitium Pharma LLC | 70954-051-20 | 70954-051 | ANDA211333 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (51672-4185-1) | Taro Pharmaceuticals U.S.A., inc. | 51672-4185-1 | 51672-4185 | ANDA207093 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 90 Tablet In 1 Bottle (51672-4185-5) | Taro Pharmaceuticals U.S.A., inc. | 51672-4185-5 | 51672-4185 | ANDA207093 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (51672-4185-6) | Taro Pharmaceuticals U.S.A., inc. | 51672-4185-6 | 51672-4185 | ANDA207093 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (51672-4186-1) | Taro Pharmaceuticals U.S.A., inc. | 51672-4186-1 | 51672-4186 | ANDA207093 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (51672-4186-5) | Taro Pharmaceuticals U.S.A., inc. | 51672-4186-5 | 51672-4186 | ANDA207093 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (51672-4186-6) | Taro Pharmaceuticals U.S.A., inc. | 51672-4186-6 | 51672-4186 | ANDA207093 | ANDA | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 237 Ml In 1 Bottle (51672-4172-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4172-1 | 51672-4172 | ANDA206314 | ANDA | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 473 Ml In 1 Bottle (51672-4172-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4172-9 | 51672-4172 | ANDA206314 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 4ug/2mL | 25 Vial, Single-Dose In 1 Carton (70121-1392-6) / 2 Ml In 1 Vial, Single-Dose (70121-1392-1) | Amneal Pharmaceuticals LLC | 70121-1392-6 | 70121-1392 | ANDA208974 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 2ug/mL | 50 Vial, Single-Dose In 1 Carton (70121-1393-5) / 1 Ml In 1 Vial, Single-Dose (70121-1393-1) | Amneal Pharmaceuticals LLC | 70121-1393-5 | 70121-1393 | ANDA208974 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 2ug/mL | 25 Vial, Single-Dose In 1 Carton (70121-1393-6) / 1 Ml In 1 Vial, Single-Dose (70121-1393-1) | Amneal Pharmaceuticals LLC | 70121-1393-6 | 70121-1393 | ANDA208974 | ANDA | N/A |
| Doxercalciferol | Injection, Solution | Intravenous | 4ug/2mL | 50 Vial, Multi-Dose In 1 Carton (70121-1408-5) / 2 Ml In 1 Vial, Multi-Dose (70121-1408-1) | Amneal Pharmaceuticals LLC | 70121-1408-5 | 70121-1408 | ANDA208975 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (42806-362-01) | EPIC PHARMA, LLC | 42806-362-01 | 42806-362 | ANDA065182 | ANDA | N/A |
| Doxycycline Hyclate | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (42806-362-10) | EPIC PHARMA, LLC | 42806-362-10 | 42806-362 | ANDA065182 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-312-01) | Epic Pharma, LLC | 42806-312-01 | 42806-312 | ANDA062269 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-312-05) | Epic Pharma, LLC | 42806-312-05 | 42806-312 | ANDA062269 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Film Coated | Oral | 100mg/1 | 50 Tablet, Film Coated In 1 Bottle (42806-312-50) | Epic Pharma, LLC | 42806-312-50 | 42806-312 | ANDA062269 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 75mg/1 | 100 Tablet, Coated In 1 Bottle (42806-645-01) | EPIC PHARMA, LLC | 42806-645-01 | 42806-645 | ANDA214207 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 75mg/1 | 500 Tablet, Coated In 1 Bottle (42806-645-05) | EPIC PHARMA, LLC | 42806-645-05 | 42806-645 | ANDA214207 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 75mg/1 | 60 Tablet, Coated In 1 Bottle (42806-645-60) | EPIC PHARMA, LLC | 42806-645-60 | 42806-645 | ANDA214207 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 150mg/1 | 100 Tablet, Coated In 1 Bottle (42806-646-01) | EPIC PHARMA, LLC | 42806-646-01 | 42806-646 | ANDA214207 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (47781-627-01) | Alvogen Inc. | 47781-627-01 | 47781-627 | ANDA204595 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (47781-630-01) | Alvogen Inc. | 47781-630-01 | 47781-630 | ANDA204595 | ANDA | N/A |
| Felis Catus Dander | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-4810-1) | Jubilant HollisterStier LLC | 65044-4810-1 | 65044-4810 | BLA103890 | BLA | N/A |
| Felis Catus Dander | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-4810-2) | Jubilant HollisterStier LLC | 65044-4810-2 | 65044-4810 | BLA103890 | BLA | N/A |
| Felis Catus Dander | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-4810-3) | Jubilant HollisterStier LLC | 65044-4810-3 | 65044-4810 | BLA103890 | BLA | N/A |
| Felis Catus Dander | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-4810-4) | Jubilant HollisterStier LLC | 65044-4810-4 | 65044-4810 | BLA103890 | BLA | N/A |
| Felis Catus Hair | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-4815-1) | Jubilant HollisterStier LLC | 65044-4815-1 | 65044-4815 | BLA103889 | BLA | N/A |
| Felis Catus Hair | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-4815-2) | Jubilant HollisterStier LLC | 65044-4815-2 | 65044-4815 | BLA103889 | BLA | N/A |
| Felis Catus Hair | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-4815-3) | Jubilant HollisterStier LLC | 65044-4815-3 | 65044-4815 | BLA103889 | BLA | N/A |
| Felis Catus Hair | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-4815-4) | Jubilant HollisterStier LLC | 65044-4815-4 | 65044-4815 | BLA103889 | BLA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-087-01) | Golden State Medical Supply, Inc. | 51407-087-01 | 51407-087 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 2.5mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-087-05) | Golden State Medical Supply, Inc. | 51407-087-05 | 51407-087 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-088-01) | Golden State Medical Supply, Inc. | 51407-088-01 | 51407-088 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-088-05) | Golden State Medical Supply, Inc. | 51407-088-05 | 51407-088 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (61442-431-01) | Carlsbad Technology, Inc. | 61442-431-01 | 61442-431 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 2.5mg/1 | 500 Tablet, Film Coated In 1 Bottle (61442-431-05) | Carlsbad Technology, Inc. | 61442-431-05 | 61442-431 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (61442-432-01) | Carlsbad Technology, Inc. | 61442-432-01 | 61442-432 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (61442-432-05) | Carlsbad Technology, Inc. | 61442-432-05 | 61442-432 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (61442-433-01) | Carlsbad Technology, Inc. | 61442-433-01 | 61442-433 | ANDA204800 | ANDA | N/A |
| Felodipine | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (61442-433-05) | Carlsbad Technology, Inc. | 61442-433-05 | 61442-433 | ANDA204800 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 150mg/1 | 500 Tablet, Coated In 1 Bottle (42806-646-05) | EPIC PHARMA, LLC | 42806-646-05 | 42806-646 | ANDA214207 | ANDA | N/A |
| Doxycycline Hyclate | Tablet, Coated | Oral | 150mg/1 | 60 Tablet, Coated In 1 Bottle (42806-646-60) | EPIC PHARMA, LLC | 42806-646-60 | 42806-646 | ANDA214207 | ANDA | N/A |
| DRONABINOL | Capsule | Oral | 2.5mg/1 | 60 Capsule In 1 Bottle (31722-960-60) | Camber Pharmaceuticals Inc | 31722-960-60 | 31722-960 | ANDA207421 | ANDA | CIII |
| Fenofibrate | Capsule | Oral | 67mg/1 | 90 Capsule In 1 Bottle (35561-345-11) | Austarpharma, LLC | 35561-345-11 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 100 Capsule In 1 Bottle (35561-345-12) | Austarpharma, LLC | 35561-345-12 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 500 Capsule In 1 Bottle (35561-345-13) | Austarpharma, LLC | 35561-345-13 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 90 Capsule In 1 Bottle (35561-346-11) | Austarpharma, LLC | 35561-346-11 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 100 Capsule In 1 Bottle (35561-346-12) | Austarpharma, LLC | 35561-346-12 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 500 Capsule In 1 Bottle (35561-346-13) | Austarpharma, LLC | 35561-346-13 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (35561-347-11) | Austarpharma, LLC | 35561-347-11 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (35561-347-12) | Austarpharma, LLC | 35561-347-12 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (35561-347-13) | Austarpharma, LLC | 35561-347-13 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 48mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-204-90) | Golden State Medical Supply, Inc. | 51407-204-90 | 51407-204 | ANDA200884 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 145mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-205-90) | Golden State Medical Supply, Inc. | 51407-205-90 | 51407-205 | ANDA200884 | ANDA | N/A |
| Fenofibrate | Tablet | Oral | 48mg/1 | 90 Tablet In 1 Bottle (69315-287-09) | Leading Pharma, LLC | 69315-287-09 | 69315-287 | ANDA211122 | ANDA | N/A |
| Fenofibrate | Tablet | Oral | 145mg/1 | 500 Tablet In 1 Bottle (69315-288-05) | Leading Pharma, LLC | 69315-288-05 | 69315-288 | ANDA211122 | ANDA | N/A |
| Fenofibrate | Tablet | Oral | 145mg/1 | 90 Tablet In 1 Bottle (69315-288-09) | Leading Pharma, LLC | 69315-288-09 | 69315-288 | ANDA211122 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 54mg/1 | 90 Tablet, Film Coated In 1 Bottle (69315-289-09) | Leading Pharma, LLC | 69315-289-09 | 69315-289 | ANDA210606 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 160mg/1 | 500 Tablet, Film Coated In 1 Bottle (69315-290-05) | Leading Pharma, LLC | 69315-290-05 | 69315-290 | ANDA210606 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 160mg/1 | 90 Tablet, Film Coated In 1 Bottle (69315-290-09) | Leading Pharma, LLC | 69315-290-09 | 69315-290 | ANDA210606 | ANDA | N/A |
| DRONABINOL | Capsule | Oral | 5mg/1 | 60 Capsule In 1 Bottle (31722-961-60) | Camber Pharmaceuticals Inc | 31722-961-60 | 31722-961 | ANDA207421 | ANDA | CIII |
| DRONABINOL | Capsule | Oral | 10mg/1 | 60 Capsule In 1 Bottle (31722-962-60) | Camber Pharmaceuticals Inc | 31722-962-60 | 31722-962 | ANDA207421 | ANDA | CIII |
| Drospirenone and ethinyl estradiol | Kit | N/A | N/A | 1 Blister Pack In 1 Carton (31722-934-31) / 1 Kit In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-934-31 | 31722-934 | ANDA211944 | ANDA | N/A |
| Drospirenone and ethinyl estradiol | Kit | N/A | N/A | 3 Blister Pack In 1 Carton (31722-934-32) / 1 Kit In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-934-32 | 31722-934 | ANDA211944 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (31722-014-90) | Camber Pharmaceuticals, Inc. | 31722-014-90 | 31722-014 | ANDA211726 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (31722-015-90) | Camber Pharmaceuticals, Inc. | 31722-015-90 | 31722-015 | ANDA211726 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-429-10) | ScieGen Pharmaceuticals Inc | 50228-429-10 | 50228-429 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-429-30) | ScieGen Pharmaceuticals Inc | 50228-429-30 | 50228-429 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (50228-429-90) | ScieGen Pharmaceuticals Inc | 50228-429-90 | 50228-429 | ANDA214017 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 43mg/1 | 100 Capsule In 1 Bottle (60505-3120-1) | Apotex Corp. | 60505-3120-1 | 60505-3120 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 43mg/1 | 30 Capsule In 1 Bottle (60505-3120-3) | Apotex Corp. | 60505-3120-3 | 60505-3120 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 130mg/1 | 100 Capsule In 1 Bottle (60505-3121-1) | Apotex Corp. | 60505-3121-1 | 60505-3121 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 130mg/1 | 30 Capsule In 1 Bottle (60505-3121-3) | Apotex Corp. | 60505-3121-3 | 60505-3121 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 130mg/1 | 500 Capsule In 1 Bottle (60505-3121-5) | Apotex Corp. | 60505-3121-5 | 60505-3121 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 130mg/1 | 90 Capsule In 1 Bottle (60505-3121-9) | Apotex Corp. | 60505-3121-9 | 60505-3121 | ANDA202252 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 90 Capsule In 1 Bottle (35561-345-11) | Austarpharma, LLC | 35561-345-11 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 100 Capsule In 1 Bottle (35561-345-12) | Austarpharma, LLC | 35561-345-12 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 500 Capsule In 1 Bottle (35561-345-13) | Austarpharma, LLC | 35561-345-13 | 35561-345 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 90 Capsule In 1 Bottle (35561-346-11) | Austarpharma, LLC | 35561-346-11 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 100 Capsule In 1 Bottle (35561-346-12) | Austarpharma, LLC | 35561-346-12 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 500 Capsule In 1 Bottle (35561-346-13) | Austarpharma, LLC | 35561-346-13 | 35561-346 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (35561-347-11) | Austarpharma, LLC | 35561-347-11 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (35561-347-12) | Austarpharma, LLC | 35561-347-12 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (35561-347-13) | Austarpharma, LLC | 35561-347-13 | 35561-347 | ANDA207805 | ANDA | N/A |
| Fenofibric Acid | Capsule, Delayed Release | Oral | 45mg/1 | 90 Capsule, Delayed Release In 1 Bottle (69315-281-09) | Leading Pharma, LLC | 69315-281-09 | 69315-281 | ANDA211626 | ANDA | N/A |
| Fenofibric Acid | Capsule, Delayed Release | Oral | 135mg/1 | 90 Capsule, Delayed Release In 1 Bottle (69315-282-09) | Leading Pharma, LLC | 69315-282-09 | 69315-282 | ANDA211626 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (50228-430-10) | ScieGen Pharmaceuticals Inc | 50228-430-10 | 50228-430 | ANDA214017 | ANDA | N/A |
| Fentanyl | Patch, Extended Release | Transdermal | 12ug/h | 5 Pouch In 1 Carton (60505-7080-2) / 1 Patch In 1 Pouch (60505-7080-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7080-2 | 60505-7080 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 25ug/h | 5 Pouch In 1 Carton (60505-7081-2) / 1 Patch In 1 Pouch (60505-7081-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7081-2 | 60505-7081 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 50ug/h | 5 Pouch In 1 Carton (60505-7082-2) / 1 Patch In 1 Pouch (60505-7082-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7082-2 | 60505-7082 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 75ug/h | 5 Pouch In 1 Carton (60505-7083-2) / 1 Patch In 1 Pouch (60505-7083-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7083-2 | 60505-7083 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 100ug/h | 5 Pouch In 1 Carton (60505-7084-2) / 1 Patch In 1 Pouch (60505-7084-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7084-2 | 60505-7084 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 37.5ug/h | 5 Pouch In 1 Carton (60505-7085-2) / 1 Patch In 1 Pouch (60505-7085-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7085-2 | 60505-7085 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 62.5ug/h | 5 Pouch In 1 Carton (60505-7086-2) / 1 Patch In 1 Pouch (60505-7086-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7086-2 | 60505-7086 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 87.5ug/h | 5 Pouch In 1 Carton (60505-7087-2) / 1 Patch In 1 Pouch (60505-7087-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7087-2 | 60505-7087 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 25ug/h | 5 Pouch In 1 Carton (60505-7006-2) / 1 Patch In 1 Pouch (60505-7006-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7006-2 | 60505-7006 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 50ug/h | 5 Pouch In 1 Carton (60505-7007-2) / 1 Patch In 1 Pouch (60505-7007-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7007-2 | 60505-7007 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 75ug/h | 5 Pouch In 1 Carton (60505-7008-2) / 1 Patch In 1 Pouch (60505-7008-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7008-2 | 60505-7008 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 100ug/h | 5 Pouch In 1 Carton (60505-7009-2) / 1 Patch In 1 Pouch (60505-7009-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7009-2 | 60505-7009 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 12ug/h | 5 Pouch In 1 Carton (60505-7010-2) / 1 Patch In 1 Pouch (60505-7010-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7010-2 | 60505-7010 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 25ug/h | 5 Pouch In 1 Carton (60505-7011-2) / 1 Patch In 1 Pouch (60505-7011-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7011-2 | 60505-7011 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 50ug/h | 5 Pouch In 1 Carton (60505-7012-2) / 1 Patch In 1 Pouch (60505-7012-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7012-2 | 60505-7012 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 75ug/h | 5 Pouch In 1 Carton (60505-7013-2) / 1 Patch In 1 Pouch (60505-7013-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7013-2 | 60505-7013 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 100ug/h | 5 Pouch In 1 Carton (60505-7014-2) / 1 Patch In 1 Pouch (60505-7014-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7014-2 | 60505-7014 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 37.5ug/h | 5 Pouch In 1 Carton (60505-7015-2) / 1 Patch In 1 Pouch (60505-7015-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7015-2 | 60505-7015 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 62.5ug/h | 5 Pouch In 1 Carton (60505-7016-2) / 1 Patch In 1 Pouch (60505-7016-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7016-2 | 60505-7016 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch, Extended Release | Transdermal | 87.5ug/h | 5 Pouch In 1 Carton (60505-7017-2) / 1 Patch In 1 Pouch (60505-7017-0) / 72 H In 1 Patch | Apotex Corp. | 60505-7017-2 | 60505-7017 | ANDA077449 | ANDA | CII |
| Fentanyl | Patch | Transdermal | 100ug/1 | 5 Pouch In 1 Carton (47781-428-47) / 1 Patch In 1 Pouch (47781-428-11) | ALVOGEN | 47781-428-47 | 47781-428 | ANDA202097 | ANDA | CII |
| Fentanyl | Patch | Transdermal | 12.5ug/1 | 5 Pouch In 1 Carton (47781-423-47) / 1 Patch In 1 Pouch (47781-423-11) | ALVOGEN | 47781-423-47 | 47781-423 | ANDA202097 | ANDA | CII |
| Fentanyl | Patch | Transdermal | 25ug/1 | 5 Pouch In 1 Carton (47781-424-47) / 1 Patch In 1 Pouch (47781-424-11) | ALVOGEN | 47781-424-47 | 47781-424 | ANDA202097 | ANDA | CII |
| Fentanyl | Patch | Transdermal | 50ug/1 | 5 Pouch In 1 Carton (47781-426-47) / 1 Patch In 1 Pouch (47781-426-11) | ALVOGEN | 47781-426-47 | 47781-426 | ANDA202097 | ANDA | CII |
| Fentanyl | Patch | Transdermal | 75ug/1 | 5 Pouch In 1 Carton (47781-427-47) / 1 Patch In 1 Pouch (47781-427-11) | ALVOGEN | 47781-427-47 | 47781-427 | ANDA202097 | ANDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 10 Ampule In 1 Carton (0641-6024-10) / 2 Ml In 1 Ampule (0641-6024-01) | Hikma Pharmaceuticals USA Inc. | 0641-6024-10 | 0641-6024 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 10 Ampule In 1 Carton (0641-6025-10) / 5 Ml In 1 Ampule (0641-6025-01) | Hikma Pharmaceuticals USA Inc. | 0641-6025-10 | 0641-6025 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intravenous | 50ug/mL | 5 Ampule In 1 Carton (0641-6026-05) / 20 Ml In 1 Ampule (0641-6026-01) | Hikma Pharmaceuticals USA Inc. | 0641-6026-05 | 0641-6026 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 25 Vial In 1 Carton (0641-6027-25) / 2 Ml In 1 Vial (0641-6027-01) | Hikma Pharmaceuticals USA Inc. | 0641-6027-25 | 0641-6027 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 10 Vial In 1 Carton (0641-6028-10) / 5 Ml In 1 Vial (0641-6028-01) | Hikma Pharmaceuticals USA Inc. | 0641-6028-10 | 0641-6028 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 25 Vial In 1 Carton (0641-6028-25) / 5 Ml In 1 Vial (0641-6028-01) | Hikma Pharmaceuticals USA Inc. | 0641-6028-25 | 0641-6028 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intravenous | 50ug/mL | 20 Ml In 1 Vial (0641-6029-01) | Hikma Pharmaceuticals USA Inc. | 0641-6029-01 | 0641-6029 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intravenous | 50ug/mL | 25 Vial In 1 Carton (0641-6029-25) / 20 Ml In 1 Vial (0641-6029-01) | Hikma Pharmaceuticals USA Inc. | 0641-6029-25 | 0641-6029 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intravenous | 50ug/mL | 50 Ml In 1 Vial (0641-6030-01) | Hikma Pharmaceuticals USA Inc. | 0641-6030-01 | 0641-6030 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 25 Vial In 1 Carton (0641-6247-25) / 1 Ml In 1 Vial (0641-6247-01) | Hikma Pharmaceuticals USA Inc. | 0641-6247-25 | 0641-6247 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 10 Syringe, Glass In 1 Carton (0641-6248-10) / 1 Ml In 1 Syringe, Glass (0641-6248-01) | Hikma Pharmaceuticals USA Inc. | 0641-6248-10 | 0641-6248 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection | Intramuscular; Intravenous | 50ug/mL | 10 Syringe, Glass In 1 Carton (0641-6249-10) / .5 Ml In 1 Syringe, Glass (0641-6249-01) | Hikma Pharmaceuticals USA Inc. | 0641-6249-10 | 0641-6249 | NDA019101 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 10 Ampule In 1 Cello Pack (0409-9093-11) / 2 Ml In 1 Ampule (0409-9093-09) | Hospira, Inc. | 0409-9093-11 | 0409-9093 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 10 Ampule In 1 Cello Pack (0409-9093-32) / 2 Ml In 1 Ampule (0409-9093-37) | Hospira, Inc. | 0409-9093-32 | 0409-9093 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 10 Ampule In 1 Cello Pack (0409-9093-35) / 5 Ml In 1 Ampule (0409-9093-45) | Hospira, Inc. | 0409-9093-35 | 0409-9093 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9094-22) / 2 Ml In 1 Vial, Single-Dose (0409-9094-12) | Hospira, Inc. | 0409-9094-22 | 0409-9094 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9094-25) / 5 Ml In 1 Vial, Single-Dose (0409-9094-18) | Hospira, Inc. | 0409-9094-25 | 0409-9094 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9094-28) / 10 Ml In 1 Vial, Single-Dose (0409-9094-17) | Hospira, Inc. | 0409-9094-28 | 0409-9094 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 25 Vial, Single-Dose In 1 Tray (0409-9094-31) / 20 Ml In 1 Vial, Single-Dose (0409-9094-16) | Hospira, Inc. | 0409-9094-31 | 0409-9094 | NDA019115 | NDA | CII |
| Fentanyl Citrate | Injection, Solution | Intramuscular; Intravenous | 50ug/mL | 25 Carton In 1 Tray (0409-9094-61) / 1 Vial, Single-Dose In 1 Carton / 50 Ml In 1 Vial, Single-Dose (0409-9094-41) | Hospira, Inc. | 0409-9094-61 | 0409-9094 | NDA019115 | NDA | CII |
| Ferric Carboxymaltose | Injection, Solution | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Box (0517-0602-01) / 2 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0602-01 | 0517-0602 | NDA203565 | NDA | N/A |
| Ferric Carboxymaltose | Injection, Solution | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Box (0517-0620-01) / 20 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0620-01 | 0517-0620 | NDA203565 | NDA | N/A |
| Ferric Carboxymaltose | Injection, Solution | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Box (0517-0650-01) / 15 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0650-01 | 0517-0650 | NDA203565 | NDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 4mg/1 | 30 Tablet, Extended Release In 1 Bottle (51407-661-30) | Golden State Medical Supply, Inc. | 51407-661-30 | 51407-661 | ANDA204975 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 8mg/1 | 30 Tablet, Extended Release In 1 Bottle (51407-662-30) | Golden State Medical Supply, Inc. | 51407-662-30 | 51407-662 | ANDA204975 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-430-30) | ScieGen Pharmaceuticals Inc | 50228-430-30 | 50228-430 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (50228-430-90) | ScieGen Pharmaceuticals Inc | 50228-430-90 | 50228-430 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (50228-431-05) | ScieGen Pharmaceuticals Inc | 50228-431-05 | 50228-431 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (50228-431-30) | ScieGen Pharmaceuticals Inc | 50228-431-30 | 50228-431 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (50228-431-90) | ScieGen Pharmaceuticals Inc | 50228-431-90 | 50228-431 | ANDA214017 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Film Coated, Extended Release | Oral | 4mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0069-0242-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0242-30 | 0069-0242 | NDA022030 | NDA | N/A |
| Fesoterodine Fumarate | Tablet, Film Coated, Extended Release | Oral | 8mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0069-0244-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0244-30 | 0069-0244 | NDA022030 | NDA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0611-1) | Jubilant HollisterStier LLC | 65044-0611-1 | 65044-0611 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0611-2) | Jubilant HollisterStier LLC | 65044-0611-2 | 65044-0611 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0611-3) | Jubilant HollisterStier LLC | 65044-0611-3 | 65044-0611 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0611-4) | Jubilant HollisterStier LLC | 65044-0611-4 | 65044-0611 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0612-1) | Jubilant HollisterStier LLC | 65044-0612-1 | 65044-0612 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0612-2) | Jubilant HollisterStier LLC | 65044-0612-2 | 65044-0612 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0612-3) | Jubilant HollisterStier LLC | 65044-0612-3 | 65044-0612 | BLA103874 | BLA | N/A |
| Festuca Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0612-4) | Jubilant HollisterStier LLC | 65044-0612-4 | 65044-0612 | BLA103874 | BLA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-429-10) | ScieGen Pharmaceuticals Inc | 50228-429-10 | 50228-429 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-429-30) | ScieGen Pharmaceuticals Inc | 50228-429-30 | 50228-429 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (50228-429-90) | ScieGen Pharmaceuticals Inc | 50228-429-90 | 50228-429 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (50228-430-10) | ScieGen Pharmaceuticals Inc | 50228-430-10 | 50228-430 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-430-30) | ScieGen Pharmaceuticals Inc | 50228-430-30 | 50228-430 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (50228-430-90) | ScieGen Pharmaceuticals Inc | 50228-430-90 | 50228-430 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (50228-431-05) | ScieGen Pharmaceuticals Inc | 50228-431-05 | 50228-431 | ANDA214017 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (50228-431-30) | ScieGen Pharmaceuticals Inc | 50228-431-30 | 50228-431 | ANDA214017 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (45802-847-78) / 100 Tablet, Film Coated In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-847-78 | 45802-847 | ANDA212971 | ANDA | N/A |
| Fexofenadine Hydrochloride | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (51672-2141-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2141-1 | 51672-2141 | ANDA208123 | ANDA | N/A |
| Fexofenadine Hydrochloride | Suspension | Oral | 30mg/5mL | 1 Bottle In 1 Carton (51672-2141-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2141-8 | 51672-2141 | ANDA208123 | ANDA | N/A |
| Droxidopa | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (50228-431-90) | ScieGen Pharmaceuticals Inc | 50228-431-90 | 50228-431 | ANDA214017 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (31722-168-01) | Camber Pharmaceuticals, Inc. | 31722-168-01 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (31722-168-10) | Camber Pharmaceuticals, Inc. | 31722-168-10 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-168-30) | Camber Pharmaceuticals, Inc. | 31722-168-30 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 7 Capsule, Delayed Release In 1 Blister Pack (31722-168-31) | Camber Pharmaceuticals, Inc. | 31722-168-31 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 105 Capsule, Delayed Release In 1 Carton (31722-168-32) | Camber Pharmaceuticals, Inc. | 31722-168-32 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 20mg/1 | 60 Capsule, Delayed Release In 1 Bottle (31722-168-60) | Camber Pharmaceuticals, Inc. | 31722-168-60 | 31722-168 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 100 Capsule, Delayed Release In 1 Bottle (31722-169-01) | Camber Pharmaceuticals, Inc. | 31722-169-01 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (31722-169-10) | Camber Pharmaceuticals, Inc. | 31722-169-10 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-169-30) | Camber Pharmaceuticals, Inc. | 31722-169-30 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 7 Capsule, Delayed Release In 1 Blister Pack (31722-169-31) | Camber Pharmaceuticals, Inc. | 31722-169-31 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 105 Capsule, Delayed Release In 1 Carton (31722-169-32) | Camber Pharmaceuticals, Inc. | 31722-169-32 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 30mg/1 | 60 Capsule, Delayed Release In 1 Bottle (31722-169-60) | Camber Pharmaceuticals, Inc. | 31722-169-60 | 31722-169 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 100 Capsule, Delayed Release In 1 Bottle (31722-170-01) | Camber Pharmaceuticals, Inc. | 31722-170-01 | 31722-170 | ANDA204343 | ANDA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 480ug/1.6mL | 10 Vial, Single-Dose In 1 Carton (0069-0294-10) / 1.6 Ml In 1 Vial, Single-Dose (0069-0294-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0294-10 | 0069-0294 | BLA761080 | BLA | N/A |
| Filgrastim | Injection, Solution | Subcutaneous | 300ug/.5mL | 1 Syringe In 1 Carton (0069-0291-01) / .5 Ml In 1 Syringe | Pfizer Laboratories Div Pfizer Inc | 0069-0291-01 | 0069-0291 | BLA761080 | BLA | N/A |
| Filgrastim | Injection, Solution | Subcutaneous | 300ug/.5mL | 10 Carton In 1 Carton (0069-0291-10) / 1 Syringe In 1 Carton (0069-0291-01) / .5 Ml In 1 Syringe | Pfizer Laboratories Div Pfizer Inc | 0069-0291-10 | 0069-0291 | BLA761080 | BLA | N/A |
| Filgrastim | Injection, Solution | Subcutaneous | 480ug/.8mL | 1 Syringe In 1 Carton (0069-0292-01) / .8 Ml In 1 Syringe | Pfizer Laboratories Div Pfizer Inc | 0069-0292-01 | 0069-0292 | BLA761080 | BLA | N/A |
| Filgrastim | Injection, Solution | Subcutaneous | 480ug/.8mL | 10 Carton In 1 Carton (0069-0292-10) / 1 Syringe In 1 Carton (0069-0292-01) / .8 Ml In 1 Syringe | Pfizer Laboratories Div Pfizer Inc | 0069-0292-10 | 0069-0292 | BLA761080 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 300ug/mL | 10 Vial, Single-Dose In 1 Carton (0069-0293-10) / 1 Ml In 1 Vial, Single-Dose (0069-0293-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0293-10 | 0069-0293 | BLA761080 | BLA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (31722-170-10) | Camber Pharmaceuticals, Inc. | 31722-170-10 | 31722-170 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-170-30) | Camber Pharmaceuticals, Inc. | 31722-170-30 | 31722-170 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 7 Capsule, Delayed Release In 1 Blister Pack (31722-170-31) | Camber Pharmaceuticals, Inc. | 31722-170-31 | 31722-170 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 105 Capsule, Delayed Release In 1 Carton (31722-170-32) | Camber Pharmaceuticals, Inc. | 31722-170-32 | 31722-170 | ANDA204343 | ANDA | N/A |
| Duloxetine | Capsule, Delayed Release | Oral | 60mg/1 | 60 Capsule, Delayed Release In 1 Bottle (31722-170-60) | Camber Pharmaceuticals, Inc. | 31722-170-60 | 31722-170 | ANDA204343 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 20mg/1 | 60 Capsule, Delayed Release In 1 Bottle (57237-017-60) | Rising Pharma Holdings, Inc. | 57237-017-60 | 57237-017 | ANDA090778 | ANDA | N/A |
| Fingolimod Hydrochloride | Capsule | Oral | .5mg/1 | 30 Capsule In 1 Bottle (60505-4332-3) | Apotex Corp. | 60505-4332-3 | 60505-4332 | ANDA207993 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (57237-017-99) | Rising Pharma Holdings, Inc. | 57237-017-99 | 57237-017 | ANDA090778 | ANDA | N/A |
| Flavoxate Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (0574-0115-01) | Padagis US LLC | 0574-0115-01 | 0574-0115 | ANDA076831 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 30 Capsule, Delayed Release In 1 Bottle (57237-018-30) | Rising Pharma Holdings, Inc. | 57237-018-30 | 57237-018 | ANDA090778 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 90 Capsule, Delayed Release In 1 Bottle (57237-018-90) | Rising Pharma Holdings, Inc. | 57237-018-90 | 57237-018 | ANDA090778 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-018-01) | Golden State Medical Supply, Inc. | 51407-018-01 | 51407-018 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (51407-019-01) | Golden State Medical Supply, Inc. | 51407-019-01 | 51407-019 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (51407-019-60) | Golden State Medical Supply, Inc. | 51407-019-60 | 51407-019 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (51407-020-01) | Golden State Medical Supply, Inc. | 51407-020-01 | 51407-020 | ANDA075882 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 30mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (57237-018-99) | Rising Pharma Holdings, Inc. | 57237-018-99 | 57237-018 | ANDA090778 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 60mg/1 | 30 Capsule, Delayed Release In 1 Bottle (57237-019-30) | Rising Pharma Holdings, Inc. | 57237-019-30 | 57237-019 | ANDA090778 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 60mg/1 | 90 Capsule, Delayed Release In 1 Bottle (57237-019-90) | Rising Pharma Holdings, Inc. | 57237-019-90 | 57237-019 | ANDA090778 | ANDA | N/A |
| Duloxetine Hydrochloride | Capsule, Delayed Release | Oral | 60mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (57237-019-99) | Rising Pharma Holdings, Inc. | 57237-019-99 | 57237-019 | ANDA090778 | ANDA | N/A |
| Dutasteride | Capsule | Oral | .5mg/1 | 30 Capsule In 1 Bottle (65162-750-03) | Amneal Pharmaceuticals LLC | 65162-750-03 | 65162-750 | ANDA203118 | ANDA | N/A |
| Dutasteride | Capsule | Oral | .5mg/1 | 90 Capsule In 1 Bottle (65162-750-09) | Amneal Pharmaceuticals LLC | 65162-750-09 | 65162-750 | ANDA203118 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (31722-131-30) | Camber Pharmaceuticals, Inc. | 31722-131-30 | 31722-131 | ANDA206574 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 90 Capsule, Liquid Filled In 1 Bottle (31722-131-90) | Camber Pharmaceuticals, Inc. | 31722-131-90 | 31722-131 | ANDA206574 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 90 Capsule, Liquid Filled In 1 Bottle (42806-549-09) | Epic Pharma, LLC | 42806-549-09 | 42806-549 | ANDA209909 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (42806-549-30) | Epic Pharma, LLC | 42806-549-30 | 42806-549 | ANDA209909 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (72865-140-30) | XLCare Pharmaceuticals, Inc. | 72865-140-30 | 72865-140 | ANDA206574 | ANDA | N/A |
| Dutasteride | Capsule, Liquid Filled | Oral | .5mg/1 | 90 Capsule, Liquid Filled In 1 Bottle (72865-140-90) | XLCare Pharmaceuticals, Inc. | 72865-140-90 | 72865-140 | ANDA206574 | ANDA | N/A |
| Edetate Calcium Disodium | Injection | Intramuscular; Intravenous | 200mg/mL | 5 Vial In 1 Carton (64980-588-51) / 5 Ml In 1 Vial (64980-588-05) | Rising Pharma Holdings, Inc. | 64980-588-51 | 64980-588 | ANDA216435 | ANDA | N/A |
| Efavirenz | Tablet, Film Coated | Oral | 600mg/1 | 250 Tablet, Film Coated In 1 Bottle (31722-504-25) | Camber Pharmaceuticals, Inc. | 31722-504-25 | 31722-504 | ANDA078886 | ANDA | N/A |
| Efavirenz | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-504-30) | Camber Pharmaceuticals, Inc. | 31722-504-30 | 31722-504 | ANDA078886 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Blister Pack In 1 Carton (0054-0010-20) / 1 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0010-20 | 0054-0010 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (0054-0010-21) | Hikma Pharmaceuticals USA Inc. | 0054-0010-21 | 0054-0010 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (0054-0010-25) | Hikma Pharmaceuticals USA Inc. | 0054-0010-25 | 0054-0010 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (0054-0011-20) / 1 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0011-20 | 0054-0011 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (0054-0011-21) | Hikma Pharmaceuticals USA Inc. | 0054-0011-21 | 0054-0011 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (0054-0011-25) | Hikma Pharmaceuticals USA Inc. | 0054-0011-25 | 0054-0011 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Blister Pack In 1 Carton (0054-0012-20) / 1 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0012-20 | 0054-0012 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (0054-0012-21) | Hikma Pharmaceuticals USA Inc. | 0054-0012-21 | 0054-0012 | ANDA076278 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (0054-0012-25) | Hikma Pharmaceuticals USA Inc. | 0054-0012-25 | 0054-0012 | ANDA076278 | ANDA | N/A |
| Floxuridine | Injection, Powder, Lyophilized, For Solution | Intra-Arterial | 100mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9270-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9270-01 | 0143-9270 | ANDA075387 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 1 Tablet In 1 Blister Pack (60760-804-01) | St Marys Medical Park Pharmacy | 60760-804-01 | 60760-804 | ANDA077253 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 1 Tablet In 1 Blister Pack (60760-803-01) | St. Mary's Medical Park Pharmacy | 60760-803-01 | 60760-803 | ANDA077253 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 1 Blister Pack In 1 Carton (60760-113-01) / 1 Tablet In 1 Blister Pack | St. Mary's Medical Park Pharmacy | 60760-113-01 | 60760-113 | ANDA208963 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 1 Tablet In 1 Blister Pack (60760-950-01) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-950-01 | 60760-950 | ANDA077731 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Carton (25021-184-66) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-184-66 | 25021-184 | ANDA079104 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Carton (25021-184-67) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-184-67 | 25021-184 | ANDA079104 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Carton (25021-184-82) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-184-82 | 25021-184 | ANDA079104 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Carton (25021-184-87) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-184-87 | 25021-184 | ANDA079104 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (51407-424-30) | Golden State Medical Supply, Inc. | 51407-424-30 | 51407-424 | ANDA078423 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (51672-4064-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4064-0 | 51672-4064 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (51672-4064-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4064-3 | 51672-4064 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (51672-4064-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4064-6 | 51672-4064 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (51672-4065-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4065-0 | 51672-4065 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (51672-4065-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4065-3 | 51672-4065 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51672-4065-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4065-6 | 51672-4065 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 12 Blister Pack In 1 Carton (51672-4066-7) / 1 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4066-7 | 51672-4066 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 200mg/1 | 10 Blister Pack In 1 Carton (51672-4067-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4067-0 | 51672-4067 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51672-4067-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4067-3 | 51672-4067 | ANDA076507 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (51672-4067-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4067-6 | 51672-4067 | ANDA076507 | ANDA | N/A |
| Efavirenz | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (64980-406-03) | Rising Pharma Holdings, Inc. | 64980-406-03 | 64980-406 | ANDA078064 | ANDA | N/A |
| Efavirenz | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (64980-407-09) | Rising Pharma Holdings, Inc. | 64980-407-09 | 64980-407 | ANDA078064 | ANDA | N/A |
| EFAVIRENZ | Tablet, Film Coated | Oral | 600mg/1 | 250 Tablet, Film Coated In 1 Bottle (72865-172-25) | XLCare Pharmaceuticals Inc. | 72865-172-25 | 72865-172 | ANDA078886 | ANDA | N/A |
| EFAVIRENZ | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-172-30) | XLCare Pharmaceuticals Inc. | 72865-172-30 | 72865-172 | ANDA078886 | ANDA | N/A |
| Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 600mg/1, 200 mg/1, 300 mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-736-30) | Camber Pharmaceuticals, Inc. | 31722-736-30 | 31722-736 | ANDA203053 | ANDA | N/A |
| Emtricitabine and tenofovir disoproxil fumarate | Tablet, Film Coated | Oral | 200mg/1, 300 mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-560-30) | Camber Pharmaceuticals, Inc. | 31722-560-30 | 31722-560 | ANDA201806 | ANDA | N/A |
| Enalapril maleate oral solution | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (31722-020-15) / 150 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-020-15 | 31722-020 | ANDA214467 | ANDA | N/A |
| Entecavir | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-449-03) | Amneal Pharmaceuticals LLC | 65162-449-03 | 65162-449 | ANDA206652 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle (31722-833-30) | Camber Pharmaceuticals, Inc. | 31722-833-30 | 31722-833 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 10 Tablet In 1 Blister Pack (31722-833-31) | Camber Pharmaceuticals, Inc. | 31722-833-31 | 31722-833 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Carton (31722-833-32) | Camber Pharmaceuticals, Inc. | 31722-833-32 | 31722-833 | ANDA205740 | ANDA | N/A |
| Fluconazole | Injection | Intravenous | 2mg/mL | 6 Container In 1 Carton (0143-9666-06) / 200 Ml In 1 Container (0143-9666-01) | Hikma Pharmaceuticals USA Inc. | 0143-9666-06 | 0143-9666 | ANDA078764 | ANDA | N/A |
| Fluconazole | Injection | Intravenous | 2mg/mL | 6 Container In 1 Carton (0143-9667-06) / 100 Ml In 1 Container (0143-9667-01) | Hikma Pharmaceuticals USA Inc. | 0143-9667-06 | 0143-9667 | ANDA078764 | ANDA | N/A |
| Fluconazole | Injection | Intravenous | 2mg/mL | 10 Container In 1 Carton (0143-9668-10) / 200 Ml In 1 Container (0143-9668-01) | Hikma Pharmaceuticals USA Inc. | 0143-9668-10 | 0143-9668 | ANDA078698 | ANDA | N/A |
| Fluconazole | Injection | Intravenous | 2mg/mL | 10 Container In 1 Carton (0143-9669-10) / 100 Ml In 1 Container (0143-9669-01) | Hikma Pharmaceuticals USA Inc. | 0143-9669-10 | 0143-9669 | ANDA078698 | ANDA | N/A |
| Fluconazole | Injection | Intravenous | 2mg/mL | 6 Vial In 1 Carton (0143-9899-91) / 100 Ml In 1 Vial (0143-9899-01) | Hikma Pharmaceuticals USA Inc. | 0143-9899-91 | 0143-9899 | ANDA076736 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 24 Bag In 1 Case (0409-4688-12) / 200 Ml In 1 Bag (0409-4688-16) | Hospira, Inc. | 0409-4688-12 | 0409-4688 | ANDA076303 | ANDA | N/A |
| Fluconazole | Injection, Solution | Intravenous | 2mg/mL | 24 Bag In 1 Case (0409-4688-18) / 100 Ml In 1 Bag (0409-4688-22) | Hospira, Inc. | 0409-4688-18 | 0409-4688 | ANDA076303 | ANDA | N/A |
| Fludarabine Phosphate | Injection, Solution | Intravenous | 25mg/mL | 1 Vial In 1 Carton (25021-242-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-242-02 | 25021-242 | ANDA076661 | ANDA | N/A |
| Fludeoxyglucose F-18 | Injection, Solution | Intravenous | 300mCi/mL | 30 Ml In 1 Vial (60055-334-30) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 60055-334-30 | 60055-334 | ANDA203920 | ANDA | N/A |
| Fludrocortisone Acetate | Tablet | Oral | .1mg/1 | 30 Tablet In 1 Bottle (70954-252-10) | Novitium Pharma LLC | 70954-252-10 | 70954-252 | ANDA215279 | ANDA | N/A |
| Fludrocortisone Acetate | Tablet | Oral | .1mg/1 | 100 Tablet In 1 Bottle (70954-252-20) | Novitium Pharma LLC | 70954-252-20 | 70954-252 | ANDA215279 | ANDA | N/A |
| Fludrocortisone Acetate | Tablet | Oral | .1mg/1 | 500 Tablet In 1 Bottle (70954-252-30) | Novitium Pharma LLC | 70954-252-30 | 70954-252 | ANDA215279 | ANDA | N/A |
| Flumazenil | Injection, Solution | Intravenous | .1mg/mL | 10 Vial, Multi-Dose In 1 Box (0143-9783-10) / 10 Ml In 1 Vial, Multi-Dose (0143-9783-01) | Hikma Pharmaceuticals USA Inc. | 0143-9783-10 | 0143-9783 | ANDA078527 | ANDA | N/A |
| Flumazenil | Injection, Solution | Intravenous | .1mg/mL | 10 Vial, Multi-Dose In 1 Box (0143-9784-10) / 5 Ml In 1 Vial, Multi-Dose (0143-9784-01) | Hikma Pharmaceuticals USA Inc. | 0143-9784-10 | 0143-9784 | ANDA078527 | ANDA | N/A |
| Flumazenil | Injection, Solution | Intravenous | .1mg/mL | 10 Vial, Multi-Dose In 1 Box (0143-9683-10) / 10 Ml In 1 Vial, Multi-Dose (0143-9683-01) | Hikma Pharmaceuticals USA Inc. | 0143-9683-10 | 0143-9683 | ANDA078527 | ANDA | N/A |
| Flumazenil | Injection, Solution | Intravenous | .1mg/mL | 10 Vial, Multi-Dose In 1 Box (0143-9684-10) / 5 Ml In 1 Vial, Multi-Dose (0143-9684-01) | Hikma Pharmaceuticals USA Inc. | 0143-9684-10 | 0143-9684 | ANDA078527 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (31722-833-90) | Camber Pharmaceuticals, Inc. | 31722-833-90 | 31722-833 | ANDA205740 | ANDA | N/A |
| Fluocinolone Acetonide | Solution/ Drops | Auricular (Otic) | .11mg/mL | 1 Bottle In 1 Carton (45802-009-10) / 20 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-009-10 | 45802-009 | ANDA202849 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .01mg/100mL | 118.28 Ml In 1 Bottle (45802-887-26) | Padagis Israel Pharmaceuticals Ltd | 45802-887-26 | 45802-887 | ANDA202847 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .01mg/100mL | 1 Bottle In 1 Carton (45802-485-26) / 118.28 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-485-26 | 45802-485 | ANDA202848 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/118.28mL | 1 Bottle In 1 Carton (51672-1356-8) / 118.28 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1356-8 | 51672-1356 | ANDA202368 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/118.28mL | 1 Bottle In 1 Carton (51672-1357-8) / 118.28 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1357-8 | 51672-1357 | ANDA209336 | ANDA | N/A |
| Fluocinolone Acetonide | Solution | Topical | .1mg/mL | 1 Bottle In 1 Carton (51672-1365-2) / 20 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1365-2 | 51672-1365 | ANDA089124 | ANDA | N/A |
| Fluocinolone Acetonide | Solution | Topical | .1mg/mL | 1 Bottle In 1 Carton (51672-1365-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1365-4 | 51672-1365 | ANDA089124 | ANDA | N/A |
| Entecavir | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle (31722-834-30) | Camber Pharmaceuticals, Inc. | 31722-834-30 | 31722-834 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | 1mg/1 | 10 Tablet In 1 Blister Pack (31722-834-31) | Camber Pharmaceuticals, Inc. | 31722-834-31 | 31722-834 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Carton (31722-834-32) | Camber Pharmaceuticals, Inc. | 31722-834-32 | 31722-834 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (31722-834-90) | Camber Pharmaceuticals, Inc. | 31722-834-90 | 31722-834 | ANDA205740 | ANDA | N/A |
| Entecavir | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle, Plastic (42806-658-30) | EPIC PHARMA, LLC | 42806-658-30 | 42806-658 | ANDA212126 | ANDA | N/A |
| Entecavir | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle, Plastic (42806-659-30) | EPIC PHARMA, LLC | 42806-659-30 | 42806-659 | ANDA212126 | ANDA | N/A |
| Fluocinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0224-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0224-15 | 0713-0224 | ANDA089524 | ANDA | N/A |
| Fluocinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0224-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0224-60 | 0713-0224 | ANDA089524 | ANDA | N/A |
| Fluocinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0709-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0709-15 | 0713-0709 | ANDA210747 | ANDA | N/A |
| Fluocinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0709-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0709-60 | 0713-0709 | ANDA210747 | ANDA | N/A |
| Fluocinolone Acetonide | Cream | Topical | .1mg/g | 1 Tube In 1 Carton (0713-0223-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0223-15 | 0713-0223 | ANDA089526 | ANDA | N/A |
| Fluocinolone Acetonide | Cream | Topical | .1mg/g | 1 Tube In 1 Carton (0713-0223-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0223-60 | 0713-0223 | ANDA089526 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/mL | 1 Bottle In 1 Carton (13925-507-04) / 118.28 Ml In 1 Bottle | Seton Pharmaceuticals | 13925-507-04 | 13925-507 | NDA019452 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Oil | Auricular (Otic) | .11mg/mL | 1 Bottle, Dropper In 1 Carton (13925-508-20) / 20 Ml In 1 Bottle, Dropper | Seton Pharmaceuticals | 13925-508-20 | 13925-508 | NDA019452 | NDA AUTHORIZED GENERIC | N/A |
| EPLERENONE | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-049-30) | Camber Pharmaceuticals, Inc. | 31722-049-30 | 31722-049 | ANDA213812 | ANDA | N/A |
| EPLERENONE | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-049-90) | Camber Pharmaceuticals, Inc. | 31722-049-90 | 31722-049 | ANDA213812 | ANDA | N/A |
| EPLERENONE | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-050-30) | Camber Pharmaceuticals, Inc. | 31722-050-30 | 31722-050 | ANDA213812 | ANDA | N/A |
| EPLERENONE | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-050-90) | Camber Pharmaceuticals, Inc. | 31722-050-90 | 31722-050 | ANDA213812 | ANDA | N/A |
| Eptifibatide | Injection | Intravenous | 2mg/mL | 1 Vial, Glass In 1 Carton (70121-1002-1) / 10 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1002-1 | 70121-1002 | ANDA205581 | ANDA | N/A |
| Eptifibatide | Injection | Intravenous | .75mg/mL | 1 Vial, Glass In 1 Carton (70121-1003-1) / 100 Ml In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1003-1 | 70121-1003 | ANDA205581 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-151-53) / 120 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-151-53 | 45802-151 | ANDA090256 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-151-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-151-94 | 45802-151 | ANDA090256 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-151-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-151-96 | 45802-151 | ANDA090256 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1353-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1353-2 | 51672-1353 | ANDA200734 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1353-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1353-3 | 51672-1353 | ANDA200734 | ANDA | N/A |
| Fluocinonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1353-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1353-4 | 51672-1353 | ANDA200734 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1253-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253-1 | 51672-1253 | NDA019117 | NDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1253-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253-2 | 51672-1253 | NDA019117 | NDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1253-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253-3 | 51672-1253 | NDA019117 | NDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1253-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253-4 | 51672-1253 | NDA019117 | NDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1254-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1254-1 | 51672-1254 | ANDA072494 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1254-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1254-2 | 51672-1254 | ANDA072494 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1254-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1254-3 | 51672-1254 | ANDA072494 | ANDA | N/A |
| Fluocinonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1264-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1264-1 | 51672-1264 | ANDA075008 | ANDA | N/A |
| Fluocinonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1264-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1264-2 | 51672-1264 | ANDA075008 | ANDA | N/A |
| Fluocinonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1264-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1264-3 | 51672-1264 | ANDA075008 | ANDA | N/A |
| Fluocinonide | Solution | Topical | .5mg/mL | 1 Bottle, Plastic In 1 Carton (51672-1273-2) / 20 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1273-2 | 51672-1273 | ANDA074799 | ANDA | N/A |
| Fluocinonide | Solution | Topical | .5mg/mL | 1 Bottle, Plastic In 1 Carton (51672-1273-4) / 60 Ml In 1 Bottle, Plastic | Taro Pharmaceuticals U.S.A., Inc. | 51672-1273-4 | 51672-1273 | ANDA074799 | ANDA | N/A |
| Fluocinonide | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1279-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1279-1 | 51672-1279 | ANDA074935 | ANDA | N/A |
| Fluocinonide | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1279-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1279-2 | 51672-1279 | ANDA074935 | ANDA | N/A |
| Fluocinonide | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1279-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1279-3 | 51672-1279 | ANDA074935 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1386-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-1386-1 | 51672-1386 | ANDA071500 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1386-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-1386-2 | 51672-1386 | ANDA071500 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1386-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-1386-3 | 51672-1386 | ANDA071500 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1386-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., inc. | 51672-1386-4 | 51672-1386 | ANDA071500 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0663-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0663-15 | 0713-0663 | ANDA073085 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0663-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0663-31 | 0713-0663 | ANDA073085 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0663-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0663-60 | 0713-0663 | ANDA073085 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0664-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0664-15 | 0713-0664 | ANDA074204 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0664-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0664-31 | 0713-0664 | ANDA074204 | ANDA | N/A |
| Fluocinonide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0664-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0664-60 | 0713-0664 | ANDA074204 | ANDA | N/A |
| Fluocinonide | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (47781-569-26) / 60 G In 1 Tube | Alvogen Inc. | 47781-569-26 | 47781-569 | NDA016909 | NDA | N/A |
| Ergocalciferol | Capsule | Oral | 1.25mg/1 | 100 Capsule In 1 Bottle (42806-547-01) | Epic Pharma LLC | 42806-547-01 | 42806-547 | ANDA204276 | ANDA | N/A |
| Fluorescein | Injection | Intravenous | 500mg/mL | 10 Vial In 1 Carton (14789-122-05) / 5 Ml In 1 Vial (14789-122-07) | Nexus Pharmaceuticals LLC | 14789-122-05 | 14789-122 | ANDA215709 | ANDA | N/A |
| Fluorescein | Injection | Intravenous | 250mg/mL | 10 Vial In 1 Carton (14789-123-05) / 2 Ml In 1 Vial (14789-123-07) | Nexus Pharmaceuticals LLC | 14789-123-05 | 14789-123 | ANDA215709 | ANDA | N/A |
| Fluorouracil | Injection, Solution | Intravenous | 50mg/mL | 1 Bottle In 1 Carton (25021-215-98) / 50 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-215-98 | 25021-215 | ANDA203609 | ANDA | N/A |
| Fluorouracil | Injection, Solution | Intravenous | 50mg/mL | 1 Bottle In 1 Carton (25021-215-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-215-99 | 25021-215 | ANDA203609 | ANDA | N/A |
| Fluorouracil | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (51672-4118-2) / 25 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4118-2 | 51672-4118 | ANDA090368 | ANDA | N/A |
| Fluorouracil | Cream | Topical | 50mg/g | 5 G In 1 Tube (51672-4118-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4118-5 | 51672-4118 | ANDA090368 | ANDA | N/A |
| Fluorouracil | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (51672-4118-6) / 40 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4118-6 | 51672-4118 | ANDA090368 | ANDA | N/A |
| Fluorouracil | Solution | Topical | 20mg/mL | 1 Bottle In 1 Carton (51672-4062-1) / 10 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4062-1 | 51672-4062 | ANDA076526 | ANDA | N/A |
| Fluorouracil | Solution | Topical | 50mg/mL | 1 Bottle In 1 Carton (51672-4063-1) / 10 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4063-1 | 51672-4063 | ANDA076526 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (75834-148-30) | Nivagen Pharmaceuticals, Inc. | 75834-148-30 | 75834-148 | ANDA209695 | ANDA | N/A |
| Fluoxetine Hydrochloride | Solution | Oral | 20mg/5mL | 120 Ml In 1 Bottle, Plastic (29033-503-31) | Nostrum Laboratories Inc. | 29033-503-31 | 29033-503 | ANDA075292 | ANDA | N/A |
| Ergocalciferol | Capsule | Oral | 1.25mg/1 | 500 Capsule In 1 Bottle (42806-547-05) | Epic Pharma LLC | 42806-547-05 | 42806-547 | ANDA204276 | ANDA | N/A |
| ERLOTINIB | Tablet, Film Coated | Oral | 25mg/1 | 1 Bottle In 1 Carton (31722-263-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-263-30 | 31722-263 | ANDA209267 | ANDA | N/A |
| ERLOTINIB | Tablet, Film Coated | Oral | 100mg/1 | 1 Bottle In 1 Carton (31722-264-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-264-30 | 31722-264 | ANDA209267 | ANDA | N/A |
| ERLOTINIB | Tablet, Film Coated | Oral | 150mg/1 | 1 Bottle In 1 Carton (31722-265-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-265-30 | 31722-265 | ANDA209267 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 200 Ml In 1 Bottle (62559-440-02) | ANI Pharmaceuticals, Inc. | 62559-440-02 | 62559-440 | ANDA062055 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 200mg/5mL | 100 Ml In 1 Bottle (62559-630-01) | ANI Pharmaceuticals, Inc. | 62559-630-01 | 62559-630 | ANDA062055 | ANDA | N/A |
| Erythromycin Ethylsuccinate | Granule, For Suspension | Oral | 400mg/5mL | 100 Ml In 1 Bottle (62559-631-01) | ANI Pharmaceuticals, Inc. | 62559-631-01 | 62559-631 | ANDA062055 | ANDA | N/A |
| erythromycin topical solution 2% | SOLUTION | TOPICAL | 20mg/mL | 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE | Saptalis Pharmaceuticals, LLC | 71656-030-60 | 71656-030 | ANDA062687 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-021-03) | Amneal Pharmaceuticals LLC | 65162-021-03 | 65162-021 | ANDA205619 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-021-09) | Amneal Pharmaceuticals LLC | 65162-021-09 | 65162-021 | ANDA205619 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-021-11) | Amneal Pharmaceuticals LLC | 65162-021-11 | 65162-021 | ANDA205619 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-021-50) | Amneal Pharmaceuticals LLC | 65162-021-50 | 65162-021 | ANDA205619 | ANDA | N/A |
| Escitalopram Oxalate | Solution | Oral | 5mg/5mL | 240 Ml In 1 Bottle (65162-705-88) | Amneal Pharmaceuticals LLC | 65162-705-88 | 65162-705 | ANDA202227 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-755-01) | Rising Pharma Holdings, Inc. | 16571-755-01 | 16571-755 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-755-10) | Rising Pharma Holdings, Inc. | 16571-755-10 | 16571-755 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-756-01) | Rising Pharma Holdings, Inc. | 16571-756-01 | 16571-756 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-756-10) | Rising Pharma Holdings, Inc. | 16571-756-10 | 16571-756 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-757-01) | Rising Pharma Holdings, Inc. | 16571-757-01 | 16571-757 | ANDA078777 | ANDA | N/A |
| Escitalopram Oxalate | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-757-10) | Rising Pharma Holdings, Inc. | 16571-757-10 | 16571-757 | ANDA078777 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (0777-3104-02) | Dista Products Company | 0777-3104-02 | 0777-3104 | NDA018936 | NDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (0777-3105-02) | Dista Products Company | 0777-3105-02 | 0777-3105 | NDA018936 | NDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 30 Capsule In 1 Bottle (0777-3105-30) | Dista Products Company | 0777-3105-30 | 0777-3105 | NDA018936 | NDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (0777-3107-30) | Dista Products Company | 0777-3107-30 | 0777-3107 | NDA018936 | NDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 500 Tablet, Film Coated In 1 Bottle (51672-5306-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5306-2 | 51672-5306 | ANDA211477 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-5306-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-5306-6 | 51672-5306 | ANDA211477 | ANDA | N/A |
| Escitalopram Oxalate | Solution | Oral | 5mg/5mL | 240 Ml In 1 Bottle (16571-769-24) | Rising Pharma Holdings, Inc. | 16571-769-24 | 16571-769 | ANDA079062 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (31722-428-30) | Camber Pharmaceuticals, Inc. | 31722-428-30 | 31722-428 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 200mg/1 | 10 Blister Pack In 1 Carton (31722-428-32) / 10 Tablet In 1 Blister Pack (31722-428-31) | Camber Pharmaceuticals, Inc. | 31722-428-32 | 31722-428 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (31722-429-30) | Camber Pharmaceuticals, Inc. | 31722-429-30 | 31722-429 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 400mg/1 | 10 Blister Pack In 1 Carton (31722-429-32) / 8 Tablet In 1 Blister Pack (31722-429-31) | Camber Pharmaceuticals, Inc. | 31722-429-32 | 31722-429 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 600mg/1 | 10 Blister Pack In 1 Carton (31722-430-32) / 10 Tablet In 1 Blister Pack (31722-430-31) | Camber Pharmaceuticals, Inc. | 31722-430-32 | 31722-430 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (31722-430-60) | Camber Pharmaceuticals, Inc. | 31722-430-60 | 31722-430 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (31722-430-90) | Camber Pharmaceuticals, Inc. | 31722-430-90 | 31722-430 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (31722-431-30) | Camber Pharmaceuticals, Inc. | 31722-431-30 | 31722-431 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 800mg/1 | 10 Blister Pack In 1 Carton (31722-431-32) / 10 Tablet In 1 Blister Pack (31722-431-31) | Camber Pharmaceuticals, Inc. | 31722-431-32 | 31722-431 | ANDA211186 | ANDA | N/A |
| Eslicarbazepine acetate | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle (31722-431-90) | Camber Pharmaceuticals, Inc. | 31722-431-90 | 31722-431 | ANDA211186 | ANDA | N/A |
| Esmolol Hydrochloride | Injection | Intravenous | 10mg/mL | 12 Pouch In 1 Carton (70121-1716-3) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1716-3 | 70121-1716 | ANDA216603 | ANDA | N/A |
| Esmolol Hydrochloride | Injection | Intravenous | 10mg/mL | 10 Pouch In 1 Carton (70121-1716-7) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1716-7 | 70121-1716 | ANDA216603 | ANDA | N/A |
| Esmolol Hydrochloride | Injection | Intravenous | 20mg/mL | 12 Pouch In 1 Carton (70121-1717-3) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1717-3 | 70121-1717 | ANDA216603 | ANDA | N/A |
| Esmolol Hydrochloride | Injection | Intravenous | 20mg/mL | 10 Pouch In 1 Carton (70121-1717-7) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1717-7 | 70121-1717 | ANDA216603 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (65162-644-03) | Amneal Pharmaceuticals LLC | 65162-644-03 | 65162-644 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (65162-644-09) | Amneal Pharmaceuticals LLC | 65162-644-09 | 65162-644 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (65162-644-11) | Amneal Pharmaceuticals LLC | 65162-644-11 | 65162-644 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 500 Capsule, Delayed Release In 1 Bottle (65162-644-50) | Amneal Pharmaceuticals LLC | 65162-644-50 | 65162-644 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (65162-645-03) | Amneal Pharmaceuticals LLC | 65162-645-03 | 65162-645 | ANDA209647 | ANDA | N/A |
| Fluphenazine Decanoate | Injection, Solution | Intramuscular; Subcutaneous | 25mg/mL | 1 Vial In 1 Carton (25021-838-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-838-05 | 25021-838 | ANDA215509 | ANDA | N/A |
| Fluphenazine Decanoate | Injection | Intramuscular; Subcutaneous | 25mg/mL | 1 Vial, Multi-Dose In 1 Box (0143-9529-01) / 5 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9529-01 | 0143-9529 | ANDA074531 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (70954-273-10) | Novitium Pharma LLC | 70954-273-10 | 70954-273 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (70954-274-10) | Novitium Pharma LLC | 70954-274-10 | 70954-274 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-275-10) | Novitium Pharma LLC | 70954-275-10 | 70954-275 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (70954-275-20) | Novitium Pharma LLC | 70954-275-20 | 70954-275 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (70954-276-10) | Novitium Pharma LLC | 70954-276-10 | 70954-276 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (70954-276-20) | Novitium Pharma LLC | 70954-276-20 | 70954-276 | ANDA214674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-458-01) | Golden State Medical Supply, Inc. | 51407-458-01 | 51407-458 | ANDA214534 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-459-01) | Golden State Medical Supply, Inc. | 51407-459-01 | 51407-459 | ANDA214534 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-460-01) | Golden State Medical Supply, Inc. | 51407-460-01 | 51407-460 | ANDA214534 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (51672-4235-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-4235-1 | 51672-4235 | ANDA215674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (51672-4236-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-4236-1 | 51672-4236 | ANDA215674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (51672-4234-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-4234-1 | 51672-4234 | ANDA215674 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (60505-4768-1) | Apotex Corp. | 60505-4768-1 | 60505-4768 | ANDA216649 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (60505-4769-1) | Apotex Corp. | 60505-4769-1 | 60505-4769 | ANDA216649 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (60505-4770-1) | Apotex Corp. | 60505-4770-1 | 60505-4770 | ANDA216649 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60505-4771-1) | Apotex Corp. | 60505-4771-1 | 60505-4771 | ANDA216649 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 90 Capsule, Delayed Release In 1 Bottle (65162-645-09) | Amneal Pharmaceuticals LLC | 65162-645-09 | 65162-645 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (65162-645-11) | Amneal Pharmaceuticals LLC | 65162-645-11 | 65162-645 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 500 Capsule, Delayed Release In 1 Bottle (65162-645-50) | Amneal Pharmaceuticals LLC | 65162-645-50 | 65162-645 | ANDA209647 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-320-31) / 14 Capsule, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-320-31 | 69230-320 | ANDA212507 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 2 Bottle In 1 Carton (69230-320-32) / 14 Capsule, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-320-32 | 69230-320 | ANDA212507 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 3 Bottle In 1 Carton (69230-320-33) / 14 Capsule, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-320-33 | 69230-320 | ANDA212507 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (31722-664-10) | Camber Pharmaceuticals, Inc. | 31722-664-10 | 31722-664 | ANDA211977 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-664-30) | Camber Pharmaceuticals, Inc. | 31722-664-30 | 31722-664 | ANDA211977 | ANDA | N/A |
| Flurandrenolide | Lotion | Topical | .5mg/mL | 120 Ml In 1 Bottle, Plastic (45802-928-03) | Padagis Israel Pharmaceuticals Ltd | 45802-928-03 | 45802-928 | ANDA207133 | ANDA | N/A |
| Flurandrenolide | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-5301-4) / 120 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5301-4 | 51672-5301 | NDA012806 | NDA | N/A |
| Flutamide | Capsule | Oral | 125mg/1 | 1 Bottle, Plastic In 1 Box (80725-600-18) / 180 Capsule In 1 Bottle, Plastic | Waylis Therapeutics LLC | 80725-600-18 | 80725-600 | ANDA075298 | ANDA | N/A |
| Fluticasone Furoate; Vilanterol Trifenatate | Powder | Respiratory (Inhalation) | 100ug/1, 25 ug/1 | 1 Tray In 1 Carton (66993-135-97) / 1 Inhaler In 1 Tray / 30 Powder In 1 Inhaler | Prasco Laboratories | 66993-135-97 | 66993-135 | NDA204275 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Furoate; Vilanterol Trifenatate | Powder | Respiratory (Inhalation) | 200ug/1, 25 ug/1 | 1 Tray In 1 Carton (66993-136-97) / 1 Inhaler In 1 Tray / 30 Powder In 1 Inhaler | Prasco Laboratories | 66993-136-97 | 66993-136 | NDA204275 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (45802-221-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-221-11 | 45802-221 | ANDA076668 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (45802-221-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-221-35 | 45802-221 | ANDA076668 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (45802-221-37) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-221-37 | 45802-221 | ANDA076668 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-222-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-222-11 | 45802-222 | ANDA076793 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-222-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-222-35 | 45802-222 | ANDA076793 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-222-37) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-222-37 | 45802-222 | ANDA076793 | ANDA | N/A |
| Fluticasone Propionate | Lotion | Topical | .5mg/mL | 60 Ml In 1 Bottle (45802-441-02) | Padagis Israel Pharmaceuticals Ltd | 45802-441-02 | 45802-441 | ANDA091553 | ANDA | N/A |
| Fluticasone Propionate | Powder, Metered | Respiratory (Inhalation) | 50ug/1 | 1 Inhaler In 1 Carton (66993-790-97) / 60 Powder, Metered In 1 Inhaler | Prasco Laboratories | 66993-790-97 | 66993-790 | NDA020833 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Powder, Metered | Respiratory (Inhalation) | 100ug/1 | 1 Inhaler In 1 Carton (66993-791-97) / 60 Powder, Metered In 1 Inhaler | Prasco Laboratories | 66993-791-97 | 66993-791 | NDA020833 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Powder, Metered | Respiratory (Inhalation) | 250ug/1 | 1 Inhaler In 1 Carton (66993-792-97) / 60 Powder, Metered In 1 Inhaler | Prasco Laboratories | 66993-792-97 | 66993-792 | NDA020833 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Aerosol, Metered | Respiratory (Inhalation) | 44ug/1 | 1 Inhaler In 1 Carton (66993-078-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-078-96 | 66993-078 | NDA021433 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Aerosol, Metered | Respiratory (Inhalation) | 110ug/1 | 1 Inhaler In 1 Carton (66993-079-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-079-96 | 66993-079 | NDA021433 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Aerosol, Metered | Respiratory (Inhalation) | 220ug/1 | 1 Inhaler In 1 Carton (66993-080-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-080-96 | 66993-080 | NDA021433 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-4095-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4095-1 | 51672-4095 | ANDA077145 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-4095-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4095-2 | 51672-4095 | ANDA077145 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (51672-4095-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4095-3 | 51672-4095 | ANDA077145 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 5 G In 1 Tube (51672-4095-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4095-5 | 51672-4095 | ANDA077145 | ANDA | N/A |
| Fluticasone Propionate | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Spray In 1 Carton (60505-0829-1) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0829-1 | 60505-0829 | ANDA077538 | ANDA | N/A |
| Fluticasone Propionate | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Spray In 1 Carton (60505-0955-1) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0955-1 | 60505-0955 | ANDA208150 | ANDA | N/A |
| Fluticasone Propionate | Spray, Metered | Nasal | 50ug/1 | 3 Bottle, Spray In 1 Carton (60505-0955-3) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0955-3 | 60505-0955 | ANDA208150 | ANDA | N/A |
| Fluticasone Propionate | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Spray In 1 Carton (60505-6205-3) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-6205-3 | 60505-6205 | ANDA208150 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0631-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0631-15 | 0713-0631 | ANDA077055 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0631-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0631-31 | 0713-0631 | ANDA077055 | ANDA | N/A |
| Fluticasone Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0631-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0631-60 | 0713-0631 | ANDA077055 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (0713-0632-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0632-15 | 0713-0632 | ANDA077168 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (0713-0632-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0632-31 | 0713-0632 | ANDA077168 | ANDA | N/A |
| Fluticasone Propionate | Ointment | Topical | .05mg/g | 1 Tube In 1 Carton (0713-0632-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0632-60 | 0713-0632 | ANDA077168 | ANDA | N/A |
| Fluticasone Propionate | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Glass In 1 Carton (0054-3270-99) / 120 Spray, Metered In 1 Bottle, Glass | Hikma Pharmaceuticals USA Inc. | 0054-3270-99 | 0054-3270 | ANDA076504 | ANDA | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 100ug/1, 50 ug/1 | 1 Inhaler In 1 Carton (66993-584-97) / 60 Powder In 1 Inhaler | Prasco Laboratories | 66993-584-97 | 66993-584 | NDA021077 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 250ug/1, 50 ug/1 | 1 Inhaler In 1 Carton (66993-585-97) / 60 Powder In 1 Inhaler | Prasco Laboratories | 66993-585-97 | 66993-585 | NDA021077 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 500ug/1, 50 ug/1 | 1 Inhaler In 1 Carton (66993-586-97) / 60 Powder In 1 Inhaler | Prasco Laboratories | 66993-586-97 | 66993-586 | NDA021077 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Aerosol, Metered | Respiratory (Inhalation) | 45ug/1, 21 ug/1 | 1 Inhaler In 1 Carton (66993-086-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-086-96 | 66993-086 | NDA021254 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Aerosol, Metered | Respiratory (Inhalation) | 115ug/1, 21 ug/1 | 1 Inhaler In 1 Carton (66993-087-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-087-96 | 66993-087 | NDA021254 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Aerosol, Metered | Respiratory (Inhalation) | 230ug/1, 21 ug/1 | 1 Inhaler In 1 Carton (66993-088-96) / 120 Aerosol, Metered In 1 Inhaler | Prasco Laboratories | 66993-088-96 | 66993-088 | NDA021254 | NDA AUTHORIZED GENERIC | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 100ug/1, 50 ug/1 | 1 Pouch In 1 Carton (0054-0326-56) / 1 Inhaler In 1 Pouch / 60 Powder In 1 Inhaler | Hikma Pharmaceuticals USA Inc. | 0054-0326-56 | 0054-0326 | ANDA203433 | ANDA | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 250ug/1, 50 ug/1 | 1 Pouch In 1 Carton (0054-0327-56) / 1 Inhaler In 1 Pouch / 60 Powder In 1 Inhaler | Hikma Pharmaceuticals USA Inc. | 0054-0327-56 | 0054-0327 | ANDA203433 | ANDA | N/A |
| Fluticasone Propionate; Salmeterol Xinafoate | Powder | Respiratory (Inhalation) | 500ug/1, 50 ug/1 | 1 Pouch In 1 Carton (0054-0328-56) / 1 Inhaler In 1 Pouch / 60 Powder In 1 Inhaler | Hikma Pharmaceuticals USA Inc. | 0054-0328-56 | 0054-0328 | ANDA203433 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (31722-664-90) | Camber Pharmaceuticals, Inc. | 31722-664-90 | 31722-664 | ANDA211977 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (31722-665-10) | Camber Pharmaceuticals, Inc. | 31722-665-10 | 31722-665 | ANDA211977 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-665-30) | Camber Pharmaceuticals, Inc. | 31722-665-30 | 31722-665 | ANDA211977 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (60505-0166-1) | Apotex Corp | 60505-0166-1 | 60505-0166 | ANDA075902 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (60505-0164-1) | Apotex Corp | 60505-0164-1 | 60505-0164 | ANDA075902 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (60505-0165-1) | Apotex Corp | 60505-0165-1 | 60505-0165 | ANDA075902 | ANDA | N/A |
| Fluvoxamine Maleate | Capsule, Extended Release | Oral | 100mg/1 | 30 Capsule, Extended Release In 1 Bottle (69452-182-13) | Bionpharma Inc. | 69452-182-13 | 69452-182 | ANDA212182 | ANDA | N/A |
| Fluvoxamine Maleate | Capsule, Extended Release | Oral | 100mg/1 | 1000 Capsule, Extended Release In 1 Bottle (69452-182-32) | Bionpharma Inc. | 69452-182-32 | 69452-182 | ANDA212182 | ANDA | N/A |
| Fluvoxamine Maleate | Capsule, Extended Release | Oral | 150mg/1 | 30 Capsule, Extended Release In 1 Bottle (69452-183-13) | Bionpharma Inc. | 69452-183-13 | 69452-183 | ANDA212182 | ANDA | N/A |
| Fluvoxamine Maleate | Capsule, Extended Release | Oral | 150mg/1 | 1000 Capsule, Extended Release In 1 Bottle (69452-183-32) | Bionpharma Inc. | 69452-183-32 | 69452-183 | ANDA212182 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (69452-287-20) | Bionpharma Inc. | 69452-287-20 | 69452-287 | ANDA217917 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (69452-288-20) | Bionpharma Inc. | 69452-288-20 | 69452-288 | ANDA217917 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (69452-289-20) | Bionpharma Inc. | 69452-289-20 | 69452-289 | ANDA217917 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (69315-127-01) | Leading Pharma, LLC | 69315-127-01 | 69315-127 | ANDA040796 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (69315-127-10) | Leading Pharma, LLC | 69315-127-10 | 69315-127 | ANDA040796 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 90 Capsule, Delayed Release In 1 Bottle (31722-665-90) | Camber Pharmaceuticals, Inc. | 31722-665-90 | 31722-665 | ANDA211977 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1 Bottle In 1 Carton (16571-880-41) / 14 Capsule, Delayed Release In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-880-41 | 16571-880 | ANDA216349 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 3 Bottle In 1 Carton (16571-880-42) / 14 Capsule, Delayed Release In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-880-42 | 16571-880 | ANDA216349 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (64980-632-03) | Rising Pharma Holdings, Inc. | 64980-632-03 | 64980-632 | ANDA212949 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (64980-632-09) | Rising Pharma Holdings, Inc. | 64980-632-09 | 64980-632 | ANDA212949 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (64980-632-10) | Rising Pharma Holdings, Inc. | 64980-632-10 | 64980-632 | ANDA212949 | ANDA | N/A |
| Fomepizole | Injection, Solution | Intravenous | 1g/mL | 1 Vial In 1 Carton (68475-510-01) / 1.5 Ml In 1 Vial | Navinta LLC | 68475-510-01 | 68475-510 | ANDA078537 | ANDA | N/A |
| Fomepizole | Injection | Intravenous | 1.5g/1.5mL | 1 Vial In 1 Carton (25021-829-02) / 1.5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-829-02 | 25021-829 | ANDA216791 | ANDA | N/A |
| Fomepizole | Injection, Solution | Intravenous | 1g/mL | 1 Vial In 1 Carton (0517-0710-88) / 1.5 Ml In 1 Vial | American Regent, Inc. | 0517-0710-88 | 0517-0710 | ANDA078368 | ANDA | N/A |
| Fomepizole | Injection, Solution | Intravenous | 1g/mL | 1 Vial In 1 Carton (0517-0710-01) / 1.5 Ml In 1 Vial | American Regent, Inc. | 0517-0710-01 | 0517-0710 | ANDA078368 | ANDA | N/A |
| Formoterol Fumarate | Solution | Respiratory (Inhalation) | .02mg/2mL | 30 Pouch In 1 Carton (73289-0060-1) / 2 Ml In 1 Pouch (73289-0060-3) | Aucta Pharmaceuticals, Inc | 73289-0060-1 | 73289-0060 | ANDA216486 | ANDA | N/A |
| Formoterol Fumarate | Solution | Respiratory (Inhalation) | .02mg/2mL | 60 Pouch In 1 Carton (73289-0060-2) / 2 Ml In 1 Pouch (73289-0060-3) | Aucta Pharmaceuticals, Inc | 73289-0060-2 | 73289-0060 | ANDA216486 | ANDA | N/A |
| Fosaprepitant | Injection, Powder, Lyophilized, For Solution | Intravenous | 150mg/5mL | 1 Vial In 1 Carton (68475-509-01) / 5 Ml In 1 Vial | Navinta LLC | 68475-509-01 | 68475-509 | ANDA212957 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (64980-633-03) | Rising Pharma Holdings, Inc. | 64980-633-03 | 64980-633 | ANDA212949 | ANDA | N/A |
| Fosaprepitant Dimeglumine | Injection, Powder, Lyophilized, For Solution | Intravenous | 150mg/5mL | 1 Vial, Single-Dose In 1 Carton (0143-9384-01) / 5 Ml In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9384-01 | 0143-9384 | ANDA213106 | ANDA | N/A |
| Fosaprepitant Dimeglumine | Injection, Powder, Lyophilized, For Solution | Intravenous | 150mg/5mL | 1 Vial, Single-Dose In 1 Carton (0143-9428-01) / 5 Ml In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9428-01 | 0143-9428 | ANDA213106 | ANDA | N/A |
| Foscarnet Sodium | Injection, Solution | Intravenous | 24mg/mL | 10 Bag In 1 Carton (25021-189-84) / 250 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-189-84 | 25021-189 | ANDA213001 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 90 Capsule, Delayed Release In 1 Bottle (64980-633-09) | Rising Pharma Holdings, Inc. | 64980-633-09 | 64980-633 | ANDA212949 | ANDA | N/A |
| Esomeprazole Magnesium | Capsule, Delayed Release | Oral | 40mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (64980-633-10) | Rising Pharma Holdings, Inc. | 64980-633-10 | 64980-633 | ANDA212949 | ANDA | N/A |
| Foscarnet Sodium | Injection, Solution | Intravenous | 24mg/mL | 10 Carton In 1 Case (0143-9192-01) / 1 Bottle In 1 Carton / 250 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0143-9192-01 | 0143-9192 | ANDA213987 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (50228-437-10) | ScieGen Pharmaceuticals, Inc | 50228-437-10 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 30 Tablet, Delayed Release In 1 Bottle (50228-437-30) | ScieGen Pharmaceuticals, Inc | 50228-437-30 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 60 Tablet, Delayed Release In 1 Bottle (50228-437-60) | ScieGen Pharmaceuticals, Inc | 50228-437-60 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 500 Tablet, Delayed Release In 1 Bottle (50228-438-05) | ScieGen Pharmaceuticals, Inc | 50228-438-05 | 50228-438 | ANDA217738 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0641-6136-25) / 2 Ml In 1 Vial (0641-6136-01) | Hikma Pharmaceuticals USA Inc. | 0641-6136-25 | 0641-6136 | ANDA077989 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (0641-6137-10) / 10 Ml In 1 Vial (0641-6137-01) | Hikma Pharmaceuticals USA Inc. | 0641-6137-10 | 0641-6137 | ANDA077989 | ANDA | N/A |
| Fosphenytoin Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 25 Vial, Single-Dose In 1 Carton (0069-5471-02) / 2 Ml In 1 Vial, Single-Dose (0069-5471-01) | Pfizer Laboratories Div Pfizer Inc | 0069-5471-02 | 0069-5471 | NDA020450 | NDA | N/A |
| Fosphenytoin Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 10 Vial, Single-Dose In 1 Package (0069-5474-02) / 10 Ml In 1 Vial, Single-Dose (0069-5474-01) | Pfizer Laboratories Div Pfizer Inc | 0069-5474-02 | 0069-5474 | NDA020450 | NDA | N/A |
| Fosphenytoin Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Package (0069-6001-21) / 10 Ml In 1 Vial (0069-6001-10) | Pfizer Laboratories Div Pfizer Inc | 0069-6001-21 | 0069-6001 | NDA020450 | NDA | N/A |
| Fosphenytoin Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0069-6001-25) / 2 Ml In 1 Vial (0069-6001-02) | Pfizer Laboratories Div Pfizer Inc | 0069-6001-25 | 0069-6001 | NDA020450 | NDA | N/A |
| Fraxinus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1060-2) | Jubilant HollisterStier LLC | 65044-1060-2 | 65044-1060 | BLA103888 | BLA | N/A |
| Fraxinus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1060-3) | Jubilant HollisterStier LLC | 65044-1060-3 | 65044-1060 | BLA103888 | BLA | N/A |
| Fraxinus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1060-4) | Jubilant HollisterStier LLC | 65044-1060-4 | 65044-1060 | BLA103888 | BLA | N/A |
| Fraxinus Americana Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1061-1) | Jubilant HollisterStier LLC | 65044-1061-1 | 65044-1061 | BLA103888 | BLA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 30 Tablet, Delayed Release In 1 Bottle (50228-438-30) | ScieGen Pharmaceuticals, Inc | 50228-438-30 | 50228-438 | ANDA217738 | ANDA | N/A |
| Fulvestrant | Injection | Intramuscular | 50mg/mL | 2 Syringe In 1 Carton (71288-555-86) / 5 Ml In 1 Syringe (71288-555-85) | Meitheal Pharmaceuticals Inc | 71288-555-86 | 71288-555 | ANDA209714 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 60 Tablet, Delayed Release In 1 Bottle (50228-438-60) | ScieGen Pharmaceuticals, Inc | 50228-438-60 | 50228-438 | ANDA217738 | ANDA | N/A |
| Fulvestrant | Injection | Intramuscular | 50mg/mL | 2 Syringe, Glass In 1 Carton (0143-9022-02) / 5 Ml In 1 Syringe, Glass (0143-9022-01) | Hikma Pharmaceuticals USA Inc. | 0143-9022-02 | 0143-9022 | ANDA214682 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-203-03) / 2 Ml In 1 Vial, Single-Dose (71288-203-02) | Meitheal Pharmaceuticals Inc. | 71288-203-03 | 71288-203 | ANDA212803 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-203-05) / 4 Ml In 1 Vial, Single-Dose (71288-203-04) | Meitheal Pharmaceuticals Inc. | 71288-203-05 | 71288-203 | ANDA212803 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-203-11) / 10 Ml In 1 Vial, Single-Dose (71288-203-10) | Meitheal Pharmaceuticals Inc. | 71288-203-11 | 71288-203 | ANDA212803 | ANDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-708-90) | St Mary's Medical Park Pharmacy | 60760-708-90 | 60760-708 | ANDA076796 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (25021-311-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-311-02 | 25021-311 | ANDA213902 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (25021-311-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-311-04 | 25021-311 | ANDA213902 | ANDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial In 1 Carton (25021-311-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-311-10 | 25021-311 | ANDA213902 | ANDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-113-01) | Golden State Medical Supply, Inc. | 51407-113-01 | 51407-113 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-113-10) | Golden State Medical Supply, Inc. | 51407-113-10 | 51407-113 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-113-90) | Golden State Medical Supply, Inc. | 51407-113-90 | 51407-113 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (51407-114-01) | Golden State Medical Supply, Inc. | 51407-114-01 | 51407-114 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (51407-114-10) | Golden State Medical Supply, Inc. | 51407-114-10 | 51407-114 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (51407-114-90) | Golden State Medical Supply, Inc. | 51407-114-90 | 51407-114 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (30698-060-01) | Validus Pharmaceuticals LLC | 30698-060-01 | 30698-060 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (30698-060-10) | Validus Pharmaceuticals LLC | 30698-060-10 | 30698-060 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (30698-060-50) | Validus Pharmaceuticals LLC | 30698-060-50 | 30698-060 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 50 Tablet In 1 Bottle (30698-066-05) | Validus Pharmaceuticals LLC | 30698-066-05 | 30698-066 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (30698-066-50) | Validus Pharmaceuticals LLC | 30698-066-50 | 30698-066 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (30698-067-01) | Validus Pharmaceuticals LLC | 30698-067-01 | 30698-067 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (30698-067-10) | Validus Pharmaceuticals LLC | 30698-067-10 | 30698-067 | NDA016273 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (69315-116-01) | Leading Pharma, LLC | 69315-116-01 | 69315-116 | ANDA077293 | ANDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (69315-116-10) | Leading Pharma, LLC | 69315-116-10 | 69315-116 | ANDA077293 | ANDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (69315-117-01) | Leading Pharma, LLC | 69315-117-01 | 69315-117 | ANDA077293 | ANDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (69315-117-10) | Leading Pharma, LLC | 69315-117-10 | 69315-117 | ANDA077293 | ANDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle (69315-118-01) | Leading Pharma, LLC | 69315-118-01 | 69315-118 | ANDA077293 | ANDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (69315-118-05) | Leading Pharma, LLC | 69315-118-05 | 69315-118 | ANDA077293 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (50228-437-10) | ScieGen Pharmaceuticals, Inc | 50228-437-10 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 30 Tablet, Delayed Release In 1 Bottle (50228-437-30) | ScieGen Pharmaceuticals, Inc | 50228-437-30 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 375 mg/1 | 60 Tablet, Delayed Release In 1 Bottle (50228-437-60) | ScieGen Pharmaceuticals, Inc | 50228-437-60 | 50228-437 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 500 Tablet, Delayed Release In 1 Bottle (50228-438-05) | ScieGen Pharmaceuticals, Inc | 50228-438-05 | 50228-438 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 30 Tablet, Delayed Release In 1 Bottle (50228-438-30) | ScieGen Pharmaceuticals, Inc | 50228-438-30 | 50228-438 | ANDA217738 | ANDA | N/A |
| Esomeprazole Magnesium; Naproxen | Tablet, Delayed Release | Oral | 20mg/1, 500 mg/1 | 60 Tablet, Delayed Release In 1 Bottle (50228-438-60) | ScieGen Pharmaceuticals, Inc | 50228-438-60 | 50228-438 | ANDA217738 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .025mg/d | 8 Pouch In 1 Carton (65162-989-08) / 1 D In 1 Pouch (65162-989-04) | Amneal Pharmaceuticals LLC | 65162-989-08 | 65162-989 | ANDA211293 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .0375mg/d | 8 Pouch In 1 Carton (65162-992-08) / 1 D In 1 Pouch (65162-992-04) | Amneal Pharmaceuticals LLC | 65162-992-08 | 65162-992 | ANDA211293 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .05mg/d | 8 Pouch In 1 Carton (65162-993-08) / 1 D In 1 Pouch (65162-993-04) | Amneal Pharmaceuticals LLC | 65162-993-08 | 65162-993 | ANDA211293 | ANDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 10mg/mL | 1 Vial In 1 Carton (0143-9158-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9158-01 | 0143-9158 | NDA018267 | NDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 10mg/mL | 1 Vial In 1 Carton (0143-9159-01) / 100 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9159-01 | 0143-9159 | NDA018267 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (0054-8297-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8297-25 | 0054-8297 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 10 Blister Pack In 1 Carton (0054-8299-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8299-25 | 0054-8299 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 10 Blister Pack In 1 Carton (0054-8301-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8301-25 | 0054-8301 | ANDA070086 | ANDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4297-25) | Hikma Pharmaceuticals USA Inc. | 0054-4297-25 | 0054-4297 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (0054-4297-31) | Hikma Pharmaceuticals USA Inc. | 0054-4297-31 | 0054-4297 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (0054-4299-25) | Hikma Pharmaceuticals USA Inc. | 0054-4299-25 | 0054-4299 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (0054-4299-31) | Hikma Pharmaceuticals USA Inc. | 0054-4299-31 | 0054-4299 | NDA018823 | NDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4301-25) | Hikma Pharmaceuticals USA Inc. | 0054-4301-25 | 0054-4301 | ANDA070086 | ANDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle, Plastic (0054-4301-29) | Hikma Pharmaceuticals USA Inc. | 0054-4301-29 | 0054-4301 | ANDA070086 | ANDA | N/A |
| Furosemide | Solution | Oral | 10mg/mL | 60 Ml In 1 Bottle (0054-3294-46) | Hikma Pharmaceuticals USA Inc. | 0054-3294-46 | 0054-3294 | ANDA070434 | ANDA | N/A |
| Furosemide | Solution | Oral | 10mg/mL | 120 Ml In 1 Bottle, Dropper (0054-3294-50) | Hikma Pharmaceuticals USA Inc. | 0054-3294-50 | 0054-3294 | ANDA070434 | ANDA | N/A |
| Furosemide | Solution | Oral | 40mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3298-63) | Hikma Pharmaceuticals USA Inc. | 0054-3298-63 | 0054-3298 | ANDA070433 | ANDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9155-25) / 2 Ml In 1 Vial, Single-Dose (0143-9155-01) | Hikma Pharmaceuticals USA Inc. | 0143-9155-25 | 0143-9155 | NDA018267 | NDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9156-10) / 4 Ml In 1 Vial, Single-Dose (0143-9156-01) | Hikma Pharmaceuticals USA Inc. | 0143-9156-10 | 0143-9156 | NDA018267 | NDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9157-10) / 10 Ml In 1 Vial, Single-Dose (0143-9157-01) | Hikma Pharmaceuticals USA Inc. | 0143-9157-10 | 0143-9157 | NDA018267 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-25) / 2 Ml In 1 Vial, Single-Dose (0409-6102-35) | Hospira, Inc. | 0409-6102-25 | 0409-6102 | NDA018667 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-26) / 4 Ml In 1 Vial, Single-Dose (0409-6102-36) | Hospira, Inc. | 0409-6102-26 | 0409-6102 | NDA018667 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-27) / 10 Ml In 1 Vial, Single-Dose (0409-6102-37) | Hospira, Inc. | 0409-6102-27 | 0409-6102 | NDA018667 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-02) / 2 Ml In 1 Vial, Single-Dose (0409-6102-19) | Hospira, Inc. | 0409-6102-02 | 0409-6102 | NDA018667 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-04) / 4 Ml In 1 Vial, Single-Dose (0409-6102-18) | Hospira, Inc. | 0409-6102-04 | 0409-6102 | NDA018667 | NDA | N/A |
| Furosemide | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6102-10) / 10 Ml In 1 Vial, Single-Dose (0409-6102-20) | Hospira, Inc. | 0409-6102-10 | 0409-6102 | NDA018667 | NDA | N/A |
| Fusarium Oxysporum Vasinfectum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5112-2) | Jubilant HollisterStier LLC | 65044-5112-2 | 65044-5112 | BLA103888 | BLA | N/A |
| Fusarium Oxysporum Vasinfectum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5112-3) | Jubilant HollisterStier LLC | 65044-5112-3 | 65044-5112 | BLA103888 | BLA | N/A |
| Fusarium Oxysporum Vasinfectum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5112-4) | Jubilant HollisterStier LLC | 65044-5112-4 | 65044-5112 | BLA103888 | BLA | N/A |
| Fusarium Oxysporum Vasinfectum | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5113-1) | Jubilant HollisterStier LLC | 65044-5113-1 | 65044-5113 | BLA103888 | BLA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .075mg/d | 8 Pouch In 1 Carton (65162-995-08) / 1 D In 1 Pouch (65162-995-04) | Amneal Pharmaceuticals LLC | 65162-995-08 | 65162-995 | ANDA211293 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .1mg/d | 8 Pouch In 1 Carton (65162-997-08) / 1 D In 1 Pouch (65162-997-04) | Amneal Pharmaceuticals LLC | 65162-997-08 | 65162-997 | ANDA211293 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .1mg/d | 8 Pouch In 1 Carton (65162-228-08) / 1 D In 1 Pouch (65162-228-04) | Amneal Pharmaceuticals LLC | 65162-228-08 | 65162-228 | ANDA211396 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .025mg/d | 8 Pouch In 1 Carton (65162-126-08) / 1 D In 1 Pouch (65162-126-04) | Amneal Pharmaceuticals LLC | 65162-126-08 | 65162-126 | ANDA211396 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .0375mg/d | 8 Pouch In 1 Carton (65162-148-08) / 1 D In 1 Pouch (65162-148-04) | Amneal Pharmaceuticals LLC | 65162-148-08 | 65162-148 | ANDA211396 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .05mg/d | 8 Pouch In 1 Carton (65162-149-08) / 1 D In 1 Pouch (65162-149-04) | Amneal Pharmaceuticals LLC | 65162-149-08 | 65162-149 | ANDA211396 | ANDA | N/A |
| Estradiol | Patch, Extended Release | Transdermal | .075mg/d | 8 Pouch In 1 Carton (65162-150-08) / 1 D In 1 Pouch (65162-150-04) | Amneal Pharmaceuticals LLC | 65162-150-08 | 65162-150 | ANDA211396 | ANDA | N/A |
| Estradiol | Tablet | Vaginal | 10ug/1 | 8 Applicator In 1 Carton (65162-226-21) / 1 Tablet In 1 Applicator | Amneal Pharmaceuticals LLC | 65162-226-21 | 65162-226 | ANDA205256 | ANDA | N/A |
| Estradiol | Tablet | Vaginal | 10ug/1 | 18 Applicator In 1 Carton (65162-226-23) / 1 Tablet In 1 Applicator | Amneal Pharmaceuticals LLC | 65162-226-23 | 65162-226 | ANDA205256 | ANDA | N/A |
| Estradiol | Gel | Topical | .5mg/.5g | 30 Packet In 1 Carton (70954-530-20) / .5 G In 1 Packet (70954-530-10) | ANI Pharmaceuticals, Inc. | 70954-530-20 | 70954-530 | ANDA217610 | ANDA | N/A |
| Estradiol | Gel | Topical | .25mg/.25g | 30 Packet In 1 Carton (70954-531-20) / .25 G In 1 Packet (70954-531-10) | ANI Pharmaceuticals, Inc. | 70954-531-20 | 70954-531 | ANDA217610 | ANDA | N/A |
| Estradiol | Gel | Topical | .75mg/.75g | 30 Packet In 1 Carton (70954-532-20) / .75 G In 1 Packet (70954-532-10) | ANI Pharmaceuticals, Inc. | 70954-532-20 | 70954-532 | ANDA217610 | ANDA | N/A |
| Estradiol | Gel | Topical | 1mg/g | 30 Packet In 1 Carton (70954-533-20) / 1 G In 1 Packet (70954-533-10) | ANI Pharmaceuticals, Inc. | 70954-533-20 | 70954-533 | ANDA217610 | ANDA | N/A |
| Estradiol | Gel | Topical | 1.25mg/1.25g | 30 Packet In 1 Carton (70954-534-20) / 1.25 G In 1 Packet (70954-534-10) | ANI Pharmaceuticals, Inc. | 70954-534-20 | 70954-534 | ANDA217610 | ANDA | N/A |
| Estradiol | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (70954-564-10) | ANI Pharmaceuticals, Inc. | 70954-564-10 | 70954-564 | ANDA217334 | ANDA | N/A |
| Estradiol | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (70954-565-10) | ANI Pharmaceuticals, Inc. | 70954-565-10 | 70954-565 | ANDA217334 | ANDA | N/A |
| Estradiol | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (70954-565-20) | ANI Pharmaceuticals, Inc. | 70954-565-20 | 70954-565 | ANDA217334 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-814-60) | St Mary's Medical Park Pharmacy | 60760-814-60 | 60760-814 | ANDA206943 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-814-90) | St Mary's Medical Park Pharmacy | 60760-814-90 | 60760-814 | ANDA206943 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 110 Capsule In 1 Bottle, Plastic (60760-814-91) | St Mary's Medical Park Pharmacy | 60760-814-91 | 60760-814 | ANDA206943 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-740-60) | St. Mary's Medical Park Pharmacy | 60760-740-60 | 60760-740 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-740-90) | St. Mary's Medical Park Pharmacy | 60760-740-90 | 60760-740 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-818-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-818-60 | 60760-818 | ANDA206943 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-818-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-818-90 | 60760-818 | ANDA206943 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-741-60) | St. Mary's Medical Park Pharmacy | 60760-741-60 | 60760-741 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-741-90) | St. Mary's Medical Park Pharmacy | 60760-741-90 | 60760-741 | ANDA204989 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-743-90) | St. Mary's Medical Park Pharmacy | 60760-743-90 | 60760-743 | ANDA205101 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (42582-114-10) | Bi-Coastal Pharma International LLC | 42582-114-10 | 42582-114 | ANDA090007 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (42582-114-18) | Bi-Coastal Pharma International LLC | 42582-114-18 | 42582-114 | ANDA090007 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle, Plastic (42582-115-10) | Bi-Coastal Pharma International LLC | 42582-115-10 | 42582-115 | ANDA090007 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle, Plastic (42582-115-18) | Bi-Coastal Pharma International LLC | 42582-115-18 | 42582-115 | ANDA090007 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle, Plastic (42582-116-10) | Bi-Coastal Pharma International LLC | 42582-116-10 | 42582-116 | ANDA090007 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle, Plastic (42582-116-18) | Bi-Coastal Pharma International LLC | 42582-116-18 | 42582-116 | ANDA090007 | ANDA | N/A |
| Estradiol | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (70954-566-10) | ANI Pharmaceuticals, Inc. | 70954-566-10 | 70954-566 | ANDA217334 | ANDA | N/A |
| Estradiol | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (70954-566-20) | ANI Pharmaceuticals, Inc. | 70954-566-20 | 70954-566 | ANDA217334 | ANDA | N/A |
| Estradiol | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (42806-087-01) | EPIC PHARMA, LLC | 42806-087-01 | 42806-087 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (42806-087-05) | EPIC PHARMA, LLC | 42806-087-05 | 42806-087 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (42806-088-01) | EPIC PHARMA, LLC | 42806-088-01 | 42806-088 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (42806-088-05) | EPIC PHARMA, LLC | 42806-088-05 | 42806-088 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (42806-089-01) | EPIC PHARMA, LLC | 42806-089-01 | 42806-089 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (42806-089-05) | EPIC PHARMA, LLC | 42806-089-05 | 42806-089 | ANDA040275 | ANDA | N/A |
| Estradiol | Tablet | Oral | 2mg/1 | 90 Tablet In 1 Bottle (42806-089-09) | EPIC PHARMA, LLC | 42806-089-09 | 42806-089 | ANDA040275 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet, Film Coated | Oral | .5mg/1, .1 mg/1 | 1 Blister Pack In 1 Carton (60846-231-01) / 28 Tablet, Film Coated In 1 Blister Pack | Amneal Pharmaceuticals LLC | 60846-231-01 | 60846-231 | NDA020907 | NDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet, Film Coated | Oral | 1mg/1, .5 mg/1 | 1 Blister Pack In 1 Carton (60846-232-01) / 28 Tablet, Film Coated In 1 Blister Pack | Amneal Pharmaceuticals LLC | 60846-232-01 | 60846-232 | NDA020907 | NDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | 1mg/1, .5 mg/1 | 1 Blister Pack In 1 Carton (50742-657-28) / 28 Tablet In 1 Blister Pack (50742-657-01) | Ingenus Pharmaceuticals, LLC | 50742-657-28 | 50742-657 | ANDA210612 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | 1mg/1, .5 mg/1 | 6 Blister Pack In 1 Carton (50742-657-68) / 28 Tablet In 1 Blister Pack (50742-657-01) | Ingenus Pharmaceuticals, LLC | 50742-657-68 | 50742-657 | ANDA210612 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | 1mg/1, .5 mg/1 | 3 Blister Pack In 1 Carton (50742-657-84) / 28 Tablet In 1 Blister Pack (50742-657-01) | Ingenus Pharmaceuticals, LLC | 50742-657-84 | 50742-657 | ANDA210612 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | .5mg/1, .1 mg/1 | 1 Blister Pack In 1 Carton (50742-658-28) / 28 Tablet In 1 Blister Pack (50742-658-01) | Ingenus Pharmaceuticals, LLC | 50742-658-28 | 50742-658 | ANDA210612 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | .5mg/1, .1 mg/1 | 6 Blister Pack In 1 Carton (50742-658-68) / 28 Tablet In 1 Blister Pack (50742-658-01) | Ingenus Pharmaceuticals, LLC | 50742-658-68 | 50742-658 | ANDA210612 | ANDA | N/A |
| Estradiol; Norethindrone Acetate | Tablet | Oral | .5mg/1, .1 mg/1 | 3 Blister Pack In 1 Carton (50742-658-84) / 28 Tablet In 1 Blister Pack (50742-658-01) | Ingenus Pharmaceuticals, LLC | 50742-658-84 | 50742-658 | ANDA210612 | ANDA | N/A |
| Estrogens, Esterified; Methyltestosterone | Tablet | Oral | 1.25mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (62559-149-01) | ANI Pharmaceuticals, Inc. | 62559-149-01 | 62559-149 | N/A | UNAPPROVED DRUG OTHER | CIII |
| Estrogens, Esterified; Methyltestosterone | Tablet | Oral | .625mg/1, 1.25 mg/1 | 100 Tablet In 1 Bottle (62559-150-01) | ANI Pharmaceuticals, Inc. | 62559-150-01 | 62559-150 | N/A | UNAPPROVED DRUG OTHER | CIII |
| Eszopiclone | Tablet, Film Coated | Oral | 1mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-855-01) | Camber Pharmaceuticals, Inc. | 31722-855-01 | 31722-855 | ANDA205504 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-855-30) | Camber Pharmaceuticals, Inc. | 31722-855-30 | 31722-855 | ANDA205504 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-856-01) | Camber Pharmaceuticals, Inc. | 31722-856-01 | 31722-856 | ANDA205504 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 2mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-856-30) | Camber Pharmaceuticals, Inc. | 31722-856-30 | 31722-856 | ANDA205504 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 3mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-857-01) | Camber Pharmaceuticals, Inc. | 31722-857-01 | 31722-857 | ANDA205504 | ANDA | CIV |
| Eszopiclone | Tablet, Film Coated | Oral | 3mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-857-30) | Camber Pharmaceuticals, Inc. | 31722-857-30 | 31722-857 | ANDA205504 | ANDA | CIV |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-334-01) | ScieGen Pharmaceuticals Inc | 50228-334-01 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (50228-334-10) | ScieGen Pharmaceuticals Inc | 50228-334-10 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (50228-334-30) | ScieGen Pharmaceuticals Inc | 50228-334-30 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-334-01) | ScieGen Pharmaceuticals Inc | 50228-334-01 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (50228-334-10) | ScieGen Pharmaceuticals Inc | 50228-334-10 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethacrynic Acid | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (50228-334-30) | ScieGen Pharmaceuticals Inc | 50228-334-30 | 50228-334 | ANDA211232 | ANDA | N/A |
| Ethambutol Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-101-01) | Epic Pharma, LLC | 42806-101-01 | 42806-101 | ANDA075095 | ANDA | N/A |
| Ethambutol Hydrochloride | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-102-01) | Epic Pharma, LLC | 42806-102-01 | 42806-102 | ANDA075095 | ANDA | N/A |
| Ethinyl Estradiol; Etonogestrel | Ring | Vaginal | .015mg/d, .12 mg/d | 3 Pouch In 1 Carton (65162-469-35) / 21 D In 1 Pouch (65162-469-32) | Amneal Pharmaceuticals LLC | 65162-469-35 | 65162-469 | ANDA210830 | ANDA | N/A |
| Ethinyl Estradiol; Levonorgestrel | Tablet | Oral | 20ug/1, 90 ug/1 | 1 Blister Pack In 1 Carton (50742-659-28) / 28 Tablet In 1 Blister Pack | Ingenus Pharmaceuticals, LLC | 50742-659-28 | 50742-659 | ANDA091692 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 5 Ml In 1 Cup, Unit-Dose (42192-608-05) | Acella Pharmaceuticals, LLC | 42192-608-05 | 42192-608 | ANDA076403 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 6 Ml In 1 Cup, Unit-Dose (42192-608-06) | Acella Pharmaceuticals, LLC | 42192-608-06 | 42192-608 | ANDA076403 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 470 Ml In 1 Bottle (42192-608-16) | Acella Pharmaceuticals, LLC | 42192-608-16 | 42192-608 | ANDA076403 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 40 Cup, Unit-Dose In 1 Box (42192-608-40) / 6 Ml In 1 Cup, Unit-Dose | Acella Pharmaceuticals, LLC | 42192-608-40 | 42192-608 | ANDA076403 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 40 Cup, Unit-Dose In 1 Box (42192-608-45) / 5 Ml In 1 Cup, Unit-Dose | Acella Pharmaceuticals, LLC | 42192-608-45 | 42192-608 | ANDA076403 | ANDA | N/A |
| Ethinyl Estradiol; Levonorgestrel | Tablet | Oral | 20ug/1, 90 ug/1 | 6 Blister Pack In 1 Carton (50742-659-68) / 28 Tablet In 1 Blister Pack | Ingenus Pharmaceuticals, LLC | 50742-659-68 | 50742-659 | ANDA091692 | ANDA | N/A |
| Ethinyl Estradiol; Levonorgestrel | Tablet | Oral | 20ug/1, 90 ug/1 | 3 Blister Pack In 1 Carton (50742-659-84) / 28 Tablet In 1 Blister Pack | Ingenus Pharmaceuticals, LLC | 50742-659-84 | 50742-659 | ANDA091692 | ANDA | N/A |
| Ethinyl Estradiol; Norelgestromin | Patch | Transdermal | 35ug/d, 150 ug/d | 3 Pouch In 1 Carton (65162-358-03) / 1 Patch In 1 Pouch (65162-358-01) / 7 D In 1 Patch | Amneal Pharmaceuticals LLC | 65162-358-03 | 65162-358 | ANDA213950 | ANDA | N/A |
| Ethosuximide | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (42806-708-01) | Epic Pharma, LLC | 42806-708-01 | 42806-708 | ANDA210654 | ANDA | N/A |
| Ethosuximide | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (42806-711-01) | Epic Pharma, LLC | 42806-711-01 | 42806-711 | ANDA210654 | ANDA | N/A |
| Etodolac | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (62559-250-01) | ANI Pharmaceuticals, Inc. | 62559-250-01 | 62559-250 | ANDA075126 | ANDA | N/A |
| Etodolac | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (62559-251-01) | ANI Pharmaceuticals, Inc. | 62559-251-01 | 62559-251 | ANDA075126 | ANDA | N/A |
| Exemestane | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-240-03) | Amneal Pharmaceuticals LLC | 65162-240-03 | 65162-240 | ANDA206421 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (50228-379-05) | ScieGen Pharmaceuticals Inc | 50228-379-05 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-379-10) | ScieGen Pharmaceuticals Inc | 50228-379-10 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-379-30) | ScieGen Pharmaceuticals Inc | 50228-379-30 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (50228-379-90) | ScieGen Pharmaceuticals Inc | 50228-379-90 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (50228-379-05) | ScieGen Pharmaceuticals Inc | 50228-379-05 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-379-10) | ScieGen Pharmaceuticals Inc | 50228-379-10 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (50228-379-30) | ScieGen Pharmaceuticals Inc | 50228-379-30 | 50228-379 | ANDA210673 | ANDA | N/A |
| Ezetimibe | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (50228-379-90) | ScieGen Pharmaceuticals Inc | 50228-379-90 | 50228-379 | ANDA210673 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-706-01) | Camber Pharmaceuticals, Inc. | 31722-706-01 | 31722-706 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-706-05) | Camber Pharmaceuticals, Inc. | 31722-706-05 | 31722-706 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-706-10) | Camber Pharmaceuticals, Inc. | 31722-706-10 | 31722-706 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-706-30) | Camber Pharmaceuticals, Inc. | 31722-706-30 | 31722-706 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-706-60) | Camber Pharmaceuticals, Inc. | 31722-706-60 | 31722-706 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-707-01) | Camber Pharmaceuticals, Inc. | 31722-707-01 | 31722-707 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-707-05) | Camber Pharmaceuticals, Inc. | 31722-707-05 | 31722-707 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-707-10) | Camber Pharmaceuticals, Inc. | 31722-707-10 | 31722-707 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-707-30) | Camber Pharmaceuticals, Inc. | 31722-707-30 | 31722-707 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-707-60) | Camber Pharmaceuticals, Inc. | 31722-707-60 | 31722-707 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-708-01) | Camber Pharmaceuticals, Inc. | 31722-708-01 | 31722-708 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-708-05) | Camber Pharmaceuticals, Inc. | 31722-708-05 | 31722-708 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-708-10) | Camber Pharmaceuticals, Inc. | 31722-708-10 | 31722-708 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-708-30) | Camber Pharmaceuticals, Inc. | 31722-708-30 | 31722-708 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-708-60) | Camber Pharmaceuticals, Inc. | 31722-708-60 | 31722-708 | ANDA202438 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 125mg/1 | 30 Tablet, Film Coated In 1 Bottle (64980-349-03) | Rising Pharma Holdings, Inc. | 64980-349-03 | 64980-349 | ANDA091114 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (64980-350-03) | Rising Pharma Holdings, Inc. | 64980-350-03 | 64980-350 | ANDA091114 | ANDA | N/A |
| Famciclovir | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (64980-351-03) | Rising Pharma Holdings, Inc. | 64980-351-03 | 64980-351 | ANDA091114 | ANDA | N/A |
| Famotidine | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle (70954-316-10) | ANI Pharmaceuticals, Inc. | 70954-316-10 | 70954-316 | ANDA215043 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (43602-602-03) / 300 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-602-03 | 43602-602 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (43602-602-30) / 30 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-602-30 | 43602-602 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (43602-501-05) | Ascent Pharmaceuticals, Inc. | 43602-501-05 | 43602-501 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (43602-501-30) | Ascent Pharmaceuticals, Inc. | 43602-501-30 | 43602-501 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (43602-502-05) | Ascent Pharmaceuticals, Inc. | 43602-502-05 | 43602-502 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (43602-502-30) | Ascent Pharmaceuticals, Inc. | 43602-502-30 | 43602-502 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (43602-511-03) / 300 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-511-03 | 43602-511 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (43602-511-30) / 30 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-511-30 | 43602-511 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (43602-501-05) | Ascent Pharmaceuticals, Inc. | 43602-501-05 | 43602-501 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (43602-501-30) | Ascent Pharmaceuticals, Inc. | 43602-501-30 | 43602-501 | ANDA215689 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (0071-0803-24) | Parke-Davis Div of Pfizer Inc | 0071-0803-24 | 0071-0803 | NDA020235 | NDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (0071-0805-24) | Parke-Davis Div of Pfizer Inc | 0071-0805-24 | 0071-0805 | NDA020235 | NDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (0071-0806-24) | Parke-Davis Div of Pfizer Inc | 0071-0806-24 | 0071-0806 | NDA020235 | NDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 1 Bottle, Plastic In 1 Carton (0071-2012-47) / 470 Ml In 1 Bottle, Plastic | Parke-Davis Div of Pfizer Inc | 0071-2012-47 | 0071-2012 | NDA021129 | NDA | N/A |
| Gabapentin | Tablet, Film Coated | Oral | 800mg/1 | 100 Tablet, Film Coated In 1 Bottle (0071-0401-24) | Parke-Davis Div of Pfizer Inc | 0071-0401-24 | 0071-0401 | NDA020882 | NDA | N/A |
| Gabapentin | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (0071-0513-24) | Parke-Davis Div of Pfizer Inc | 0071-0513-24 | 0071-0513 | NDA020882 | NDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (43602-502-05) | Ascent Pharmaceuticals, Inc. | 43602-502-05 | 43602-502 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (43602-502-30) | Ascent Pharmaceuticals, Inc. | 43602-502-30 | 43602-502 | ANDA215689 | ANDA | N/A |
| Famotidine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (43602-511-03) / 300 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-511-03 | 43602-511 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (43602-511-30) / 30 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-511-30 | 43602-511 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (43602-602-03) / 300 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-602-03 | 43602-602 | ANDA216030 | ANDA | N/A |
| Famotidine | Tablet | Oral | 20mg/1 | 1 Bottle In 1 Carton (43602-602-30) / 30 Tablet In 1 Bottle | Ascent Pharmaceuticals, Inc. | 43602-602-30 | 43602-602 | ANDA216030 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-326-01) / 100 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-326-01 | 69230-326 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-326-05) / 500 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-326-05 | 69230-326 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-326-10) / 1000 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-326-10 | 69230-326 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-326-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-326-30 | 69230-326 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-326-60) / 60 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-326-60 | 69230-326 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-327-01) / 100 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-327-01 | 69230-327 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-327-05) / 500 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-327-05 | 69230-327 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-327-10) / 1000 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-327-10 | 69230-327 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-327-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-327-30 | 69230-327 | ANDA215766 | ANDA | N/A |
| famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-327-50) / 50 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-327-50 | 69230-327 | ANDA215766 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-017-01) | Camber Pharmaceuticals, Inc. | 31722-017-01 | 31722-017 | ANDA215767 | ANDA | N/A |
| Gabapentin Enacarbil | Tablet, Extended Release | Oral | 600mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (53451-0101-1) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0101-1 | 53451-0101 | NDA022399 | NDA | N/A |
| Gabapentin Enacarbil | Tablet, Extended Release | Oral | 600mg/1 | 5 Tablet, Extended Release In 1 Bottle, Plastic (53451-0101-9) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0101-9 | 53451-0101 | NDA022399 | NDA | N/A |
| Gabapentin Enacarbil | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (53451-0103-1) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0103-1 | 53451-0103 | NDA022399 | NDA | N/A |
| Gabapentin Enacarbil | Tablet, Extended Release | Oral | 300mg/1 | 5 Tablet, Extended Release In 1 Bottle, Plastic (53451-0103-9) | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0103-9 | 53451-0103 | NDA022399 | NDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 4mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-906-60) | Golden State Medical Supply, Inc. | 51407-906-60 | 51407-906 | ANDA077604 | ANDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 8mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-907-60) | Golden State Medical Supply, Inc. | 51407-907-60 | 51407-907 | ANDA077604 | ANDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 12mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-908-60) | Golden State Medical Supply, Inc. | 51407-908-60 | 51407-908 | ANDA077604 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-017-10) | Camber Pharmaceuticals, Inc. | 31722-017-10 | 31722-017 | ANDA215767 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-018-01) | Camber Pharmaceuticals, Inc. | 31722-018-01 | 31722-018 | ANDA215767 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-018-05) | Camber Pharmaceuticals, Inc. | 31722-018-05 | 31722-018 | ANDA215767 | ANDA | N/A |
| Galantamine Hydrobromide | Solution | Oral | 4mg/mL | 100 Ml In 1 Bottle (0054-0137-49) | Hikma Pharmaceuticals USA Inc. | 0054-0137-49 | 0054-0137 | ANDA078185 | ANDA | N/A |
| Ganciclovir Sodium | Injection, Solution | Intravenous | 50mg/mL | 25 Vial In 1 Carton (25021-185-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-185-10 | 25021-185 | ANDA207645 | ANDA | N/A |
| Ganciclovir Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/mL | 10 Vial In 1 Box (0143-9299-10) / 10 Ml In 1 Vial (0143-9299-01) | Hikma Pharmaceuticals USA Inc. | 0143-9299-10 | 0143-9299 | ANDA076222 | ANDA | N/A |
| Ganirelix Acetate | Injection, Solution | Subcutaneous | 250ug/.5mL | 1 Blister Pack In 1 Carton (71288-554-80) / 1 Syringe, Glass In 1 Blister Pack / .5 Ml In 1 Syringe, Glass | Meitheal Pharmaceuticals Inc. | 71288-554-80 | 71288-554 | ANDA214996 | ANDA | N/A |
| Ganirelix Acetate | Injection | Subcutaneous | 250ug/.5mL | 1 Syringe In 1 Carton (0548-5001-00) / .5 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5001-00 | 0548-5001 | ANDA212613 | ANDA | N/A |
| Ganirelix Acetate | Injection | Subcutaneous | 250ug/.5mL | 1 Syringe In 1 Carton (0548-5001-00) / .5 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5001-00 | 0548-5001 | ANDA212613 | ANDA | N/A |
| Gefitinib | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle (60505-4512-3) | Apotex Corp. | 60505-4512-3 | 60505-4512 | ANDA209532 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-018-10) | Camber Pharmaceuticals, Inc. | 31722-018-10 | 31722-018 | ANDA215767 | ANDA | N/A |
| Gemcitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 200mg/1 | 1 Vial, Single-Dose In 1 Carton (0143-9394-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9394-01 | 0143-9394 | ANDA206617 | ANDA | N/A |
| Gemcitabine | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 1 Vial, Single-Dose In 1 Carton (0143-9395-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9395-01 | 0143-9395 | ANDA206617 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-117-06) / 5.26 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-117-06 | 71288-117 | ANDA212129 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-117-28) / 26.3 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-117-28 | 71288-117 | ANDA212129 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-117-54) / 52.6 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-117-54 | 71288-117 | ANDA212129 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 200mg/1 | 1 Vial, Single-Dose In 1 Carton (71288-113-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-113-10 | 71288-113 | ANDA091365 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 1 Vial, Single-Dose In 1 Carton (71288-114-50) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-114-50 | 71288-114 | ANDA091365 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 200mg/5mL | 1 Vial In 1 Carton (25021-234-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-234-10 | 25021-234 | ANDA202485 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/25mL | 1 Vial In 1 Carton (25021-235-50) / 25 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-235-50 | 25021-235 | ANDA202485 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/25mL | 10 Vial In 1 Carton (25021-235-51) / 25 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-235-51 | 25021-235 | ANDA202485 | ANDA | N/A |
| FAMOTIDINE | Powder, For Suspension | Oral | 40mg/5mL | 50 Ml In 1 Bottle (31722-063-31) | Camber Pharmaceuticals, Inc. | 31722-063-31 | 31722-063 | ANDA217330 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-623-01) | Rising Pharma Holdings, Inc. | 64980-623-01 | 64980-623 | ANDA218181 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (64980-623-10) | Rising Pharma Holdings, Inc. | 64980-623-10 | 64980-623 | ANDA218181 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0181-25) / 26.3 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0181-25 | 0409-0181 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0181-01) / 26.3 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0181-01 | 0409-0181 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0182-25) / 52.6 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0182-25 | 0409-0182 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0182-01) / 52.6 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0182-01 | 0409-0182 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0183-25) / 5.26 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0183-25 | 0409-0183 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0183-01) / 5.26 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0183-01 | 0409-0183 | NDA200795 | NDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0185-01) / 5 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0185-01 | 0409-0185 | ANDA078339 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0186-01) / 25 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0186-01 | 0409-0186 | ANDA078339 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0187-01) / 50 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0187-01 | 0409-0187 | ANDA079183 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (75834-131-05) | Nivagen Pharmaceuticals, Inc. | 75834-131-05 | 75834-131 | ANDA203266 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 180 Tablet In 1 Bottle (75834-131-18) | Nivagen Pharmaceuticals, Inc. | 75834-131-18 | 75834-131 | ANDA203266 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (75834-131-60) | Nivagen Pharmaceuticals, Inc. | 75834-131-60 | 75834-131 | ANDA203266 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (64980-623-50) | Rising Pharma Holdings, Inc. | 64980-623-50 | 64980-623 | ANDA218181 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-624-01) | Rising Pharma Holdings, Inc. | 64980-624-01 | 64980-624 | ANDA218181 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (64980-624-10) | Rising Pharma Holdings, Inc. | 64980-624-10 | 64980-624 | ANDA218181 | ANDA | N/A |
| Famotidine | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (64980-624-50) | Rising Pharma Holdings, Inc. | 64980-624-50 | 64980-624 | ANDA218181 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-214-01) | XLCare Pharmaceuticals, Inc. | 72865-214-01 | 72865-214 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-214-05) | XLCare Pharmaceuticals, Inc. | 72865-214-05 | 72865-214 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 20mg/1 | 180 Tablet, Film Coated In 1 Bottle (72865-214-18) | XLCare Pharmaceuticals, Inc. | 72865-214-18 | 72865-214 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-214-30) | XLCare Pharmaceuticals, Inc. | 72865-214-30 | 72865-214 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-215-01) | XLCare Pharmaceuticals, Inc. | 72865-215-01 | 72865-215 | ANDA215689 | ANDA | N/A |
| Gemfibrozil | Tablet, Film Coated | Oral | 600mg/1 | 60 Tablet, Film Coated In 1 Bottle (0071-0737-20) | Parke-Davis Div of Pfizer Inc | 0071-0737-20 | 0071-0737 | NDA018422 | NDA | N/A |
| Gemfibrozil | Tablet, Film Coated | Oral | 600mg/1 | 500 Tablet, Film Coated In 1 Bottle (0071-0737-30) | Parke-Davis Div of Pfizer Inc | 0071-0737-30 | 0071-0737 | NDA018422 | NDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-215-05) | XLCare Pharmaceuticals, Inc. | 72865-215-05 | 72865-215 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 40mg/1 | 180 Tablet, Film Coated In 1 Bottle (72865-215-18) | XLCare Pharmaceuticals, Inc. | 72865-215-18 | 72865-215 | ANDA215689 | ANDA | N/A |
| FAMOTIDINE | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-215-30) | XLCare Pharmaceuticals, Inc. | 72865-215-30 | 72865-215 | ANDA215689 | ANDA | N/A |
| Gemtuzumab Ozogamicin | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/5mL | 1 Vial, Single-Dose In 1 Carton (0008-4510-01) / 5 Ml In 1 Vial, Single-Dose | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4510-01 | 0008-4510 | BLA761060 | BLA | N/A |
| Gentamicin Sulfate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-046-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-046-11 | 45802-046 | ANDA062351 | ANDA | N/A |
| Gentamicin Sulfate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-046-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-046-35 | 45802-046 | ANDA062351 | ANDA | N/A |
| Gentamicin Sulfate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-056-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-056-11 | 45802-056 | ANDA062307 | ANDA | N/A |
| Gentamicin Sulfate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-056-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-056-35 | 45802-056 | ANDA062307 | ANDA | N/A |
| Gentamicin Sulfate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0682-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0682-15 | 0713-0682 | ANDA064054 | ANDA | N/A |
| Gentamicin Sulfate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0682-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0682-31 | 0713-0682 | ANDA064054 | ANDA | N/A |
| Gentamicin Sulfate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0683-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0683-15 | 0713-0683 | ANDA064056 | ANDA | N/A |
| Gentamicin Sulfate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0683-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0683-31 | 0713-0683 | ANDA064056 | ANDA | N/A |
| Gentamicin Sulfate | Injection, Solution | Intramuscular; Intravenous | 40mg/mL | 25 Vial In 1 Carton (0143-9128-25) / 2 Ml In 1 Vial (0143-9128-01) | Hikma Pharmaceuticals USA Inc. | 0143-9128-25 | 0143-9128 | ANDA062251 | ANDA | N/A |
| Gentamicin Sulfate | Injection, Solution | Intramuscular; Intravenous | 40mg/mL | 10 Vial In 1 Carton (0143-9129-10) / 20 Ml In 1 Vial (0143-9129-01) | Hikma Pharmaceuticals USA Inc. | 0143-9129-10 | 0143-9129 | ANDA062251 | ANDA | N/A |
| Gentamicin Sulfate | Injection, Solution | Intramuscular; Intravenous | 40mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1207-03) / 2 Ml In 1 Vial, Single-Dose (0409-1207-13) | Hospira, Inc. | 0409-1207-03 | 0409-1207 | ANDA062420 | ANDA | N/A |
| Glasdegib | Tablet, Film Coated | Oral | 25mg/1 | 60 Tablet, Film Coated In 1 Bottle (0069-0298-60) | Pfizer Laboratories Div Pfizer Inc | 0069-0298-60 | 0069-0298 | NDA210656 | NDA | N/A |
| Glasdegib | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-1531-30) | Pfizer Laboratories Div Pfizer Inc | 0069-1531-30 | 0069-1531 | NDA210656 | NDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-800-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-800-90 | 60760-800 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (60429-918-01) | Golden State Medical Supply, Inc. | 60429-918-01 | 60429-918 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (60429-919-01) | Golden State Medical Supply, Inc. | 60429-919-01 | 60429-919 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (60429-920-01) | Golden State Medical Supply, Inc. | 60429-920-01 | 60429-920 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (61442-115-01) | Carlsbad Technology, Inc. | 61442-115-01 | 61442-115 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (61442-115-05) | Carlsbad Technology, Inc. | 61442-115-05 | 61442-115 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (61442-115-10) | Carlsbad Technology, Inc. | 61442-115-10 | 61442-115 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (61442-116-01) | Carlsbad Technology, Inc. | 61442-116-01 | 61442-116 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (61442-116-05) | Carlsbad Technology, Inc. | 61442-116-05 | 61442-116 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (61442-116-10) | Carlsbad Technology, Inc. | 61442-116-10 | 61442-116 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (61442-117-01) | Carlsbad Technology, Inc. | 61442-117-01 | 61442-117 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (61442-117-05) | Carlsbad Technology, Inc. | 61442-117-05 | 61442-117 | ANDA077911 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (61442-117-10) | Carlsbad Technology, Inc. | 61442-117-10 | 61442-117 | ANDA077911 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 500 Tablet In 1 Bottle (43602-544-05) | Ascent Pharmaceuticals, Inc. | 43602-544-05 | 43602-544 | ANDA216814 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 30 Tablet In 1 Bottle (43602-544-30) | Ascent Pharmaceuticals, Inc. | 43602-544-30 | 43602-544 | ANDA216814 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 90 Tablet In 1 Bottle (43602-544-90) | Ascent Pharmaceuticals, Inc. | 43602-544-90 | 43602-544 | ANDA216814 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 500 Tablet In 1 Bottle (43602-544-05) | Ascent Pharmaceuticals, Inc. | 43602-544-05 | 43602-544 | ANDA216814 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 30 Tablet In 1 Bottle (43602-544-30) | Ascent Pharmaceuticals, Inc. | 43602-544-30 | 43602-544 | ANDA216814 | ANDA | N/A |
| Famotidine; Ibuprofen | Tablet | Oral | 26.6mg/1, 800 mg/1 | 90 Tablet In 1 Bottle (43602-544-90) | Ascent Pharmaceuticals, Inc. | 43602-544-90 | 43602-544 | ANDA216814 | ANDA | N/A |
| Glimepiride; Pioglitazone Hydrochloride | Tablet | Oral | 2mg/1, 30 mg/1 | 30 Tablet In 1 Bottle (66993-821-30) | Prasco Laboratories | 66993-821-30 | 66993-821 | NDA021925 | NDA AUTHORIZED GENERIC | N/A |
| Glimepiride; Pioglitazone Hydrochloride | Tablet | Oral | 4mg/1, 30 mg/1 | 30 Tablet In 1 Bottle (66993-822-30) | Prasco Laboratories | 66993-822-30 | 66993-822 | NDA021925 | NDA AUTHORIZED GENERIC | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 237 Ml In 1 Bottle (65162-686-88) | Amneal Pharmaceuticals LLC | 65162-686-88 | 65162-686 | ANDA202385 | ANDA | N/A |
| Felbamate | Suspension | Oral | 600mg/5mL | 473 Ml In 1 Bottle (65162-686-90) | Amneal Pharmaceuticals LLC | 65162-686-90 | 65162-686 | ANDA202385 | ANDA | N/A |
| Glipizide | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (60505-0141-0) | Apotex Corp. | 60505-0141-0 | 60505-0141 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (60505-0141-1) | Apotex Corp. | 60505-0141-1 | 60505-0141 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (60505-0141-2) | Apotex Corp. | 60505-0141-2 | 60505-0141 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 5mg/1 | 18000 Tablet In 1 Bottle (60505-0141-8) | Apotex Corp. | 60505-0141-8 | 60505-0141 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60505-0142-0) | Apotex Corp. | 60505-0142-0 | 60505-0142 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-0142-1) | Apotex Corp. | 60505-0142-1 | 60505-0142 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (60505-0142-2) | Apotex Corp. | 60505-0142-2 | 60505-0142 | ANDA075795 | ANDA | N/A |
| Glipizide | Tablet | Oral | 10mg/1 | 10000 Tablet In 1 Bottle (60505-0142-4) | Apotex Corp. | 60505-0142-4 | 60505-0142 | ANDA075795 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (65162-734-03) | Amneal Pharmaceuticals LLC | 65162-734-03 | 65162-734 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 90 Tablet In 1 Bottle (65162-734-09) | Amneal Pharmaceuticals LLC | 65162-734-09 | 65162-734 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 270 Tablet In 1 Bottle (65162-734-27) | Amneal Pharmaceuticals LLC | 65162-734-27 | 65162-734 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle (65162-734-50) | Amneal Pharmaceuticals LLC | 65162-734-50 | 65162-734 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (65162-735-03) | Amneal Pharmaceuticals LLC | 65162-735-03 | 65162-735 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (65162-735-09) | Amneal Pharmaceuticals LLC | 65162-735-09 | 65162-735 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 180 Tablet In 1 Bottle (65162-735-18) | Amneal Pharmaceuticals LLC | 65162-735-18 | 65162-735 | ANDA201680 | ANDA | N/A |
| Glucagon | Powder | Nasal | 3mg/1 | 1 Tube In 1 Carton (0548-8351-01) / 1 Bottle, Unit-Dose In 1 Tube / 1 Powder In 1 Bottle, Unit-Dose | Amphastar Pharmaceuticals, Inc. | 0548-8351-01 | 0548-8351 | NDA210134 | NDA | N/A |
| Glucagon | Powder | Nasal | 3mg/1 | 2 Tube In 1 Carton (0548-8352-02) / 1 Bottle, Unit-Dose In 1 Tube / 1 Powder In 1 Bottle, Unit-Dose | Amphastar Pharmaceuticals, Inc. | 0548-8352-02 | 0548-8352 | NDA210134 | NDA | N/A |
| Glucagon | Powder | Nasal | 3mg/1 | 1 Tube In 1 Carton (0548-8351-01) / 1 Bottle, Unit-Dose In 1 Tube / 1 Powder In 1 Bottle, Unit-Dose | Amphastar Pharmaceuticals, Inc. | 0548-8351-01 | 0548-8351 | NDA210134 | NDA | N/A |
| Glucagon | Powder | Nasal | 3mg/1 | 2 Tube In 1 Carton (0548-8352-02) / 1 Bottle, Unit-Dose In 1 Tube / 1 Powder In 1 Bottle, Unit-Dose | Amphastar Pharmaceuticals, Inc. | 0548-8352-02 | 0548-8352 | NDA210134 | NDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 270 Tablet In 1 Bottle (65162-735-27) | Amneal Pharmaceuticals LLC | 65162-735-27 | 65162-735 | ANDA201680 | ANDA | N/A |
| Glyburide | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (75834-203-00) | Nivagen Pharmaceuticals, Inc. | 75834-203-00 | 75834-203 | ANDA203379 | ANDA | N/A |
| Glyburide | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (75834-203-01) | Nivagen Pharmaceuticals, Inc. | 75834-203-01 | 75834-203 | ANDA203379 | ANDA | N/A |
| Glyburide | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (75834-204-00) | Nivagen Pharmaceuticals, Inc. | 75834-204-00 | 75834-204 | ANDA203379 | ANDA | N/A |
| Glyburide | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (75834-204-01) | Nivagen Pharmaceuticals, Inc. | 75834-204-01 | 75834-204 | ANDA203379 | ANDA | N/A |
| Glyburide | Tablet | Oral | 1.25mg/1 | 1000 Tablet In 1 Bottle (75834-202-00) | Nivagen Pharmaceuticals, Inc. | 75834-202-00 | 75834-202 | ANDA203379 | ANDA | N/A |
| Glyburide | Tablet | Oral | 1.25mg/1 | 100 Tablet In 1 Bottle (75834-202-01) | Nivagen Pharmaceuticals, Inc. | 75834-202-01 | 75834-202 | ANDA203379 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (65162-735-50) | Amneal Pharmaceuticals LLC | 65162-735-50 | 65162-735 | ANDA201680 | ANDA | N/A |
| Felbamate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (62559-730-01) | ANI Pharmaceuticals, Inc. | 62559-730-01 | 62559-730 | ANDA202284 | ANDA | N/A |
| Felbamate | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (62559-731-01) | ANI Pharmaceuticals, Inc. | 62559-731-01 | 62559-731 | ANDA202284 | ANDA | N/A |
| Felodipine | Tablet, Film Coated, Extended Release | Oral | 2.5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (57237-108-01) | Rising Pharma Holdings, Inc. | 57237-108-01 | 57237-108 | ANDA203417 | ANDA | N/A |
| Felodipine | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (57237-109-01) | Rising Pharma Holdings, Inc. | 57237-109-01 | 57237-109 | ANDA203417 | ANDA | N/A |
| Felodipine | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (57237-110-01) | Rising Pharma Holdings, Inc. | 57237-110-01 | 57237-110 | ANDA203417 | ANDA | N/A |
| Glycerin | Gel | Topical | .2g/g | 1 Bottle In 1 Box (51672-5309-7) / 10 G In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5309-7 | 51672-5309 | part347 | OTC MONOGRAPH FINAL | N/A |
| Glycerin | Solution/ Drops | Ophthalmic | 2mg/mL | 1 Bottle, Dropper In 1 Carton (73017-3111-1) / 10 Ml In 1 Bottle, Dropper | Eyeganics LLC | 73017-3111-1 | 73017-3111 | M018 | OTC MONOGRAPH DRUG | N/A |
| Fenofibrate | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (62559-460-90) | ANI Pharmaceuticals, Inc. | 62559-460-90 | 62559-460 | NDA021612 | NDA AUTHORIZED GENERIC | N/A |
| Fenofibrate | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (62559-461-90) | ANI Pharmaceuticals, Inc. | 62559-461-90 | 62559-461 | NDA021612 | NDA AUTHORIZED GENERIC | N/A |
| Fenofibrate | Capsule | Oral | 67mg/1 | 100 Capsule In 1 Bottle (43975-444-10) | ANI Pharmaceuticals, Inc. | 43975-444-10 | 43975-444 | ANDA209504 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 100 Capsule In 1 Bottle (43975-305-10) | ANI Pharmaceuticals, Inc. | 43975-305-10 | 43975-305 | ANDA209504 | ANDA | N/A |
| Glycerin; Kaolin; Menthol; Zinc Oxide | Cream | Topical | 25g/100g, 12.5 g/100g, 1 g/100g, 12.5 g/100g | 1 Tube In 1 Box (71831-005-01) / 35 G In 1 Tube | PRANICURA GROUP LLC | 71831-005-01 | 71831-005 | M015 | OTC MONOGRAPH DRUG | N/A |
| Glycerin; Kaolin; Menthol; Zinc Oxide | Cream | Topical | 25g/100g, 12.5 g/100g, 1 g/100g, 12.5 g/100g | 1 Tube In 1 Box (71831-005-02) / 35 G In 1 Tube | PRANICURA GROUP LLC | 71831-005-02 | 71831-005 | M015 | OTC MONOGRAPH DRUG | N/A |
| Glycerin; Kaolin; Menthol; Zinc Oxide | Cream | Topical | 25g/100g, 12.5 g/100g, 1 g/100g, 12.5 g/100g | 1 Tube In 1 Box (71831-005-03) / 35 G In 1 Tube | PRANICURA GROUP LLC | 71831-005-03 | 71831-005 | M015 | OTC MONOGRAPH DRUG | N/A |
| Glycerin; Kaolin; Menthol; Zinc Oxide | Cream | Topical | 25g/100g, 12.5 g/100g, 1 g/100g, 12.5 g/100g | 60 G In 1 Jar (71831-004-01) | PRANICURA GROUP LLC | 71831-004-01 | 71831-004 | M015 | OTC MONOGRAPH DRUG | N/A |
| Glycopyrrolate | Tablet | Oral | 1.5mg/1 | 100 Tablet In 1 Bottle, Plastic (79739-7097-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7097-1 | 79739-7097 | ANDA091522 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-414-92) / 1 Ml In 1 Vial, Single-Dose (71288-414-91) | Meitheal Pharmaceuticals Inc. | 71288-414-92 | 71288-414 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-414-94) / 2 Ml In 1 Vial, Single-Dose (71288-414-93) | Meitheal Pharmaceuticals Inc. | 71288-414-94 | 71288-414 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-414-03) / 1 Ml In 1 Vial, Single-Dose (71288-414-01) | Meitheal Pharmaceuticals Inc. | 71288-414-03 | 71288-414 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-414-04) / 2 Ml In 1 Vial, Single-Dose (71288-414-02) | Meitheal Pharmaceuticals Inc. | 71288-414-04 | 71288-414 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Carton (71288-415-96) / 5 Ml In 1 Vial, Multi-Dose (71288-415-95) | Meitheal Pharmaceuticals Inc. | 71288-415-96 | 71288-415 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-415-98) / 20 Ml In 1 Vial, Multi-Dose (71288-415-97) | Meitheal Pharmaceuticals Inc. | 71288-415-98 | 71288-415 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Carton (71288-415-06) / 5 Ml In 1 Vial, Multi-Dose (71288-415-05) | Meitheal Pharmaceuticals Inc. | 71288-415-06 | 71288-415 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-415-21) / 20 Ml In 1 Vial, Multi-Dose (71288-415-20) | Meitheal Pharmaceuticals Inc. | 71288-415-21 | 71288-415 | ANDA212802 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (75834-193-25) / 1 Ml In 1 Vial, Single-Dose | Nivagen Pharmaceuticals, Inc. | 75834-193-25 | 75834-193 | ANDA212591 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (75834-194-25) / 2 Ml In 1 Vial, Single-Dose | Nivagen Pharmaceuticals, Inc. | 75834-194-25 | 75834-194 | ANDA212591 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Carton (75834-195-25) / 5 Ml In 1 Vial, Multi-Dose | Nivagen Pharmaceuticals, Inc. | 75834-195-25 | 75834-195 | ANDA212591 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Multi-Dose In 1 Carton (75834-196-10) / 20 Ml In 1 Vial, Multi-Dose | Nivagen Pharmaceuticals, Inc. | 75834-196-10 | 75834-196 | ANDA212591 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-011-25) / 1 Ml In 1 Vial (70069-011-01) | Somerset Therapeutics, LLC | 70069-011-25 | 70069-011 | ANDA211705 | ANDA | N/A |
| Glycopyrrolate | Solution | Intramuscular; Intravenous | .2mg/mL | 10 Vial In 1 Carton (70069-616-10) / 20 Ml In 1 Vial (70069-616-01) | Somerset Therapeutics, LLC | 70069-616-10 | 70069-616 | ANDA207639 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-012-25) / 2 Ml In 1 Vial (70069-012-01) | Somerset Therapeutics, LLC | 70069-012-25 | 70069-012 | ANDA211705 | ANDA | N/A |
| Glycopyrrolate | Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-617-25) / 1 Ml In 1 Vial (70069-617-01) | Somerset Therapeutics, LLC | 70069-617-25 | 70069-617 | ANDA207639 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-013-25) / 5 Ml In 1 Vial (70069-013-01) | Somerset Therapeutics, LLC | 70069-013-25 | 70069-013 | ANDA211705 | ANDA | N/A |
| Glycopyrrolate | Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-618-25) / 2 Ml In 1 Vial (70069-618-01) | Somerset Therapeutics, LLC | 70069-618-25 | 70069-618 | ANDA207639 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial In 1 Carton (70069-014-10) / 20 Ml In 1 Vial (70069-014-01) | Somerset Therapeutics, LLC | 70069-014-10 | 70069-014 | ANDA211705 | ANDA | N/A |
| Glycopyrrolate | Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70069-619-25) / 5 Ml In 1 Vial (70069-619-01) | Somerset Therapeutics, LLC | 70069-619-25 | 70069-619 | ANDA207639 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (60429-665-01) | Golden State Medical Supply, Inc. | 60429-665-01 | 60429-665 | ANDA091182 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (60429-666-01) | Golden State Medical Supply, Inc. | 60429-666-01 | 60429-666 | ANDA091182 | ANDA | N/A |
| Glycopyrrolate | Liquid | Oral | 1mg/5mL | 1 Bottle In 1 Carton (51672-5316-9) / 500 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A. Inc. | 51672-5316-9 | 51672-5316 | ANDA212467 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (69315-139-01) | Leading Pharma, LLC | 69315-139-01 | 69315-139 | ANDA090195 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (69315-140-01) | Leading Pharma, LLC | 69315-140-01 | 69315-140 | ANDA090195 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (60505-6179-5) / 1 Ml In 1 Vial | Apotex Corp. | 60505-6179-5 | 60505-6179 | ANDA210246 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (60505-6180-5) / 2 Ml In 1 Vial | Apotex Corp. | 60505-6180-5 | 60505-6180 | ANDA210246 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (60505-6181-5) / 5 Ml In 1 Vial | Apotex Corp. | 60505-6181-5 | 60505-6181 | ANDA210246 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial In 1 Carton (60505-6182-4) / 20 Ml In 1 Vial | Apotex Corp. | 60505-6182-4 | 60505-6182 | ANDA210246 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 134mg/1 | 500 Capsule In 1 Bottle (43975-305-50) | ANI Pharmaceuticals, Inc. | 43975-305-50 | 43975-305 | ANDA209504 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (43975-306-10) | ANI Pharmaceuticals, Inc. | 43975-306-10 | 43975-306 | ANDA209504 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (43975-306-50) | ANI Pharmaceuticals, Inc. | 43975-306-50 | 43975-306 | ANDA209504 | ANDA | N/A |
| Fenofibrate | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (62559-305-90) | ANI Pharmaceuticals, Inc. | 62559-305-90 | 62559-305 | NDA021612 | NDA | N/A |
| Fenofibrate | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (62559-306-90) | ANI Pharmaceuticals, Inc. | 62559-306-90 | 62559-306 | NDA021612 | NDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 48mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-595-30) | Camber Pharmaceuticals, Inc. | 31722-595-30 | 31722-595 | ANDA204598 | ANDA | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-4601-25) / 1 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-4601-25 | 0517-4601 | ANDA089335 | ANDA | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-4602-25) / 2 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-4602-25 | 0517-4602 | ANDA089335 | ANDA | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Tray (0517-4605-25) / 5 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-4605-25 | 0517-4605 | ANDA089335 | ANDA | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Tray (0517-4620-25) / 20 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-4620-25 | 0517-4620 | ANDA089335 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 48mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-595-31) | Camber Pharmaceuticals, Inc. | 31722-595-31 | 31722-595 | ANDA204598 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 48mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-595-32) | Camber Pharmaceuticals, Inc. | 31722-595-32 | 31722-595 | ANDA204598 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 48mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-595-90) | Camber Pharmaceuticals, Inc. | 31722-595-90 | 31722-595 | ANDA204598 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 145mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-596-30) | Camber Pharmaceuticals, Inc. | 31722-596-30 | 31722-596 | ANDA204598 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Multi-Dose In 1 Carton (0143-9584-10) / 20 Ml In 1 Vial, Multi-Dose (0143-9584-01) | Hikma Pharmaceuticals USA Inc. | 0143-9584-10 | 0143-9584 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 10 Vial In 1 Carton (0143-9679-10) / 20 Ml In 1 Vial (0143-9679-01) | Hikma Pharmaceuticals USA Inc. | 0143-9679-10 | 0143-9679 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Multi-Dose In 1 Carton (0143-9585-25) / 5 Ml In 1 Vial, Multi-Dose (0143-9585-01) | Hikma Pharmaceuticals USA Inc. | 0143-9585-25 | 0143-9585 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (0143-9680-25) / 5 Ml In 1 Vial (0143-9680-01) | Hikma Pharmaceuticals USA Inc. | 0143-9680-25 | 0143-9680 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9586-25) / 2 Ml In 1 Vial, Single-Dose (0143-9586-01) | Hikma Pharmaceuticals USA Inc. | 0143-9586-25 | 0143-9586 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (0143-9681-25) / 2 Ml In 1 Vial (0143-9681-01) | Hikma Pharmaceuticals USA Inc. | 0143-9681-25 | 0143-9681 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9587-25) / 1 Ml In 1 Vial, Single-Dose (0143-9587-01) | Hikma Pharmaceuticals USA Inc. | 0143-9587-25 | 0143-9587 | ANDA090963 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (0143-9682-25) / 1 Ml In 1 Vial (0143-9682-01) | Hikma Pharmaceuticals USA Inc. | 0143-9682-25 | 0143-9682 | ANDA090963 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 145mg/1 | 70 Tablet, Film Coated In 1 Blister Pack (31722-596-31) | Camber Pharmaceuticals, Inc. | 31722-596-31 | 31722-596 | ANDA204598 | ANDA | N/A |
| Granisetron Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 2 Blister Pack In 1 Carton (69452-350-01) / 1 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-350-01 | 69452-350 | ANDA078678 | ANDA | N/A |
| Granisetron Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (69452-350-11) | Bionpharma Inc. | 69452-350-11 | 69452-350 | ANDA078678 | ANDA | N/A |
| Granisetron Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 2 Blister Pack In 1 Carton (69452-350-92) / 10 Tablet, Film Coated In 1 Blister Pack | Bionpharma Inc. | 69452-350-92 | 69452-350 | ANDA078678 | ANDA | N/A |
| Granisetron Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Vial, Single-Use In 1 Package (0143-9744-10) / 1 Ml In 1 Vial, Single-Use (0143-9744-01) | Hikma Pharmaceuticals USA Inc. | 0143-9744-10 | 0143-9744 | ANDA078629 | ANDA | N/A |
| Granisetron Hydrochloride | Injection | Intravenous | 1mg/mL | 5 Vial, Multi-Dose In 1 Carton (0143-9745-05) / 4 Ml In 1 Vial, Multi-Dose (0143-9745-01) | Hikma Pharmaceuticals USA Inc. | 0143-9745-05 | 0143-9745 | ANDA078629 | ANDA | N/A |
| Granisetron Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (0143-9745-10) / 4 Ml In 1 Vial, Multi-Dose (0143-9745-01) | Hikma Pharmaceuticals USA Inc. | 0143-9745-10 | 0143-9745 | ANDA078629 | ANDA | N/A |
| Griseofulvin | Suspension | Oral | 125mg/5mL | 118 Ml In 1 Bottle, Plastic (0713-0850-04) | Cosette Pharmaceuticals, Inc. | 0713-0850-04 | 0713-0850 | ANDA065438 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 145mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-596-32) | Camber Pharmaceuticals, Inc. | 31722-596-32 | 31722-596 | ANDA204598 | ANDA | N/A |
| Fenofibrate | Tablet, Film Coated | Oral | 145mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-596-90) | Camber Pharmaceuticals, Inc. | 31722-596-90 | 31722-596 | ANDA204598 | ANDA | N/A |
| Fenoprofen Calcium | Capsule | Oral | 400mg/1 | 90 Capsule In 1 Bottle (16571-688-09) | Rising Pharma Holdings, Inc. | 16571-688-09 | 16571-688 | ANDA214475 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 4mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-369-03) | Amneal Pharmaceuticals LLC | 65162-369-03 | 65162-369 | ANDA205002 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 4mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-369-09) | Amneal Pharmaceuticals LLC | 65162-369-09 | 65162-369 | ANDA205002 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 8mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-370-03) | Amneal Pharmaceuticals LLC | 65162-370-03 | 65162-370 | ANDA205002 | ANDA | N/A |
| Guanfacine | Tablet, Extended Release | Oral | 1mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-960-01) | Golden State Medical Supply, Inc. | 60429-960-01 | 60429-960 | ANDA201408 | ANDA | N/A |
| Guanfacine | Tablet, Extended Release | Oral | 2mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-961-01) | Golden State Medical Supply, Inc. | 60429-961-01 | 60429-961 | ANDA201408 | ANDA | N/A |
| Guanfacine | Tablet, Extended Release | Oral | 3mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-962-01) | Golden State Medical Supply, Inc. | 60429-962-01 | 60429-962 | ANDA201408 | ANDA | N/A |
| Guanfacine | Tablet, Extended Release | Oral | 4mg/1 | 100 Tablet, Extended Release In 1 Bottle (60429-963-01) | Golden State Medical Supply, Inc. | 60429-963-01 | 60429-963 | ANDA201408 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet, Extended Release | Oral | 1mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-3927-1) | Apotex Corp. | 60505-3927-1 | 60505-3927 | ANDA205430 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet, Extended Release | Oral | 2mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-3928-1) | Apotex Corp. | 60505-3928-1 | 60505-3928 | ANDA205430 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet, Extended Release | Oral | 3mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-3929-1) | Apotex Corp. | 60505-3929-1 | 60505-3929 | ANDA205430 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet, Extended Release | Oral | 4mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-3930-1) | Apotex Corp. | 60505-3930-1 | 60505-3930 | ANDA205430 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Extended Release | Oral | 8mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-370-09) | Amneal Pharmaceuticals LLC | 65162-370-09 | 65162-370 | ANDA205002 | ANDA | N/A |
| Fesoterodine Fumarate | Tablet, Film Coated, Extended Release | Oral | 8mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (62559-376-30) | ANI Pharmaceuticals, Inc. | 62559-376-30 | 62559-376 | ANDA204504 | ANDA | N/A |
| FESOTERODINE FUMARATE | Tablet, Film Coated, Extended Release | Oral | 4mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-033-30) | Camber Pharmaceuticals, Inc. | 31722-033-30 | 31722-033 | ANDA204792 | ANDA | N/A |
| FESOTERODINE FUMARATE | Tablet, Film Coated, Extended Release | Oral | 4mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (31722-033-90) | Camber Pharmaceuticals, Inc. | 31722-033-90 | 31722-033 | ANDA204792 | ANDA | N/A |
| FESOTERODINE FUMARATE | Tablet, Film Coated, Extended Release | Oral | 8mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-034-30) | Camber Pharmaceuticals, Inc. | 31722-034-30 | 31722-034 | ANDA204792 | ANDA | N/A |
| FESOTERODINE FUMARATE | Tablet, Film Coated, Extended Release | Oral | 8mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (31722-034-90) | Camber Pharmaceuticals, Inc. | 31722-034-90 | 31722-034 | ANDA204792 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 60mg/1 | 100 Tablet, Film Coated In 1 Bottle (69230-201-01) | Camber Consumer Care | 69230-201-01 | 69230-201 | ANDA204507 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-129-32) / 50 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-129-32 | 45802-129 | ANDA077123 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-129-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-129-35 | 45802-129 | ANDA077123 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-131-32) / 50 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-131-32 | 45802-131 | ANDA076872 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (45802-131-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-131-35 | 45802-131 | ANDA076872 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1321-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1321-1 | 51672-1321 | ANDA077227 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1321-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1321-3 | 51672-1321 | ANDA077227 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1322-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1322-1 | 51672-1322 | ANDA076994 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1322-3) / 50 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1322-3 | 51672-1322 | ANDA076994 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 5 G In 1 Tube (51672-1322-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1322-5 | 51672-1322 | ANDA076994 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 15 G In 1 Tube (0713-0640-15) | Cosette Pharmaceuticals, Inc. | 0713-0640-15 | 0713-0640 | ANDA078162 | ANDA | N/A |
| Halobetasol Propionate | Cream | Topical | .5mg/g | 50 G In 1 Tube (0713-0640-86) | Cosette Pharmaceuticals, Inc. | 0713-0640-86 | 0713-0640 | ANDA078162 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0339-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0339-15 | 0713-0339 | ANDA077109 | ANDA | N/A |
| Halobetasol Propionate | Ointment | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0339-86) / 50 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0339-86 | 0713-0339 | ANDA077109 | ANDA | N/A |
| Haloperidol | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (71247-150-01) | Innogenix, Inc. | 71247-150-01 | 71247-150 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (71247-150-10) | Innogenix, Inc. | 71247-150-10 | 71247-150 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (71247-151-01) | Innogenix, Inc. | 71247-151-01 | 71247-151 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (71247-151-10) | Innogenix, Inc. | 71247-151-10 | 71247-151 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (71247-152-01) | Innogenix, Inc. | 71247-152-01 | 71247-152 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (71247-152-10) | Innogenix, Inc. | 71247-152-10 | 71247-152 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (71247-153-01) | Innogenix, Inc. | 71247-153-01 | 71247-153 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (71247-153-10) | Innogenix, Inc. | 71247-153-10 | 71247-153 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (71247-154-01) | Innogenix, Inc. | 71247-154-01 | 71247-154 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (71247-154-10) | Innogenix, Inc. | 71247-154-10 | 71247-154 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (71247-155-01) | Innogenix, Inc. | 71247-155-01 | 71247-155 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (71247-155-10) | Innogenix, Inc. | 71247-155-10 | 71247-155 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (71247-150-01) | Innogenix, Inc. | 71247-150-01 | 71247-150 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (71247-150-10) | Innogenix, Inc. | 71247-150-10 | 71247-150 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (71247-151-01) | Innogenix, Inc. | 71247-151-01 | 71247-151 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (71247-151-10) | Innogenix, Inc. | 71247-151-10 | 71247-151 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (71247-152-01) | Innogenix, Inc. | 71247-152-01 | 71247-152 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (71247-152-10) | Innogenix, Inc. | 71247-152-10 | 71247-152 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (71247-153-01) | Innogenix, Inc. | 71247-153-01 | 71247-153 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (71247-153-10) | Innogenix, Inc. | 71247-153-10 | 71247-153 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (71247-154-01) | Innogenix, Inc. | 71247-154-01 | 71247-154 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (71247-154-10) | Innogenix, Inc. | 71247-154-10 | 71247-154 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (71247-155-01) | Innogenix, Inc. | 71247-155-01 | 71247-155 | ANDA071173 | ANDA | N/A |
| Haloperidol | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (71247-155-10) | Innogenix, Inc. | 71247-155-10 | 71247-155 | ANDA071173 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 10 Vial, Single-Dose In 1 Carton (71288-502-02) / 1 Ml In 1 Vial, Single-Dose (71288-502-01) | Meitheal Pharmaceuticals Inc. | 71288-502-02 | 71288-502 | ANDA214507 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 10 Vial, Single-Dose In 1 Carton (71288-503-02) / 1 Ml In 1 Vial, Single-Dose (71288-503-01) | Meitheal Pharmaceuticals Inc. | 71288-503-02 | 71288-503 | ANDA214507 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 1 Vial, Multi-Dose In 1 Carton (71288-504-05) / 5 Ml In 1 Vial, Multi-Dose | Meitheal Pharmaceuticals Inc. | 71288-504-05 | 71288-504 | ANDA214507 | ANDA | N/A |
| Haloperidol Decanoate | Injection, Solution | Intramuscular | 50mg/mL | 10 Vial In 1 Carton (25021-831-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-831-01 | 25021-831 | ANDA205241 | ANDA | N/A |
| Haloperidol Decanoate | Injection, Solution | Intramuscular | 100mg/mL | 10 Vial In 1 Carton (25021-833-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-833-01 | 25021-833 | ANDA205241 | ANDA | N/A |
| Haloperidol Decanoate | Injection, Solution | Intramuscular | 500mg/5mL | 1 Vial In 1 Carton (25021-834-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-834-05 | 25021-834 | ANDA205241 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 1 Vial, Single-Dose In 1 Carton (70069-381-01) / 1 Ml In 1 Vial, Single-Dose | Somerset Therapeutics, LLC | 70069-381-01 | 70069-381 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 10 Vial, Single-Dose In 1 Carton (70069-381-10) / 1 Ml In 1 Vial, Single-Dose | Somerset Therapeutics, LLC | 70069-381-10 | 70069-381 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 1 Vial, Multi-Dose In 1 Carton (70069-382-01) / 5 Ml In 1 Vial, Multi-Dose | Somerset Therapeutics, LLC | 70069-382-01 | 70069-382 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 5 Vial, Multi-Dose In 1 Carton (70069-382-05) / 5 Ml In 1 Vial, Multi-Dose | Somerset Therapeutics, LLC | 70069-382-05 | 70069-382 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 1 Vial, Single-Dose In 1 Carton (70069-383-01) / 1 Ml In 1 Vial, Single-Dose | Somerset Therapeutics, LLC | 70069-383-01 | 70069-383 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 5 Vial, Single-Dose In 1 Carton (70069-383-05) / 1 Ml In 1 Vial, Single-Dose | Somerset Therapeutics, LLC | 70069-383-05 | 70069-383 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 10 Vial, Single-Dose In 1 Carton (70069-383-10) / 1 Ml In 1 Vial, Single-Dose | Somerset Therapeutics, LLC | 70069-383-10 | 70069-383 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 1 Vial, Multi-Dose In 1 Carton (70069-384-01) / 5 Ml In 1 Vial, Multi-Dose | Somerset Therapeutics, LLC | 70069-384-01 | 70069-384 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 5 Vial, Multi-Dose In 1 Carton (70069-384-05) / 5 Ml In 1 Vial, Multi-Dose | Somerset Therapeutics, LLC | 70069-384-05 | 70069-384 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 3 Ampule In 1 Carton (70069-030-03) / 1 Ml In 1 Ampule | Somerset Therapeutics, LLC | 70069-030-03 | 70069-030 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 50mg/mL | 5 Ampule In 1 Carton (70069-030-05) / 1 Ml In 1 Ampule | Somerset Therapeutics, LLC | 70069-030-05 | 70069-030 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 5 Ampule In 1 Carton (70069-031-05) / 1 Ml In 1 Ampule (70069-031-01) | Somerset Therapeutics, LLC | 70069-031-05 | 70069-031 | ANDA209101 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 1 Vial In 1 Box (0143-9295-01) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9295-01 | 0143-9295 | ANDA075305 | ANDA | N/A |
| Haloperidol Decanoate | Injection | Intramuscular | 100mg/mL | 1 Vial In 1 Box (0143-9296-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9296-01 | 0143-9296 | ANDA075305 | ANDA | N/A |
| Haloperidol Lactate | Injection, Solution | Intramuscular | 5mg/mL | 10 Vial In 1 Carton (25021-806-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-806-01 | 25021-806 | ANDA091637 | ANDA | N/A |
| Haloperidol Lactate | Injection | Intramuscular | 5mg/mL | 25 Vial In 1 Box (0143-9501-25) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9501-25 | 0143-9501 | ANDA075858 | ANDA | N/A |
| Haloperidol Lactate | Injection | Intramuscular | 5mg/mL | 1 Vial In 1 Box (0143-9502-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9502-01 | 0143-9502 | ANDA075858 | ANDA | N/A |
| Haloperidol Lactate | Injection | Intramuscular | 5mg/mL | 25 Vial In 1 Box (0143-9319-25) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9319-25 | 0143-9319 | ANDA075858 | ANDA | N/A |
| Hazelnut, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3305-2) | Jubilant HollisterStier LLC | 65044-3305-2 | 65044-3305 | BLA103888 | BLA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-420-96) / 10 Ml In 1 Vial, Multi-Dose (71288-420-95) | Meitheal Pharmaceuticals Inc. | 71288-420-96 | 71288-420 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-421-96) / 30 Ml In 1 Vial, Multi-Dose (71288-421-95) | Meitheal Pharmaceuticals Inc. | 71288-421-96 | 71288-421 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-422-96) / 1 Ml In 1 Vial, Single-Dose (71288-422-95) | Meitheal Pharmaceuticals Inc. | 71288-422-96 | 71288-422 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-423-96) / 10 Ml In 1 Vial, Multi-Dose (71288-423-95) | Meitheal Pharmaceuticals Inc. | 71288-423-96 | 71288-423 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-424-96) / 1 Ml In 1 Vial, Single-Dose (71288-424-95) | Meitheal Pharmaceuticals Inc. | 71288-424-96 | 71288-424 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-425-96) / 4 Ml In 1 Vial, Multi-Dose (71288-425-95) | Meitheal Pharmaceuticals Inc. | 71288-425-96 | 71288-425 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 2000[USP'U]/2mL | 25 Vial, Single-Dose In 1 Carton (71288-400-03) / 2 Ml In 1 Vial, Single-Dose (71288-400-02) | Meitheal Pharmaceuticals Inc. | 71288-400-03 | 71288-400 | ANDA211005 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 20000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-401-02) / 1 Ml In 1 Vial, Multi-Dose (71288-401-01) | Meitheal Pharmaceuticals Inc. | 71288-401-02 | 71288-401 | ANDA211004 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-402-02) / 1 Ml In 1 Vial, Single-Dose (71288-402-01) | Meitheal Pharmaceuticals Inc. | 71288-402-02 | 71288-402 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-402-11) / 10 Ml In 1 Vial, Multi-Dose (71288-402-10) | Meitheal Pharmaceuticals Inc. | 71288-402-11 | 71288-402 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-402-31) / 30 Ml In 1 Vial, Multi-Dose (71288-402-30) | Meitheal Pharmaceuticals Inc. | 71288-402-31 | 71288-402 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-403-02) / 1 Ml In 1 Vial, Single-Dose (71288-403-01) | Meitheal Pharmaceuticals Inc. | 71288-403-02 | 71288-403 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-403-11) / 10 Ml In 1 Vial, Multi-Dose (71288-403-10) | Meitheal Pharmaceuticals Inc. | 71288-403-11 | 71288-403 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-404-02) / 1 Ml In 1 Vial, Single-Dose (71288-404-01) | Meitheal Pharmaceuticals Inc. | 71288-404-02 | 71288-404 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Carton (71288-404-05) / 4 Ml In 1 Vial, Multi-Dose (71288-404-04) | Meitheal Pharmaceuticals Inc. | 71288-404-05 | 71288-404 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/.5mL | 24 Blister Pack In 1 Carton (71288-405-81) / 1 Syringe, Glass In 1 Blister Pack (71288-405-80) / .5 Ml In 1 Syringe, Glass | Meitheal Pharmaceuticals Inc. | 71288-405-81 | 71288-405 | ANDA212060 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 24 Blister Pack In 1 Carton (71288-406-82) / 1 Syringe, Glass In 1 Blister Pack / 1 Ml In 1 Syringe, Glass (71288-406-81) | Meitheal Pharmaceuticals Inc. | 71288-406-82 | 71288-406 | ANDA212061 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (71288-419-96) / 1 Ml In 1 Vial, Single-Dose (71288-419-95) | Meitheal Pharmaceuticals Inc. | 71288-419-96 | 71288-419 | ANDA211007 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-66) / 1 Ml In 1 Vial | Sagent Pharmaceticals | 25021-400-66 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-67) / 10 Ml In 1 Vial | Sagent Pharmaceticals | 25021-400-67 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-68) / 30 Ml In 1 Vial | Sagent Pharmaceticals | 25021-400-68 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Carton (25021-402-66) / 1 Ml In 1 Vial | Sagent Pharmaceticals | 25021-402-66 | 25021-402 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial In 1 Carton (25021-403-66) / 1 Ml In 1 Vial | Sagent Pharmaceticals | 25021-403-66 | 25021-403 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-400-01 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-400-10 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-400-30) / 30 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-400-30 | 25021-400 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Carton (25021-401-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-401-02 | 25021-401 | ANDA090810 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Carton (25021-402-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-402-01 | 25021-402 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Carton (25021-402-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-402-10 | 25021-402 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial In 1 Carton (25021-403-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-403-01 | 25021-403 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial In 1 Carton (25021-403-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-403-04 | 25021-403 | ANDA090808 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 20000[USP'U]/mL | 25 Vial In 1 Carton (25021-404-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-404-01 | 25021-404 | ANDA090809 | ANDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Package (0641-2450-55) / 30 Ml In 1 Vial, Multi-Dose (0641-2450-30) | Hikma Pharmaceuticals USA Inc. | 0641-2450-55 | 0641-2450 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Package (0641-2460-55) / 10 Ml In 1 Vial, Multi-Dose (0641-2460-30) | Hikma Pharmaceuticals USA Inc. | 0641-2460-55 | 0641-2460 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 10 Syringe, Glass In 1 Carton (0641-6199-10) / 1 Ml In 1 Syringe, Glass (0641-6199-01) | Hikma Pharmaceuticals USA Inc. | 0641-6199-10 | 0641-6199 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/.5mL | 10 Syringe, Glass In 1 Carton (0641-6204-10) / .5 Ml In 1 Syringe, Glass (0641-6204-01) | Hikma Pharmaceuticals USA Inc. | 0641-6204-10 | 0641-6204 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Package (0641-0391-12) / 1 Ml In 1 Vial (0641-0391-37) | Hikma Pharmaceuticals USA Inc. | 0641-0391-12 | 0641-0391 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Package (0641-0400-12) / 1 Ml In 1 Vial (0641-0400-37) | Hikma Pharmaceuticals USA Inc. | 0641-0400-12 | 0641-0400 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial In 1 Package (0641-0410-12) / 1 Ml In 1 Vial (0641-0410-37) | Hikma Pharmaceuticals USA Inc. | 0641-0410-12 | 0641-0410 | NDA017037 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Container (0069-0043-01) / 2 Ml In 1 Vial (0069-0043-02) | Pfizer Laboratories Div Pfizer Inc | 0069-0043-01 | 0069-0043 | NDA201370 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial In 1 Container (0069-0058-01) / 10 Ml In 1 Vial (0069-0058-02) | Pfizer Laboratories Div Pfizer Inc | 0069-0058-01 | 0069-0058 | NDA201370 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Container (0069-0059-01) / 10 Ml In 1 Vial (0069-0059-02) | Pfizer Laboratories Div Pfizer Inc | 0069-0059-01 | 0069-0059 | NDA201370 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial In 1 Container (0069-0059-03) / 1 Ml In 1 Vial (0069-0059-04) | Pfizer Laboratories Div Pfizer Inc | 0069-0059-03 | 0069-0059 | NDA201370 | NDA | N/A |
| Heparin Sodium | Injection | Intravenous; Subcutaneous | 1000[USP'U]/mL | 10 Vial In 1 Carton (0069-0137-03) / 30 Ml In 1 Vial (0069-0137-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0137-03 | 0069-0137 | NDA201370 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Single-Dose In 1 Tray (0409-2720-01) / 1 Ml In 1 Vial, Single-Dose (0409-2720-30) | Hospira, Inc. | 0409-2720-01 | 0409-2720 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Tray (0409-2720-02) / 10 Ml In 1 Vial, Multi-Dose (0409-2720-31) | Hospira, Inc. | 0409-2720-02 | 0409-2720 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 1000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Tray (0409-2720-03) / 30 Ml In 1 Vial, Multi-Dose (0409-2720-32) | Hospira, Inc. | 0409-2720-03 | 0409-2720 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 200[USP'U]/100mL | 20 Pouch In 1 Case (0409-1005-20) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-1005-01) | Hospira, Inc. | 0409-1005-20 | 0409-1005 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 10000[USP'U]/mL | 25 Vial, Single-Dose In 1 Tray (0409-2721-01) / 1 Ml In 1 Vial, Single-Dose (0409-2721-30) | Hospira, Inc. | 0409-2721-01 | 0409-2721 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Single-Dose In 1 Tray (0409-2723-01) / 1 Ml In 1 Vial, Single-Dose (0409-2723-30) | Hospira, Inc. | 0409-2723-01 | 0409-2723 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 25 Vial, Multi-Dose In 1 Tray (0409-2723-02) / 10 Ml In 1 Vial, Multi-Dose (0409-2723-31) | Hospira, Inc. | 0409-2723-02 | 0409-2723 | ANDA090571 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 5000[USP'U]/100mL | 20 Pouch In 1 Case (0409-3150-20) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-3150-05) | Hospira, Inc. | 0409-3150-20 | 0409-3150 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 200[USP'U]/100mL | 18 Pouch In 1 Case (0409-7620-03) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-7620-13) | Hospira, Inc. | 0409-7620-03 | 0409-7620 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 200[USP'U]/100mL | 12 Pouch In 1 Case (0409-7620-59) / 1 Bag In 1 Pouch / 1000 Ml In 1 Bag (0409-7620-49) | Hospira, Inc. | 0409-7620-59 | 0409-7620 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 10000[USP'U]/mL | 50 Cartridge In 1 Container (0409-1316-32) / .5 Ml In 1 Cartridge (0409-1316-11) | Hospira, Inc. | 0409-1316-32 | 0409-1316 | ANDA089522 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 10000[USP'U]/100mL | 30 Pouch In 1 Case (0409-7650-30) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-7650-05) | Hospira, Inc. | 0409-7650-30 | 0409-7650 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 10000[USP'U]/100mL | 24 Pouch In 1 Case (0409-7650-62) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-7650-52) | Hospira, Inc. | 0409-7650-62 | 0409-7650 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 200[USP'U]/100mL | 12 Pouch In 1 Case (0409-2222-12) / 1 Bag In 1 Pouch / 1000 Ml In 1 Bag (0409-2222-01) | Hospira, Inc. | 0409-2222-12 | 0409-2222 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous; Subcutaneous | 5000[USP'U]/mL | 50 Cartridge In 1 Box (0409-1402-12) / 1 Ml In 1 Cartridge (0409-1402-27) | Hospira, Inc. | 0409-1402-12 | 0409-1402 | ANDA088100 | ANDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 5000[USP'U]/100mL | 30 Pouch In 1 Case (0409-0012-30) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-0012-02) | Hospira, Inc. | 0409-0012-30 | 0409-0012 | NDA018916 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 10000[USP'U]/100mL | 30 Pouch In 1 Case (0409-4520-30) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-4520-02) | Hospira, Inc. | 0409-4520-30 | 0409-4520 | NDA019339 | NDA | N/A |
| Heparin Sodium | Injection, Solution | Intravenous | 10000[USP'U]/100mL | 24 Pouch In 1 Case (0409-7793-62) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-7793-52) | Hospira, Inc. | 0409-7793-62 | 0409-7793 | NDA019339 | NDA | N/A |
| Hetastarch | Injection, Solution | Intravenous | 6g/100mL | 12 Container In 1 Case (0409-7248-03) / 500 Ml In 1 Container (0409-7248-13) | Hospira, Inc. | 0409-7248-03 | 0409-7248 | BA740193 | ANDA | N/A |
| Hetastarch | Injection, Solution | Intravenous | 6g/100mL | 12 Bag In 1 Case (0409-1555-54) / 500 Ml In 1 Bag (0409-1555-64) | Hospira, Inc. | 0409-1555-54 | 0409-1555 | BN200952 | NDA | N/A |
| Histamine | Injection | Percutaneous | 6mg/mL | 5 Ml In 1 Vial (65044-9998-1) | Jubilant HollisterStier LLC | 65044-9998-1 | 65044-9998 | BLA103891 | BLA | N/A |
| Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet | Oral | 1.5mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (10702-055-01) | KVK-Tech, Inc. | 10702-055-01 | 10702-055 | ANDA207176 | ANDA | CII |
| Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet | Oral | 1.5mg/1, 5 mg/1 | 30 Tablet In 1 Bottle (10702-055-03) | KVK-Tech, Inc. | 10702-055-03 | 10702-055 | ANDA207176 | ANDA | CII |
| Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet | Oral | 1.5mg/1, 5 mg/1 | 90 Tablet In 1 Bottle (10702-055-09) | KVK-Tech, Inc. | 10702-055-09 | 10702-055 | ANDA207176 | ANDA | CII |
| Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet | Oral | 1.5mg/1, 5 mg/1 | 1000 Tablet In 1 Bottle (10702-055-10) | KVK-Tech, Inc. | 10702-055-10 | 10702-055 | ANDA207176 | ANDA | CII |
| Homatropine Methylbromide; Hydrocodone Bitartrate | Liquid | Oral | 1.5mg/5mL, 5 mg/5mL | 473 Ml In 1 Bottle (10702-150-16) | KVK-Tech, Inc. | 10702-150-16 | 10702-150 | ANDA207487 | ANDA | CII |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1476-02) / 12 Ml In 1 Vial, Glass (0069-1476-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1476-02 | 0069-1476 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1509-02) / 24 Ml In 1 Vial, Glass (0069-1509-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1509-02 | 0069-1509 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1802-02) / 10 Ml In 1 Vial, Glass (0069-1802-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1802-02 | 0069-1802 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1960-02) / 20 Ml In 1 Vial, Glass (0069-1960-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1960-02 | 0069-1960 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1965-02) / 48 Ml In 1 Vial, Glass (0069-1965-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1965-02 | 0069-1965 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Subcutaneous | 165mg/mL | 1 Vial, Glass In 1 Carton (0069-1061-02) / 6 Ml In 1 Vial, Glass (0069-1061-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1061-02 | 0069-1061 | BLA125668 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-6237-02) / 200 Ml In 1 Bottle, Glass (0069-6237-01) | Pfizer Laboratories Div Pfizer Inc | 0069-6237-02 | 0069-6237 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-6339-02) / 300 Ml In 1 Bottle, Glass (0069-6339-01) | Pfizer Laboratories Div Pfizer Inc | 0069-6339-02 | 0069-6339 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-6550-02) / 50 Ml In 1 Bottle, Glass (0069-6550-01) | Pfizer Laboratories Div Pfizer Inc | 0069-6550-02 | 0069-6550 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 50mg/mL | 1 Bottle, Glass In 1 Carton (0069-8400-02) / 20 Ml In 1 Bottle, Glass (0069-8400-01) | Pfizer Laboratories Div Pfizer Inc | 0069-8400-02 | 0069-8400 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 50mg/mL | 1 Bottle, Glass In 1 Carton (0069-8425-02) / 50 Ml In 1 Bottle, Glass (0069-8425-01) | Pfizer Laboratories Div Pfizer Inc | 0069-8425-02 | 0069-8425 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 50mg/mL | 1 Bottle, Glass In 1 Carton (0069-8451-02) / 100 Ml In 1 Bottle, Glass (0069-8451-01) | Pfizer Laboratories Div Pfizer Inc | 0069-8451-02 | 0069-8451 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 50mg/mL | 1 Bottle, Glass In 1 Carton (0069-8476-02) / 200 Ml In 1 Bottle, Glass (0069-8476-01) | Pfizer Laboratories Div Pfizer Inc | 0069-8476-02 | 0069-8476 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-6002-02) / 20 Ml In 1 Bottle, Glass (0069-6002-01) | Pfizer Laboratories Div Pfizer Inc | 0069-6002-02 | 0069-6002 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-6111-02) / 100 Ml In 1 Bottle, Glass (0069-6111-01) | Pfizer Laboratories Div Pfizer Inc | 0069-6111-02 | 0069-6111 | BLA125062 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1415-02) / 200 Ml In 1 Bottle, Glass (0069-1415-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1415-02 | 0069-1415 | BLA125587 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1558-02) / 300 Ml In 1 Bottle, Glass (0069-1558-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1558-02 | 0069-1558 | BLA125587 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1011-02) / 10 Ml In 1 Bottle, Glass (0069-1011-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1011-02 | 0069-1011 | BLA125587 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1109-02) / 25 Ml In 1 Bottle, Glass (0069-1109-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1109-02 | 0069-1109 | BLA125587 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1224-02) / 50 Ml In 1 Bottle, Glass (0069-1224-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1224-02 | 0069-1224 | BLA125587 | BLA | N/A |
| Human Immunoglobulin G | Solution | Intravenous | 100mg/mL | 1 Bottle, Glass In 1 Carton (0069-1312-02) / 100 Ml In 1 Bottle, Glass (0069-1312-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1312-02 | 0069-1312 | BLA125587 | BLA | N/A |
| Hyaluronate Sodium; Menthol; Niacinamide; Salicylic Acid; Zinc Gluconate | Cream | Topical | .05g/50g, .03 g/50g, 2 g/50g, 1.5 g/50g, .5 g/50g | 50 G In 1 Bottle (83325-004-01) | Volans Epic LLC | 83325-004-01 | 83325-004 | M006 | OTC MONOGRAPH DRUG | N/A |
| Hyaluronidase | Injection | Subcutaneous | 150[USP'U]/mL | 10 Vial, Single-Dose In 1 Carton (0548-9090-10) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-9090-10 | 0548-9090 | BLA021665 | BLA | N/A |
| Hyaluronidase | Injection | Subcutaneous | 150[USP'U]/mL | 10 Vial, Single-Dose In 1 Carton (0548-9090-10) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-9090-10 | 0548-9090 | BLA021665 | BLA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (75834-126-00) | Nivagen Pharmaceuticals, Inc. | 75834-126-00 | 75834-126 | ANDA203845 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (75834-126-01) | Nivagen Pharmaceuticals, Inc. | 75834-126-01 | 75834-126 | ANDA203845 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (75834-127-00) | Nivagen Pharmaceuticals, Inc. | 75834-127-00 | 75834-127 | ANDA203845 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (75834-127-01) | Nivagen Pharmaceuticals, Inc. | 75834-127-01 | 75834-127 | ANDA203845 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (75834-128-00) | Nivagen Pharmaceuticals, Inc. | 75834-128-00 | 75834-128 | ANDA203845 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (75834-128-01) | Nivagen Pharmaceuticals, Inc. | 75834-128-01 | 75834-128 | ANDA203845 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 60mg/1 | 500 Tablet, Film Coated In 1 Bottle (69230-201-05) | Camber Consumer Care | 69230-201-05 | 69230-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-202-01) / 100 Tablet, Film Coated In 1 Bottle | Camber Consumer Care | 69230-202-01 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 500 Tablet, Film Coated In 1 Bottle (69230-202-05) | Camber Consumer Care | 69230-202-05 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69230-202-11) | Camber Consumer Care | 69230-202-11 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-202-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Consumer Care | 69230-202-30 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-202-45) / 45 Tablet, Film Coated In 1 Bottle | Camber Consumer Care | 69230-202-45 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-202-60) / 60 Tablet, Film Coated In 1 Bottle | Camber Consumer Care | 69230-202-60 | 69230-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine HCl | Tablet, Film Coated | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-202-90) / 90 Tablet, Film Coated In 1 Bottle | Camber Consumer Care | 69230-202-90 | 69230-202 | ANDA204507 | ANDA | N/A |
| Hydralazine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-0901-25) / 1 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-0901-25 | 0517-0901 | ANDA040136 | ANDA | N/A |
| Fexofenadine HCL | Tablet | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-300-01) / 100 Tablet In 1 Bottle | Camber Consumer Care | 69230-300-01 | 69230-300 | ANDA204097 | ANDA | N/A |
| Fexofenadine HCL | Tablet | Oral | 180mg/1 | 500 Tablet In 1 Bottle (69230-300-05) | Camber Consumer Care | 69230-300-05 | 69230-300 | ANDA204097 | ANDA | N/A |
| Fexofenadine HCL | Tablet | Oral | 180mg/1 | 1 Bottle In 1 Carton (69230-300-30) / 30 Tablet In 1 Bottle | Camber Consumer Care | 69230-300-30 | 69230-300 | ANDA204097 | ANDA | N/A |
| Fexofenadine HCL | Tablet | Oral | 60mg/1 | 1 Bottle In 1 Carton (69230-301-01) / 100 Tablet In 1 Bottle | Camber Consumer Care | 69230-301-01 | 69230-301 | ANDA204097 | ANDA | N/A |
| Fexofenadine HCL | Tablet | Oral | 60mg/1 | 1 Bottle In 1 Carton (69230-301-30) / 30 Tablet In 1 Bottle | Camber Consumer Care | 69230-301-30 | 69230-301 | ANDA204097 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-201-01) | ScieGen Pharmaceuticals, Inc. | 50228-201-01 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-201-02) | ScieGen Pharmaceuticals, Inc. | 50228-201-02 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-201-03) | ScieGen Pharmaceuticals, Inc. | 50228-201-03 | 50228-201 | ANDA204507 | ANDA | N/A |
| Hydralazine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Single-Dose In 1 Carton (0641-6231-25) / 20 Ml In 1 Vial, Single-Dose (0641-6231-01) | Hikma Pharmaceuticals USA Inc. | 0641-6231-25 | 0641-6231 | ANDA213667 | ANDA | N/A |
| Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet, Film Coated | Oral | 37.5mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (52536-006-09) | Wilshire Pharmaceuticals | 52536-006-09 | 52536-006 | NDA020727 | NDA AUTHORIZED GENERIC | N/A |
| Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet, Film Coated | Oral | 37.5mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (24338-010-09) | Azurity | 24338-010-09 | 24338-010 | NDA020727 | NDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-201-04) | ScieGen Pharmaceuticals, Inc. | 50228-201-04 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-202-01) | ScieGen Pharmaceuticals, Inc. | 50228-202-01 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-202-02) | ScieGen Pharmaceuticals, Inc. | 50228-202-02 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-202-03) | ScieGen Pharmaceuticals, Inc. | 50228-202-03 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-202-04) | ScieGen Pharmaceuticals, Inc. | 50228-202-04 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-201-01) | ScieGen Pharmaceuticals, Inc. | 50228-201-01 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-201-02) | ScieGen Pharmaceuticals, Inc. | 50228-201-02 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-201-03) | ScieGen Pharmaceuticals, Inc. | 50228-201-03 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-201-04) | ScieGen Pharmaceuticals, Inc. | 50228-201-04 | 50228-201 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-202-01) | ScieGen Pharmaceuticals, Inc. | 50228-202-01 | 50228-202 | ANDA204507 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 12.5mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-662-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-662-90 | 60760-662 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-330-01) | Golden State Medical Supply, Inc. | 51407-330-01 | 51407-330 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-330-10) | Golden State Medical Supply, Inc. | 51407-330-10 | 51407-330 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-331-01) | Golden State Medical Supply, Inc. | 51407-331-01 | 51407-331 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-331-10) | Golden State Medical Supply, Inc. | 51407-331-10 | 51407-331 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-331-90) | Golden State Medical Supply, Inc. | 51407-331-90 | 51407-331 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-332-01) | Golden State Medical Supply, Inc. | 51407-332-01 | 51407-332 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-332-10) | Golden State Medical Supply, Inc. | 51407-332-10 | 51407-332 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-332-90) | Golden State Medical Supply, Inc. | 51407-332-90 | 51407-332 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (69315-130-01) | Leading Pharma, LLC | 69315-130-01 | 69315-130 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle, Plastic (69315-130-10) | Leading Pharma, LLC | 69315-130-10 | 69315-130 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle, Plastic (69315-131-01) | Leading Pharma, LLC | 69315-131-01 | 69315-131 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle, Plastic (69315-131-10) | Leading Pharma, LLC | 69315-131-10 | 69315-131 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 5000 Tablet In 1 Bottle, Plastic (69315-131-50) | Leading Pharma, LLC | 69315-131-50 | 69315-131 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle, Plastic (69315-155-01) | Leading Pharma, LLC | 69315-155-01 | 69315-155 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle, Plastic (69315-155-10) | Leading Pharma, LLC | 69315-155-10 | 69315-155 | ANDA040702 | ANDA | N/A |
| Hydrochlorothiazide | Capsule, Gelatin Coated | Oral | 12.5mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (59746-382-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-382-05 | 59746-382 | ANDA078391 | ANDA | N/A |
| Hydrochlorothiazide | Capsule, Gelatin Coated | Oral | 12.5mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (59746-382-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-382-06 | 59746-382 | ANDA078391 | ANDA | N/A |
| Hydrochlorothiazide | Capsule, Gelatin Coated | Oral | 12.5mg/1 | 1000 Capsule, Gelatin Coated In 1 Bottle (59746-382-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-382-10 | 59746-382 | ANDA078391 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-202-02) | ScieGen Pharmaceuticals, Inc. | 50228-202-02 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-202-03) | ScieGen Pharmaceuticals, Inc. | 50228-202-03 | 50228-202 | ANDA204507 | ANDA | N/A |
| Fexofenadine Hydrochloride | Tablet, Film Coated | Oral | 180mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-202-04) | ScieGen Pharmaceuticals, Inc. | 50228-202-04 | 50228-202 | ANDA204507 | ANDA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 300ug/.5mL | 1 Syringe In 1 Box (70121-1568-1) / .5 Ml In 1 Syringe | Amneal Pharmaceuticals LLC | 70121-1568-1 | 70121-1568 | BLA761082 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 300ug/.5mL | 10 Syringe In 1 Box (70121-1568-7) / .5 Ml In 1 Syringe | Amneal Pharmaceuticals LLC | 70121-1568-7 | 70121-1568 | BLA761082 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 300ug/mL | 10 Vial In 1 Package (70121-1569-7) / 1 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1569-7 | 70121-1569 | BLA761082 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 480ug/.8mL | 1 Syringe In 1 Box (70121-1570-1) / .8 Ml In 1 Syringe | Amneal Pharmaceuticals LLC | 70121-1570-1 | 70121-1570 | BLA761082 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 480ug/.8mL | 10 Syringe In 1 Box (70121-1570-7) / .8 Ml In 1 Syringe | Amneal Pharmaceuticals LLC | 70121-1570-7 | 70121-1570 | BLA761082 | BLA | N/A |
| Filgrastim | Injection, Solution | Intravenous; Subcutaneous | 480ug/1.6mL | 10 Vial In 1 Package (70121-1571-7) / 1.6 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1571-7 | 70121-1571 | BLA761082 | BLA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-525-01) | Camber Pharmaceuticals, Inc. | 31722-525-01 | 31722-525 | ANDA090061 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-525-05) | Camber Pharmaceuticals, Inc. | 31722-525-05 | 31722-525 | ANDA090061 | ANDA | N/A |
| Hydrochlorothiazide; Irbesartan | Tablet | Oral | 12.5mg/1, 150 mg/1 | 30 Tablet In 1 Bottle (0054-0254-13) | Hikma Pharmaceuticals USA Inc. | 0054-0254-13 | 0054-0254 | ANDA090351 | ANDA | N/A |
| Hydrochlorothiazide; Irbesartan | Tablet | Oral | 12.5mg/1, 150 mg/1 | 90 Tablet In 1 Bottle (0054-0254-22) | Hikma Pharmaceuticals USA Inc. | 0054-0254-22 | 0054-0254 | ANDA090351 | ANDA | N/A |
| Hydrochlorothiazide; Irbesartan | Tablet | Oral | 12.5mg/1, 300 mg/1 | 30 Tablet In 1 Bottle (0054-0255-13) | Hikma Pharmaceuticals USA Inc. | 0054-0255-13 | 0054-0255 | ANDA090351 | ANDA | N/A |
| Hydrochlorothiazide; Irbesartan | Tablet | Oral | 12.5mg/1, 300 mg/1 | 90 Tablet In 1 Bottle (0054-0255-22) | Hikma Pharmaceuticals USA Inc. | 0054-0255-22 | 0054-0255 | ANDA090351 | ANDA | N/A |
| Hydrochlorothiazide; Lisinopril | Tablet | Oral | 12.5mg/1, 20 mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-519-90) | St Mary's Medical Park Pharmacy | 60760-519-90 | 60760-519 | ANDA076230 | ANDA | N/A |
| Hydrochlorothiazide; Lisinopril | Tablet | Oral | 12.5mg/1, 10 mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-586-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-586-90 | 60760-586 | ANDA076230 | ANDA | N/A |
| Hydrochlorothiazide; Lisinopril | Tablet | Oral | 12.5mg/1, 10 mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-968-90) | St. Mary's Medical Park Pharmacy | 60760-968-90 | 60760-968 | ANDA204058 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 50 mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-337-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-337-01 | 59746-337 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 50 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-337-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-337-10 | 59746-337 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 50 mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-337-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-337-30 | 59746-337 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 50 mg/1 | 90 Tablet, Film Coated In 1 Bottle (59746-337-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-337-90 | 59746-337 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 100 mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-338-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-338-01 | 59746-338 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 100 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-338-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-338-10 | 59746-338 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 100 mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-338-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-338-30 | 59746-338 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 12.5mg/1, 100 mg/1 | 90 Tablet, Film Coated In 1 Bottle (59746-338-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-338-90 | 59746-338 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1, 100 mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-339-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-339-01 | 59746-339 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1, 100 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-339-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-339-10 | 59746-339 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1, 100 mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-339-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-339-30 | 59746-339 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1, 100 mg/1 | 90 Tablet, Film Coated In 1 Bottle (59746-339-90) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-339-90 | 59746-339 | ANDA201845 | ANDA | N/A |
| Hydrochlorothiazide; Metoprolol Tartrate | Tablet | Oral | 25mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (30698-461-01) | Validus Pharmaceuticals LLC | 30698-461-01 | 30698-461 | NDA018303 | NDA | N/A |
| Hydrochlorothiazide; Metoprolol Tartrate | Tablet | Oral | 50mg/1, 100 mg/1 | 100 Tablet In 1 Bottle (30698-462-01) | Validus Pharmaceuticals LLC | 30698-462-01 | 30698-462 | NDA018303 | NDA | N/A |
| Hydrochlorothiazide; Metoprolol Tartrate | Tablet | Oral | 25mg/1, 50 mg/1 | 100 Tablet In 1 Bottle (30698-463-01) | Validus Pharmaceuticals LLC | 30698-463-01 | 30698-463 | NDA018303 | NDA | N/A |
| Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 12.5mg/1, 20 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0863-30) | Cosette Pharmaceuticals, Inc. | 0713-0863-30 | 0713-0863 | NDA021532 | NDA | N/A |
| Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 12.5mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0864-30) | Cosette Pharmaceuticals, Inc. | 0713-0864-30 | 0713-0864 | NDA021532 | NDA | N/A |
| Hydrochlorothiazide; Olmesartan Medoxomil | Tablet, Film Coated | Oral | 25mg/1, 40 mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0865-30) | Cosette Pharmaceuticals, Inc. | 0713-0865-30 | 0713-0865 | NDA021532 | NDA | N/A |
| Hydrochlorothiazide; Quinapril Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 10 mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-3112-23) | Parke-Davis Div of Pfizer Inc | 0071-3112-23 | 0071-3112 | NDA020125 | NDA | N/A |
| Hydrochlorothiazide; Quinapril Hydrochloride | Tablet, Film Coated | Oral | 12.5mg/1, 20 mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-5212-23) | Parke-Davis Div of Pfizer Inc | 0071-5212-23 | 0071-5212 | NDA020125 | NDA | N/A |
| Hydrochlorothiazide; Spironolactone | Tablet, Film Coated | Oral | 25mg/1, 25 mg/1 | 100 Tablet, Film Coated In 1 Bottle (66993-188-02) | Prasco Laboratories | 66993-188-02 | 66993-188 | NDA012616 | NDA AUTHORIZED GENERIC | N/A |
| Hydrochlorothiazide; Spironolactone | Tablet, Film Coated | Oral | 50mg/1, 50 mg/1 | 100 Tablet, Film Coated In 1 Bottle (0025-1021-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1021-31 | 0025-1021 | NDA012616 | NDA | N/A |
| Hydrochlorothiazide; Triamterene | Capsule | Oral | 25mg/1, 37.5 mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-783-90) | St Mary's Medical Park Pharmacy | 60760-783-90 | 60760-783 | ANDA208358 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Capsule | Oral | 25mg/1, 37.5 mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-535-90) | St. Mary's Medical Park Pharmacy | 60760-535-90 | 60760-535 | ANDA201407 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 25mg/1, 37.5 mg/1 | 100 Tablet In 1 Bottle (51407-286-01) | Golden State Medical Supply, Inc. | 51407-286-01 | 51407-286 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 25mg/1, 37.5 mg/1 | 500 Tablet In 1 Bottle (51407-286-05) | Golden State Medical Supply, Inc. | 51407-286-05 | 51407-286 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 25mg/1, 37.5 mg/1 | 100 Tablet In 1 Bottle (60505-2656-1) | Apotex Corp. | 60505-2656-1 | 60505-2656 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 25mg/1, 37.5 mg/1 | 500 Tablet In 1 Bottle (60505-2656-5) | Apotex Corp. | 60505-2656-5 | 60505-2656 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 25mg/1, 37.5 mg/1 | 6500 Tablet In 1 Bottle (60505-2656-7) | Apotex Corp. | 60505-2656-7 | 60505-2656 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 50mg/1, 75 mg/1 | 100 Tablet In 1 Bottle (60505-2657-1) | Apotex Corp. | 60505-2657-1 | 60505-2657 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 50mg/1, 75 mg/1 | 500 Tablet In 1 Bottle (60505-2657-5) | Apotex Corp. | 60505-2657-5 | 60505-2657 | ANDA071251 | ANDA | N/A |
| Hydrochlorothiazide; Triamterene | Tablet | Oral | 50mg/1, 75 mg/1 | 7000 Tablet In 1 Bottle (60505-2657-7) | Apotex Corp. | 60505-2657-7 | 60505-2657 | ANDA071251 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-525-10) | Camber Pharmaceuticals, Inc. | 31722-525-10 | 31722-525 | ANDA090061 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 12 Bottle In 1 Case (31722-525-30) / 30 Tablet, Film Coated In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-525-30 | 31722-525 | ANDA090061 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 12 Bottle In 1 Case (31722-525-90) / 90 Tablet, Film Coated In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-525-90 | 31722-525 | ANDA090061 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 1mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-526-10) | Camber Pharmaceuticals, Inc. | 31722-526-10 | 31722-526 | ANDA090060 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-526-30) | Camber Pharmaceuticals, Inc. | 31722-526-30 | 31722-526 | ANDA090060 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 1mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-526-90) | Camber Pharmaceuticals, Inc. | 31722-526-90 | 31722-526 | ANDA090060 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-061-30) | Rising Pharma Holdings, Inc. | 57237-061-30 | 57237-061 | ANDA203687 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 1mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-061-90) | Rising Pharma Holdings, Inc. | 57237-061-90 | 57237-061 | ANDA203687 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-062-05) | Rising Pharma Holdings, Inc. | 57237-062-05 | 57237-062 | ANDA078341 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-062-30) | Rising Pharma Holdings, Inc. | 57237-062-30 | 57237-062 | ANDA078341 | ANDA | N/A |
| Finasteride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-062-90) | Rising Pharma Holdings, Inc. | 57237-062-90 | 57237-062 | ANDA078341 | ANDA | N/A |
| Fingolimod | Capsule | Oral | .5mg/1 | 30 Capsule In 1 Bottle (31722-889-30) | Camber Pharmaceuticals, Inc. | 31722-889-30 | 31722-889 | ANDA207933 | ANDA | N/A |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 20mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-392-60) | Alvogen Inc. | 47781-392-60 | 47781-392 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 30mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-393-60) | Alvogen Inc. | 47781-393-60 | 47781-393 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 40mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-394-60) | Alvogen Inc. | 47781-394-60 | 47781-394 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 60mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-395-60) | Alvogen Inc. | 47781-395-60 | 47781-395 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 80mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-396-60) | Alvogen Inc. | 47781-396-60 | 47781-396 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 100mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-397-60) | Alvogen Inc. | 47781-397-60 | 47781-397 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Tablet, Extended Release | Oral | 120mg/1 | 60 Tablet, Extended Release In 1 Bottle (47781-398-60) | Alvogen Inc. | 47781-398-60 | 47781-398 | ANDA208269 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 10mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-409-60) | Alvogen Inc. | 47781-409-60 | 47781-409 | ANDA206986 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 15mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-410-60) | Alvogen Inc. | 47781-410-60 | 47781-410 | ANDA206986 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 20mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-411-60) | Alvogen Inc. | 47781-411-60 | 47781-411 | ANDA206986 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 30mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-412-60) | Alvogen Inc. | 47781-412-60 | 47781-412 | ANDA206986 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 40mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-413-60) | Alvogen Inc. | 47781-413-60 | 47781-413 | ANDA206986 | ANDA | CII |
| Hydrocodone Bitartrate | Capsule, Extended Release | Oral | 50mg/1 | 60 Capsule, Extended Release In 1 Bottle (47781-414-60) | Alvogen Inc. | 47781-414-60 | 47781-414 | ANDA206986 | ANDA | CII |
| Fingolimod | Capsule | Oral | .5mg/1 | 30 Capsule In 1 Bottle (72865-257-30) | XLCare Pharmaceuticals Inc. | 72865-257-30 | 72865-257 | ANDA207933 | ANDA | N/A |
| Fingolimod Hydrochloride | Capsule | Oral | .5mg/1 | 30 Capsule In 1 Bottle (64980-449-03) | Rising Pharma Holdings, Inc. | 64980-449-03 | 64980-449 | ANDA207939 | ANDA | N/A |
| Flavoxate Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (42806-058-01) | Epic Pharma, LLC | 42806-058-01 | 42806-058 | ANDA076835 | ANDA | N/A |
| Flavoxate Hydrochloride | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (42806-058-10) | Epic Pharma, LLC | 42806-058-10 | 42806-058 | ANDA076835 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (65162-641-10) | Amneal Pharmaceuticals LLC | 65162-641-10 | 65162-641 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (65162-641-11) | Amneal Pharmaceuticals LLC | 65162-641-11 | 65162-641 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (65162-642-10) | Amneal Pharmaceuticals LLC | 65162-642-10 | 65162-642 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (65162-642-11) | Amneal Pharmaceuticals LLC | 65162-642-11 | 65162-642 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (65162-643-10) | Amneal Pharmaceuticals LLC | 65162-643-10 | 65162-643 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (65162-643-11) | Amneal Pharmaceuticals LLC | 65162-643-11 | 65162-643 | ANDA075442 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (62559-380-01) | ANI Pharmaceuticals, Inc. | 62559-380-01 | 62559-380 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (62559-381-01) | ANI Pharmaceuticals, Inc. | 62559-381-01 | 62559-381 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (62559-382-01) | ANI Pharmaceuticals, Inc. | 62559-382-01 | 62559-382 | ANDA075882 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (42806-817-01) | Epic Pharma, LLC | 42806-817-01 | 42806-817 | ANDA215599 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (45802-004-02) / 20 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-004-02 | 45802-004 | ANDA085025 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (45802-004-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-004-03 | 45802-004 | ANDA085025 | ANDA | N/A |
| Hydrocortisone | Ointment | Topical | 25mg/g | 1 Tube In 1 Carton (45802-014-02) / 20 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-014-02 | 45802-014 | ANDA085027 | ANDA | N/A |
| Hydrocortisone | Ointment | Topical | 25mg/g | 454 G In 1 Jar (45802-014-05) | Padagis Israel Pharmaceuticals Ltd | 45802-014-05 | 45802-014 | ANDA085027 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (45802-438-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-438-03 | 45802-438 | M017 | OTC MONOGRAPH DRUG | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 454 G In 1 Jar (45802-438-05) | Padagis Israel Pharmaceuticals Ltd | 45802-438-05 | 45802-438 | M017 | OTC MONOGRAPH DRUG | N/A |
| Hydrocortisone | Ointment | Topical | 1g/100g | 1 Tube In 1 Carton (45802-276-03) / 28 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-276-03 | 45802-276 | M017 | OTC MONOGRAPH DRUG | N/A |
| Hydrocortisone | Lotion | Topical | 25mg/mL | 59 Ml In 1 Bottle (45802-937-16) | Padagis Israel Pharmaceuticals Ltd | 45802-937-16 | 45802-937 | ANDA089074 | ANDA | N/A |
| Hydrocortisone | Lotion | Topical | 25mg/mL | 118 Ml In 1 Bottle (45802-937-26) | Padagis Israel Pharmaceuticals Ltd | 45802-937-26 | 45802-937 | ANDA089074 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 10mg/g | 1 Tube In 1 Box (80684-038-01) / 28 G In 1 Tube | Fourstar Group USA, Inc. | 80684-038-01 | 80684-038 | M017 | OTC MONOGRAPH DRUG | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2013-1) / 14.2 G In 1 Tube | Taro Phamaceuticals U.S.A., Inc. | 51672-2013-1 | 51672-2013 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2013-2) / 28.4 G In 1 Tube | Taro Phamaceuticals U.S.A., Inc. | 51672-2013-2 | 51672-2013 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2013-3) / 60 G In 1 Tube | Taro Phamaceuticals U.S.A., Inc. | 51672-2013-3 | 51672-2013 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Cream | Topical | .5g/100g | 1 Tube In 1 Carton (51672-2010-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2010-2 | 51672-2010 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Ointment | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2018-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2018-2 | 51672-2018 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (51672-3003-0) / 20 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3003-0 | 51672-3003 | ANDA088799 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (51672-3003-2) / 28.35 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3003-2 | 51672-3003 | ANDA088799 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-3004-2) / 28.35 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3004-2 | 51672-3004 | ANDA086155 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2063-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2063-2 | 51672-2063 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (69315-312-28) / 28 G In 1 Tube | Leading Pharma, LLC | 69315-312-28 | 69315-312 | ANDA085025 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (42806-818-01) | Epic Pharma, LLC | 42806-818-01 | 42806-818 | ANDA215599 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (42806-819-01) | Epic Pharma, LLC | 42806-819-01 | 42806-819 | ANDA215599 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (57237-063-01) | Rising Pharma Holdings, Inc. | 57237-063-01 | 57237-063 | ANDA202821 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (57237-064-01) | Rising Pharma Holdings, Inc. | 57237-064-01 | 57237-064 | ANDA202821 | ANDA | N/A |
| Flecainide Acetate | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (57237-065-01) | Rising Pharma Holdings, Inc. | 57237-065-01 | 57237-065 | ANDA202821 | ANDA | N/A |
| Hydrocortisone | Granule | Oral | .5mg/1 | 1 Bottle, Plastic In 1 Carton (71863-109-50) / 50 Granule In 1 Bottle, Plastic | Eton Pharmaceuticals, Inc. | 71863-109-50 | 71863-109 | NDA213876 | NDA | N/A |
| Hydrocortisone | Granule | Oral | 1mg/1 | 1 Bottle, Plastic In 1 Carton (71863-110-50) / 50 Granule In 1 Bottle, Plastic | Eton Pharmaceuticals, Inc. | 71863-110-50 | 71863-110 | NDA213876 | NDA | N/A |
| Hydrocortisone | Granule | Oral | 2mg/1 | 1 Bottle, Plastic In 1 Carton (71863-111-50) / 50 Granule In 1 Bottle, Plastic | Eton Pharmaceuticals, Inc. | 71863-111-50 | 71863-111 | NDA213876 | NDA | N/A |
| Hydrocortisone | Granule | Oral | 5mg/1 | 1 Bottle, Plastic In 1 Carton (71863-112-50) / 50 Granule In 1 Bottle, Plastic | Eton Pharmaceuticals, Inc. | 71863-112-50 | 71863-112 | NDA213876 | NDA | N/A |
| Hydrocortisone | Granule | Oral | .5mg/1 | 50 Granule In 1 Bottle (71863-117-50) | Eton Pharmaceuticals, Inc. | 71863-117-50 | 71863-117 | NDA213876 | NDA | N/A |
| Hydrocortisone | Granule | Oral | 1mg/1 | 50 Granule In 1 Bottle (71863-118-50) | Eton Pharmaceuticals, Inc. | 71863-118-50 | 71863-118 | NDA213876 | NDA | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (62559-990-30) | ANI Pharmaceuticals, Inc. | 62559-990-30 | 62559-990 | ANDA078423 | ANDA | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 2 Blister Pack In 1 Carton (75834-147-12) / 6 Suppository In 1 Blister Pack (75834-147-06) | Nivagen Pharmaceuticals, Inc. | 75834-147-12 | 75834-147 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 4 Blister Pack In 1 Carton (75834-147-24) / 6 Suppository In 1 Blister Pack (75834-147-06) | Nivagen Pharmaceuticals, Inc. | 75834-147-24 | 75834-147 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 12 Packet In 1 Box (0574-7090-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7090-12 | 0574-7090 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 30mg/1 | 12 Packet In 1 Box (0574-7093-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7093-12 | 0574-7093 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 30mg/1 | 12 Suppository In 1 Carton (39328-129-12) | Patrin Pharma Inc. | 39328-129-12 | 39328-129 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 12 Suppository In 1 Carton (39328-029-12) | Patrin Pharma Inc. | 39328-029-12 | 39328-029 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 24 Suppository In 1 Carton (39328-029-24) | Patrin Pharma Inc. | 39328-029-24 | 39328-029 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 2 Blister Pack In 1 Box (51407-665-12) / 6 Suppository In 1 Blister Pack | Golden State Medical Supply, Inc. | 51407-665-12 | 51407-665 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 4 Blister Pack In 1 Box (51407-665-24) / 6 Suppository In 1 Blister Pack | Golden State Medical Supply, Inc. | 51407-665-24 | 51407-665 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2069-2) / 28.4 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2069-2 | 51672-2069 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone Acetate | Cream | Topical | 1g/100g | 454 G In 1 Jar (51672-2069-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-2069-9 | 51672-2069 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Hydrocortisone Acetate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-3009-2) / 28.35 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3009-2 | 51672-3009 | ANDA089472 | ANDA | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 100 Suppository In 1 Carton (0713-0503-01) | Cosette Pharmaceuticals, Inc. | 0713-0503-01 | 0713-0503 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 12 Suppository In 1 Carton (0713-0503-12) | Cosette Pharmaceuticals, Inc. | 0713-0503-12 | 0713-0503 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 24 Suppository In 1 Carton (0713-0503-24) | Cosette Pharmaceuticals, Inc. | 0713-0503-24 | 0713-0503 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 30mg/1 | 12 Packet In 1 Box (0713-0493-12) / 1 Suppository In 1 Packet | Cosette Pharmaceuticals, Inc. | 0713-0493-12 | 0713-0493 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Fluconazole | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (62559-991-30) | ANI Pharmaceuticals, Inc. | 62559-991-30 | 62559-991 | ANDA078423 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 12 Blister Pack In 1 Carton (62559-992-12) / 1 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-992-12 | 62559-992 | ANDA078423 | ANDA | N/A |
| Hydrocortisone Acetate; Lidocaine Hydrochloride | Cream | Topical | 5mg/g, 30 mg/g | 1 Tube In 1 Carton (13925-160-01) / 28.35 G In 1 Tube | Seton Pharmaceuticals | 13925-160-01 | 13925-160 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Lidocaine Hydrochloride | Cream | Topical | 5mg/g, 30 mg/g | 1 Tube In 1 Carton (13925-160-03) / 85 G In 1 Tube | Seton Pharmaceuticals | 13925-160-03 | 13925-160 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Lidocaine Hydrochloride | Cream | Rectal | 10mg/g, 30 mg/g | 20 Tube In 1 Kit (13925-163-20) / 7 G In 1 Tube (13925-163-07) | Seton Pharmaceuticals | 13925-163-20 | 13925-163 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Lidocaine Hydrochloride | Gel | Rectal | 25mg/g, 30 mg/g | 20 Tube In 1 Kit (13925-164-20) / 7 G In 1 Tube (13925-164-07) | Seton Pharmaceuticals | 13925-164-20 | 13925-164 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Lidocaine Hydrochloride | Cream | Rectal | 5mg/g, 30 mg/g | 20 Tube In 1 Kit (13925-165-20) / 7 G In 1 Tube | Seton Pharmaceuticals | 13925-165-20 | 13925-165 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 25mg/g, 10 mg/g | 1 Tube, With Applicator In 1 Carton (75834-197-01) / 28.5 G In 1 Tube, With Applicator | Nivagen Pharmaceuticals Inc. | 75834-197-01 | 75834-197 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 2.5g/100g, 1 g/100g | 1 Tube In 1 Carton (45802-124-16) / 57 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-124-16 | 45802-124 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 2.5g/100g, 1 g/100g | 1 Tube In 1 Carton (45802-124-64) / 28.4 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-124-64 | 45802-124 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 2.5g/100g, 1 g/100g | 12 Tube In 1 Carton (45802-472-53) / 4 G In 1 Tube (45802-472-01) | Padagis Israel Pharmaceuticals Ltd | 45802-472-53 | 45802-472 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 2.5g/100g, 1 g/100g | 1 Tube In 1 Carton (45802-472-64) / 28.35 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-472-64 | 45802-472 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 2.5g/100g, 1 g/100g | 30 Tube In 1 Carton (45802-472-65) / 4 G In 1 Tube (45802-472-01) | Padagis Israel Pharmaceuticals Ltd | 45802-472-65 | 45802-472 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydrocortisone Acetate; Pramoxine Hydrochloride | Cream | Topical | 1g/100g, 1 g/100g | 1 Tube In 1 Carton (45802-144-64) / 28.35 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-144-64 | 45802-144 | ANDA085368 | ANDA | N/A |
| Hydrocortisone Butyrate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (51672-4061-2) / 20 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4061-2 | 51672-4061 | ANDA076364 | ANDA | N/A |
| Hydrocortisone Butyrate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (51672-4061-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4061-4 | 51672-4061 | ANDA076364 | ANDA | N/A |
| Hydrocortisone Butyrate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4074-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-1 | 51672-4074 | ANDA076654 | ANDA | N/A |
| Hydrocortisone Butyrate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4074-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-2 | 51672-4074 | ANDA076654 | ANDA | N/A |
| Hydrocortisone Butyrate | Cream | Topical | 1mg/g | 5 G In 1 Tube (51672-4074-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-5 | 51672-4074 | ANDA076654 | ANDA | N/A |
| Hydrocortisone Butyrate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4074-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-6 | 51672-4074 | ANDA076654 | ANDA | N/A |
| Hydrocortisone Butyrate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4074-7) / 10 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-7 | 51672-4074 | ANDA076654 | ANDA | N/A |
| Hydrocortisone Butyrate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4083-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4083-1 | 51672-4083 | ANDA076842 | ANDA | N/A |
| Hydrocortisone Butyrate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4083-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4083-2 | 51672-4083 | ANDA076842 | ANDA | N/A |
| Hydrocortisone Butyrate | Ointment | Topical | 1mg/g | 5 G In 1 Tube (51672-4083-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4083-5 | 51672-4083 | ANDA076842 | ANDA | N/A |
| Hydrocortisone Butyrate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4083-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4083-6 | 51672-4083 | ANDA076842 | ANDA | N/A |
| Hydrocortisone Butyrate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-4083-7) / 10 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4083-7 | 51672-4083 | ANDA076842 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (62559-993-30) | ANI Pharmaceuticals, Inc. | 62559-993-30 | 62559-993 | ANDA078423 | ANDA | N/A |
| Fluconazole | Powder, For Suspension | Oral | 10mg/mL | 1 Bottle In 1 Carton (57237-149-35) / 35 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 57237-149-35 | 57237-149 | ANDA079150 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1290-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1290-1 | 51672-1290 | ANDA075042 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1290-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1290-3 | 51672-1290 | ANDA075042 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1290-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1290-6 | 51672-1290 | ANDA075042 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1292-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1292-1 | 51672-1292 | ANDA075043 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1292-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1292-3 | 51672-1292 | ANDA075043 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (51672-1292-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1292-6 | 51672-1292 | ANDA075043 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0720-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0720-15 | 0713-0720 | ANDA213724 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0720-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0720-37 | 0713-0720 | ANDA213724 | ANDA | N/A |
| Hydrocortisone Valerate | Cream | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0720-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0720-60 | 0713-0720 | ANDA213724 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0560-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0560-15 | 0713-0560 | ANDA211764 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0560-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0560-37 | 0713-0560 | ANDA211764 | ANDA | N/A |
| Hydrocortisone Valerate | Ointment | Topical | 2mg/g | 1 Tube In 1 Carton (0713-0560-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0560-60 | 0713-0560 | ANDA211764 | ANDA | N/A |
| Fluconazole | Powder, For Suspension | Oral | 40mg/mL | 1 Bottle In 1 Carton (57237-150-35) / 35 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 57237-150-35 | 57237-150 | ANDA079150 | ANDA | N/A |
| Hydrogen Peroxide | Solution | Topical | 3mL/100mL | 473 Ml In 1 Bottle, Plastic (82749-001-16) | Epic Medical Supply Corp. | 82749-001-16 | 82749-001 | M003 | OTC MONOGRAPH DRUG | N/A |
| Hydrogen Peroxide | Solution | Topical | 3mL/100mL | 946 Ml In 1 Bottle, Plastic (82749-001-32) | Epic Medical Supply Corp. | 82749-001-32 | 82749-001 | M003 | OTC MONOGRAPH DRUG | N/A |
| Hydrogen Peroxide | Solution | Topical | 3mL/100mL | 3785 Ml In 1 Bottle, Plastic (82749-001-99) | Epic Medical Supply Corp. | 82749-001-99 | 82749-001 | M003 | OTC MONOGRAPH DRUG | N/A |
| Fluconazole | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (57237-003-30) | Rising Pharma Holdings, Inc. | 57237-003-30 | 57237-003 | ANDA077731 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (57237-004-30) | Rising Pharma Holdings, Inc. | 57237-004-30 | 57237-004 | ANDA077731 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 150mg/1 | 12 Blister Pack In 1 Carton (57237-005-11) / 1 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-005-11 | 57237-005 | ANDA077731 | ANDA | N/A |
| Fluconazole | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (57237-006-01) | Rising Pharma Holdings, Inc. | 57237-006-01 | 57237-006 | ANDA077731 | ANDA | N/A |
| Hydromorphone Hydrochloride | Suppository | Rectal | 3mg/1 | 6 Packet In 1 Box (0574-7224-06) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7224-06 | 0574-7224 | N/A | UNAPPROVED DRUG OTHER | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 100 Tablet, Extended Release In 1 Bottle (0574-0293-01) | Padagis US LLC | 0574-0293-01 | 0574-0293 | ANDA204278 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 100 Tablet, Extended Release In 1 Bottle (0574-0294-01) | Padagis US LLC | 0574-0294-01 | 0574-0294 | ANDA204278 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 100 Tablet, Extended Release In 1 Bottle (0574-0295-01) | Padagis US LLC | 0574-0295-01 | 0574-0295 | ANDA204278 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 100 Tablet, Extended Release In 1 Bottle (0574-0297-01) | Padagis US LLC | 0574-0297-01 | 0574-0297 | ANDA204278 | ANDA | CII |
| Fluconazole | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (57237-006-30) | Rising Pharma Holdings, Inc. | 57237-006-30 | 57237-006 | ANDA077731 | ANDA | N/A |
| Flunisolide | Solution | Nasal | .25mg/mL | 1 Bottle, Pump In 1 Carton (50742-317-25) / 25 Ml In 1 Bottle, Pump | Ingenus Pharmaceuticals, LLC | 50742-317-25 | 50742-317 | ANDA207802 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Auricular (Otic) | .11mg/20mL | 1 Bottle In 1 Carton (65162-702-94) / 20 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-702-94 | 65162-702 | ANDA091306 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/118.28mL | 1 Bottle In 1 Carton (65162-703-86) / 118.28 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-703-86 | 65162-703 | ANDA201759 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/118.28mL | 1 Bottle In 1 Carton (65162-704-86) / 118.28 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-704-86 | 65162-704 | ANDA201764 | ANDA | N/A |
| Fluocinolone Acetonide | Cream | Topical | .1mg/g | 1 Tube In 1 Carton (62559-288-15) / 15 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-288-15 | 62559-288 | NDA012787 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Cream | Topical | .1mg/g | 1 Tube In 1 Carton (62559-288-60) / 60 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-288-60 | 62559-288 | NDA012787 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (62559-289-15) / 15 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-289-15 | 62559-289 | NDA012787 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (62559-289-60) / 60 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-289-60 | 62559-289 | NDA012787 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (62559-299-15) / 15 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-299-15 | 62559-299 | NDA013960 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (62559-299-60) / 60 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-299-60 | 62559-299 | NDA013960 | NDA AUTHORIZED GENERIC | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/mL | 118.28 Ml In 1 Bottle (64980-330-04) | Rising Pharmaceuticals, Inc. | 64980-330-04 | 64980-330 | ANDA090982 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Topical | .11mg/mL | 118.28 Ml In 1 Bottle (64980-331-04) | Rising Pharmaceuticals, Inc. | 64980-331-04 | 64980-331 | ANDA203377 | ANDA | N/A |
| Fluocinolone Acetonide | Oil | Auricular (Otic) | .11mg/mL | 20 Ml In 1 Bottle (64980-329-20) | Rising Pharmaceuticals, Inc. | 64980-329-20 | 64980-329 | ANDA203378 | ANDA | N/A |
| Fluocinonide | Solution | Topical | .5mg/mL | 1 Bottle, Plastic In 1 Carton (64980-452-06) / 60 Ml In 1 Bottle, Plastic | Rising Pharmaceuticals, Inc. | 64980-452-06 | 64980-452 | ANDA209699 | ANDA | N/A |
| Fluoxetine Hydrochloride | Solution | Oral | 20mg/5mL | 120 Ml In 1 Bottle, Plastic (70954-600-10) | ANI Pharmaceuticals, Inc. | 70954-600-10 | 70954-600 | ANDA216448 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (50228-420-01) | ScieGen Pharmaceuticals, Inc | 50228-420-01 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-420-10) | ScieGen Pharmaceuticals, Inc | 50228-420-10 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-420-30) | ScieGen Pharmaceuticals, Inc | 50228-420-30 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (50228-421-01) | ScieGen Pharmaceuticals, Inc | 50228-421-01 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-421-10) | ScieGen Pharmaceuticals, Inc | 50228-421-10 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-421-30) | ScieGen Pharmaceuticals, Inc | 50228-421-30 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (50228-420-01) | ScieGen Pharmaceuticals, Inc | 50228-420-01 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-420-10) | ScieGen Pharmaceuticals, Inc | 50228-420-10 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-420-30) | ScieGen Pharmaceuticals, Inc | 50228-420-30 | 50228-420 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (50228-421-01) | ScieGen Pharmaceuticals, Inc | 50228-421-01 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-421-10) | ScieGen Pharmaceuticals, Inc | 50228-421-10 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-421-30) | ScieGen Pharmaceuticals, Inc | 50228-421-30 | 50228-421 | ANDA210935 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle (50228-422-10) | ScieGen Pharmaceuticals, Inc. | 50228-422-10 | 50228-422 | ANDA211282 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (50228-422-30) | ScieGen Pharmaceuticals, Inc. | 50228-422-30 | 50228-422 | ANDA211282 | ANDA | N/A |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 25 Vial, Single-Dose In 1 Carton (0641-6151-25) / 1 Ml In 1 Vial, Single-Dose (0641-6151-01) | Hikma Pharmaceuticals USA Inc. | 0641-6151-25 | 0641-6151 | ANDA202159 | ANDA | CII |
| Hydromorphone Hydrochloride | Solution | Oral | 1mg/mL | 473 Ml In 1 Bottle (0054-0386-63) | Hikma Pharmaceuticals USA Inc. | 0054-0386-63 | 0054-0386 | ANDA074653 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Syringe In 1 Carton (0641-6169-10) / 1 Ml In 1 Syringe (0641-6169-01) | Hikma Pharmaceuticals USA Inc. | 0641-6169-10 | 0641-6169 | ANDA216899 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 10 Syringe In 1 Carton (0641-6170-10) / 1 Ml In 1 Syringe (0641-6170-01) | Hikma Pharmaceuticals USA Inc. | 0641-6170-10 | 0641-6170 | ANDA216899 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 20 Vial In 1 Carton (0641-2341-41) / 20 Ml In 1 Vial (0641-2341-39) | Hikma Pharmaceuticals USA Inc. | 0641-2341-41 | 0641-2341 | N/A | UNAPPROVED DRUG OTHER | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | .2mg/mL | 10 Syringe In 1 Carton (0641-6259-10) / 1 Ml In 1 Syringe (0641-6259-01) | Hikma Pharmaceuticals USA Inc. | 0641-6259-10 | 0641-6259 | ANDA216899 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 25 Vial In 1 Carton (0641-0121-25) / 1 Ml In 1 Vial (0641-0121-21) | Hikma Pharmaceuticals USA Inc. | 0641-0121-25 | 0641-0121 | N/A | UNAPPROVED DRUG OTHER | CII |
| Hydromorphone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | .5mg/.5mL | 10 Syringe In 1 Carton (0641-6206-10) / .5 Ml In 1 Syringe (0641-6206-01) | Hikma Pharmaceuticals USA Inc. | 0641-6206-10 | 0641-6206 | ANDA216899 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Syringe In 1 Cello Pack (0409-1283-37) / 1 Ml In 1 Syringe (0409-1283-17) | Hospira, Inc. | 0409-1283-37 | 0409-1283 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Cartridge In 1 Carton (0409-1283-31) / 1 Ml In 1 Cartridge (0409-1283-03) | Hospira, Inc. | 0409-1283-31 | 0409-1283 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 4mg/mL | 10 Cartridge In 1 Carton (0409-1304-31) / 1 Ml In 1 Cartridge (0409-1304-03) | Hospira, Inc. | 0409-1304-31 | 0409-1304 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 10 Syringe In 1 Cello Pack (0409-1312-36) / 1 Ml In 1 Syringe (0409-1312-16) | Hospira, Inc. | 0409-1312-36 | 0409-1312 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 10 Cartridge In 1 Carton (0409-1312-30) / 1 Ml In 1 Cartridge (0409-1312-03) | Hospira, Inc. | 0409-1312-30 | 0409-1312 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .25mg/.5mL | 10 Syringe In 1 Cello Pack (0409-1805-01) / .5 Ml In 1 Syringe (0409-1805-10) | Hospira, Inc. | 0409-1805-01 | 0409-1805 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-3365-10) / 1 Ml In 1 Vial, Single-Dose (0409-3365-11) | Hospira, Inc. | 0409-3365-10 | 0409-3365 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Ampule In 1 Carton (0409-2552-01) / 1 Ml In 1 Ampule (0409-2552-11) | Hospira, Inc. | 0409-2552-01 | 0409-2552 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .5mg/.5mL | 10 Syringe In 1 Cello Pack (0409-4264-01) / .5 Ml In 1 Syringe (0409-4264-11) | Hospira, Inc. | 0409-4264-01 | 0409-4264 | NDA200403 | NDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 10 Vial, Single-Dose In 1 Box (0409-2634-01) / 1 Ml In 1 Vial, Single-Dose (0409-2634-10) | Hospira, Inc. | 0409-2634-01 | 0409-2634 | ANDA078591 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 10 Vial, Single-Dose In 1 Box (0409-2634-05) / 5 Ml In 1 Vial, Single-Dose (0409-2634-25) | Hospira, Inc. | 0409-2634-05 | 0409-2634 | ANDA078591 | ANDA | CII |
| Hydromorphone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 1 Vial, Single-Dose In 1 Box (0409-2634-50) / 50 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-2634-50 | 0409-2634 | ANDA078591 | ANDA | CII |
| Hydroquinone | Cream | Topical | 40mg/g | 1 Tube In 1 Carton (75834-137-01) / 28.4 G In 1 Tube | Nivagen Pharmaceuticals, Inc. | 75834-137-01 | 75834-137 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hydroquinone | Cream | Topical | 40mg/g | 1 Tube In 1 Carton (42192-151-01) / 28.35 G In 1 Tube | Acella Pharmaceuticals, LLC | 42192-151-01 | 42192-151 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (50228-113-01) | ScieGen Pharmaceuticals, Inc. | 50228-113-01 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (50228-113-05) | ScieGen Pharmaceuticals, Inc. | 50228-113-05 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (50228-113-10) | ScieGen Pharmaceuticals, Inc. | 50228-113-10 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (50228-113-30) | ScieGen Pharmaceuticals, Inc. | 50228-113-30 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (50228-114-01) | ScieGen Pharmaceuticals, Inc. | 50228-114-01 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle (50228-114-05) | ScieGen Pharmaceuticals, Inc. | 50228-114-05 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 1000 Capsule In 1 Bottle (50228-114-10) | ScieGen Pharmaceuticals, Inc. | 50228-114-10 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 30 Capsule In 1 Bottle (50228-114-30) | ScieGen Pharmaceuticals, Inc. | 50228-114-30 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 100 Capsule In 1 Bottle (50228-115-01) | ScieGen Pharmaceuticals, Inc. | 50228-115-01 | 50228-115 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 500 Capsule In 1 Bottle (50228-115-05) | ScieGen Pharmaceuticals, Inc. | 50228-115-05 | 50228-115 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (50228-115-30) | ScieGen Pharmaceuticals, Inc. | 50228-115-30 | 50228-115 | ANDA204597 | ANDA | N/A |
| Hydroxyprogesterone Caproate | Injection | Intramuscular | 250mg/mL | 1 Vial In 1 Box (0517-1767-01) / 1 Ml In 1 Vial | American Regent, Inc. | 0517-1767-01 | 0517-1767 | ANDA210723 | ANDA | N/A |
| Hydroxyurea | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle (70069-820-01) | Somerset Therapeutics, LLC | 70069-820-01 | 70069-820 | ANDA218021 | ANDA | N/A |
| Hydroxyurea | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle, Plastic (51407-909-01) | Golden State Medical Supply, Inc. | 51407-909-01 | 51407-909 | ANDA213438 | ANDA | N/A |
| Hydroxyurea | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle (60429-265-01) | Golden State Medical Supply, Inc. | 60429-265-01 | 60429-265 | ANDA075340 | ANDA | N/A |
| Hydroxyurea | Capsule | Oral | 500mg/1 | 100 Capsule In 1 Bottle, Plastic (69315-164-01) | Leading Pharma, LLC | 69315-164-01 | 69315-164 | ANDA213438 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (60760-285-20) | St Mary's Medical Park Pharmacy | 60760-285-20 | 60760-285 | ANDA088617 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-971-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-971-30 | 60760-971 | ANDA088618 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (10702-010-01) | KVK-Tech, Inc. | 10702-010-01 | 10702-010 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (10702-010-10) | KVK-Tech, Inc. | 10702-010-10 | 10702-010 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (10702-010-50) | KVK-Tech, Inc. | 10702-010-50 | 10702-010 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (10702-011-01) | KVK-Tech, Inc. | 10702-011-01 | 10702-011 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (10702-011-10) | KVK-Tech, Inc. | 10702-011-10 | 10702-011 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (10702-011-50) | KVK-Tech, Inc. | 10702-011-50 | 10702-011 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (10702-012-01) | KVK-Tech, Inc. | 10702-012-01 | 10702-012 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (10702-012-10) | KVK-Tech, Inc. | 10702-012-10 | 10702-012 | ANDA040786 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (10702-012-50) | KVK-Tech, Inc. | 10702-012-50 | 10702-012 | ANDA040786 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle (50228-422-10) | ScieGen Pharmaceuticals, Inc. | 50228-422-10 | 50228-422 | ANDA211282 | ANDA | N/A |
| Fluoxetine Hydrochloride | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle (50228-422-30) | ScieGen Pharmaceuticals, Inc. | 50228-422-30 | 50228-422 | ANDA211282 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (50228-113-01) | ScieGen Pharmaceuticals, Inc. | 50228-113-01 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (50228-113-05) | ScieGen Pharmaceuticals, Inc. | 50228-113-05 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (50228-113-10) | ScieGen Pharmaceuticals, Inc. | 50228-113-10 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (50228-113-30) | ScieGen Pharmaceuticals, Inc. | 50228-113-30 | 50228-113 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (50228-114-01) | ScieGen Pharmaceuticals, Inc. | 50228-114-01 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle (50228-114-05) | ScieGen Pharmaceuticals, Inc. | 50228-114-05 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 1000 Capsule In 1 Bottle (50228-114-10) | ScieGen Pharmaceuticals, Inc. | 50228-114-10 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 20mg/1 | 30 Capsule In 1 Bottle (50228-114-30) | ScieGen Pharmaceuticals, Inc. | 50228-114-30 | 50228-114 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 100 Capsule In 1 Bottle (50228-115-01) | ScieGen Pharmaceuticals, Inc. | 50228-115-01 | 50228-115 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 500 Capsule In 1 Bottle (50228-115-05) | ScieGen Pharmaceuticals, Inc. | 50228-115-05 | 50228-115 | ANDA204597 | ANDA | N/A |
| Fluoxetine Hydrochloride | Capsule | Oral | 40mg/1 | 30 Capsule In 1 Bottle (50228-115-30) | ScieGen Pharmaceuticals, Inc. | 50228-115-30 | 50228-115 | ANDA204597 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 90 Tablet, Film Coated In 1 Container (16571-889-09) | Rising Pharma Holdings, Inc. | 16571-889-09 | 16571-889 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 500 Tablet, Film Coated In 1 Container (16571-889-50) | Rising Pharma Holdings, Inc. | 16571-889-50 | 16571-889 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 90 Tablet, Film Coated In 1 Container (16571-890-09) | Rising Pharma Holdings, Inc. | 16571-890-09 | 16571-890 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 500 Tablet, Film Coated In 1 Container (16571-890-50) | Rising Pharma Holdings, Inc. | 16571-890-50 | 16571-890 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Container (16571-891-09) | Rising Pharma Holdings, Inc. | 16571-891-09 | 16571-891 | ANDA218283 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Injection, Solution | Intramuscular | 50mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-5601-25) / 1 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-5601-25 | 0517-5601 | ANDA087408 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Injection, Solution | Intramuscular | 50mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-5602-25) / 2 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-5602-25 | 0517-5602 | ANDA087408 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Injection, Solution | Intramuscular | 25mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-4201-25) / 1 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-4201-25 | 0517-4201 | ANDA087408 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Container (16571-891-50) | Rising Pharma Holdings, Inc. | 16571-891-50 | 16571-891 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Container (16571-892-09) | Rising Pharma Holdings, Inc. | 16571-892-09 | 16571-892 | ANDA218283 | ANDA | N/A |
| Fluphenazine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Container (16571-892-50) | Rising Pharma Holdings, Inc. | 16571-892-50 | 16571-892 | ANDA218283 | ANDA | N/A |
| Fluvoxamine Maleate | Tablet, Coated | Oral | 25mg/1 | 100 Tablet, Coated In 1 Bottle (62559-158-01) | ANI Pharmaceuticals, Inc. | 62559-158-01 | 62559-158 | NDA021519 | NDA AUTHORIZED GENERIC | N/A |
| Fluvoxamine Maleate | Tablet, Coated | Oral | 50mg/1 | 100 Tablet, Coated In 1 Bottle (62559-159-01) | ANI Pharmaceuticals, Inc. | 62559-159-01 | 62559-159 | NDA021519 | NDA AUTHORIZED GENERIC | N/A |
| Fluvoxamine Maleate | Tablet, Coated | Oral | 100mg/1 | 100 Tablet, Coated In 1 Bottle (62559-160-01) | ANI Pharmaceuticals, Inc. | 62559-160-01 | 62559-160 | NDA021519 | NDA AUTHORIZED GENERIC | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 10 Tablet In 1 Bottle (65162-361-01) | Amneal Pharmaceuticals LLC | 65162-361-01 | 65162-361 | ANDA040625 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (65162-361-10) | Amneal Pharmaceuticals LLC | 65162-361-10 | 65162-361 | ANDA040625 | ANDA | N/A |
| Hydroxyzine Pamoate | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (0069-5410-66) | Pfizer Laboratories Div Pfizer Inc | 0069-5410-66 | 0069-5410 | NDA011459 | NDA | N/A |
| Hyoscyamine Sulfate | Tablet, Orally Disintegrating | Oral | .125mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle, Plastic (39328-049-10) | Patrin Pharma, Inc. | 39328-049-10 | 39328-049 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle, Plastic (39328-050-10) | Patrin Pharma, Inc. | 39328-050-10 | 39328-050 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Sublingual | .125mg/1 | 100 Tablet In 1 Bottle, Plastic (39328-051-10) | Patrin Pharma, Inc. | 39328-051-10 | 39328-051 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet, Extended Release | Oral | .375mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (39328-052-10) | Patrin Pharma, Inc. | 39328-052-10 | 39328-052 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (65162-361-11) | Amneal Pharmaceuticals LLC | 65162-361-11 | 65162-361 | ANDA040625 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (65162-361-50) | Amneal Pharmaceuticals LLC | 65162-361-50 | 65162-361 | ANDA040625 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (16571-881-01) | Rising Pharma Holdings, Inc. | 16571-881-01 | 16571-881 | ANDA211064 | ANDA | N/A |
| Folic Acid | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (16571-881-10) | Rising Pharma Holdings, Inc. | 16571-881-10 | 16571-881 | ANDA211064 | ANDA | N/A |
| Hyoscyamine Sulfate | Tablet, Orally Disintegrating | Oral | .125mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (42192-338-01) | Acella Pharmaceuticals, LLC | 42192-338-01 | 42192-338 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Sublingual | .125mg/1 | 100 Tablet In 1 Bottle (42192-339-01) | Acella Pharmaceuticals, LLC | 42192-339-01 | 42192-339 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (42192-340-01) | Acella Pharmaceuticals, LLC | 42192-340-01 | 42192-340 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Oral; Sublingual | .125mg/1 | 100 Tablet In 1 Bottle (47781-011-01) | Alvogen Inc. | 47781-011-01 | 47781-011 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet, Orally Disintegrating | Oral | .125mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (47781-012-01) | Alvogen Inc. | 47781-012-01 | 47781-012 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (47781-013-01) | Alvogen Inc. | 47781-013-01 | 47781-013 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet, Extended Release | Oral | .375mg/1 | 100 Tablet, Extended Release In 1 Bottle (47781-014-01) | Alvogen Inc. | 47781-014-01 | 47781-014 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Ibandronate Sodium | Tablet, Film Coated | Oral | 150mg/1 | 3 Blister Pack In 1 Package (60429-643-73) / 1 Tablet, Film Coated In 1 Blister Pack | Golden State Medical Supply, Inc. | 60429-643-73 | 60429-643 | ANDA078948 | ANDA | N/A |
| Ibandronate Sodium | Tablet, Film Coated | Oral | 150mg/1 | 3 Blister Pack In 1 Package (60505-2795-0) / 1 Tablet, Film Coated In 1 Blister Pack | Apotex Corp | 60505-2795-0 | 60505-2795 | ANDA078948 | ANDA | N/A |
| Ibandronate Sodium | Injection | Intravenous | 3mg/3mL | 1 Syringe, Glass In 1 Carton (60505-6097-0) / 3 Ml In 1 Syringe, Glass | Apotex Corp. | 60505-6097-0 | 60505-6097 | ANDA204222 | ANDA | N/A |
| Ibandronate Sodium | Tablet | Oral | 150mg/1 | 1 Blister Pack In 1 Carton (69452-378-74) / 3 Tablet In 1 Blister Pack | Bionpharma Inc. | 69452-378-74 | 69452-378 | ANDA078998 | ANDA | N/A |
| Ibandronate Sodium | Tablet | Oral | 150mg/1 | 1 Blister Pack In 1 Carton (47781-103-21) / 3 Tablet In 1 Blister Pack | Alvogen Inc. | 47781-103-21 | 47781-103 | ANDA078998 | ANDA | N/A |
| Ibandronate Sodium | Tablet | Oral | 150mg/1 | 3 Blister Pack In 1 Box (47781-103-33) / 1 Tablet In 1 Blister Pack (47781-103-07) | Alvogen Inc. | 47781-103-33 | 47781-103 | ANDA078998 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (45802-133-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-133-26 | 45802-133 | ANDA074937 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (45802-140-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-140-26 | 45802-140 | ANDA074937 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (45802-897-26) / 118 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-897-26 | 45802-897 | ANDA074937 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (45802-897-34) / 237 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-897-34 | 45802-897 | ANDA074937 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (45802-952-26) / 120 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-952-26 | 45802-952 | ANDA076925 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 473 Ml In 1 Bottle (45802-952-43) | Padagis Israel Pharmaceuticals Ltd | 45802-952-43 | 45802-952 | ANDA076925 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 50mg/1.25mL | 1 Bottle In 1 Carton (45802-057-05) / 15 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-057-05 | 45802-057 | ANDA075217 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 200mg/1 | 24 Tablet, Film Coated In 1 Bottle, Plastic (60760-529-24) | St. Mary's Medical Park Pharmacy | 60760-529-24 | 60760-529 | ANDA072096 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-929-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-929-20 | 60760-929 | ANDA213794 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-929-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-929-60 | 60760-929 | ANDA213794 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-929-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-929-90 | 60760-929 | ANDA213794 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 200mg/1 | 24 Tablet, Film Coated In 1 Bottle, Plastic (60760-941-24) | St. Mary's Medical Park Pharmacy | 60760-941-24 | 60760-941 | ANDA075010 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 800mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-596-30) | St. Mary's Medical Park Pharmacy | 60760-596-30 | 60760-596 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 800mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-596-60) | St. Mary's Medical Park Pharmacy | 60760-596-60 | 60760-596 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 28 Tablet, Film Coated In 1 Bottle, Plastic (60760-597-28) | St. Mary's Medical Park Pharmacy | 60760-597-28 | 60760-597 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-597-30) | St. Mary's Medical Park Pharmacy | 60760-597-30 | 60760-597 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 40 Tablet, Film Coated In 1 Bottle, Plastic (60760-597-40) | St. Mary's Medical Park Pharmacy | 60760-597-40 | 60760-597 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-597-90) | St. Mary's Medical Park Pharmacy | 60760-597-90 | 60760-597 | ANDA078329 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (60760-603-20) | St. Mary's Medical Park Pharmacy | 60760-603-20 | 60760-603 | ANDA090796 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 28 Tablet, Film Coated In 1 Bottle, Plastic (60760-603-28) | St. Mary's Medical Park Pharmacy | 60760-603-28 | 60760-603 | ANDA090796 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-603-30) | St. Mary's Medical Park Pharmacy | 60760-603-30 | 60760-603 | ANDA090796 | ANDA | N/A |
| Ibuprofen | Tablet, Film Coated | Oral | 600mg/1 | 40 Tablet, Film Coated In 1 Bottle, Plastic (60760-603-40) | St. Mary's Medical Park Pharmacy | 60760-603-40 | 60760-603 | ANDA090796 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-1409-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1409-8 | 51672-1409 | ANDA209204 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 473 Ml In 1 Bottle (51672-1409-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1409-9 | 51672-1409 | ANDA209204 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-2130-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2130-1 | 51672-2130 | ANDA209207 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-2130-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2130-8 | 51672-2130 | ANDA209207 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-2144-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2144-1 | 51672-2144 | ANDA209207 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-2144-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2144-8 | 51672-2144 | ANDA209207 | ANDA | N/A |
| Ibuprofen | Suspension/ Drops | Oral | 50mg/1.25mL | 1 Bottle In 1 Carton (51672-2146-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2146-3 | 51672-2146 | ANDA217261 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (51672-1385-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1385-8 | 51672-1385 | ANDA209204 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 473 Ml In 1 Bottle (51672-1385-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-1385-9 | 51672-1385 | ANDA209204 | ANDA | N/A |
| Ibuprofen | Suspension | Oral | 100mg/5mL | 1 Bottle, Plastic In 1 Carton (51672-5321-8) / 120 Ml In 1 Bottle, Plastic | TARO PHARMACEUTICALS U.S.A., INC. | 51672-5321-8 | 51672-5321 | ANDA211666 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (21130-220-78) / 80 Capsule, Liquid Filled In 1 Bottle | Albertsons Companies | 21130-220-78 | 21130-220 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1201 | 180 Capsule, Liquid Filled In 1 Bottle (69452-302-25) | Bionpharma Inc. | 69452-302-25 | 69452-302 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 360 Capsule, Liquid Filled In 1 Bottle (69452-212-90) | Bionpharma Inc. | 69452-212-90 | 69452-212 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 400 Capsule, Liquid Filled In 1 Bottle (69452-305-81) | Bionpharma Inc. | 69452-305-81 | 69452-305 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (69452-239-22) | Bionpharma Inc. | 69452-239-22 | 69452-239 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (69452-263-11) / 20 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-263-11 | 69452-263 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (69452-263-78) / 80 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-263-78 | 69452-263 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 160 Capsule, Liquid Filled In 1 Bottle (69452-263-79) | Bionpharma Inc. | 69452-263-79 | 69452-263 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (69452-260-11) / 20 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-260-11 | 69452-260 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (69452-260-78) / 80 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-260-78 | 69452-260 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 160 Capsule, Liquid Filled In 1 Bottle (69452-260-79) | Bionpharma Inc. | 69452-260-79 | 69452-260 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 240 Capsule, Liquid Filled In 1 Bottle (69452-260-82) | Bionpharma Inc. | 69452-260-82 | 69452-260 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 300 Capsule, Liquid Filled In 1 Bottle (69452-260-83) | Bionpharma Inc. | 69452-260-83 | 69452-260 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (69452-262-30) | Bionpharma Inc. | 69452-262-30 | 69452-262 | ANDA078682 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 240 Capsule, Liquid Filled In 1 Bottle (69452-262-82) | Bionpharma Inc. | 69452-262-82 | 69452-262 | ANDA078682 | ANDA | N/A |
| Fosaprepitant | Injection, Powder, Lyophilized, For Solution | Intravenous | 150mg/5mL | 1 Vial, Single-Dose In 1 Carton (31722-165-31) / 5 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals, Inc. | 31722-165-31 | 31722-165 | ANDA214616 | ANDA | N/A |
| Fosaprepitant Dimeglumine | Injection | Intravenous | 150mg/50mL | 1 Vial, Single-Dose In 1 Carton (70121-2631-1) / 50 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-2631-1 | 70121-2631 | NDA216686 | NDA | N/A |
| Foscarnet Sodium | Injection | Intravenous | 24mg/mL | 12 Pouch In 1 Carton (70121-1744-2) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1744-2 | 70121-1744 | ANDA216602 | ANDA | N/A |
| Foscarnet Sodium | Injection | Intravenous | 24mg/mL | 10 Pouch In 1 Carton (70121-1744-7) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1744-7 | 70121-1744 | ANDA216602 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (65162-998-25) / 2 Ml In 1 Vial (65162-998-01) | Amneal Pharmaceuticals LLC | 65162-998-25 | 65162-998 | ANDA078476 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (65162-999-10) / 2 Ml In 1 Vial (65162-999-01) | Amneal Pharmaceuticals LLC | 65162-999-10 | 65162-999 | ANDA078476 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (70121-1381-5) / 2 Ml In 1 Vial (70121-1381-1) | Amneal Pharmaceuticals LLC | 70121-1381-5 | 70121-1381 | ANDA078476 | ANDA | N/A |
| Fosphenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (70121-1390-7) / 10 Ml In 1 Vial (70121-1390-1) | Amneal Pharmaceuticals LLC | 70121-1390-7 | 70121-1390 | ANDA078476 | ANDA | N/A |
| Frovatriptan Succinate | Tablet, Film Coated | Oral | 2.5mg/1 | 1 Blister Pack In 1 Carton (50742-299-09) / 9 Tablet, Film Coated In 1 Blister Pack | Ingenus Pharmaceuticals, LLC | 50742-299-09 | 50742-299 | ANDA213891 | ANDA | N/A |
| Fulvestrant | Injection, Solution | Intramuscular | 250mg/5mL | 2 Syringe, Glass In 1 Carton (70121-1463-2) / 5 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-1463-2 | 70121-1463 | ANDA210044 | ANDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 100mg/10mL | 25 Vial, Glass In 1 Carton (70121-1076-5) / 10 Ml In 1 Vial, Glass (70121-1076-1) | Amneal Pharmaceuticals LLC | 70121-1076-5 | 70121-1076 | ANDA207552 | ANDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 20mg/2mL | 25 Vial, Glass In 1 Carton (70121-1163-5) / 2 Ml In 1 Vial, Glass (70121-1163-1) | Amneal Pharmaceuticals LLC | 70121-1163-5 | 70121-1163 | ANDA207552 | ANDA | N/A |
| Furosemide | Injection | Intramuscular; Intravenous | 40mg/4mL | 25 Vial, Glass In 1 Carton (70121-1164-5) / 4 Ml In 1 Vial, Glass (70121-1164-1) | Amneal Pharmaceuticals LLC | 70121-1164-5 | 70121-1164 | ANDA207552 | ANDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (64980-562-01) | Rising Pharma Holdings, Inc. | 64980-562-01 | 64980-562 | ANDA216629 | ANDA | N/A |
| Furosemide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (64980-562-10) | Rising Pharma Holdings, Inc. | 64980-562-10 | 64980-562 | ANDA216629 | ANDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (64980-563-01) | Rising Pharma Holdings, Inc. | 64980-563-01 | 64980-563 | ANDA216629 | ANDA | N/A |
| Furosemide | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (64980-563-10) | Rising Pharma Holdings, Inc. | 64980-563-10 | 64980-563 | ANDA216629 | ANDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle (64980-564-01) | Rising Pharma Holdings, Inc. | 64980-564-01 | 64980-564 | ANDA216629 | ANDA | N/A |
| Furosemide | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (64980-564-50) | Rising Pharma Holdings, Inc. | 64980-564-50 | 64980-564 | ANDA216629 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (65162-101-03) | Amneal Pharmaceuticals LLC | 65162-101-03 | 65162-101 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (65162-101-10) | Amneal Pharmaceuticals LLC | 65162-101-10 | 65162-101 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (65162-101-11) | Amneal Pharmaceuticals LLC | 65162-101-11 | 65162-101 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (65162-101-50) | Amneal Pharmaceuticals LLC | 65162-101-50 | 65162-101 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (65162-102-03) | Amneal Pharmaceuticals LLC | 65162-102-03 | 65162-102 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (65162-102-10) | Amneal Pharmaceuticals LLC | 65162-102-10 | 65162-102 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle (65162-102-11) | Amneal Pharmaceuticals LLC | 65162-102-11 | 65162-102 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (65162-102-50) | Amneal Pharmaceuticals LLC | 65162-102-50 | 65162-102 | ANDA078428 | ANDA | N/A |
| Ibuprofen Lysine | Solution | Intravenous | 10mg/mL | 3 Vial In 1 Carton (66993-490-36) / 2 Ml In 1 Vial | Prasco Laboratories | 66993-490-36 | 66993-490 | NDA021903 | NDA AUTHORIZED GENERIC | N/A |
| Icatibant Acetate | Injection, Solution | Subcutaneous | 30mg/3mL | 1 Syringe, Glass In 1 Carton (60505-6214-1) / 3 Ml In 1 Syringe, Glass | Apotex Corp. | 60505-6214-1 | 60505-6214 | ANDA212081 | ANDA | N/A |
| Icatibant Acetate | Injection, Solution | Subcutaneous | 30mg/3mL | 1 Syringe, Glass In 1 Carton (24201-207-01) / 3 Ml In 1 Syringe, Glass | Hikma Pharmaceuticals USA Inc. | 24201-207-01 | 24201-207 | ANDA211021 | ANDA | N/A |
| Icatibant Acetate | Injection, Solution | Subcutaneous | 30mg/3mL | 3 Carton In 1 Carton (24201-207-03) / 1 Syringe, Glass In 1 Carton / 3 Ml In 1 Syringe, Glass | Hikma Pharmaceuticals USA Inc. | 24201-207-03 | 24201-207 | ANDA211021 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 120 Capsule In 1 Bottle (60505-4033-1) | Apotex Corp | 60505-4033-1 | 60505-4033 | ANDA209437 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (65162-103-03) | Amneal Pharmaceuticals LLC | 65162-103-03 | 65162-103 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (65162-103-10) | Amneal Pharmaceuticals LLC | 65162-103-10 | 65162-103 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 1000 Capsule In 1 Bottle (65162-103-11) | Amneal Pharmaceuticals LLC | 65162-103-11 | 65162-103 | ANDA078428 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (65162-103-50) | Amneal Pharmaceuticals LLC | 65162-103-50 | 65162-103 | ANDA078428 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 50 Cup, Unit-Dose In 1 Carton (65162-698-54) / 5 Ml In 1 Cup, Unit-Dose (65162-698-39) | Amneal Pharmaceuticals LLC | 65162-698-54 | 65162-698 | ANDA202024 | ANDA | N/A |
| Gabapentin | Solution | Oral | 250mg/5mL | 473 Ml In 1 Bottle (65162-698-90) | Amneal Pharmaceuticals LLC | 65162-698-90 | 65162-698 | ANDA202024 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (43602-466-05) | Ascent Pharmaceuticals, Inc | 43602-466-05 | 43602-466 | ANDA214957 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (43602-466-30) | Ascent Pharmaceuticals, Inc | 43602-466-30 | 43602-466 | ANDA214957 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (43602-467-05) | Ascent Pharmaceuticals, Inc | 43602-467-05 | 43602-467 | ANDA214957 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (43602-467-30) | Ascent Pharmaceuticals, Inc | 43602-467-30 | 43602-467 | ANDA214957 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (43602-469-10) | Ascent Pharmaceuticals, Inc | 43602-469-10 | 43602-469 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (43602-469-30) | Ascent Pharmaceuticals, Inc | 43602-469-30 | 43602-469 | ANDA214956 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 120 Capsule In 1 Bottle (0054-0508-23) | Hikma Pharmaceuticals USA Inc. | 0054-0508-23 | 0054-0508 | ANDA209457 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 240 Capsule In 1 Bottle (0054-0621-27) | Hikma Pharmaceuticals USA Inc. | 0054-0621-27 | 0054-0621 | ANDA209457 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (43602-470-05) | Ascent Pharmaceuticals, Inc | 43602-470-05 | 43602-470 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (43602-470-30) | Ascent Pharmaceuticals, Inc | 43602-470-30 | 43602-470 | ANDA214956 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9306-01) / 5 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9306-01 | 0143-9306 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9307-01) / 10 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9307-01 | 0143-9307 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9308-01) / 20 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9308-01 | 0143-9308 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9217-01) / 5 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9217-01 | 0143-9217 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9218-01) / 10 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9218-01 | 0143-9218 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Glass In 1 Box (0143-9219-01) / 20 Ml In 1 Vial, Glass | Hikma Pharmaceuticals USA Inc. | 0143-9219-01 | 0143-9219 | ANDA065275 | ANDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2576-05) / 5 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2576-05 | 0013-2576 | NDA050734 | NDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2576-91) / 5 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2576-91 | 0013-2576 | NDA050734 | NDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2586-10) / 10 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2586-10 | 0013-2586 | NDA050734 | NDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2586-91) / 10 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2586-91 | 0013-2586 | NDA050734 | NDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2596-20) / 20 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2596-20 | 0013-2596 | NDA050734 | NDA | N/A |
| Idarubicin Hydrochloride | Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0013-2596-91) / 20 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0013-2596-91 | 0013-2596 | NDA050734 | NDA | N/A |
| Ifosfamide | Injection | Intravenous | 50mg/mL | 1 Vial In 1 Box (0143-9530-01) / 60 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9530-01 | 0143-9530 | ANDA076619 | ANDA | N/A |
| Ifosfamide | Injection | Intravenous | 50mg/mL | 1 Vial In 1 Box (0143-9531-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9531-01 | 0143-9531 | ANDA076619 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 4mg/1 | 60 Tablet In 1 Bottle (51672-4180-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4180-4 | 51672-4180 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 6mg/1 | 60 Tablet In 1 Bottle (51672-4181-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4181-4 | 51672-4181 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 8mg/1 | 60 Tablet In 1 Bottle (51672-4182-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4182-4 | 51672-4182 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 10mg/1 | 60 Tablet In 1 Bottle (51672-4183-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4183-4 | 51672-4183 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 12mg/1 | 60 Tablet In 1 Bottle (51672-4184-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4184-4 | 51672-4184 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 1mg/1 | 60 Tablet In 1 Bottle (51672-4178-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4178-4 | 51672-4178 | ANDA207098 | ANDA | N/A |
| Iloperidone | Tablet | Oral | 2mg/1 | 60 Tablet In 1 Bottle (51672-4179-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4179-4 | 51672-4179 | ANDA207098 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (51407-269-90) | Golden State Medical Supply, Inc. | 51407-269-90 | 51407-269 | ANDA204644 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-270-30) | Golden State Medical Supply, Inc. | 51407-270-30 | 51407-270 | ANDA204644 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (60505-2900-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp | 60505-2900-0 | 60505-2900 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-2900-1) | Apotex Corp | 60505-2900-1 | 60505-2900 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2900-3) | Apotex Corp | 60505-2900-3 | 60505-2900 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-2900-8) | Apotex Corp | 60505-2900-8 | 60505-2900 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2900-9) | Apotex Corp | 60505-2900-9 | 60505-2900 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 10 Blister Pack In 1 Carton (60505-2901-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp | 60505-2901-0 | 60505-2901 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-2901-1) | Apotex Corp | 60505-2901-1 | 60505-2901 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-2901-3) | Apotex Corp | 60505-2901-3 | 60505-2901 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-2901-5) | Apotex Corp | 60505-2901-5 | 60505-2901 | ANDA079179 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 90 Tablet, Film Coated In 1 Bottle (60505-2901-9) | Apotex Corp | 60505-2901-9 | 60505-2901 | ANDA079179 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (43602-471-05) | Ascent Pharmaceuticals, Inc | 43602-471-05 | 43602-471 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (43602-471-30) | Ascent Pharmaceuticals, Inc | 43602-471-30 | 43602-471 | ANDA214956 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (43602-466-05) | Ascent Pharmaceuticals, Inc | 43602-466-05 | 43602-466 | ANDA214957 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (43602-466-30) | Ascent Pharmaceuticals, Inc | 43602-466-30 | 43602-466 | ANDA214957 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (69315-133-01) | Leading Pharma, LLC | 69315-133-01 | 69315-133 | ANDA040903 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69315-133-10) | Leading Pharma, LLC | 69315-133-10 | 69315-133 | ANDA040903 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (69315-134-01) | Leading Pharma, LLC | 69315-134-01 | 69315-134 | ANDA040903 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69315-134-10) | Leading Pharma, LLC | 69315-134-10 | 69315-134 | ANDA040903 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (69315-135-01) | Leading Pharma, LLC | 69315-135-01 | 69315-135 | ANDA040903 | ANDA | N/A |
| Imipramine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69315-135-10) | Leading Pharma, LLC | 69315-135-10 | 69315-135 | ANDA040903 | ANDA | N/A |
| Imipramine Pamoate | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (0054-0273-13) | Hikma Pharmaceuticals USA Inc | 0054-0273-13 | 0054-0273 | ANDA091099 | ANDA | N/A |
| Imipramine Pamoate | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (0054-0274-13) | Hikma Pharmaceuticals USA Inc | 0054-0274-13 | 0054-0274 | ANDA091099 | ANDA | N/A |
| Imipramine Pamoate | Capsule | Oral | 125mg/1 | 30 Capsule In 1 Bottle (0054-0275-13) | Hikma Pharmaceuticals USA Inc | 0054-0275-13 | 0054-0275 | ANDA091099 | ANDA | N/A |
| Imipramine Pamoate | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (0054-0276-13) | Hikma Pharmaceuticals USA Inc | 0054-0276-13 | 0054-0276 | ANDA091099 | ANDA | N/A |
| Imiquimod | Cream | Topical | 12.5mg/.25g | 12 Packet In 1 Carton (45802-368-53) / .25 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-368-53 | 45802-368 | ANDA078837 | ANDA | N/A |
| Imiquimod | Cream | Topical | 12.5mg/.25g | 24 Packet In 1 Carton (45802-368-62) / .25 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-368-62 | 45802-368 | ANDA078837 | ANDA | N/A |
| Imiquimod | Cream | Topical | 50mg/g | 24 Packet In 1 Carton (51672-4145-6) / .25 G In 1 Packet (51672-4145-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4145-6 | 51672-4145 | ANDA200173 | ANDA | N/A |
| Imiquimod | Cream | Topical | 37.5mg/g | 28 Packet In 1 Carton (51672-4174-6) / .25 G In 1 Packet (51672-4174-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4174-6 | 51672-4174 | ANDA205971 | ANDA | N/A |
| Imiquimod | Cream | Topical | 37.5mg/g | 1 Bottle, Pump In 1 Carton (51672-4174-9) / 7.5 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-4174-9 | 51672-4174 | ANDA205971 | ANDA | N/A |
| Indapamide | Tablet, Film Coated | Oral | 1.25mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-024-01) | Golden State Medical Supply, Inc. | 51407-024-01 | 51407-024 | ANDA074299 | ANDA | N/A |
| Indapamide | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (51407-025-01) | Golden State Medical Supply, Inc. | 51407-025-01 | 51407-025 | ANDA074299 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (43602-467-05) | Ascent Pharmaceuticals, Inc | 43602-467-05 | 43602-467 | ANDA214957 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (43602-467-30) | Ascent Pharmaceuticals, Inc | 43602-467-30 | 43602-467 | ANDA214957 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (43602-469-10) | Ascent Pharmaceuticals, Inc | 43602-469-10 | 43602-469 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (43602-469-30) | Ascent Pharmaceuticals, Inc | 43602-469-30 | 43602-469 | ANDA214956 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-916-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-916-30 | 60760-916 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 21 Capsule In 1 Bottle, Plastic (60760-294-21) | St. Mary's Medical Park Pharmacy | 60760-294-21 | 60760-294 | ANDA091276 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-294-30) | St. Mary's Medical Park Pharmacy | 60760-294-30 | 60760-294 | ANDA091276 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 100 Capsule, Extended Release In 1 Bottle (10702-016-01) | KVK-Tech, Inc. | 10702-016-01 | 10702-016 | ANDA079175 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 30 Capsule, Extended Release In 1 Bottle (10702-016-03) | KVK-Tech, Inc. | 10702-016-03 | 10702-016 | ANDA079175 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 60 Capsule, Extended Release In 1 Bottle (10702-016-06) | KVK-Tech, Inc. | 10702-016-06 | 10702-016 | ANDA079175 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 90 Capsule, Extended Release In 1 Bottle (10702-016-09) | KVK-Tech, Inc. | 10702-016-09 | 10702-016 | ANDA079175 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 1000 Capsule, Extended Release In 1 Bottle (10702-016-10) | KVK-Tech, Inc. | 10702-016-10 | 10702-016 | ANDA079175 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 500 Capsule, Extended Release In 1 Bottle (10702-016-50) | KVK-Tech, Inc. | 10702-016-50 | 10702-016 | ANDA079175 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (43602-470-05) | Ascent Pharmaceuticals, Inc | 43602-470-05 | 43602-470 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (43602-470-30) | Ascent Pharmaceuticals, Inc | 43602-470-30 | 43602-470 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (43602-471-05) | Ascent Pharmaceuticals, Inc | 43602-471-05 | 43602-471 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (43602-471-30) | Ascent Pharmaceuticals, Inc | 43602-471-30 | 43602-471 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (31722-166-01) | Camber Pharmaceuticals, Inc. | 31722-166-01 | 31722-166 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (31722-166-05) | Camber Pharmaceuticals, Inc. | 31722-166-05 | 31722-166 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (31722-167-01) | Camber Pharmaceuticals, Inc. | 31722-167-01 | 31722-167 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (31722-167-05) | Camber Pharmaceuticals, Inc. | 31722-167-05 | 31722-167 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Solution | Oral | 250mg/5mL | 1 Bottle In 1 Carton (31722-069-47) / 470 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-069-47 | 31722-069 | ANDA217682 | ANDA | N/A |
| GABAPENTIN | Tablet, Film Coated | Oral | 300mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-091-90) | Camber Pharmaceuticals, Inc. | 31722-091-90 | 31722-091 | ANDA218075 | ANDA | N/A |
| GABAPENTIN | Tablet, Film Coated | Oral | 600mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-092-90) | Camber Pharmaceuticals, Inc. | 31722-092-90 | 31722-092 | ANDA218075 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (31722-148-01) | Camber Pharmaceuticals, Inc. | 31722-148-01 | 31722-148 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (31722-148-05) | Camber Pharmaceuticals, Inc. | 31722-148-05 | 31722-148 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (31722-148-10) | Camber Pharmaceuticals, Inc. | 31722-148-10 | 31722-148 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (31722-149-01) | Camber Pharmaceuticals, Inc. | 31722-149-01 | 31722-149 | ANDA214956 | ANDA | N/A |
| Infliximab | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Use In 1 Carton (0069-0809-01) / 10 Ml In 1 Vial, Single-Use | Pfizer Laboratories Div Pfizer Inc | 0069-0809-01 | 0069-0809 | BLA125544 | BLA | N/A |
| Inotuzumab Ozogamicin | Injection, Powder, Lyophilized, For Solution | Intravenous | .25mg/mL | 1 Vial, Single-Dose In 1 Carton (0008-0100-01) / 4 Ml In 1 Vial, Single-Dose | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0100-01 | 0008-0100 | BLA761040 | BLA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (31722-149-05) | Camber Pharmaceuticals, Inc. | 31722-149-05 | 31722-149 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (31722-150-01) | Camber Pharmaceuticals, Inc. | 31722-150-01 | 31722-150 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (31722-150-05) | Camber Pharmaceuticals, Inc. | 31722-150-05 | 31722-150 | ANDA214956 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (42806-509-01) | Epic Pharma, LLC | 42806-509-01 | 42806-509 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (42806-509-10) | Epic Pharma, LLC | 42806-509-10 | 42806-509 | ANDA207099 | ANDA | N/A |
| Ipratropium Bromide | Spray, Metered | Nasal | 21ug/1 | 1 Bottle, Spray In 1 Carton (60505-0826-1) / 345 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-0826-1 | 60505-0826 | ANDA076156 | ANDA | N/A |
| Ipratropium Bromide | Spray, Metered | Nasal | 42ug/1 | 1 Bottle, Pump In 1 Carton (60505-0827-1) / 165 Spray, Metered In 1 Bottle, Pump | Apotex Corp. | 60505-0827-1 | 60505-0827 | ANDA076155 | ANDA | N/A |
| Ipratropium Bromide | Spray | Nasal | 21ug/1 | 1 Bottle, Spray In 1 Carton (0054-0045-44) / 345 Spray In 1 Bottle, Spray | Hikma Pharmaceuticals USA Inc. | 0054-0045-44 | 0054-0045 | ANDA076664 | ANDA | N/A |
| Ipratropium Bromide | Spray | Nasal | 42ug/1 | 1 Bottle, Spray In 1 Carton (0054-0046-41) / 165 Spray In 1 Bottle, Spray | Hikma Pharmaceuticals USA Inc. | 0054-0046-41 | 0054-0046 | ANDA076598 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (42806-509-30) | Epic Pharma, LLC | 42806-509-30 | 42806-509 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (42806-510-01) | Epic Pharma, LLC | 42806-510-01 | 42806-510 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle (42806-510-10) | Epic Pharma, LLC | 42806-510-10 | 42806-510 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (42806-510-30) | Epic Pharma, LLC | 42806-510-30 | 42806-510 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (42806-511-01) | Epic Pharma, LLC | 42806-511-01 | 42806-511 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 1000 Capsule In 1 Bottle (42806-511-10) | Epic Pharma, LLC | 42806-511-10 | 42806-511 | ANDA207099 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (59746-447-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-447-05 | 59746-447 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (59746-447-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-447-30 | 59746-447 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (59746-447-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-447-90 | 59746-447 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (59746-448-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-448-05 | 59746-448 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (59746-448-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-448-30 | 59746-448 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 90 Tablet In 1 Bottle (59746-448-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-448-90 | 59746-448 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (59746-449-05) | Jubilant Cadista Pharmaceuticals Inc. | 59746-449-05 | 59746-449 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (59746-449-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-449-30 | 59746-449 | ANDA203534 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (59746-449-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-449-90 | 59746-449 | ANDA203534 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (42806-511-30) | Epic Pharma, LLC | 42806-511-30 | 42806-511 | ANDA207099 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (42806-656-09) | Epic Pharma, LLC | 42806-656-09 | 42806-656 | ANDA216252 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (42806-657-09) | Epic Pharma, LLC | 42806-657-09 | 42806-657 | ANDA216252 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (16571-226-01) | Rising Pharma Holdings, Inc. | 16571-226-01 | 16571-226 | ANDA217995 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (16571-226-50) | Rising Pharma Holdings, Inc. | 16571-226-50 | 16571-226 | ANDA217995 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (16571-867-01) | Rising Pharma Holdings, Inc. | 16571-867-01 | 16571-867 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (16571-867-03) | Rising Pharma Holdings, Inc. | 16571-867-03 | 16571-867 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (16571-867-10) | Rising Pharma Holdings, Inc. | 16571-867-10 | 16571-867 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (16571-867-50) | Rising Pharma Holdings, Inc. | 16571-867-50 | 16571-867 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (16571-868-01) | Rising Pharma Holdings, Inc. | 16571-868-01 | 16571-868 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (16571-868-03) | Rising Pharma Holdings, Inc. | 16571-868-03 | 16571-868 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle (16571-868-10) | Rising Pharma Holdings, Inc. | 16571-868-10 | 16571-868 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (16571-868-50) | Rising Pharma Holdings, Inc. | 16571-868-50 | 16571-868 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle (16571-869-01) | Rising Pharma Holdings, Inc. | 16571-869-01 | 16571-869 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle (16571-869-03) | Rising Pharma Holdings, Inc. | 16571-869-03 | 16571-869 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 1000 Capsule In 1 Bottle (16571-869-10) | Rising Pharma Holdings, Inc. | 16571-869-10 | 16571-869 | ANDA207099 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (16571-869-50) | Rising Pharma Holdings, Inc. | 16571-869-50 | 16571-869 | ANDA207099 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial In 1 Carton (25021-230-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-230-02 | 25021-230 | ANDA090675 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial In 1 Carton (25021-230-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-230-05 | 25021-230 | ANDA090675 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Use In 1 Carton (60505-6272-1) / 5 Ml In 1 Vial, Single-Use | Apotex Corp. | 60505-6272-1 | 60505-6272 | ANDA203380 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Use In 1 Carton (60505-6128-0) / 2 Ml In 1 Vial, Single-Use | Apotex Corp. | 60505-6128-0 | 60505-6128 | ANDA203380 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Use In 1 Carton (60505-6128-1) / 5 Ml In 1 Vial, Single-Use | Apotex Corp. | 60505-6128-1 | 60505-6128 | ANDA203380 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection | Intravenous | 20mg/mL | 5 Ml In 1 Vial, Glass (0143-9583-01) | Hikma Pharmaceuticals USA Inc. | 0143-9583-01 | 0143-9583 | ANDA091032 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection | Intravenous | 20mg/mL | 5 Ml In 1 Vial, Glass (0143-9701-01) | Hikma Pharmaceuticals USA Inc. | 0143-9701-01 | 0143-9701 | ANDA091032 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection | Intravenous | 20mg/mL | 2 Ml In 1 Vial, Glass (0143-9702-01) | Hikma Pharmaceuticals USA Inc. | 0143-9702-01 | 0143-9702 | ANDA091032 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (16571-116-01) | Rising Pharma Holdings, Inc. | 16571-116-01 | 16571-116 | ANDA217995 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (16571-116-50) | Rising Pharma Holdings, Inc. | 16571-116-50 | 16571-116 | ANDA217995 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-349-09) / 5 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-349-09 | 61703-349 | ANDA077915 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-349-16) / 2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-349-16 | 61703-349 | ANDA077915 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-349-36) / 25 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-349-36 | 61703-349 | ANDA077915 | ANDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 5 Vial, Single-Dose In 1 Box (0517-2310-05) / 10 Ml In 1 Vial, Single-Dose (0517-2310-01) | American Regent, Inc. | 0517-2310-05 | 0517-2310 | NDA021135 | NDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 10 Vial, Single-Dose In 1 Box (0517-2325-10) / 2.5 Ml In 1 Vial, Single-Dose (0517-2325-01) | American Regent, Inc. | 0517-2325-10 | 0517-2325 | NDA021135 | NDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 1 Vial, Single-Dose In 1 Box (0517-2340-01) / 5 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-2340-01 | 0517-2340 | NDA021135 | NDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 10 Vial, Single-Dose In 1 Box (0517-2340-10) / 5 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-2340-10 | 0517-2340 | NDA021135 | NDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-2340-25) / 5 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-2340-25 | 0517-2340 | NDA021135 | NDA | N/A |
| Iron Sucrose | Injection, Solution | Intravenous | 20mg/mL | 10 Vial, Single-Dose In 1 Carton (0517-2340-99) / 5 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-2340-99 | 0517-2340 | NDA021135 | NDA | N/A |
| Isocarboxazid | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (30698-032-01) | Validus Pharmaceuticals LLC | 30698-032-01 | 30698-032 | NDA011961 | NDA | N/A |
| Isopropyl Alcohol | Liquid | Topical | 91mL/100mL | 473 Ml In 1 Bottle, Plastic (82749-004-16) | Epic Medical Supply Corp. | 82749-004-16 | 82749-004 | M003 | OTC MONOGRAPH DRUG | N/A |
| Isopropyl Alcohol | Solution | Topical | 70mL/100mL | 473 Ml In 1 Bottle, Plastic (82749-002-16) | Epic Medical Supply Corp. | 82749-002-16 | 82749-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Isopropyl Alcohol | Solution | Topical | 70mL/100mL | 946 Ml In 1 Bottle, Plastic (82749-002-32) | Epic Medical Supply Corp. | 82749-002-32 | 82749-002 | M003 | OTC MONOGRAPH DRUG | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Single-Dose In 1 Carton (14789-011-01) / 1 Ml In 1 Vial, Single-Dose | Nexus Pharmaceuticals Inc | 14789-011-01 | 14789-011 | ANDA206961 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 10 Vial, Single-Dose In 1 Carton (14789-015-05) / 5 Ml In 1 Vial, Single-Dose | Nexus Pharmaceuticals Inc | 14789-015-05 | 14789-015 | ANDA206961 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intracardiac; Intramuscular; Intravenous; Subcutaneous | .2mg/mL | 10 Vial In 1 Carton (0548-9501-00) / 1 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-9501-00 | 0548-9501 | ANDA210106 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intracardiac; Intramuscular; Intravenous; Subcutaneous | .2mg/mL | 10 Vial In 1 Carton (0548-9502-00) / 5 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-9502-00 | 0548-9502 | ANDA210106 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intravenous | .2mg/mL | 10 Vial In 1 Carton (10702-364-51) / 5 Ml In 1 Vial (10702-364-05) | KVK-Tech, Inc. | 10702-364-51 | 10702-364 | ANDA215542 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (16571-117-01) | Rising Pharma Holdings, Inc. | 16571-117-01 | 16571-117 | ANDA217995 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (16571-117-50) | Rising Pharma Holdings, Inc. | 16571-117-50 | 16571-117 | ANDA217995 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intracardiac; Intramuscular; Intravenous; Subcutaneous | .2mg/mL | 10 Vial In 1 Carton (0548-9501-00) / 1 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-9501-00 | 0548-9501 | ANDA210106 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intracardiac; Intramuscular; Intravenous; Subcutaneous | .2mg/mL | 10 Vial In 1 Carton (0548-9502-00) / 5 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-9502-00 | 0548-9502 | ANDA210106 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-147-01) | Golden State Medical Supply, Inc. | 51407-147-01 | 51407-147 | ANDA086067 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-147-10) | Golden State Medical Supply, Inc. | 51407-147-10 | 51407-147 | ANDA086067 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (0143-1769-01) | Hikma Pharmaceuticals USA Inc. | 0143-1769-01 | 0143-1769 | ANDA086067 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1769-10) | Hikma Pharmaceuticals USA Inc. | 0143-1769-10 | 0143-1769 | ANDA086067 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (0143-1771-01) | Hikma Pharmaceuticals USA Inc. | 0143-1771-01 | 0143-1771 | ANDA086066 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1771-10) | Hikma Pharmaceuticals USA Inc. | 0143-1771-10 | 0143-1771 | ANDA086066 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (0143-1772-01) | Hikma Pharmaceuticals USA Inc. | 0143-1772-01 | 0143-1772 | ANDA088088 | ANDA | N/A |
| Isosorbide Dinitrate | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (0143-1772-10) | Hikma Pharmaceuticals USA Inc. | 0143-1772-10 | 0143-1772 | ANDA088088 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 30mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-208-01) | Golden State Medical Supply, Inc. | 51407-208-01 | 51407-208 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 30mg/1 | 500 Tablet, Extended Release In 1 Bottle (51407-208-05) | Golden State Medical Supply, Inc. | 51407-208-05 | 51407-208 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 60mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-209-01) | Golden State Medical Supply, Inc. | 51407-209-01 | 51407-209 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 60mg/1 | 500 Tablet, Extended Release In 1 Bottle (51407-209-05) | Golden State Medical Supply, Inc. | 51407-209-05 | 51407-209 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 120mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-210-01) | Golden State Medical Supply, Inc. | 51407-210-01 | 51407-210 | ANDA210918 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (50228-177-01) | ScieGen Pharmaceuticals, Inc. | 50228-177-01 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (50228-177-05) | ScieGen Pharmaceuticals, Inc. | 50228-177-05 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (50228-177-30) | ScieGen Pharmaceuticals, Inc. | 50228-177-30 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (50228-178-01) | ScieGen Pharmaceuticals, Inc. | 50228-178-01 | 50228-178 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (50228-178-05) | ScieGen Pharmaceuticals, Inc. | 50228-178-05 | 50228-178 | ANDA205101 | ANDA | N/A |
| Isosulfan Blue | Injection, Solution | Subcutaneous | 10mg/mL | 6 Vial, Single-Dose In 1 Carton (71288-805-06) / 5 Ml In 1 Vial, Single-Dose (71288-805-05) | Meitheal Pharmaceuticals Inc. | 71288-805-06 | 71288-805 | ANDA213130 | ANDA | N/A |
| Isosulfan Blue | Injection, Solution | Subcutaneous | 10mg/mL | 6 Vial In 1 Carton (70069-221-06) / 5 Ml In 1 Vial (70069-221-01) | Somerset Therapeutics, LLC | 70069-221-06 | 70069-221 | ANDA210558 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (50228-178-30) | ScieGen Pharmaceuticals, Inc. | 50228-178-30 | 50228-178 | ANDA205101 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-179-01) | ScieGen Pharmaceuticals, Inc. | 50228-179-01 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-179-05) | ScieGen Pharmaceuticals, Inc. | 50228-179-05 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle, Plastic (50228-179-10) | ScieGen Pharmaceuticals, Inc. | 50228-179-10 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-179-30) | ScieGen Pharmaceuticals, Inc. | 50228-179-30 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-180-01) | ScieGen Pharmaceuticals, Inc. | 50228-180-01 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-180-05) | ScieGen Pharmaceuticals, Inc. | 50228-180-05 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle, Plastic (50228-180-10) | ScieGen Pharmaceuticals, Inc. | 50228-180-10 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-180-30) | ScieGen Pharmaceuticals, Inc. | 50228-180-30 | 50228-180 | ANDA204989 | ANDA | N/A |
| Ivermectin | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (45802-102-84) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-102-84 | 45802-102 | ANDA210225 | ANDA | N/A |
| Ivermectin | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (0574-2107-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2107-45 | 0574-2107 | NDA206255 | NDA AUTHORIZED GENERIC | N/A |
| Ivermectin | Lotion | Topical | 5mg/g | 1 Tube In 1 Carton (51672-4230-8) / 117 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4230-8 | 51672-4230 | ANDA210720 | ANDA | N/A |
| Ivermectin | Lotion | Topical | 5mg/g | 1 Tube In 1 Carton (24338-185-04) / 117 G In 1 Tube | Azurity Pharmaceuticals | 24338-185-04 | 24338-185 | NDA202736 | NDA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2626-2) | Jubilant HollisterStier LLC | 65044-2626-2 | 65044-2626 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2626-3) | Jubilant HollisterStier LLC | 65044-2626-3 | 65044-2626 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2626-4) | Jubilant HollisterStier LLC | 65044-2626-4 | 65044-2626 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2627-1) | Jubilant HollisterStier LLC | 65044-2627-1 | 65044-2627 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2629-2) | Jubilant HollisterStier LLC | 65044-2629-2 | 65044-2629 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2629-3) | Jubilant HollisterStier LLC | 65044-2629-3 | 65044-2629 | BLA103888 | BLA | N/A |
| Juglans Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2629-4) | Jubilant HollisterStier LLC | 65044-2629-4 | 65044-2629 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1336-2) | Jubilant HollisterStier LLC | 65044-1336-2 | 65044-1336 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1336-3) | Jubilant HollisterStier LLC | 65044-1336-3 | 65044-1336 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1336-4) | Jubilant HollisterStier LLC | 65044-1336-4 | 65044-1336 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1337-1) | Jubilant HollisterStier LLC | 65044-1337-1 | 65044-1337 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1339-2) | Jubilant HollisterStier LLC | 65044-1339-2 | 65044-1339 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1339-3) | Jubilant HollisterStier LLC | 65044-1339-3 | 65044-1339 | BLA103888 | BLA | N/A |
| Juniperus Ashei Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1339-4) | Jubilant HollisterStier LLC | 65044-1339-4 | 65044-1339 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1340-1) | Jubilant HollisterStier LLC | 65044-1340-1 | 65044-1340 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1342-2) | Jubilant HollisterStier LLC | 65044-1342-2 | 65044-1342 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1342-3) | Jubilant HollisterStier LLC | 65044-1342-3 | 65044-1342 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1342-4) | Jubilant HollisterStier LLC | 65044-1342-4 | 65044-1342 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1343-2) | Jubilant HollisterStier LLC | 65044-1343-2 | 65044-1343 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1343-3) | Jubilant HollisterStier LLC | 65044-1343-3 | 65044-1343 | BLA103888 | BLA | N/A |
| Juniperus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1343-4) | Jubilant HollisterStier LLC | 65044-1343-4 | 65044-1343 | BLA103888 | BLA | N/A |
| Ketamine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-682-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-682-20 | 25021-682 | ANDA216809 | ANDA | CIII |
| Ketamine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (25021-683-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-683-10 | 25021-683 | ANDA216809 | ANDA | CIII |
| Ketamine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 10 Vial In 1 Carton (25021-684-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-684-05 | 25021-684 | ANDA216809 | ANDA | CIII |
| Ketamine Hydrochloride | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Box (0143-9508-10) / 10 Ml In 1 Vial (0143-9508-01) | Hikma Pharmaceuticals USA Inc. | 0143-9508-10 | 0143-9508 | ANDA074524 | ANDA | CIII |
| Ketamine Hydrochloride | Injection | Intramuscular; Intravenous | 100mg/mL | 10 Vial In 1 Box (0143-9509-10) / 5 Ml In 1 Vial (0143-9509-01) | Hikma Pharmaceuticals USA Inc. | 0143-9509-10 | 0143-9509 | ANDA074524 | ANDA | CIII |
| Ketamine Hydrochloride | Injection, Solution, Concentrate | Intramuscular; Intravenous | 100mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-0040-10) / 5 Ml In 1 Vial, Multi-Dose (0409-0040-05) | Hospira, Inc. | 0409-0040-10 | 0409-0040 | ANDA074549 | ANDA | CIII |
| Ketamine Hydrochloride | Injection, Solution, Concentrate | Intramuscular; Intravenous | 100mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-2051-05) / 5 Ml In 1 Vial, Multi-Dose (0409-2051-15) | Hospira, Inc. | 0409-2051-05 | 0409-2051 | ANDA074549 | ANDA | CIII |
| Ketamine Hydrochloride | Injection, Solution, Concentrate | Intramuscular; Intravenous | 50mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-2053-10) / 10 Ml In 1 Vial, Multi-Dose (0409-2053-20) | Hospira, Inc. | 0409-2053-10 | 0409-2053 | ANDA074549 | ANDA | CIII |
| Ketoconazole | Shampoo, Suspension | Topical | 20mg/mL | 120 Ml In 1 Bottle (45802-465-64) | Padagis Israel Pharmaceuticals Ltd | 45802-465-64 | 45802-465 | ANDA076419 | ANDA | N/A |
| Ketoconazole | Aerosol, Foam | Topical | 2g/100g | 1 Canister In 1 Carton (45802-532-32) / 50 G In 1 Canister | Padagis Israel Pharmaceuticals Ltd | 45802-532-32 | 45802-532 | ANDA091550 | ANDA | N/A |
| Ketoconazole | Aerosol, Foam | Topical | 2g/100g | 1 Canister In 1 Carton (45802-532-33) / 100 G In 1 Canister | Padagis Israel Pharmaceuticals Ltd | 45802-532-33 | 45802-532 | ANDA091550 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51407-279-15) / 15 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-279-15 | 51407-279 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51407-279-30) / 30 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-279-30 | 51407-279 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51407-279-60) / 60 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-279-60 | 51407-279 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (60429-020-01) | Golden State Medical Supply, Inc. | 60429-020-01 | 60429-020 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1298-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1298-1 | 51672-1298 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1298-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1298-2 | 51672-1298 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1298-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1298-3 | 51672-1298 | ANDA075638 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 10 Blister Pack In 1 Box (51672-4026-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-0 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51672-4026-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-1 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51672-4026-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-2 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (51672-4026-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-6 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 3 Blister Pack In 1 Box (51672-4026-8) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-8 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Ketoconazole | Tablet | Oral | 200mg/1 | 5 Blister Pack In 1 Box (51672-4026-9) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4026-9 | 51672-4026 | ANDA075319 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-181-01) | ScieGen Pharmaceuticals, Inc. | 50228-181-01 | 50228-181 | ANDA204989 | ANDA | N/A |
| Ketorolac Tromethamine | Spray, Metered | Nasal | 15.75mg/1 | 5 Bottle, Spray In 1 Carton (66993-193-95) / 1 Bottle, Unit-Dose In 1 Bottle, Spray (66993-193-83) / 8 Spray, Metered In 1 Bottle, Unit-Dose | Prasco Laboratories | 66993-193-95 | 66993-193 | NDA022382 | NDA AUTHORIZED GENERIC | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular; Intravenous | 30mg/mL | 25 Vial In 1 Carton (25021-701-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-701-01 | 25021-701 | ANDA204216 | ANDA | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular; Intravenous | 30mg/mL | 25 Vial In 1 Carton (25021-701-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-701-02 | 25021-701 | ANDA204216 | ANDA | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular; Intravenous | 15mg/mL | 25 Vial In 1 Carton (25021-700-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-700-01 | 25021-700 | ANDA204216 | ANDA | N/A |
| Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (69315-322-03) / 3 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-322-03 | 69315-322 | ANDA218204 | ANDA | N/A |
| Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (69315-322-05) / 5 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-322-05 | 69315-322 | ANDA218204 | ANDA | N/A |
| Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (69315-322-10) / 10 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-322-10 | 69315-322 | ANDA218204 | ANDA | N/A |
| Ketorolac Tromethamine | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (69315-260-01) | Leading Pharma, LLC | 69315-260-01 | 69315-260 | ANDA215745 | ANDA | N/A |
| Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1003-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-1003-1 | 60505-1003 | ANDA076109 | ANDA | N/A |
| Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1003-2) / 10 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-1003-2 | 60505-1003 | ANDA076109 | ANDA | N/A |
| Ketorolac Tromethamine | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (69452-275-20) | Bionpharma Inc. | 69452-275-20 | 69452-275 | ANDA216759 | ANDA | N/A |
| Ketorolac Tromethamine | Injection | Intramuscular; Intravenous | 15mg/mL | 25 Vial In 1 Carton (0641-6041-25) / 1 Ml In 1 Vial (0641-6041-01) | Hikma Pharmaceuticals USA Inc. | 0641-6041-25 | 0641-6041 | ANDA075772 | ANDA | N/A |
| Ketorolac Tromethamine | Injection | Intramuscular; Intravenous | 30mg/mL | 25 Vial In 1 Carton (0641-6042-25) / 1 Ml In 1 Vial (0641-6042-01) | Hikma Pharmaceuticals USA Inc. | 0641-6042-25 | 0641-6042 | ANDA075772 | ANDA | N/A |
| Ketorolac Tromethamine | Injection | Intramuscular | 30mg/mL | 25 Vial In 1 Carton (0641-6043-25) / 2 Ml In 1 Vial (0641-6043-01) | Hikma Pharmaceuticals USA Inc. | 0641-6043-25 | 0641-6043 | ANDA075772 | ANDA | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular; Intravenous | 15mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-3793-01) / 1 Ml In 1 Vial, Single-Dose (0409-3793-19) | Hospira, Inc. | 0409-3793-01 | 0409-3793 | ANDA074802 | ANDA | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular; Intravenous | 30mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-3795-01) / 1 Ml In 1 Vial, Single-Dose (0409-3795-19) | Hospira, Inc. | 0409-3795-01 | 0409-3795 | ANDA074802 | ANDA | N/A |
| Ketorolac Tromethamine | Injection, Solution | Intramuscular | 60mg/2mL | 25 Vial, Single-Dose In 1 Tray (0409-3796-01) / 2 Ml In 1 Vial, Single-Dose (0409-3796-19) | Hospira, Inc. | 0409-3796-01 | 0409-3796 | ANDA074802 | ANDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-317-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-317-20 | 25021-317 | ANDA214533 | ANDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-317-40) / 40 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-317-40 | 25021-317 | ANDA214533 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-181-05) | ScieGen Pharmaceuticals, Inc. | 50228-181-05 | 50228-181 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-181-30) | ScieGen Pharmaceuticals, Inc. | 50228-181-30 | 50228-181 | ANDA204989 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (50228-177-01) | ScieGen Pharmaceuticals, Inc. | 50228-177-01 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (50228-177-05) | ScieGen Pharmaceuticals, Inc. | 50228-177-05 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (50228-177-30) | ScieGen Pharmaceuticals, Inc. | 50228-177-30 | 50228-177 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (50228-178-01) | ScieGen Pharmaceuticals, Inc. | 50228-178-01 | 50228-178 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (50228-178-05) | ScieGen Pharmaceuticals, Inc. | 50228-178-05 | 50228-178 | ANDA205101 | ANDA | N/A |
| Gabapentin | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (50228-178-30) | ScieGen Pharmaceuticals, Inc. | 50228-178-30 | 50228-178 | ANDA205101 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-179-01) | ScieGen Pharmaceuticals, Inc. | 50228-179-01 | 50228-179 | ANDA204989 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-130-01) | Innogenix, Inc. | 71247-130-01 | 71247-130 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (71247-130-05) | Innogenix, Inc. | 71247-130-05 | 71247-130 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-126-01) | Innogenix, Inc. | 71247-126-01 | 71247-126 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (71247-126-05) | Innogenix, Inc. | 71247-126-05 | 71247-126 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-127-01) | Innogenix, Inc. | 71247-127-01 | 71247-127 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (71247-127-05) | Innogenix, Inc. | 71247-127-05 | 71247-127 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-130-01) | Innogenix, Inc. | 71247-130-01 | 71247-130 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (71247-130-05) | Innogenix, Inc. | 71247-130-05 | 71247-130 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-126-01) | Innogenix, Inc. | 71247-126-01 | 71247-126 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (71247-126-05) | Innogenix, Inc. | 71247-126-05 | 71247-126 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (71247-127-01) | Innogenix, Inc. | 71247-127-01 | 71247-127 | ANDA075215 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (47781-586-29) / 20 Ml In 1 Vial, Multi-Dose | Alvogen Inc. | 47781-586-29 | 47781-586 | ANDA090699 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (47781-586-56) / 40 Ml In 1 Vial, Multi-Dose | Alvogen Inc. | 47781-586-56 | 47781-586 | ANDA090699 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Bag In 1 Box (0143-9366-10) / 200 Ml In 1 Bag (0143-9366-01) | Hikma Pharmaceuticals USA Inc. | 0143-9366-10 | 0143-9366 | NDA213330 | NDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Bag In 1 Box (0143-9363-10) / 100 Ml In 1 Bag (0143-9363-01) | Hikma Pharmaceuticals USA Inc. | 0143-9363-10 | 0143-9363 | NDA213330 | NDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Bag In 1 Box (0143-9364-10) / 200 Ml In 1 Bag (0143-9364-01) | Hikma Pharmaceuticals USA Inc. | 0143-9364-10 | 0143-9364 | NDA213330 | NDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Bag In 1 Box (0143-9365-10) / 300 Ml In 1 Bag (0143-9365-01) | Hikma Pharmaceuticals USA Inc. | 0143-9365-10 | 0143-9365 | NDA213330 | NDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9622-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9622-01 | 0143-9622 | ANDA075303 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9623-01) / 40 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9623-01 | 0143-9623 | ANDA075303 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 1 Vial In 1 Box, Unit-Dose (0143-9320-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9320-01 | 0143-9320 | ANDA075303 | ANDA | N/A |
| Labetalol Hydrochloride | Injection | Intravenous | 5mg/mL | 10 Syringe, Glass In 1 Carton (0641-6252-10) / 2 Ml In 1 Syringe, Glass | Hikma Pharmaceuticals USA Inc. | 0641-6252-10 | 0641-6252 | NDA213330 | NDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-0125-25) / 20 Ml In 1 Vial, Multi-Dose (0409-0125-01) | Hospira, Inc. | 0409-0125-25 | 0409-0125 | ANDA075240 | ANDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-2267-20) / 20 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-2267-20 | 0409-2267 | ANDA075240 | ANDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-2267-54) / 40 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-2267-54 | 0409-2267 | ANDA075240 | ANDA | N/A |
| Labetalol Hydrochloride | Injection, Solution | Intravenous | 5mg/mL | 10 Carton In 1 Package (0409-2339-34) / 1 Cartridge In 1 Carton / 4 Ml In 1 Cartridge (0409-2339-24) | Hospira, Inc. | 0409-2339-34 | 0409-2339 | ANDA075239 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-179-05) | ScieGen Pharmaceuticals, Inc. | 50228-179-05 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle, Plastic (50228-179-10) | ScieGen Pharmaceuticals, Inc. | 50228-179-10 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-179-30) | ScieGen Pharmaceuticals, Inc. | 50228-179-30 | 50228-179 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-180-01) | ScieGen Pharmaceuticals, Inc. | 50228-180-01 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-180-05) | ScieGen Pharmaceuticals, Inc. | 50228-180-05 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle, Plastic (50228-180-10) | ScieGen Pharmaceuticals, Inc. | 50228-180-10 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-180-30) | ScieGen Pharmaceuticals, Inc. | 50228-180-30 | 50228-180 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 100 Capsule In 1 Bottle, Plastic (50228-181-01) | ScieGen Pharmaceuticals, Inc. | 50228-181-01 | 50228-181 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle, Plastic (50228-181-05) | ScieGen Pharmaceuticals, Inc. | 50228-181-05 | 50228-181 | ANDA204989 | ANDA | N/A |
| Gabapentin | Capsule | Oral | 400mg/1 | 30 Capsule In 1 Bottle, Plastic (50228-181-30) | ScieGen Pharmaceuticals, Inc. | 50228-181-30 | 50228-181 | ANDA204989 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (72865-255-05) | XLCare Pharmaceuticals, Inc. | 72865-255-05 | 72865-255 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (72865-255-90) | XLCare Pharmaceuticals, Inc. | 72865-255-90 | 72865-255 | ANDA214957 | ANDA | N/A |
| Lacosamide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Glass In 1 Carton (25021-791-20) / 20 Ml In 1 Vial, Glass | Sagent Pharmaceuticals | 25021-791-20 | 25021-791 | ANDA214301 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-721-60) | Golden State Medical Supply, Inc. | 51407-721-60 | 51407-721 | ANDA204921 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-722-60) | Golden State Medical Supply, Inc. | 51407-722-60 | 51407-722 | ANDA204921 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-723-60) | Golden State Medical Supply, Inc. | 51407-723-60 | 51407-723 | ANDA204921 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-724-60) | Golden State Medical Supply, Inc. | 51407-724-60 | 51407-724 | ANDA204921 | ANDA | CV |
| Lacosamide | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (27808-243-01) | Tris Pharma Inc | 27808-243-01 | 27808-243 | ANDA208308 | ANDA | CV |
| Lacosamide | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (27808-244-01) | Tris Pharma Inc | 27808-244-01 | 27808-244 | ANDA208308 | ANDA | CV |
| Lacosamide | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (27808-245-01) | Tris Pharma Inc | 27808-245-01 | 27808-245 | ANDA208308 | ANDA | CV |
| Lacosamide | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (27808-246-01) | Tris Pharma Inc | 27808-246-01 | 27808-246 | ANDA208308 | ANDA | CV |
| Lacosamide | Solution | Oral | 10mg/mL | 200 Ml In 1 Bottle, Plastic (69315-318-20) | Leading Pharma, LLC | 69315-318-20 | 69315-318 | ANDA216461 | ANDA | CV |
| Lacosamide | Solution | Oral | 10mg/mL | 465 Ml In 1 Bottle, Plastic (69315-318-46) | Leading Pharma, LLC | 69315-318-46 | 69315-318 | ANDA216461 | ANDA | CV |
| GABAPENTIN | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (72865-256-05) | XLCare Pharmaceuticals, Inc. | 72865-256-05 | 72865-256 | ANDA214957 | ANDA | N/A |
| Lacosamide | Injection | Intravenous | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (60505-6235-4) / 20 Ml In 1 Vial, Single-Dose | Apotex Corp | 60505-6235-4 | 60505-6235 | ANDA216670 | ANDA | CV |
| Lacosamide | Solution | Oral | 10mg/mL | 200 Ml In 1 Bottle, Plastic (60505-0405-4) | Apotex Corp. | 60505-0405-4 | 60505-0405 | ANDA206355 | ANDA | CV |
| Lacosamide | Capsule, Extended Release | Oral | 150mg/1 | 60 Capsule, Extended Release In 1 Bottle, Plastic (73289-0064-2) | Aucta Pharmaceuticals, Inc. | 73289-0064-2 | 73289-0064 | NDA216185 | NDA | CV |
| Lacosamide | Capsule, Extended Release | Oral | 200mg/1 | 60 Capsule, Extended Release In 1 Bottle, Plastic (73289-0065-2) | Aucta Pharmaceuticals, Inc. | 73289-0065-2 | 73289-0065 | NDA216185 | NDA | CV |
| Lacosamide | Capsule, Extended Release | Oral | 100mg/1 | 1 Blister Pack In 1 Carton (73289-0063-1) / 14 Capsule, Extended Release In 1 Blister Pack | Aucta Pharmaceuticals, Inc. | 73289-0063-1 | 73289-0063 | NDA216185 | NDA | CV |
| GABAPENTIN | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle (72865-256-90) | XLCare Pharmaceuticals, Inc. | 72865-256-90 | 72865-256 | ANDA214957 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (72865-252-05) | XLCare Pharmaceuticals, Inc. | 72865-252-05 | 72865-252 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 180 Capsule In 1 Bottle (72865-252-18) | XLCare Pharmaceuticals, Inc. | 72865-252-18 | 72865-252 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 270 Capsule In 1 Bottle (72865-252-27) | XLCare Pharmaceuticals, Inc. | 72865-252-27 | 72865-252 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (72865-252-90) | XLCare Pharmaceuticals, Inc. | 72865-252-90 | 72865-252 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (72865-253-05) | XLCare Pharmaceuticals, Inc. | 72865-253-05 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 180 Capsule In 1 Bottle (72865-253-18) | XLCare Pharmaceuticals, Inc. | 72865-253-18 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 270 Capsule In 1 Bottle (72865-253-27) | XLCare Pharmaceuticals, Inc. | 72865-253-27 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (72865-253-30) | XLCare Pharmaceuticals, Inc. | 72865-253-30 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle (72865-253-60) | XLCare Pharmaceuticals, Inc. | 72865-253-60 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (72865-253-90) | XLCare Pharmaceuticals, Inc. | 72865-253-90 | 72865-253 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 400mg/1 | 500 Capsule In 1 Bottle (72865-254-05) | XLCare Pharmaceuticals, Inc. | 72865-254-05 | 72865-254 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 400mg/1 | 270 Capsule In 1 Bottle (72865-254-27) | XLCare Pharmaceuticals, Inc. | 72865-254-27 | 72865-254 | ANDA214956 | ANDA | N/A |
| GABAPENTIN | Capsule | Oral | 400mg/1 | 90 Capsule In 1 Bottle (72865-254-90) | XLCare Pharmaceuticals, Inc. | 72865-254-90 | 72865-254 | ANDA214956 | ANDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 4mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-049-60) | Rising Pharma Holdings, Inc. | 57237-049-60 | 57237-049 | ANDA090957 | ANDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 8mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-050-60) | Rising Pharma Holdings, Inc. | 57237-050-60 | 57237-050 | ANDA090957 | ANDA | N/A |
| Galantamine Hydrobromide | Tablet, Film Coated | Oral | 12mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-051-60) | Rising Pharma Holdings, Inc. | 57237-051-60 | 57237-051 | ANDA090957 | ANDA | N/A |
| Gefitinib | Tablet, Coated | Oral | 250mg/1 | 30 Tablet, Coated In 1 Bottle (50742-366-30) | Ingenus Pharmaceuticals, LLC | 50742-366-30 | 50742-366 | ANDA211591 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (50742-496-26) / 26.3 Ml In 1 Vial, Single-Dose | Ingenus Pharmaceuticals, LLC | 50742-496-26 | 50742-496 | ANDA210383 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (50742-497-53) / 52.6 Ml In 1 Vial, Single-Dose | Ingenus Pharmaceuticals, LLC | 50742-497-53 | 50742-497 | ANDA210383 | ANDA | N/A |
| Gemcitabine Hydrochloride | Injection, Solution | Intravenous | 38mg/mL | 1 Vial, Single-Dose In 1 Carton (50742-498-05) / 5.26 Ml In 1 Vial, Single-Dose | Ingenus Pharmaceuticals, LLC | 50742-498-05 | 50742-498 | ANDA210383 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 1000 Tablet In 1 Bottle (43602-452-10) | Ascent Pharmaceuticals, Inc. | 43602-452-10 | 43602-452 | ANDA214603 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (43602-452-30) | Ascent Pharmaceuticals, Inc. | 43602-452-30 | 43602-452 | ANDA214603 | ANDA | N/A |
| Lactulose | Solution | Oral | 20g/30mL | 5 Tray In 1 Case (66689-038-50) / 10 Cup, Unit-Dose In 1 Tray / 30 Ml In 1 Cup, Unit-Dose (66689-038-01) | VistaPharm, LLC | 66689-038-50 | 66689-038 | ANDA074138 | ANDA | N/A |
| Lactulose | Solution | Oral | 20g/30mL | 10 Tray In 1 Case (66689-038-99) / 10 Cup, Unit-Dose In 1 Tray / 30 Ml In 1 Cup, Unit-Dose (66689-038-01) | VistaPharm, LLC | 66689-038-99 | 66689-038 | ANDA074138 | ANDA | N/A |
| Lactulose | Solution | Oral | 10g/15mL | 5 Tray In 1 Case (66689-039-50) / 10 Cup, Unit-Dose In 1 Tray / 15 Ml In 1 Cup, Unit-Dose (66689-039-01) | VistaPharm, LLC | 66689-039-50 | 66689-039 | ANDA074138 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 1000 Tablet In 1 Bottle (43602-452-10) | Ascent Pharmaceuticals, Inc. | 43602-452-10 | 43602-452 | ANDA214603 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (43602-452-30) | Ascent Pharmaceuticals, Inc. | 43602-452-30 | 43602-452 | ANDA214603 | ANDA | N/A |
| GEMFIBROZIL | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (31722-128-05) | Camber Pharmaceuticals, Inc. | 31722-128-05 | 31722-128 | ANDA214603 | ANDA | N/A |
| GEMFIBROZIL | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (31722-128-60) | Camber Pharmaceuticals, Inc. | 31722-128-60 | 31722-128 | ANDA214603 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (42806-260-05) | Epic Pharma, LLC | 42806-260-05 | 42806-260 | ANDA078012 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 180 Tablet In 1 Bottle (42806-260-18) | Epic Pharma, LLC | 42806-260-18 | 42806-260 | ANDA078012 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (66993-478-60) | Prasco Laboratories | 66993-478-60 | 66993-478 | NDA021003 | NDA AUTHORIZED GENERIC | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (60429-353-60) | Golden State Medical Supply, Inc. | 60429-353-60 | 60429-353 | ANDA091606 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-354-30) | Golden State Medical Supply, Inc. | 60429-354-30 | 60429-354 | ANDA091606 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-3250-6) | Apotex Corp. | 60505-3250-6 | 60505-3250 | ANDA202941 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (60505-3251-6) | Apotex Corp. | 60505-3251-6 | 60505-3251 | ANDA091606 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3251-8) | Apotex Corp. | 60505-3251-8 | 60505-3251 | ANDA091606 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3252-3) | Apotex Corp. | 60505-3252-3 | 60505-3252 | ANDA091606 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3252-8) | Apotex Corp. | 60505-3252-8 | 60505-3252 | ANDA091606 | ANDA | N/A |
| Gemfibrozil | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (42806-260-60) | Epic Pharma, LLC | 42806-260-60 | 42806-260 | ANDA078012 | ANDA | N/A |
| Gemfibrozil | Tablet, Film Coated | Oral | 600mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-784-06) | Rising Pharma Holdings, Inc. | 16571-784-06 | 16571-784 | ANDA202726 | ANDA | N/A |
| Gemfibrozil | Tablet, Film Coated | Oral | 600mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-784-50) | Rising Pharma Holdings, Inc. | 16571-784-50 | 16571-784 | ANDA202726 | ANDA | N/A |
| GEMFIBROZIL | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (72865-186-05) | XLCare Pharmaceuticals, Inc. | 72865-186-05 | 72865-186 | ANDA214603 | ANDA | N/A |
| GEMFIBROZIL | Tablet | Oral | 600mg/1 | 180 Tablet In 1 Bottle (72865-186-18) | XLCare Pharmaceuticals, Inc. | 72865-186-18 | 72865-186 | ANDA214603 | ANDA | N/A |
| GEMFIBROZIL | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (72865-186-60) | XLCare Pharmaceuticals, Inc. | 72865-186-60 | 72865-186 | ANDA214603 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (16571-773-01) | Rising Pharma Holdings, Inc. | 16571-773-01 | 16571-773 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (16571-773-50) | Rising Pharma Holdings, Inc. | 16571-773-50 | 16571-773 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (16571-774-01) | Rising Pharma Holdings, Inc. | 16571-774-01 | 16571-774 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (16571-774-50) | Rising Pharma Holdings, Inc. | 16571-774-50 | 16571-774 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (16571-775-01) | Rising Pharma Holdings, Inc. | 16571-775-01 | 16571-775 | ANDA202759 | ANDA | N/A |
| Glimepiride | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (16571-775-50) | Rising Pharma Holdings, Inc. | 16571-775-50 | 16571-775 | ANDA202759 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-543-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-543-30 | 60760-543 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 10 Blister Pack In 1 Carton (51672-4130-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4130-0 | 51672-4130 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (51672-4130-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4130-1 | 51672-4130 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (51672-4130-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4130-3 | 51672-4130 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 60 Tablet In 1 Bottle (51672-4130-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4130-4 | 51672-4130 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (51672-4130-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4130-6 | 51672-4130 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (51672-4131-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4131-0 | 51672-4131 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (51672-4131-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4131-1 | 51672-4131 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (51672-4131-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4131-3 | 51672-4131 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (51672-4131-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4131-4 | 51672-4131 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51672-4131-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4131-6 | 51672-4131 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 10 Blister Pack In 1 Carton (51672-4132-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-0 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (51672-4132-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-1 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (51672-4132-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-2 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (51672-4132-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-3 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (51672-4132-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-4 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (51672-4132-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4132-6 | 51672-4132 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 10 Blister Pack In 1 Carton (51672-4133-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-0 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51672-4133-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-1 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51672-4133-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-2 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51672-4133-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-3 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (51672-4133-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-4 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (51672-4133-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4133-6 | 51672-4133 | ANDA078525 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (59746-245-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-245-01 | 59746-245 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (59746-245-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-245-05 | 59746-245 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (59746-245-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-245-10 | 59746-245 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (59746-246-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-246-01 | 59746-246 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (59746-246-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-246-10 | 59746-246 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (59746-247-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-247-05 | 59746-247 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (59746-247-60) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-247-60 | 59746-247 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (59746-248-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-248-05 | 59746-248 | ANDA079132 | ANDA | N/A |
| Lamotrigine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (59746-248-60) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-248-60 | 59746-248 | ANDA079132 | ANDA | N/A |
| Glipizide | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (62559-315-10) | ANI Pharmaceuticals, Inc. | 62559-315-10 | 62559-315 | ANDA074497 | ANDA | N/A |
| Glipizide | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (62559-316-10) | ANI Pharmaceuticals, Inc. | 62559-316-10 | 62559-316 | ANDA074497 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 2.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-279-03) | Rising Pharma Holdings, Inc. | 64980-279-03 | 64980-279 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-280-01) | Rising Pharma Holdings, Inc. | 64980-280-01 | 64980-280 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-280-05) | Rising Pharma Holdings, Inc. | 64980-280-05 | 64980-280 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-280-10) | Rising Pharma Holdings, Inc. | 64980-280-10 | 64980-280 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-281-01) | Rising Pharma Holdings, Inc. | 64980-281-01 | 64980-281 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-281-05) | Rising Pharma Holdings, Inc. | 64980-281-05 | 64980-281 | ANDA204720 | ANDA | N/A |
| Glipizide | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (64980-281-10) | Rising Pharma Holdings, Inc. | 64980-281-10 | 64980-281 | ANDA204720 | ANDA | N/A |
| Glutamine | Powder, For Solution | Oral | 5g/1 | 60 Packet In 1 Carton (70954-417-20) / 1 Powder, For Solution In 1 Packet (70954-417-10) | ANI Pharmaceuticals, Inc. | 70954-417-20 | 70954-417 | ANDA215647 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 1.25mg/1, 250 mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-023-01) | Rising Pharma Holdings, Inc. | 57237-023-01 | 57237-023 | ANDA077870 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 1.25mg/1, 250 mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-023-05) | Rising Pharma Holdings, Inc. | 57237-023-05 | 57237-023 | ANDA077870 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1, 500 mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-024-01) | Rising Pharma Holdings, Inc. | 57237-024-01 | 57237-024 | ANDA077870 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1, 500 mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-024-05) | Rising Pharma Holdings, Inc. | 57237-024-05 | 57237-024 | ANDA077870 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 5mg/1, 500 mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-025-01) | Rising Pharma Holdings, Inc. | 57237-025-01 | 57237-025 | ANDA077870 | ANDA | N/A |
| Glyburide; Metformin Hydrochloride | Tablet, Film Coated | Oral | 5mg/1, 500 mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-025-05) | Rising Pharma Holdings, Inc. | 57237-025-05 | 57237-025 | ANDA077870 | ANDA | N/A |
| Glycerin | Suppository | Rectal | 2g/1 | 2 Blister Pack In 1 Carton (57237-325-21) / 6 Suppository In 1 Blister Pack (57237-325-16) | Rising Pharma Holdings, Inc. | 57237-325-21 | 57237-325 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Glycerin | Suppository | Rectal | 2g/1 | 5 Blister Pack In 1 Carton (57237-325-52) / 5 Suppository In 1 Blister Pack (57237-325-51) | Rising Pharma Holdings, Inc. | 57237-325-52 | 57237-325 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Glycerin | Suppository | Rectal | 1.2g/1 | 2 Blister Pack In 1 Carton (57237-326-21) / 6 Suppository In 1 Blister Pack (57237-326-16) | Rising Pharma Holdings, Inc. | 57237-326-21 | 57237-326 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Glycerin | Suppository | Rectal | 1.2g/1 | 5 Blister Pack In 1 Carton (57237-326-52) / 5 Suppository In 1 Blister Pack (57237-326-51) | Rising Pharma Holdings, Inc. | 57237-326-52 | 57237-326 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 10 Syringe, Glass In 1 Carton (70121-1698-7) / 1 Ml In 1 Syringe, Glass (70121-1698-1) | Amneal Pharmaceuticals LLC | 70121-1698-7 | 70121-1698 | ANDA215333 | ANDA | N/A |
| Glycopyrrolate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 10 Syringe, Glass In 1 Carton (70121-1699-7) / 2 Ml In 1 Syringe, Glass (70121-1699-1) | Amneal Pharmaceuticals LLC | 70121-1699-7 | 70121-1699 | ANDA215333 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 1 Bottle In 1 Carton (45802-878-01) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-878-01 | 45802-878 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 2 Bottle In 1 Carton (45802-878-02) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-878-02 | 45802-878 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 3 Bottle In 1 Carton (45802-878-03) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-878-03 | 45802-878 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 1 Bottle In 1 Carton (45802-245-01) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-245-01 | 45802-245 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 2 Bottle In 1 Carton (45802-245-02) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-245-02 | 45802-245 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 3 Bottle In 1 Carton (45802-245-03) / 14 Capsule, Delayed Release In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-245-03 | 45802-245 | ANDA202319 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 30mg/1 | 100 Capsule, Delayed Release In 1 Bottle (51407-324-01) | Golden State Medical Supply, Inc. | 51407-324-01 | 51407-324 | ANDA203203 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 1 Bottle In 1 Carton (21130-046-14) / 14 Capsule, Delayed Release In 1 Bottle | Albertsons Companies | 21130-046-14 | 21130-046 | ANDA202194 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 3 Bottle In 1 Carton (21130-046-42) / 14 Capsule, Delayed Release In 1 Bottle | Albertsons Companies | 21130-046-42 | 21130-046 | ANDA202194 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .2mg/mL | 25 Vial In 1 Carton (70121-1394-5) / 1 Ml In 1 Vial (70121-1394-1) | Amneal Pharmaceuticals LLC | 70121-1394-5 | 70121-1394 | ANDA208973 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | .4mg/2mL | 25 Vial In 1 Carton (70121-1395-5) / 2 Ml In 1 Vial (70121-1395-1) | Amneal Pharmaceuticals LLC | 70121-1395-5 | 70121-1395 | ANDA208973 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | 1mg/5mL | 25 Vial In 1 Carton (70121-1396-5) / 5 Ml In 1 Vial (70121-1396-1) | Amneal Pharmaceuticals LLC | 70121-1396-5 | 70121-1396 | ANDA208973 | ANDA | N/A |
| Glycopyrrolate | Injection | Intramuscular; Intravenous | 4mg/20mL | 10 Vial In 1 Carton (70121-1397-7) / 20 Ml In 1 Vial (70121-1397-1) | Amneal Pharmaceuticals LLC | 70121-1397-7 | 70121-1397 | ANDA208973 | ANDA | N/A |
| Glycopyrrolate | Solution | Oral | 1mg/5mL | 1 Bottle In 1 Carton (31722-016-47) / 473 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-016-47 | 31722-016 | ANDA213698 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Container (16571-743-03) | Rising Pharma Holdings, Inc. | 16571-743-03 | 16571-743 | NDA012827 | NDA AUTHORIZED GENERIC | N/A |
| Glycopyrrolate | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Container (16571-743-09) | Rising Pharma Holdings, Inc. | 16571-743-09 | 16571-743 | NDA012827 | NDA AUTHORIZED GENERIC | N/A |
| Lanthanum Carbonate | Tablet, Chewable | Oral | 500mg/1 | 2 Bottle In 1 Package (66993-422-85) / 45 Tablet, Chewable In 1 Bottle (66993-422-47) | Prasco Laboratories | 66993-422-85 | 66993-422 | NDA021468 | NDA AUTHORIZED GENERIC | N/A |
| Lanthanum Carbonate | Tablet, Chewable | Oral | 750mg/1 | 6 Bottle In 1 Package (66993-423-85) / 15 Tablet, Chewable In 1 Bottle (66993-423-53) | Prasco Laboratories | 66993-423-85 | 66993-423 | NDA021468 | NDA AUTHORIZED GENERIC | N/A |
| Lanthanum Carbonate | Tablet, Chewable | Oral | 1000mg/1 | 9 Bottle In 1 Package (66993-424-85) / 10 Tablet, Chewable In 1 Bottle (66993-424-75) | Prasco Laboratories | 66993-424-85 | 66993-424 | NDA021468 | NDA AUTHORIZED GENERIC | N/A |
| Latanoprost | Solution/ Drops | Ophthalmic | 50ug/mL | 1 Bottle In 1 Carton (70069-421-01) / 2.5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-421-01 | 70069-421 | ANDA201786 | ANDA | N/A |
| Latanoprost | Solution/ Drops | Ophthalmic | 50ug/mL | 3 Bottle In 1 Carton (70069-421-03) / 2.5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-421-03 | 70069-421 | ANDA201786 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Container (16571-744-03) | Rising Pharma Holdings, Inc. | 16571-744-03 | 16571-744 | NDA012827 | NDA AUTHORIZED GENERIC | N/A |
| Latanoprost | Solution | Ophthalmic | 50ug/mL | 1 Bottle, Dropper In 1 Carton (0013-8303-04) / 2.5 Ml In 1 Bottle, Dropper | PFIZER LABORATORIES DIV PFIZER INC | 0013-8303-04 | 0013-8303 | NDA020597 | NDA | N/A |
| Leflunomide | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (10702-277-03) | KVK-Tech, Inc. | 10702-277-03 | 10702-277 | ANDA212453 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (10702-278-03) | KVK-Tech, Inc. | 10702-278-03 | 10702-278 | ANDA212453 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (60505-2502-1) | Apotex Corp. | 60505-2502-1 | 60505-2502 | ANDA077090 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60505-2502-2) | Apotex Corp. | 60505-2502-2 | 60505-2502 | ANDA077090 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-2502-3) | Apotex Corp. | 60505-2502-3 | 60505-2502 | ANDA077090 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (60505-2503-1) | Apotex Corp. | 60505-2503-1 | 60505-2503 | ANDA077090 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (60505-2503-2) | Apotex Corp. | 60505-2503-2 | 60505-2503 | ANDA077090 | ANDA | N/A |
| Leflunomide | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (60505-2503-3) | Apotex Corp. | 60505-2503-3 | 60505-2503 | ANDA077090 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 2.5mg/1 | 28 Capsule In 1 Bottle (60505-4532-2) | Apotex Corp. | 60505-4532-2 | 60505-4532 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 5mg/1 | 28 Capsule In 1 Bottle (60505-4533-2) | Apotex Corp. | 60505-4533-2 | 60505-4533 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 10mg/1 | 28 Capsule In 1 Bottle (60505-4534-2) | Apotex Corp. | 60505-4534-2 | 60505-4534 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 15mg/1 | 21 Capsule In 1 Bottle (60505-4535-2) | Apotex Corp. | 60505-4535-2 | 60505-4535 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 20mg/1 | 21 Capsule In 1 Bottle (60505-4536-2) | Apotex Corp. | 60505-4536-2 | 60505-4536 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 25mg/1 | 21 Capsule In 1 Bottle (60505-4537-2) | Apotex Corp. | 60505-4537-2 | 60505-4537 | ANDA211022 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (47781-483-01) | Alvogen, Inc. | 47781-483-01 | 47781-483 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 2.5mg/1 | 28 Capsule In 1 Bottle (47781-483-28) | Alvogen, Inc. | 47781-483-28 | 47781-483 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (47781-484-01) | Alvogen, Inc. | 47781-484-01 | 47781-484 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 5mg/1 | 28 Capsule In 1 Bottle (47781-484-28) | Alvogen, Inc. | 47781-484-28 | 47781-484 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (47781-485-01) | Alvogen, Inc. | 47781-485-01 | 47781-485 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 10mg/1 | 28 Capsule In 1 Bottle (47781-485-28) | Alvogen, Inc. | 47781-485-28 | 47781-485 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 15mg/1 | 100 Capsule In 1 Bottle (47781-486-01) | Alvogen, Inc. | 47781-486-01 | 47781-486 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 15mg/1 | 21 Capsule In 1 Bottle (47781-486-77) | Alvogen, Inc. | 47781-486-77 | 47781-486 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (47781-487-01) | Alvogen, Inc. | 47781-487-01 | 47781-487 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 20mg/1 | 21 Capsule In 1 Bottle (47781-487-77) | Alvogen, Inc. | 47781-487-77 | 47781-487 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (47781-488-01) | Alvogen, Inc. | 47781-488-01 | 47781-488 | ANDA210480 | ANDA | N/A |
| Lenalidomide | Capsule | Oral | 25mg/1 | 21 Capsule In 1 Bottle (47781-488-77) | Alvogen, Inc. | 47781-488-77 | 47781-488 | ANDA210480 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 50mg/5mL | 1 Vial, Single-Dose In 1 Carton (71288-160-10) / 5 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-160-10 | 71288-160 | ANDA216590 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 100mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-161-20) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-161-20 | 71288-161 | ANDA216590 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 200mg/20mL | 1 Vial, Single-Dose In 1 Carton (71288-162-30) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-162-30 | 71288-162 | ANDA216590 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 350mg/17.5mL | 1 Vial, Single-Dose In 1 Carton (71288-163-30) / 17.5 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-163-30 | 71288-163 | ANDA216590 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 500mg/50mL | 1 Vial, Single-Dose In 1 Carton (71288-164-50) / 50 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-164-50 | 71288-164 | ANDA216590 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 50mg/5mL | 10 Vial In 1 Carton (25021-813-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-813-10 | 25021-813 | ANDA200753 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 100mg/10mL | 1 Vial In 1 Carton (25021-814-30) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-814-30 | 25021-814 | ANDA200753 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 200mg/20mL | 1 Vial In 1 Carton (25021-815-30) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-815-30 | 25021-815 | ANDA200753 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 350mg/17.5mL | 1 Vial In 1 Carton (25021-816-30) / 17.5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-816-30 | 25021-816 | ANDA200855 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 500mg/50mL | 1 Vial In 1 Carton (25021-828-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-828-50 | 25021-828 | ANDA209110 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (69315-184-01) | Leading Pharma, LLC | 69315-184-01 | 69315-184 | ANDA213929 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (69315-184-03) | Leading Pharma, LLC | 69315-184-03 | 69315-184 | ANDA213929 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 12 Tablet In 1 Bottle (69315-185-12) | Leading Pharma, LLC | 69315-185-12 | 69315-185 | ANDA213929 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 24 Tablet In 1 Bottle (69315-185-24) | Leading Pharma, LLC | 69315-185-24 | 69315-185 | ANDA213929 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 15mg/1 | 24 Tablet In 1 Bottle (69315-186-24) | Leading Pharma, LLC | 69315-186-24 | 69315-186 | ANDA213929 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 25mg/1 | 25 Tablet In 1 Bottle (69315-187-25) | Leading Pharma, LLC | 69315-187-25 | 69315-187 | ANDA213929 | ANDA | N/A |
| Glycopyrrolate | Tablet | Oral | 2mg/1 | 90 Tablet In 1 Container (16571-744-09) | Rising Pharma Holdings, Inc. | 16571-744-09 | 16571-744 | NDA012827 | NDA AUTHORIZED GENERIC | N/A |
| Granisetron | Patch | Transdermal | 3.1mg/24h | 168 H In 1 Pouch (66220-637-31) | Cumberland Pharmaceuticals Inc. | 66220-637-31 | 66220-637 | NDA022198 | NDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 600mg/1 | 2 Blister Pack In 1 Carton (65162-036-02) / 10 Tablet, Extended Release In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-036-02 | 65162-036 | ANDA207342 | ANDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 600mg/1 | 1 Bottle In 1 Carton (65162-036-03) / 30 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-036-03 | 65162-036 | ANDA207342 | ANDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 600mg/1 | 1 Bottle In 1 Carton (65162-036-06) / 60 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-036-06 | 65162-036 | ANDA207342 | ANDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 1200mg/1 | 1 Bottle In 1 Carton (65162-037-03) / 30 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-037-03 | 65162-037 | ANDA207342 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 350mg/17.5mL | 1 Vial In 1 Box, Unit-Dose (0143-9552-01) / 17.5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9552-01 | 0143-9552 | ANDA040335 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 200mg/20mL | 1 Vial In 1 Box, Unit-Dose (0143-9553-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9553-01 | 0143-9553 | ANDA040056 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 100mg/10mL | 1 Vial In 1 Box (0143-9554-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9554-01 | 0143-9554 | ANDA089717 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 50mg/5mL | 1 Vial In 1 Box (0143-9555-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9555-01 | 0143-9555 | ANDA089384 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 5 Blister Pack In 1 Carton (0054-8496-19) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8496-19 | 0054-8496 | ANDA072733 | ANDA | N/A |
| Leucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 200mg/20mL | 1 Vial In 1 Box, Unit-Dose (0143-9368-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9368-01 | 0143-9368 | ANDA040056 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (0054-4496-13) | Hikma Pharmaceuticals USA Inc. | 0054-4496-13 | 0054-4496 | ANDA072733 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0054-4496-25) | Hikma Pharmaceuticals USA Inc. | 0054-4496-25 | 0054-4496 | ANDA072733 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 12 Tablet In 1 Bottle (0054-4497-05) | Hikma Pharmaceuticals USA Inc. | 0054-4497-05 | 0054-4497 | ANDA072734 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 24 Tablet In 1 Bottle (0054-4497-10) | Hikma Pharmaceuticals USA Inc. | 0054-4497-10 | 0054-4497 | ANDA072734 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 15mg/1 | 24 Tablet In 1 Bottle (0054-4498-10) | Hikma Pharmaceuticals USA Inc. | 0054-4498-10 | 0054-4498 | ANDA072735 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 25mg/1 | 25 Tablet In 1 Bottle (0054-4499-11) | Hikma Pharmaceuticals USA Inc. | 0054-4499-11 | 0054-4499 | ANDA072736 | ANDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 1200mg/1 | 1 Bottle In 1 Carton (65162-037-06) / 60 Tablet, Extended Release In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-037-06 | 65162-037 | ANDA207342 | ANDA | N/A |
| Guaifenesin | Tablet, Extended Release | Oral | 1200mg/1 | 2 Blister Pack In 1 Carton (65162-037-28) / 14 Tablet, Extended Release In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-037-28 | 65162-037 | ANDA207342 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle (65162-711-03) | Amneal Pharmaceuticals LLC | 65162-711-03 | 65162-711 | ANDA075109 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (65162-711-10) | Amneal Pharmaceuticals LLC | 65162-711-10 | 65162-711 | ANDA075109 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (65162-713-03) | Amneal Pharmaceuticals LLC | 65162-713-03 | 65162-713 | ANDA075109 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (65162-713-10) | Amneal Pharmaceuticals LLC | 65162-713-10 | 65162-713 | ANDA075109 | ANDA | N/A |
| Leuprolide Acetate | Injection, Suspension, Extended Release | Subcutaneous | 22.5mg/.375mL | 1 Syringe In 1 Carton (62935-227-10) / .375 Ml In 1 Syringe | TOLMAR Inc. | 62935-227-10 | 62935-227 | NDA021379 | NDA | N/A |
| Leuprolide Acetate | Injection, Suspension, Extended Release | Subcutaneous | 30mg/.5mL | 1 Syringe In 1 Carton (62935-306-40) / .5 Ml In 1 Syringe | TOLMAR Inc. | 62935-306-40 | 62935-306 | NDA021488 | NDA | N/A |
| Leuprolide Acetate | Injection, Suspension, Extended Release | Subcutaneous | 45mg/.375mL | 1 Syringe In 1 Carton (62935-461-50) / .375 Ml In 1 Syringe | TOLMAR Inc. | 62935-461-50 | 62935-461 | NDA021731 | NDA | N/A |
| Leuprolide Acetate | Injection, Suspension, Extended Release | Subcutaneous | 7.5mg/.25mL | 1 Syringe In 1 Carton (62935-756-80) / .25 Ml In 1 Syringe | TOLMAR Inc. | 62935-756-80 | 62935-756 | NDA021343 | NDA | N/A |
| Leuprolide Acetate | Injection, Suspension, Extended Release | Subcutaneous | 45mg/.375mL | 1 Syringe In 1 Carton (62935-163-60) / .375 Ml In 1 Syringe | TOLMAR Inc. | 62935-163-60 | 62935-163 | NDA213150 | NDA | N/A |
| Levetiracetam | Injection | Intravenous | 5mg/mL | 10 Bag In 1 Carton (14789-110-05) / 100 Ml In 1 Bag (14789-110-08) | Nexus Pharmaceuticals LLC | 14789-110-05 | 14789-110 | ANDA213532 | ANDA | N/A |
| Levetiracetam | Injection | Intravenous | 10mg/mL | 10 Bag In 1 Carton (14789-220-10) / 100 Ml In 1 Bag (14789-220-08) | Nexus Pharmaceuticals LLC | 14789-220-10 | 14789-220 | ANDA213532 | ANDA | N/A |
| Levetiracetam | Injection | Intravenous | 15mg/mL | 10 Bag In 1 Carton (14789-330-15) / 100 Ml In 1 Bag (14789-330-08) | Nexus Pharmaceuticals LLC | 14789-330-15 | 14789-330 | ANDA213532 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (75834-245-05) | Nivagen Pharmaceuticals, Inc. | 75834-245-05 | 75834-245 | ANDA201464 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (75834-245-60) | Nivagen Pharmaceuticals, Inc. | 75834-245-60 | 75834-245 | ANDA201464 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (75834-246-05) | Nivagen Pharmaceuticals, Inc. | 75834-246-05 | 75834-246 | ANDA201464 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (75834-246-60) | Nivagen Pharmaceuticals, Inc. | 75834-246-60 | 75834-246 | ANDA201464 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (65162-713-50) | Amneal Pharmaceuticals LLC | 65162-713-50 | 65162-713 | ANDA075109 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (42806-296-01) | Epic Pharma, LLC | 42806-296-01 | 42806-296 | ANDA074673 | ANDA | N/A |
| Guanfacine Hydrochloride | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (42806-048-01) | Epic Pharma, LLC | 42806-048-01 | 42806-048 | ANDA074673 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (50228-182-01) | ScieGen Pharmaceuticals, Inc. | 50228-182-01 | 50228-182 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-182-10) | ScieGen Pharmaceuticals, Inc. | 50228-182-10 | 50228-182 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (50228-183-01) | ScieGen Pharmaceuticals, Inc. | 50228-183-01 | 50228-183 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-183-10) | ScieGen Pharmaceuticals, Inc. | 50228-183-10 | 50228-183 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (50228-184-01) | ScieGen Pharmaceuticals, Inc. | 50228-184-01 | 50228-184 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (50228-184-10) | ScieGen Pharmaceuticals, Inc. | 50228-184-10 | 50228-184 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (50228-185-01) | ScieGen Pharmaceuticals, Inc. | 50228-185-01 | 50228-185 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (50228-185-10) | ScieGen Pharmaceuticals, Inc. | 50228-185-10 | 50228-185 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (50228-182-01) | ScieGen Pharmaceuticals, Inc. | 50228-182-01 | 50228-182 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (50228-182-10) | ScieGen Pharmaceuticals, Inc. | 50228-182-10 | 50228-182 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (50228-183-01) | ScieGen Pharmaceuticals, Inc. | 50228-183-01 | 50228-183 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-183-10) | ScieGen Pharmaceuticals, Inc. | 50228-183-10 | 50228-183 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (50228-184-01) | ScieGen Pharmaceuticals, Inc. | 50228-184-01 | 50228-184 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (50228-184-10) | ScieGen Pharmaceuticals, Inc. | 50228-184-10 | 50228-184 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (50228-185-01) | ScieGen Pharmaceuticals, Inc. | 50228-185-01 | 50228-185 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (50228-185-10) | ScieGen Pharmaceuticals, Inc. | 50228-185-10 | 50228-185 | ANDA205236 | ANDA | N/A |
| Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet | Oral | 37.5mg/1, 20 mg/1 | 180 Tablet In 1 Bottle (50742-246-18) | Ingenus Pharmaceuticals, LLC | 50742-246-18 | 50742-246 | ANDA215586 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 5 Ml In 1 Cup, Unit-Dose (39328-511-05) | Patrin Pharma, Inc. | 39328-511-05 | 39328-511 | ANDA078582 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 3 Tray In 1 Case (39328-511-30) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose | Patrin Pharma, Inc. | 39328-511-30 | 39328-511 | ANDA078582 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 4 Tray In 1 Case (39328-511-40) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose | Patrin Pharma, Inc. | 39328-511-40 | 39328-511 | ANDA078582 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 5 Tray In 1 Case (39328-511-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose | Patrin Pharma, Inc. | 39328-511-50 | 39328-511 | ANDA078582 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (76494-528-12) | Prinston Pharmaceutical Inc. | 76494-528-12 | 76494-528 | ANDA078106 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (76494-529-12) | Prinston Pharmaceutical Inc. | 76494-529-12 | 76494-529 | ANDA078106 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (76494-530-12) | Prinston Pharmaceutical Inc. | 76494-530-12 | 76494-530 | ANDA078106 | ANDA | N/A |
| Levetiracetam | Injection, Solution, Concentrate | Intravenous | 500mg/5mL | 10 Vial In 1 Carton (25021-780-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-780-05 | 25021-780 | ANDA091627 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (60429-349-60) | Golden State Medical Supply, Inc. | 60429-349-60 | 60429-349 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (60429-350-60) | Golden State Medical Supply, Inc. | 60429-350-60 | 60429-350 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 3785 Ml In 1 Bottle (51672-4136-0) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4136-0 | 51672-4136 | ANDA078774 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 100 Ml In 1 Bottle (51672-4136-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4136-7 | 51672-4136 | ANDA078774 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 473 Ml In 1 Bottle (51672-4136-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4136-9 | 51672-4136 | ANDA078774 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (51672-4137-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4137-4 | 51672-4137 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4137-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4137-6 | 51672-4137 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 750 Tablet, Film Coated In 1 Bottle (51672-4137-8) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4137-8 | 51672-4137 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 10 Blister Pack In 1 Carton (51672-4141-0) / 10 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4141-0 | 51672-4141 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (51672-4141-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4141-1 | 51672-4141 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51672-4141-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4141-3 | 51672-4141 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4141-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4141-6 | 51672-4141 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 10 Blister Pack In 1 Carton (51672-4142-0) / 10 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4142-0 | 51672-4142 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (51672-4142-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4142-1 | 51672-4142 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51672-4142-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4142-3 | 51672-4142 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4142-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4142-6 | 51672-4142 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 10 Blister Pack In 1 Carton (51672-4143-0) / 10 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4143-0 | 51672-4143 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (51672-4143-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4143-1 | 51672-4143 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 1000 Tablet, Film Coated In 1 Bottle (51672-4143-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4143-3 | 51672-4143 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4143-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4143-6 | 51672-4143 | ANDA078960 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 250mg/1 | 120 Tablet In 1 Bottle (27808-263-01) | Tris Pharma Inc | 27808-263-01 | 27808-263 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (27808-263-02) | Tris Pharma Inc | 27808-263-02 | 27808-263 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 500mg/1 | 120 Tablet In 1 Bottle (27808-264-01) | Tris Pharma Inc | 27808-264-01 | 27808-264 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (27808-264-02) | Tris Pharma Inc | 27808-264-02 | 27808-264 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 750mg/1 | 120 Tablet In 1 Bottle (27808-265-01) | Tris Pharma Inc | 27808-265-01 | 27808-265 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (27808-265-02) | Tris Pharma Inc | 27808-265-02 | 27808-265 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet | Oral | 1000mg/1 | 60 Tablet In 1 Bottle (27808-266-01) | Tris Pharma Inc | 27808-266-01 | 27808-266 | ANDA091491 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3518-6) | Apotex Corp. | 60505-3518-6 | 60505-3518 | ANDA202958 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3280-5) | Apotex Corp. | 60505-3280-5 | 60505-3280 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3280-6) | Apotex Corp. | 60505-3280-6 | 60505-3280 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3280-8) | Apotex Corp. | 60505-3280-8 | 60505-3280 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3517-5) | Apotex Corp. | 60505-3517-5 | 60505-3517 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (60505-3517-6) | Apotex Corp. | 60505-3517-6 | 60505-3517 | ANDA091261 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 473 Ml In 1 Bottle (69452-412-88) | Bionpharma Inc. | 69452-412-88 | 69452-412 | ANDA079120 | ANDA | N/A |
| Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet | Oral | 37.5mg/1, 20 mg/1 | 90 Tablet In 1 Bottle (50742-246-90) | Ingenus Pharmaceuticals, LLC | 50742-246-90 | 50742-246 | ANDA215586 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 100 Capsule In 1 Bottle (57237-002-01) | Rising Pharma Holdings, Inc. | 57237-002-01 | 57237-002 | ANDA078164 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 500 Capsule In 1 Bottle (57237-002-05) | Rising Pharma Holdings, Inc. | 57237-002-05 | 57237-002 | ANDA078164 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 1000 Capsule In 1 Bottle (57237-002-99) | Rising Pharma Holdings, Inc. | 57237-002-99 | 57237-002 | ANDA078164 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 100 Capsule In 1 Bottle (50228-146-01) | ScieGen Pharmaceuticals Inc | 50228-146-01 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 500 Capsule In 1 Bottle (50228-146-05) | ScieGen Pharmaceuticals Inc | 50228-146-05 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 1000 Capsule In 1 Bottle (50228-146-10) | ScieGen Pharmaceuticals Inc | 50228-146-10 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 30 Capsule In 1 Bottle (50228-146-30) | ScieGen Pharmaceuticals Inc | 50228-146-30 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 100 Capsule In 1 Bottle (50228-146-01) | ScieGen Pharmaceuticals Inc | 50228-146-01 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 500 Capsule In 1 Bottle (50228-146-05) | ScieGen Pharmaceuticals Inc | 50228-146-05 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 1000 Capsule In 1 Bottle (50228-146-10) | ScieGen Pharmaceuticals Inc | 50228-146-10 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Capsule | Oral | 12.5mg/1 | 30 Capsule In 1 Bottle (50228-146-30) | ScieGen Pharmaceuticals Inc | 50228-146-30 | 50228-146 | ANDA203561 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-111-10) | ScieGen Pharmaceuticals, Inc. | 50228-111-10 | 50228-111 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (50228-111-30) | ScieGen Pharmaceuticals, Inc. | 50228-111-30 | 50228-111 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (50228-112-10) | ScieGen Pharmaceuticals, Inc. | 50228-112-10 | 50228-112 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (50228-112-30) | ScieGen Pharmaceuticals, Inc. | 50228-112-30 | 50228-112 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (50228-111-10) | ScieGen Pharmaceuticals, Inc. | 50228-111-10 | 50228-111 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (50228-111-30) | ScieGen Pharmaceuticals, Inc. | 50228-111-30 | 50228-111 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (50228-112-10) | ScieGen Pharmaceuticals, Inc. | 50228-112-10 | 50228-112 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (50228-112-30) | ScieGen Pharmaceuticals, Inc. | 50228-112-30 | 50228-112 | ANDA203018 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 80 mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-845-03) | Amneal Pharmaceuticals LLC | 65162-845-03 | 65162-845 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 80 mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-845-09) | Amneal Pharmaceuticals LLC | 65162-845-09 | 65162-845 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 80 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-845-11) | Amneal Pharmaceuticals LLC | 65162-845-11 | 65162-845 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 80 mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-845-50) | Amneal Pharmaceuticals LLC | 65162-845-50 | 65162-845 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 160 mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-846-03) | Amneal Pharmaceuticals LLC | 65162-846-03 | 65162-846 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 160 mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-846-09) | Amneal Pharmaceuticals LLC | 65162-846-09 | 65162-846 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 160 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-846-11) | Amneal Pharmaceuticals LLC | 65162-846-11 | 65162-846 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 12.5mg/1, 160 mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-846-50) | Amneal Pharmaceuticals LLC | 65162-846-50 | 65162-846 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 25mg/1, 160 mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-847-03) | Amneal Pharmaceuticals LLC | 65162-847-03 | 65162-847 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 25mg/1, 160 mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-847-09) | Amneal Pharmaceuticals LLC | 65162-847-09 | 65162-847 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 25mg/1, 160 mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-847-11) | Amneal Pharmaceuticals LLC | 65162-847-11 | 65162-847 | ANDA204382 | ANDA | N/A |
| Hydrochlorothiazide; Valsartan | Tablet, Film Coated | Oral | 25mg/1, 160 mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-847-50) | Amneal Pharmaceuticals LLC | 65162-847-50 | 65162-847 | ANDA204382 | ANDA | N/A |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (31722-996-01) | Camber Pharmaceuticals, Inc. | 31722-996-01 | 31722-996 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (31722-996-05) | Camber Pharmaceuticals, Inc. | 31722-996-05 | 31722-996 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (31722-997-01) | Camber Pharmaceuticals, Inc. | 31722-997-01 | 31722-997 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (31722-997-05) | Camber Pharmaceuticals, Inc. | 31722-997-05 | 31722-997 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (72865-201-01) | XLCare Pharmaceuticals, Inc. | 72865-201-01 | 72865-201 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (72865-202-01) | XLCare Pharmaceuticals, Inc. | 72865-202-01 | 72865-202 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (72865-202-05) | XLCare Pharmaceuticals, Inc. | 72865-202-05 | 72865-202 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (72865-203-01) | XLCare Pharmaceuticals, Inc. | 72865-203-01 | 72865-203 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (72865-203-05) | XLCare Pharmaceuticals, Inc. | 72865-203-05 | 72865-203 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (72865-204-01) | XLCare Pharmaceuticals, Inc. | 72865-204-01 | 72865-204 | ANDA211487 | ANDA | CII |
| Levetiracetam | Injection | Intravenous | 100mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9574-10) / 5 Ml In 1 Vial, Single-Dose (0143-9574-01) | Hikma Pharmaceuticals USA Inc. | 0143-9574-10 | 0143-9574 | ANDA090981 | ANDA | N/A |
| Levetiracetam | Injection | Intravenous | 100mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9574-25) / 5 Ml In 1 Vial, Single-Dose (0143-9574-01) | Hikma Pharmaceuticals USA Inc. | 0143-9574-25 | 0143-9574 | ANDA090981 | ANDA | N/A |
| Levetiracetam | Injection | Intravenous | 100mg/mL | 10 Vial, Glass In 1 Box (0143-9673-10) / 5 Ml In 1 Vial, Glass (0143-9673-01) | Hikma Pharmaceuticals USA Inc. | 0143-9673-10 | 0143-9673 | ANDA090981 | ANDA | N/A |
| Levetiracetam | Injection | Intravenous | 100mg/mL | 25 Vial, Glass In 1 Carton (0143-9673-25) / 5 Ml In 1 Vial, Glass (0143-9673-01) | Hikma Pharmaceuticals USA Inc. | 0143-9673-25 | 0143-9673 | ANDA090981 | ANDA | N/A |
| Levetiracetam | Injection, Solution | Intravenous | 100mg/mL | 25 Vial, Single-Dose In 1 Carton (0409-2011-25) / 5 Ml In 1 Vial, Single-Dose (0409-2011-05) | Hospira, Inc. | 0409-2011-25 | 0409-2011 | ANDA202869 | ANDA | N/A |
| Levetiracetam | Injection, Solution | Intravenous | 100mg/mL | 25 Vial, Single-Dose In 1 Carton (0409-1886-02) / 5 Ml In 1 Vial, Single-Dose (0409-1886-22) | Hospira, Inc. | 0409-1886-02 | 0409-1886 | ANDA202869 | ANDA | N/A |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (72865-204-05) | XLCare Pharmaceuticals, Inc. | 72865-204-05 | 72865-204 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (72865-109-01) | XLCare Pharmaceuticals, Inc. | 72865-109-01 | 72865-109 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (72865-110-01) | XLCare Pharmaceuticals, Inc. | 72865-110-01 | 72865-110 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (72865-110-05) | XLCare Pharmaceuticals, Inc. | 72865-110-05 | 72865-110 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (72865-111-01) | XLCare Pharmaceuticals, Inc. | 72865-111-01 | 72865-111 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (72865-111-05) | XLCare Pharmaceuticals, Inc. | 72865-111-05 | 72865-111 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (72865-112-01) | XLCare Pharmaceuticals, Inc. | 72865-112-01 | 72865-112 | ANDA211487 | ANDA | CII |
| Hydrocodone Bitartrate and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (72865-112-05) | XLCare Pharmaceuticals, Inc. | 72865-112-05 | 72865-112 | ANDA211487 | ANDA | CII |
| Hydrocortisone | Enema | Rectal | 100mg/60mL | 7 Bottle, Unit-Dose In 1 Carton (62559-111-07) / 60 Ml In 1 Bottle, Unit-Dose | ANI Pharmaceuticals, Inc. | 62559-111-07 | 62559-111 | NDA016199 | NDA | N/A |
| Hydrocortisone | Enema | Rectal | 100mg/60mL | 1 Bottle, Unit-Dose In 1 Carton (62559-111-11) / 60 Ml In 1 Bottle, Unit-Dose | ANI Pharmaceuticals, Inc. | 62559-111-11 | 62559-111 | NDA016199 | NDA | N/A |
| Levocarnitine | Injection, Solution | Intravenous | 200mg/mL | 5 Vial, Single-Dose In 1 Carton (0517-1045-05) / 5 Ml In 1 Vial, Single-Dose (0517-1045-01) | American Regent, Inc. | 0517-1045-05 | 0517-1045 | ANDA075861 | ANDA | N/A |
| Levocarnitine | Injection, Solution | Intravenous | 200mg/mL | 1 Vial, Single-Dose In 1 Carton (0517-1075-01) / 20 Ml In 1 Vial, Single-Dose | American Regent, Inc. | 0517-1075-01 | 0517-1075 | ANDA075861 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (62559-430-01) / 28.4 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-430-01 | 62559-430 | ANDA080706 | ANDA | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (62559-431-30) / 30 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-431-30 | 62559-431 | ANDA080706 | ANDA | N/A |
| Levocarnitine | Injection | Intravenous | 1g/5mL | 10 Vial, Single-Use In 1 Carton (0143-9852-10) / 5 Ml In 1 Vial, Single-Use (0143-9852-01) | Hikma Pharmaceuticals USA Inc. | 0143-9852-10 | 0143-9852 | ANDA075567 | ANDA | N/A |
| Hydrocortisone | Enema | Rectal | 100mg/60mL | 7 Bottle In 1 Box (62559-138-07) / 60 Ml In 1 Bottle (62559-138-11) | ANI Pharmaceuticals, Inc. | 62559-138-07 | 62559-138 | NDA016199 | NDA AUTHORIZED GENERIC | N/A |
| Hydrocortisone | Cream | Topical | 25mg/g | 1 Tube In 1 Carton (64980-324-30) / 30 G In 1 Tube | Rising Pharma Holdings, Inc. | 64980-324-30 | 64980-324 | ANDA040879 | ANDA | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 12 Suppository In 1 Carton (16571-676-21) | Rising Pharma Holdings, Inc. | 16571-676-21 | 16571-676 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levocetirizine Dihydrochloride | Solution | Oral | .5mg/mL | 148 Ml In 1 Bottle (45802-680-28) | Padagis Israel Pharmaceuticals Ltd | 45802-680-28 | 45802-680 | ANDA091263 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (51407-892-90) | Golden State Medical Supply, Inc. | 51407-892-90 | 51407-892 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Solution | Oral | .5mg/mL | 1 Bottle In 1 Carton (51672-4161-1) / 237 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., inc. | 51672-4161-1 | 51672-4161 | ANDA202673 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Solution | Oral | .5mg/mL | 1 Bottle In 1 Carton (51672-4161-4) / 59 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., inc. | 51672-4161-4 | 51672-4161 | ANDA202673 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Solution | Oral | .5mg/mL | 1 Bottle In 1 Carton (51672-4161-5) / 177 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., inc. | 51672-4161-5 | 51672-4161 | ANDA202673 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Solution | Oral | .5mg/mL | 1 Bottle In 1 Carton (51672-4161-8) / 118 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., inc. | 51672-4161-8 | 51672-4161 | ANDA202673 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Coated | Oral | 5mg/1 | 2 Blister Pack In 1 Carton (21130-732-10) / 5 Tablet, Coated In 1 Blister Pack | Albertsons Companies | 21130-732-10 | 21130-732 | ANDA210375 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Coated | Oral | 5mg/1 | 1 Bottle In 1 Carton (21130-732-35) / 35 Tablet, Coated In 1 Bottle | Albertsons Companies | 21130-732-35 | 21130-732 | ANDA210375 | ANDA | N/A |
| Hydrocortisone Acetate | Suppository | Rectal | 25mg/1 | 24 Suppository In 1 Carton (16571-676-42) | Rising Pharma Holdings, Inc. | 16571-676-42 | 16571-676 | N/A | UNAPPROVED DRUG OTHER | N/A |
| hydrocortisone and acetic acid | SOLUTION | AURICULAR (OTIC) | 20.75mg/mL, 10.375 mg/mL | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER | Saptalis Pharmaceuticals, LLC | 71656-064-10 | 71656-064 | NDA012770 | NDA | N/A |
| Hydrocortisone Probutate | Cream | Topical | 1mg/g | 6 Tube In 1 Carton (62559-325-26) / 2 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-325-26 | 62559-325 | NDA020453 | NDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Carton (25021-132-81) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-132-81 | 25021-132 | ANDA090343 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Carton (25021-132-82) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-132-82 | 25021-132 | ANDA090343 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Carton (25021-132-83) / 1 Bag In 1 Pouch / 150 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-132-83 | 25021-132 | ANDA090343 | ANDA | N/A |
| Hydrocortisone Probutate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (62559-325-80) / 80 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-325-80 | 62559-325 | NDA020453 | NDA | N/A |
| Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | Suspension | Auricular (Otic) | 10mg/mL, 3.5 mg/mL, 10000 [USP'U]/mL | 1 Bottle In 1 Carton (64980-448-01) / 10 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-448-01 | 64980-448 | NDA060613 | NDA AUTHORIZED GENERIC | N/A |
| Hydromorphone Hydrochloride | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle (43602-001-47) | Ascent Pharmaceuticals Inc | 43602-001-47 | 43602-001 | ANDA210176 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (43602-002-05) | Ascent Pharmaceuticals Inc | 43602-002-05 | 43602-002 | ANDA210506 | ANDA | CII |
| Levofloxacin | Injection, Solution | Intravenous | 750mg/150mL | 24 Bag In 1 Carton (0143-9720-24) / 150 Ml In 1 Bag (0143-9720-01) | Hikma Pharmaceuticals USA Inc. | 0143-9720-24 | 0143-9720 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 500mg/100mL | 24 Bag In 1 Carton (0143-9721-24) / 100 Ml In 1 Bag (0143-9721-01) | Hikma Pharmaceuticals USA Inc. | 0143-9721-24 | 0143-9721 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 250mg/50mL | 24 Bag In 1 Carton (0143-9722-24) / 50 Ml In 1 Bag (0143-9722-01) | Hikma Pharmaceuticals USA Inc. | 0143-9722-24 | 0143-9722 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 250mg/50mL | 24 Bag In 1 Carton (0143-9315-24) / 50 Ml In 1 Bag (0143-9315-01) | Hikma Pharmaceuticals USA Inc. | 0143-9315-24 | 0143-9315 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 500mg/100mL | 24 Bag In 1 Carton (0143-9316-24) / 100 Ml In 1 Bag (0143-9316-01) | Hikma Pharmaceuticals USA Inc. | 0143-9316-24 | 0143-9316 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 750mg/150mL | 24 Bag In 1 Carton (0143-9317-24) / 150 Ml In 1 Bag (0143-9317-01) | Hikma Pharmaceuticals USA Inc. | 0143-9317-24 | 0143-9317 | ANDA091375 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 750mg/150mL | 24 Pouch In 1 Carton (0409-4444-24) / 1 Bag In 1 Pouch (0409-4444-01) / 150 Ml In 1 Bag | Hospira, Inc | 0409-4444-24 | 0409-4444 | ANDA090343 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 250mg/50mL | 24 Pouch In 1 Carton (0409-2220-24) / 1 Bag In 1 Pouch (0409-2220-01) / 50 Ml In 1 Bag | Hospira, Inc | 0409-2220-24 | 0409-2220 | ANDA090343 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 500mg/100mL | 24 Pouch In 1 Carton (0409-3330-24) / 1 Bag In 1 Pouch (0409-3330-01) / 100 Ml In 1 Bag | Hospira, Inc | 0409-3330-24 | 0409-3330 | ANDA090343 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Case (0409-0528-15) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-0528-13) | Hospira, Inc. | 0409-0528-15 | 0409-0528 | ANDA078579 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Case (0409-0528-25) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-0528-23) | Hospira, Inc. | 0409-0528-25 | 0409-0528 | ANDA078579 | ANDA | N/A |
| Levofloxacin | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Case (0409-0528-35) / 1 Bag In 1 Pouch / 150 Ml In 1 Bag (0409-0528-31) | Hospira, Inc. | 0409-0528-35 | 0409-0528 | ANDA078579 | ANDA | N/A |
| Levoleucovorin Calcium | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-105-18) / 17.5 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-105-18 | 71288-105 | ANDA211002 | ANDA | N/A |
| Levoleucovorin Calcium | Injection, Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-105-25) / 25 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-105-25 | 71288-105 | ANDA211002 | ANDA | N/A |
| Hydromorphone Hydrochloride | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (43602-002-30) | Ascent Pharmaceuticals Inc | 43602-002-30 | 43602-002 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (43602-003-05) | Ascent Pharmaceuticals Inc | 43602-003-05 | 43602-003 | ANDA210506 | ANDA | CII |
| Levoleucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 1 Vial In 1 Box (0143-9558-01) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9558-01 | 0143-9558 | ANDA206263 | ANDA | N/A |
| Hydromorphone Hydrochloride | Tablet | Oral | 4mg/1 | 30 Tablet In 1 Bottle (43602-003-30) | Ascent Pharmaceuticals Inc | 43602-003-30 | 43602-003 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 8mg/1 | 500 Tablet In 1 Bottle (43602-004-05) | Ascent Pharmaceuticals Inc | 43602-004-05 | 43602-004 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 8mg/1 | 30 Tablet In 1 Bottle (43602-004-30) | Ascent Pharmaceuticals Inc | 43602-004-30 | 43602-004 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle (43602-001-47) | Ascent Pharmaceuticals Inc | 43602-001-47 | 43602-001 | ANDA210176 | ANDA | CII |
| Levonorgestrel | Tablet | Oral | 1.5mg/1 | 3 Carton In 1 Package (50102-211-13) / 1 Blister Pack In 1 Carton (50102-211-11) / 1 Tablet In 1 Blister Pack (50102-211-01) | Afaxys Pharma, LLC | 50102-211-13 | 50102-211 | ANDA206867 | ANDA | N/A |
| Hydromorphone Hydrochloride | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (43602-002-05) | Ascent Pharmaceuticals Inc | 43602-002-05 | 43602-002 | ANDA210506 | ANDA | CII |
| Levorphanol Tartrate | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0438-25) | Hikma Pharmaceuticals USA Inc. | 0054-0438-25 | 0054-0438 | ANDA074278 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 2mg/1 | 30 Tablet In 1 Bottle (43602-002-30) | Ascent Pharmaceuticals Inc | 43602-002-30 | 43602-002 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (43602-003-05) | Ascent Pharmaceuticals Inc | 43602-003-05 | 43602-003 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 4mg/1 | 30 Tablet In 1 Bottle (43602-003-30) | Ascent Pharmaceuticals Inc | 43602-003-30 | 43602-003 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 8mg/1 | 500 Tablet In 1 Bottle (43602-004-05) | Ascent Pharmaceuticals Inc | 43602-004-05 | 43602-004 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet | Oral | 8mg/1 | 30 Tablet In 1 Bottle (43602-004-30) | Ascent Pharmaceuticals Inc | 43602-004-30 | 43602-004 | ANDA210506 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-266-05) | Ascent Pharmaceuticals, Inc. | 43602-266-05 | 43602-266 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-266-30) | Ascent Pharmaceuticals, Inc. | 43602-266-30 | 43602-266 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-267-05) | Ascent Pharmaceuticals, Inc. | 43602-267-05 | 43602-267 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-267-30) | Ascent Pharmaceuticals, Inc. | 43602-267-30 | 43602-267 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-268-05) | Ascent Pharmaceuticals, Inc. | 43602-268-05 | 43602-268 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-268-30) | Ascent Pharmaceuticals, Inc. | 43602-268-30 | 43602-268 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-269-05) | Ascent Pharmaceuticals, Inc. | 43602-269-05 | 43602-269 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-269-30) | Ascent Pharmaceuticals, Inc. | 43602-269-30 | 43602-269 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-266-05) | Ascent Pharmaceuticals, Inc. | 43602-266-05 | 43602-266 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-266-30) | Ascent Pharmaceuticals, Inc. | 43602-266-30 | 43602-266 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-267-05) | Ascent Pharmaceuticals, Inc. | 43602-267-05 | 43602-267 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-267-30) | Ascent Pharmaceuticals, Inc. | 43602-267-30 | 43602-267 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-268-05) | Ascent Pharmaceuticals, Inc. | 43602-268-05 | 43602-268 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-268-30) | Ascent Pharmaceuticals, Inc. | 43602-268-30 | 43602-268 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-269-05) | Ascent Pharmaceuticals, Inc. | 43602-269-05 | 43602-269 | ANDA212133 | ANDA | CII |
| Hydromorphone Hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-269-30) | Ascent Pharmaceuticals, Inc. | 43602-269-30 | 43602-269 | ANDA212133 | ANDA | CII |
| hydromorphone hydrochloride | Tablet, Extended Release | Oral | 8mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-168-01) | XLCare Pharmaceuticals, Inc. | 72865-168-01 | 72865-168 | ANDA212133 | ANDA | CII |
| hydromorphone hydrochloride | Tablet, Extended Release | Oral | 12mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-169-01) | XLCare Pharmaceuticals, Inc. | 72865-169-01 | 72865-169 | ANDA212133 | ANDA | CII |
| hydromorphone hydrochloride | Tablet, Extended Release | Oral | 16mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-170-01) | XLCare Pharmaceuticals, Inc. | 72865-170-01 | 72865-170 | ANDA212133 | ANDA | CII |
| hydromorphone hydrochloride | Tablet, Extended Release | Oral | 32mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-171-01) | XLCare Pharmaceuticals, Inc. | 72865-171-01 | 72865-171 | ANDA212133 | ANDA | CII |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (70954-804-10) | ANI Pharmaceuticals, Inc. | 70954-804-10 | 70954-804 | NDA214581 | NDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (70954-804-20) | ANI Pharmaceuticals, Inc. | 70954-804-20 | 70954-804 | NDA214581 | NDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 14 Tablet, Film Coated In 1 Bottle (70954-804-30) | ANI Pharmaceuticals, Inc. | 70954-804-30 | 70954-804 | NDA214581 | NDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (70954-805-10) | ANI Pharmaceuticals, Inc. | 70954-805-10 | 70954-805 | NDA214581 | NDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 300mg/1 | 14 Tablet, Film Coated In 1 Bottle (70954-805-20) | ANI Pharmaceuticals, Inc. | 70954-805-20 | 70954-805 | NDA214581 | NDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-687-01) | Rising Pharma Holdings, Inc. | 16571-687-01 | 16571-687 | ANDA210959 | ANDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-687-50) | Rising Pharma Holdings, Inc. | 16571-687-50 | 16571-687 | ANDA210959 | ANDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-112-01) | Rising Pharma Holdings, Inc. | 16571-112-01 | 16571-112 | ANDA210959 | ANDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-112-06) | Rising Pharma Holdings, Inc. | 16571-112-06 | 16571-112 | ANDA210959 | ANDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-112-10) | Rising Pharma Holdings, Inc. | 16571-112-10 | 16571-112 | ANDA210959 | ANDA | N/A |
| Hydroxychloroquine Sulfate | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-112-50) | Rising Pharma Holdings, Inc. | 16571-112-50 | 16571-112 | ANDA210959 | ANDA | N/A |
| Levothyroxine Sodium | Solution | Oral | 100ug/5mL | 1 Bottle, Glass In 1 Carton (52652-1950-1) / 100 Ml In 1 Bottle, Glass | Azurity Pharmaceuticals, Inc. | 52652-1950-1 | 52652-1950 | NDA214047 | NDA | N/A |
| Levothyroxine Sodium | Solution | Oral | 100ug/5mL | 2 Carton In 1 Carton (52652-1950-2) / 1 Bottle, Glass In 1 Carton / 100 Ml In 1 Bottle, Glass | Azurity Pharmaceuticals, Inc. | 52652-1950-2 | 52652-1950 | NDA214047 | NDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-575-10) | Amneal Pharmaceuticals LLC | 65162-575-10 | 65162-575 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-575-11) | Amneal Pharmaceuticals LLC | 65162-575-11 | 65162-575 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-575-50) | Amneal Pharmaceuticals LLC | 65162-575-50 | 65162-575 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-577-10) | Amneal Pharmaceuticals LLC | 65162-577-10 | 65162-577 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-577-11) | Amneal Pharmaceuticals LLC | 65162-577-11 | 65162-577 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-577-50) | Amneal Pharmaceuticals LLC | 65162-577-50 | 65162-577 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-671-10) | Amneal Pharmaceuticals LLC | 65162-671-10 | 65162-671 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-671-11) | Amneal Pharmaceuticals LLC | 65162-671-11 | 65162-671 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-671-50) | Amneal Pharmaceuticals LLC | 65162-671-50 | 65162-671 | ANDA040808 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-159-01) | Epic Pharma, LLC | 42806-159-01 | 42806-159 | ANDA040600 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-159-05) | Epic Pharma, LLC | 42806-159-05 | 42806-159 | ANDA040600 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-159-10) | Epic Pharma, LLC | 42806-159-10 | 42806-159 | ANDA040600 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 112ug/1 | 1000 Tablet In 1 Bottle (47781-654-10) | Alvogen, Inc. | 47781-654-10 | 47781-654 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 112ug/1 | 90 Tablet In 1 Bottle (47781-654-90) | Alvogen, Inc. | 47781-654-90 | 47781-654 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 125ug/1 | 1000 Tablet In 1 Bottle (47781-657-10) | Alvogen, Inc. | 47781-657-10 | 47781-657 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 125ug/1 | 90 Tablet In 1 Bottle (47781-657-90) | Alvogen, Inc. | 47781-657-90 | 47781-657 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 137ug/1 | 1000 Tablet In 1 Bottle (47781-659-10) | Alvogen, Inc. | 47781-659-10 | 47781-659 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 137ug/1 | 90 Tablet In 1 Bottle (47781-659-90) | Alvogen, Inc. | 47781-659-90 | 47781-659 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 150ug/1 | 1000 Tablet In 1 Bottle (47781-662-10) | Alvogen, Inc. | 47781-662-10 | 47781-662 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 150ug/1 | 90 Tablet In 1 Bottle (47781-662-90) | Alvogen, Inc. | 47781-662-90 | 47781-662 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 175ug/1 | 1000 Tablet In 1 Bottle (47781-665-10) | Alvogen, Inc. | 47781-665-10 | 47781-665 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 175ug/1 | 90 Tablet In 1 Bottle (47781-665-90) | Alvogen, Inc. | 47781-665-90 | 47781-665 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 200ug/1 | 1000 Tablet In 1 Bottle (47781-668-10) | Alvogen, Inc. | 47781-668-10 | 47781-668 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 200ug/1 | 90 Tablet In 1 Bottle (47781-668-90) | Alvogen, Inc. | 47781-668-90 | 47781-668 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 300ug/1 | 1000 Tablet In 1 Bottle (47781-671-10) | Alvogen, Inc. | 47781-671-10 | 47781-671 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 300ug/1 | 90 Tablet In 1 Bottle (47781-671-90) | Alvogen, Inc. | 47781-671-90 | 47781-671 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 25ug/1 | 1000 Tablet In 1 Bottle (47781-640-10) | Alvogen, Inc. | 47781-640-10 | 47781-640 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 25ug/1 | 90 Tablet In 1 Bottle (47781-640-90) | Alvogen, Inc. | 47781-640-90 | 47781-640 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 50ug/1 | 1000 Tablet In 1 Bottle (47781-643-10) | Alvogen, Inc. | 47781-643-10 | 47781-643 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 50ug/1 | 90 Tablet In 1 Bottle (47781-643-90) | Alvogen, Inc. | 47781-643-90 | 47781-643 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 75ug/1 | 1000 Tablet In 1 Bottle (47781-646-10) | Alvogen, Inc. | 47781-646-10 | 47781-646 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 75ug/1 | 90 Tablet In 1 Bottle (47781-646-90) | Alvogen, Inc. | 47781-646-90 | 47781-646 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 88ug/1 | 1000 Tablet In 1 Bottle (47781-649-10) | Alvogen, Inc. | 47781-649-10 | 47781-649 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 88ug/1 | 90 Tablet In 1 Bottle (47781-649-90) | Alvogen, Inc. | 47781-649-90 | 47781-649 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 100ug/1 | 1000 Tablet In 1 Bottle (47781-651-10) | Alvogen, Inc. | 47781-651-10 | 47781-651 | NDA021116 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 100ug/1 | 90 Tablet In 1 Bottle (47781-651-90) | Alvogen, Inc. | 47781-651-90 | 47781-651 | NDA021116 | NDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-160-01) | Epic Pharma, LLC | 42806-160-01 | 42806-160 | ANDA040602 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-160-05) | Epic Pharma, LLC | 42806-160-05 | 42806-160 | ANDA040602 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-160-10) | Epic Pharma, LLC | 42806-160-10 | 42806-160 | ANDA040602 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-161-01) | Epic Pharma, LLC | 42806-161-01 | 42806-161 | ANDA040604 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-161-05) | Epic Pharma, LLC | 42806-161-05 | 42806-161 | ANDA040604 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-161-10) | Epic Pharma, LLC | 42806-161-10 | 42806-161 | ANDA040604 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-113-01) | Rising Pharma Holdings, Inc. | 16571-113-01 | 16571-113 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-113-50) | Rising Pharma Holdings, Inc. | 16571-113-50 | 16571-113 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-114-01) | Rising Pharma Holdings, Inc. | 16571-114-01 | 16571-114 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-114-10) | Rising Pharma Holdings, Inc. | 16571-114-10 | 16571-114 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-114-50) | Rising Pharma Holdings, Inc. | 16571-114-50 | 16571-114 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-115-01) | Rising Pharma Holdings, Inc. | 16571-115-01 | 16571-115 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-115-10) | Rising Pharma Holdings, Inc. | 16571-115-10 | 16571-115 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Dihydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-115-50) | Rising Pharma Holdings, Inc. | 16571-115-50 | 16571-115 | ANDA217652 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-500-01) | Camber Pharmaceuticals, Inc. | 31722-500-01 | 31722-500 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-500-05) | Camber Pharmaceuticals, Inc. | 31722-500-05 | 31722-500 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-500-10) | Camber Pharmaceuticals, Inc. | 31722-500-10 | 31722-500 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-501-01) | Camber Pharmaceuticals, Inc. | 31722-501-01 | 31722-501 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-501-05) | Camber Pharmaceuticals, Inc. | 31722-501-05 | 31722-501 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-501-10) | Camber Pharmaceuticals, Inc. | 31722-501-10 | 31722-501 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-502-01) | Camber Pharmaceuticals, Inc. | 31722-502-01 | 31722-502 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-502-05) | Camber Pharmaceuticals, Inc. | 31722-502-05 | 31722-502 | ANDA040805 | ANDA | N/A |
| Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-502-10) | Camber Pharmaceuticals, Inc. | 31722-502-10 | 31722-502 | ANDA040805 | ANDA | N/A |
| Hyoscyamine Sulfate | Tablet | Sublingual | .125mg/1 | 100 Tablet In 1 Bottle (62559-424-01) | ANI Pharmaceuticals, Inc. | 62559-424-01 | 62559-424 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (62559-421-01) | ANI Pharmaceuticals, Inc. | 62559-421-01 | 62559-421 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet, Orally Disintegrating | Oral | .125mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (62559-422-01) | ANI Pharmaceuticals, Inc. | 62559-422-01 | 62559-422 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Hyoscyamine Sulfate | Tablet, Extended Release | Oral | .375mg/1 | 100 Tablet, Extended Release In 1 Bottle (62559-423-01) | ANI Pharmaceuticals, Inc. | 62559-423-01 | 62559-423 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Ibuprofen | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (65162-464-03) | Amneal Pharmaceuticals LLC | 65162-464-03 | 65162-464 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 400mg/1 | 60 Tablet In 1 Bottle (65162-464-06) | Amneal Pharmaceuticals LLC | 65162-464-06 | 65162-464 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 400mg/1 | 90 Tablet In 1 Bottle (65162-464-09) | Amneal Pharmaceuticals LLC | 65162-464-09 | 65162-464 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (65162-464-10) | Amneal Pharmaceuticals LLC | 65162-464-10 | 65162-464 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle (65162-464-50) | Amneal Pharmaceuticals LLC | 65162-464-50 | 65162-464 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (65162-465-03) | Amneal Pharmaceuticals LLC | 65162-465-03 | 65162-465 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 50 Tablet In 1 Bottle (65162-465-05) | Amneal Pharmaceuticals LLC | 65162-465-05 | 65162-465 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 60 Tablet In 1 Bottle (65162-465-06) | Amneal Pharmaceuticals LLC | 65162-465-06 | 65162-465 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 90 Tablet In 1 Bottle (65162-465-09) | Amneal Pharmaceuticals LLC | 65162-465-09 | 65162-465 | ANDA078558 | ANDA | N/A |
| Levothyroxine Sodium | Injection, Solution | Intravenous | 100ug/mL | 1 Vial, Single-Dose In 1 Carton (24201-002-01) / 2 Ml In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 24201-002-01 | 24201-002 | NDA214253 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 25ug/1 | 100 Tablet In 1 Bottle (60793-850-01) | Pfizer Laboratories Div Pfizer Inc | 60793-850-01 | 60793-850 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 25ug/1 | 1000 Tablet In 1 Bottle (60793-850-10) | Pfizer Laboratories Div Pfizer Inc | 60793-850-10 | 60793-850 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 50ug/1 | 100 Tablet In 1 Bottle (60793-851-01) | Pfizer Laboratories Div Pfizer Inc | 60793-851-01 | 60793-851 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 50ug/1 | 1000 Tablet In 1 Bottle (60793-851-10) | Pfizer Laboratories Div Pfizer Inc | 60793-851-10 | 60793-851 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 75ug/1 | 100 Tablet In 1 Bottle (60793-852-01) | Pfizer Laboratories Div Pfizer Inc | 60793-852-01 | 60793-852 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 75ug/1 | 1000 Tablet In 1 Bottle (60793-852-10) | Pfizer Laboratories Div Pfizer Inc | 60793-852-10 | 60793-852 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 88ug/1 | 100 Tablet In 1 Bottle (60793-853-01) | Pfizer Laboratories Div Pfizer Inc | 60793-853-01 | 60793-853 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 88ug/1 | 1000 Tablet In 1 Bottle (60793-853-10) | Pfizer Laboratories Div Pfizer Inc | 60793-853-10 | 60793-853 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 100ug/1 | 100 Tablet In 1 Bottle (60793-854-01) | Pfizer Laboratories Div Pfizer Inc | 60793-854-01 | 60793-854 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 100ug/1 | 1000 Tablet In 1 Bottle (60793-854-10) | Pfizer Laboratories Div Pfizer Inc | 60793-854-10 | 60793-854 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 112ug/1 | 100 Tablet In 1 Bottle (60793-855-01) | Pfizer Laboratories Div Pfizer Inc | 60793-855-01 | 60793-855 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 112ug/1 | 1000 Tablet In 1 Bottle (60793-855-10) | Pfizer Laboratories Div Pfizer Inc | 60793-855-10 | 60793-855 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 125ug/1 | 100 Tablet In 1 Bottle (60793-856-01) | Pfizer Laboratories Div Pfizer Inc | 60793-856-01 | 60793-856 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 125ug/1 | 1000 Tablet In 1 Bottle (60793-856-10) | Pfizer Laboratories Div Pfizer Inc | 60793-856-10 | 60793-856 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 137ug/1 | 100 Tablet In 1 Bottle (60793-857-01) | Pfizer Laboratories Div Pfizer Inc | 60793-857-01 | 60793-857 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 137ug/1 | 1000 Tablet In 1 Bottle (60793-857-10) | Pfizer Laboratories Div Pfizer Inc | 60793-857-10 | 60793-857 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 150ug/1 | 100 Tablet In 1 Bottle (60793-858-01) | Pfizer Laboratories Div Pfizer Inc | 60793-858-01 | 60793-858 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 150ug/1 | 1000 Tablet In 1 Bottle (60793-858-10) | Pfizer Laboratories Div Pfizer Inc | 60793-858-10 | 60793-858 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 175ug/1 | 100 Tablet In 1 Bottle (60793-859-01) | Pfizer Laboratories Div Pfizer Inc | 60793-859-01 | 60793-859 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 175ug/1 | 1000 Tablet In 1 Bottle (60793-859-10) | Pfizer Laboratories Div Pfizer Inc | 60793-859-10 | 60793-859 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 200ug/1 | 100 Tablet In 1 Bottle (60793-860-01) | Pfizer Laboratories Div Pfizer Inc | 60793-860-01 | 60793-860 | NDA021301 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 200ug/1 | 1000 Tablet In 1 Bottle (60793-860-10) | Pfizer Laboratories Div Pfizer Inc | 60793-860-10 | 60793-860 | NDA021301 | NDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (65162-465-10) | Amneal Pharmaceuticals LLC | 65162-465-10 | 65162-465 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 600mg/1 | 500 Tablet In 1 Bottle (65162-465-50) | Amneal Pharmaceuticals LLC | 65162-465-50 | 65162-465 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (65162-466-03) | Amneal Pharmaceuticals LLC | 65162-466-03 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 50 Tablet In 1 Bottle (65162-466-05) | Amneal Pharmaceuticals LLC | 65162-466-05 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 60 Tablet In 1 Bottle (65162-466-06) | Amneal Pharmaceuticals LLC | 65162-466-06 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle (65162-466-09) | Amneal Pharmaceuticals LLC | 65162-466-09 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (65162-466-10) | Amneal Pharmaceuticals LLC | 65162-466-10 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (65162-466-50) | Amneal Pharmaceuticals LLC | 65162-466-50 | 65162-466 | ANDA078558 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (65162-356-02) / 20 Capsule, Liquid Filled In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-356-02 | 65162-356 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1000 Capsule, Liquid Filled In 1 Bottle (65162-356-11) | Amneal Pharmaceuticals LLC | 65162-356-11 | 65162-356 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (65162-356-50) | Amneal Pharmaceuticals LLC | 65162-356-50 | 65162-356 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (65162-356-69) / 80 Capsule, Liquid Filled In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-356-69 | 65162-356 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (65162-770-02) / 20 Capsule, Liquid Filled In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-770-02 | 65162-770 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1000 Capsule, Liquid Filled In 1 Bottle (65162-770-11) | Amneal Pharmaceuticals LLC | 65162-770-11 | 65162-770 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 500 Capsule, Liquid Filled In 1 Bottle (65162-770-50) | Amneal Pharmaceuticals LLC | 65162-770-50 | 65162-770 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Capsule, Liquid Filled | Oral | 200mg/1 | 1 Bottle In 1 Carton (65162-770-69) / 80 Capsule, Liquid Filled In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-770-69 | 65162-770 | ANDA202300 | ANDA | N/A |
| Ibuprofen | Injection | Intravenous | 800mg/200mL | 20 Bag In 1 Case (66220-284-22) / 200 Ml In 1 Bag (66220-284-11) | Cumberland Pharmaceuticals Inc. | 66220-284-22 | 66220-284 | NDA022348 | NDA | N/A |
| Ibuprofen | Injection | Intravenous | 800mg/8mL | 25 Vial In 1 Carton (66220-287-08) / 8 Ml In 1 Vial | Cumberland Pharmaceuticals Inc. | 66220-287-08 | 66220-287 | NDA022348 | NDA | N/A |
| IBUPROFEN AND FAMOTIDINE | Tablet | Oral | 26.6mg/1, 800 mg/1 | 90 Tablet In 1 Bottle (31722-315-90) | Camber Pharmaceuticals, Inc. | 31722-315-90 | 31722-315 | ANDA216814 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-309-11) / 118 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-309-11 | 69230-309 | ANDA210602 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-309-12) / 237 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-309-12 | 69230-309 | ANDA210602 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-310-11) / 118 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-310-11 | 69230-310 | ANDA210602 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-310-12) / 237 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-310-12 | 69230-310 | ANDA210602 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-311-11) / 118 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-311-11 | 69230-311 | ANDA210602 | ANDA | N/A |
| Levothyroxine Sodium Anhydrous | Injection, Powder, Lyophilized, For Solution | Intravenous | 100ug/5mL | 1 Vial In 1 Carton (25021-468-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-468-10 | 25021-468 | ANDA208749 | ANDA | N/A |
| Levothyroxine Sodium Anhydrous | Injection, Powder, Lyophilized, For Solution | Intravenous | 200ug/5mL | 1 Vial In 1 Carton (25021-469-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-469-10 | 25021-469 | ANDA208749 | ANDA | N/A |
| Levothyroxine Sodium Anhydrous | Injection, Powder, Lyophilized, For Solution | Intravenous | 500ug/5mL | 1 Vial In 1 Carton (25021-470-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-470-10 | 25021-470 | ANDA208749 | ANDA | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 9.5ug/1, 2.25 ug/1 | 14 Tablet In 1 Bottle (24338-016-14) | Azurity Pharmaceuticals, Inc. | 24338-016-14 | 24338-016 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 9.5ug/1, 2.25 ug/1 | 90 Tablet In 1 Bottle (24338-016-90) | Azurity Pharmaceuticals, Inc. | 24338-016-90 | 24338-016 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 19ug/1, 4.5 ug/1 | 14 Tablet In 1 Bottle (24338-032-14) | Azurity Pharmaceuticals, Inc. | 24338-032-14 | 24338-032 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 19ug/1, 4.5 ug/1 | 90 Tablet In 1 Bottle (24338-032-90) | Azurity Pharmaceuticals, Inc. | 24338-032-90 | 24338-032 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 38ug/1, 9 ug/1 | 14 Tablet In 1 Bottle (24338-065-14) | Azurity Pharmaceuticals, Inc. | 24338-065-14 | 24338-065 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 38ug/1, 9 ug/1 | 90 Tablet In 1 Bottle (24338-065-90) | Azurity Pharmaceuticals, Inc. | 24338-065-90 | 24338-065 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 57ug/1, 13.5 ug/1 | 14 Tablet In 1 Bottle (24338-097-14) | Azurity Pharmaceuticals, Inc. | 24338-097-14 | 24338-097 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 57ug/1, 13.5 ug/1 | 90 Tablet In 1 Bottle (24338-097-90) | Azurity Pharmaceuticals, Inc. | 24338-097-90 | 24338-097 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 76ug/1, 18 ug/1 | 14 Tablet In 1 Bottle (24338-113-14) | Azurity Pharmaceuticals, Inc. | 24338-113-14 | 24338-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 76ug/1, 18 ug/1 | 90 Tablet In 1 Bottle (24338-113-90) | Azurity Pharmaceuticals, Inc. | 24338-113-90 | 24338-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 76ug/1, 18 ug/1 | 90 Tablet In 1 Bottle (24338-009-90) | Azurity Pharmaceuticals, Inc. | 24338-009-90 | 24338-009 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 9.5ug/1, 2.25 ug/1 | 90 Tablet In 1 Bottle (24338-005-90) | Azurity Pharmaceuticals, Inc. | 24338-005-90 | 24338-005 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 19ug/1, 4.5 ug/1 | 90 Tablet In 1 Bottle (24338-006-90) | Azurity Pharmaceuticals, Inc. | 24338-006-90 | 24338-006 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 38ug/1, 9 ug/1 | 90 Tablet In 1 Bottle (24338-007-90) | Azurity Pharmaceuticals, Inc. | 24338-007-90 | 24338-007 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 57ug/1, 13.5 ug/1 | 90 Tablet In 1 Bottle (24338-008-90) | Azurity Pharmaceuticals, Inc. | 24338-008-90 | 24338-008 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 76ug/1, 18 ug/1 | 100 Tablet In 1 Bottle (42192-328-01) | Acella Pharmaceuticals, LLC | 42192-328-01 | 42192-328 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 9.5ug/1, 2.25 ug/1 | 100 Tablet In 1 Bottle (42192-327-01) | Acella Pharmaceuticals, LLC | 42192-327-01 | 42192-327 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 19ug/1, 4.5 ug/1 | 100 Tablet In 1 Bottle (42192-329-01) | Acella Pharmaceuticals, LLC | 42192-329-01 | 42192-329 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 38ug/1, 9 ug/1 | 100 Tablet In 1 Bottle (42192-330-01) | Acella Pharmaceuticals, LLC | 42192-330-01 | 42192-330 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Levothyroxine; Liothyronine | Tablet | Oral | 57ug/1, 13.5 ug/1 | 100 Tablet In 1 Bottle (42192-331-01) | Acella Pharmaceuticals, LLC | 42192-331-01 | 42192-331 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Lidocaine | Cream | Topical | 50mg/g | 30 G In 1 Tube (75834-141-30) | Nivagen Pharmaceuticals, Inc. | 75834-141-30 | 75834-141 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Lidocaine | Cream | Topical | 40mg/g | 1 Tube In 1 Carton (39328-024-15) / 15 G In 1 Tube | Patrin Pharma Inc. | 39328-024-15 | 39328-024 | part348 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Topical | 40mg/g | 1 Tube In 1 Carton (39328-024-30) / 30 G In 1 Tube | Patrin Pharma Inc. | 39328-024-30 | 39328-024 | part348 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Topical | 40mg/g | 5 Tube In 1 Carton (39328-024-55) / 5 G In 1 Tube | Patrin Pharma Inc. | 39328-024-55 | 39328-024 | part348 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Topical | 40mg/g | 5 Tube In 1 Carton (39328-024-56) / 5 G In 1 Tube | Patrin Pharma Inc. | 39328-024-56 | 39328-024 | part348 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Rectal | 50mg/g | 1 Tube In 1 Carton (39328-025-15) / 15 G In 1 Tube | Patrin Pharma Inc. | 39328-025-15 | 39328-025 | part346 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Rectal | 50mg/g | 1 Tube In 1 Carton (39328-025-30) / 30 G In 1 Tube | Patrin Pharma Inc. | 39328-025-30 | 39328-025 | part346 | OTC MONOGRAPH FINAL | N/A |
| Lidocaine | Cream | Topical | 4.27g/100g | 30 G In 1 Tube (73715-001-01) | Mohnark Pharmaceuticals Inc. | 73715-001-01 | 73715-001 | M017 | OTC MONOGRAPH DRUG | N/A |
| Lidocaine | Patch | Topical | 700mg/1 | 5 Pouch In 1 Bag (60760-657-05) / 1 Patch In 1 Pouch | ST. MARY'S MEDICAL PARK PHARMACY | 60760-657-05 | 60760-657 | ANDA209190 | ANDA | N/A |
| Lidocaine | Cream | Rectal; Topical | 5.25g/100g | 30 G In 1 Tube (73715-002-01) | Mohnark Pharmaceuticals Inc. | 73715-002-01 | 73715-002 | M015 | OTC MONOGRAPH DRUG | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (51407-383-35) / 35.44 G In 1 Tube | Golden State Medical Supply, Inc. | 51407-383-35 | 51407-383 | ANDA086724 | ANDA | N/A |
| Lidocaine | Patch | Cutaneous | 50mg/g | 30 Pouch In 1 Carton (51407-827-30) / 1 G In 1 Pouch | Golden State Medical Supply, Inc. | 51407-827-30 | 51407-827 | NDA020612 | NDA AUTHORIZED GENERIC | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 50 G In 1 Jar (51672-3008-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-3008-3 | 51672-3008 | ANDA086724 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Jar In 1 Carton (51672-3008-5) / 50 G In 1 Jar | Taro Pharmaceuticals U.S.A., Inc. | 51672-3008-5 | 51672-3008 | ANDA086724 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (51672-3020-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3020-2 | 51672-3020 | ANDA086724 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (51672-3020-9) / 35.44 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-3020-9 | 51672-3020 | ANDA086724 | ANDA | N/A |
| Lidocaine | Cream | Topical | 5g/100g | 1 Tube In 1 Carton (69315-301-30) / 30 G In 1 Tube | Leading Pharma, LLC | 69315-301-30 | 69315-301 | part346 | OTC MONOGRAPH FINAL | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-311-12) / 237 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-311-12 | 69230-311 | ANDA210602 | ANDA | N/A |
| Ibuprofen Oral | Suspension | Oral | 100mg/5mL | 1 Bottle In 1 Carton (69230-308-11) / 118 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-308-11 | 69230-308 | ANDA210602 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 240 Capsule In 1 Bottle (69238-2597-7) | Amneal Pharmaceuticals LLC | 69238-2597-7 | 69238-2597 | ANDA217844 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 120 Capsule In 1 Bottle (69238-2598-8) | Amneal Pharmaceuticals LLC | 69238-2598-8 | 69238-2598 | ANDA217844 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 500 Capsule In 1 Bottle (43602-291-05) | Ascent Pharmaceuticals, Inc | 43602-291-05 | 43602-291 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 30 Capsule In 1 Bottle (43602-291-30) | Ascent Pharmaceuticals, Inc | 43602-291-30 | 43602-291 | ANDA216811 | ANDA | N/A |
| Lidocaine Hydrochloride | Solution | Topical | 40mg/mL | 1 Bottle In 1 Carton (70954-518-10) / 50 Ml In 1 Bottle | Novitium Pharma LLC | 70954-518-10 | 70954-518 | ANDA216250 | ANDA | N/A |
| Lidocaine Hydrochloride | Solution | Topical | 40mg/mL | 50 Ml In 1 Bottle (51407-825-50) | Golden State Medical Supply, Inc. | 51407-825-50 | 51407-825 | ANDA088803 | ANDA | N/A |
| Lidocaine Hydrochloride | Liquid | Topical | 40mg/mL | 74 Ml In 1 Bottle (80684-098-00) | Fourstar Group USA, Inc. | 80684-098-00 | 80684-098 | M017 | OTC MONOGRAPH DRUG | N/A |
| Lidocaine Hydrochloride | Solution | Topical | 40mg/mL | 1 Bottle In 1 Carton (51672-1411-3) / 50 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1411-3 | 51672-1411 | ANDA218182 | ANDA | N/A |
| Lidocaine Hydrochloride | Liquid | Topical | 4g/100mL | 1 Bottle, With Applicator In 1 Carton (69452-393-63) / 74 Ml In 1 Bottle, With Applicator | Bionpharma Inc. | 69452-393-63 | 69452-393 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Lidocaine Hydrochloride | Cream | Topical | 30mg/g | 1 Tube In 1 Carton (13925-159-01) / 28.35 G In 1 Tube | Seton Pharmaceuticals | 13925-159-01 | 13925-159 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Lidocaine Hydrochloride | Cream | Topical | 30mg/g | 1 Tube In 1 Carton (13925-159-03) / 85 G In 1 Tube | Seton Pharmaceuticals | 13925-159-03 | 13925-159 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Lidocaine Hydrochloride | Injection | Infiltration; Perineural | 10mg/mL | 10 Vial, Multi-Dose In 1 Tray (50102-400-10) / 20 Ml In 1 Vial, Multi-Dose (50102-400-01) | Afaxys Pharma LLC | 50102-400-10 | 50102-400 | ANDA215132 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 10 Vial, Multi-Dose In 1 Package (0143-9575-10) / 50 Ml In 1 Vial, Multi-Dose (0143-9575-01) | Hikma Pharmaceuticals USA Inc. | 0143-9575-10 | 0143-9575 | ANDA080407 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 25 Vial, Multi-Dose In 1 Package (0143-9576-25) / 2 Ml In 1 Vial, Multi-Dose (0143-9576-01) | Hikma Pharmaceuticals USA Inc. | 0143-9576-25 | 0143-9576 | ANDA080407 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10mg/mL | 10 Vial, Multi-Dose In 1 Package (0143-9577-10) / 50 Ml In 1 Vial, Multi-Dose (0143-9577-01) | Hikma Pharmaceuticals USA Inc. | 0143-9577-10 | 0143-9577 | ANDA080407 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10mg/mL | 10 Vial, Multi-Dose In 1 Package (0143-9578-10) / 30 Ml In 1 Vial, Multi-Dose (0143-9578-01) | Hikma Pharmaceuticals USA Inc. | 0143-9578-10 | 0143-9578 | ANDA080407 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10mg/mL | 25 Vial, Multi-Dose In 1 Package (0143-9579-25) / 2 Ml In 1 Vial, Multi-Dose (0143-9579-01) | Hikma Pharmaceuticals USA Inc. | 0143-9579-25 | 0143-9579 | ANDA080407 | ANDA | N/A |
| Lidocaine Hydrochloride | Solution | Topical | 40mg/mL | 50 Ml In 1 Bottle (0054-3505-47) | Hikma Pharmaceuticals USA Inc. | 0054-3505-47 | 0054-3505 | ANDA088803 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal | 20mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9594-25) / 5 Ml In 1 Vial, Single-Dose (0143-9594-01) | Hikma Pharmaceuticals USA Inc. | 0143-9594-25 | 0143-9594 | ANDA084625 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (0143-9595-25) / 5 Ml In 1 Vial, Single-Dose (0143-9595-01) | Hikma Pharmaceuticals USA Inc. | 0143-9595-25 | 0143-9595 | ANDA084625 | ANDA | N/A |
| Lidocaine Hydrochloride | Solution | Oral; Topical | 20mg/mL | 1 Bottle In 1 Carton (0054-3500-49) / 100 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-3500-49 | 0054-3500 | ANDA088802 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-4277-01) / 20 Ml In 1 Vial, Multi-Dose (0409-4277-16) | Hospira, Inc. | 0409-4277-01 | 0409-4277 | ANDA088327 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-4277-02) / 50 Ml In 1 Vial, Multi-Dose (0409-4277-17) | Hospira, Inc. | 0409-4277-02 | 0409-4277 | ANDA088327 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4278-01) / 50 Ml In 1 Vial, Single-Dose (0409-4278-16) | Hospira, Inc. | 0409-4278-01 | 0409-4278 | ANDA088328 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 10mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4279-02) / 30 Ml In 1 Vial, Single-Dose (0409-4279-16) | Hospira, Inc. | 0409-4279-02 | 0409-4279 | ANDA088329 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 20mg/mL | 5 Cello Pack In 1 Package (0409-4282-01) / 5 Ampule In 1 Cello Pack (0409-4282-25) / 2 Ml In 1 Ampule (0409-4282-11) | Hospira, Inc. | 0409-4282-01 | 0409-4282 | ANDA088294 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 20mg/mL | 25 Ampule In 1 Carton (0409-4282-02) / 10 Ml In 1 Ampule (0409-4282-12) | Hospira, Inc. | 0409-4282-02 | 0409-4282 | ANDA088294 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Retrobulbar; Topical | 40mg/mL | 5 Cello Pack In 1 Package (0409-4283-01) / 5 Ampule In 1 Cello Pack (0409-4283-25) / 5 Ml In 1 Ampule (0409-4283-11) | Hospira, Inc. | 0409-4283-01 | 0409-4283 | ANDA088295 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 20mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2066-05) / 5 Ml In 1 Vial, Single-Dose (0409-2066-10) | Hospira, Inc. | 0409-2066-05 | 0409-2066 | ANDA040078 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 10 Carton In 1 Container (0409-1323-05) / 1 Syringe, Plastic In 1 Carton / 5 Ml In 1 Syringe, Plastic (0409-1323-15) | Hospira, Inc. | 0409-1323-05 | 0409-1323 | ANDA040302 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 10mg/mL | 5 Cello Pack In 1 Package (0409-4713-02) / 5 Ampule In 1 Cello Pack (0409-4713-26) / 5 Ml In 1 Ampule (0409-4713-12) | Hospira, Inc. | 0409-4713-02 | 0409-4713 | ANDA080408 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 10mg/mL | 5 Carton In 1 Package (0409-4713-32) / 10 Ampule In 1 Carton (0409-4713-25) / 2 Ml In 1 Ampule (0409-4713-42) | Hospira, Inc. | 0409-4713-32 | 0409-4713 | ANDA080408 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 10mg/mL | 800 Ampule In 1 Case (0409-4713-62) / 2 Ml In 1 Ampule (0409-4713-72) | Hospira, Inc. | 0409-4713-62 | 0409-4713 | ANDA080408 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 10mg/mL | 800 Ampule In 1 Case (0409-4713-65) / 5 Ml In 1 Ampule (0409-4713-75) | Hospira, Inc. | 0409-4713-65 | 0409-4713 | ANDA080408 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Intracaudal; Perineural | 15mg/mL | 25 Ampule In 1 Carton (0409-4776-01) / 20 Ml In 1 Ampule (0409-4776-10) | Hospira, Inc. | 0409-4776-01 | 0409-4776 | ANDA080408 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Intravenous | 20mg/mL | 10 Carton In 1 Container (0409-4903-34) / 1 Syringe In 1 Carton / 5 Ml In 1 Syringe (0409-4903-11) | Hospira, Inc. | 0409-4903-34 | 0409-4903 | ANDA083158 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 10 Carton In 1 Container (0409-4904-34) / 1 Syringe In 1 Carton / 5 Ml In 1 Syringe (0409-4904-11) | Hospira, Inc. | 0409-4904-34 | 0409-4904 | ANDA083158 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 10 Carton In 1 Container (0409-9137-05) / 1 Syringe, Plastic In 1 Carton / 5 Ml In 1 Syringe, Plastic (0409-9137-11) | Hospira, Inc. | 0409-9137-05 | 0409-9137 | ANDA040302 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 5mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-4275-01) / 50 Ml In 1 Vial, Multi-Dose (0409-4275-16) | Hospira, Inc. | 0409-4275-01 | 0409-4275 | ANDA088325 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-4276-01) / 20 Ml In 1 Vial, Multi-Dose (0409-4276-16) | Hospira, Inc. | 0409-4276-01 | 0409-4276 | ANDA088299 | ANDA | N/A |
| Lidocaine Hydrochloride | Injection, Solution | Infiltration; Perineural | 10mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-4276-02) / 50 Ml In 1 Vial, Multi-Dose (0409-4276-17) | Hospira, Inc. | 0409-4276-02 | 0409-4276 | ANDA088299 | ANDA | N/A |
| Lidocaine Hydrochloride Anhydrous | Jelly | Topical | 20mg/mL | 10 Syringe In 1 Carton (25021-673-76) / 6 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-673-76 | 25021-673 | ANDA201094 | ANDA | N/A |
| Lidocaine Hydrochloride Anhydrous | Jelly | Topical | 20mg/mL | 10 Syringe In 1 Carton (25021-673-77) / 11 Ml In 1 Syringe | Sagent Pharmaceuticals | 25021-673-77 | 25021-673 | ANDA201094 | ANDA | N/A |
| Lidocaine Hydrochloride; Menthol | Liquid | Topical | 40mg/mL, 10 mg/mL | 73 Ml In 1 Container (72614-265-02) | Hempagenix, LLC | 72614-265-02 | 72614-265 | M017 | OTC MONOGRAPH DRUG | N/A |
| Lidocaine; Phenylephrine Hydrochloride | Gel | Topical | 50mg/g, 2.5 mg/g | 1 Tube In 1 Box (83120-378-00) / 31.18 G In 1 Tube | LALANI Rx Consulting, Inc. | 83120-378-00 | 83120-378 | M015 | OTC MONOGRAPH DRUG | N/A |
| Lidocaine; Prilocaine | Cream | Topical | 25mg/g, 25 mg/g | 1 Tube In 1 Carton (0574-2042-30) / 30 G In 1 Tube | Padagis US LLC | 0574-2042-30 | 0574-2042 | ANDA212482 | ANDA | N/A |
| Lidocaine; Tetracaine | Cream | Topical | 70mg/g, 70 mg/g | 1 Tube In 1 Carton (51672-5305-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-5305-2 | 51672-5305 | NDA021717 | NDA | N/A |
| Ligustrum Vulgare Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2252-1) | Jubilant HollisterStier LLC | 65044-2252-1 | 65044-2252 | BLA103888 | BLA | N/A |
| Ligustrum Vulgare Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2251-2) | Jubilant HollisterStier LLC | 65044-2251-2 | 65044-2251 | BLA103888 | BLA | N/A |
| Ligustrum Vulgare Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2251-3) | Jubilant HollisterStier LLC | 65044-2251-3 | 65044-2251 | BLA103888 | BLA | N/A |
| Ligustrum Vulgare Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2251-4) | Jubilant HollisterStier LLC | 65044-2251-4 | 65044-2251 | BLA103888 | BLA | N/A |
| Lincomycin Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subconjunctival | 300mg/mL | 10 Vial In 1 Carton (25021-193-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-193-02 | 25021-193 | ANDA215657 | ANDA | N/A |
| Lincomycin Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subconjunctival | 300mg/mL | 10 Vial In 1 Carton (25021-193-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-193-10 | 25021-193 | ANDA215657 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 500 Capsule In 1 Bottle (43602-547-05) | Ascent Pharmaceuticals, Inc | 43602-547-05 | 43602-547 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 30 Capsule In 1 Bottle (43602-547-30) | Ascent Pharmaceuticals, Inc | 43602-547-30 | 43602-547 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 500 Capsule In 1 Bottle (43602-291-05) | Ascent Pharmaceuticals, Inc | 43602-291-05 | 43602-291 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | 1g/1 | 30 Capsule In 1 Bottle (43602-291-30) | Ascent Pharmaceuticals, Inc | 43602-291-30 | 43602-291 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 500 Capsule In 1 Bottle (43602-547-05) | Ascent Pharmaceuticals, Inc | 43602-547-05 | 43602-547 | ANDA216811 | ANDA | N/A |
| Linezolid | Powder, For Suspension | Oral | 100mg/5mL | 150 Ml In 1 Bottle (0054-0319-50) | Hikma Pharmaceuticals USA Inc. | 0054-0319-50 | 0054-0319 | ANDA200068 | ANDA | N/A |
| Linezolid | Injection, Solution | Intravenous | 600mg/300mL | 10 Pouch In 1 Box (0143-9534-10) / 1 Bag In 1 Pouch / 300 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9534-10 | 0143-9534 | ANDA206454 | ANDA | N/A |
| Linezolid | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Case (0409-4883-01) / 1 Bag In 1 Pouch / 300 Ml In 1 Bag (0409-4883-11) | Hospira, Inc. | 0409-4883-01 | 0409-4883 | NDA206473 | NDA | N/A |
| Linezolid | Injection, Solution | Intravenous | 2mg/mL | 10 Pouch In 1 Case (0409-4883-10) / 1 Bag In 1 Pouch / 300 Ml In 1 Bag (0409-4883-03) | Hospira, Inc. | 0409-4883-10 | 0409-4883 | NDA206473 | NDA | N/A |
| Liothyronine Sodium | Tablet | Oral | 5ug/1 | 100 Tablet In 1 Bottle, Plastic (51407-384-01) | Golden State Medical Supply, Inc. | 51407-384-01 | 51407-384 | ANDA090097 | ANDA | N/A |
| Liothyronine Sodium | Tablet | Oral | 25ug/1 | 100 Tablet In 1 Bottle, Plastic (51407-385-01) | Golden State Medical Supply, Inc. | 51407-385-01 | 51407-385 | ANDA090097 | ANDA | N/A |
| Liothyronine Sodium | Tablet | Oral | 5ug/1 | 100 Tablet In 1 Bottle (60793-115-01) | Pfizer Laboratories Div Pfizer Inc | 60793-115-01 | 60793-115 | NDA010379 | NDA | N/A |
| Liothyronine Sodium | Tablet | Oral | 25ug/1 | 100 Tablet In 1 Bottle (60793-116-01) | Pfizer Laboratories Div Pfizer Inc | 60793-116-01 | 60793-116 | NDA010379 | NDA | N/A |
| Liothyronine Sodium | Tablet | Oral | 50ug/1 | 100 Tablet In 1 Bottle (60793-117-01) | Pfizer Laboratories Div Pfizer Inc | 60793-117-01 | 60793-117 | NDA010379 | NDA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1662-2) | Jubilant HollisterStier LLC | 65044-1662-2 | 65044-1662 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1662-3) | Jubilant HollisterStier LLC | 65044-1662-3 | 65044-1662 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1662-4) | Jubilant HollisterStier LLC | 65044-1662-4 | 65044-1662 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1660-2) | Jubilant HollisterStier LLC | 65044-1660-2 | 65044-1660 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1660-3) | Jubilant HollisterStier LLC | 65044-1660-3 | 65044-1660 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1660-4) | Jubilant HollisterStier LLC | 65044-1660-4 | 65044-1660 | BLA103888 | BLA | N/A |
| Liquidambar Styraciflua Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1661-1) | Jubilant HollisterStier LLC | 65044-1661-1 | 65044-1661 | BLA103888 | BLA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (60505-4739-1) | Apotex Corp. | 60505-4739-1 | 60505-4739 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (60505-4740-1) | Apotex Corp. | 60505-4740-1 | 60505-4740 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (60505-4741-1) | Apotex Corp. | 60505-4741-1 | 60505-4741 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 100 Capsule In 1 Bottle (60505-4742-1) | Apotex Corp. | 60505-4742-1 | 60505-4742 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (60505-4743-1) | Apotex Corp. | 60505-4743-1 | 60505-4743 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 100 Capsule In 1 Bottle (60505-4744-1) | Apotex Corp. | 60505-4744-1 | 60505-4744 | ANDA216944 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 100 Capsule In 1 Bottle (60505-4745-1) | Apotex Corp. | 60505-4745-1 | 60505-4745 | ANDA216944 | ANDA | CII |
| Icosapent Ethyl | Capsule | Oral | .5g/1 | 30 Capsule In 1 Bottle (43602-547-30) | Ascent Pharmaceuticals, Inc | 43602-547-30 | 43602-547 | ANDA216811 | ANDA | N/A |
| Icosapent Ethyl | Capsule, Liquid Filled | Oral | .5g/1 | 240 Capsule, Liquid Filled In 1 Bottle (42806-559-24) | EPIC PHARMA, LLC | 42806-559-24 | 42806-559 | ANDA217919 | ANDA | N/A |
| Icosapent Ethyl | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (42806-560-12) | EPIC PHARMA, LLC | 42806-560-12 | 42806-560 | ANDA217919 | ANDA | N/A |
| ICOSAPENT ETHYL | Capsule | Oral | .5g/1 | 240 Capsule In 1 Bottle (72865-289-24) | XLCare Pharmaceuticals, Inc. | 72865-289-24 | 72865-289 | ANDA216811 | ANDA | N/A |
| ICOSAPENT ETHYL | Capsule | Oral | 1g/1 | 120 Capsule In 1 Bottle (72865-290-12) | XLCare Pharmaceuticals, Inc. | 72865-290-12 | 72865-290 | ANDA216811 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-794-03) | Amneal Pharmaceuticals LLC | 65162-794-03 | 65162-794 | ANDA207495 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-794-09) | Amneal Pharmaceuticals LLC | 65162-794-09 | 65162-794 | ANDA207495 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-795-03) | Amneal Pharmaceuticals LLC | 65162-795-03 | 65162-795 | ANDA207495 | ANDA | N/A |
| Imatinib Mesylate | Tablet, Film Coated | Oral | 400mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-795-09) | Amneal Pharmaceuticals LLC | 65162-795-09 | 65162-795 | ANDA207495 | ANDA | N/A |
| Indapamide | Tablet, Film Coated | Oral | 1.25mg/1 | 100 Tablet, Film Coated In 1 Bottle (62559-510-01) | ANI Pharmaceuticals, Inc. | 62559-510-01 | 62559-510 | ANDA074299 | ANDA | N/A |
| Indapamide | Tablet, Film Coated | Oral | 2.5mg/1 | 100 Tablet, Film Coated In 1 Bottle (62559-511-01) | ANI Pharmaceuticals, Inc. | 62559-511-01 | 62559-511 | ANDA074299 | ANDA | N/A |
| Indapamide | Tablet | Oral | 1.25mg/1 | 100 Tablet In 1 Bottle (16571-875-01) | Rising Pharma Holdings, Inc. | 16571-875-01 | 16571-875 | ANDA074461 | ANDA | N/A |
| Indapamide | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (16571-876-01) | Rising Pharma Holdings, Inc. | 16571-876-01 | 16571-876 | ANDA074461 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-506-03) | Amneal Pharmaceuticals LLC | 65162-506-03 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 60 Capsule, Extended Release In 1 Bottle (65162-506-06) | Amneal Pharmaceuticals LLC | 65162-506-06 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 90 Capsule, Extended Release In 1 Bottle (65162-506-09) | Amneal Pharmaceuticals LLC | 65162-506-09 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 100 Capsule, Extended Release In 1 Bottle (65162-506-10) | Amneal Pharmaceuticals LLC | 65162-506-10 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 1000 Capsule, Extended Release In 1 Bottle (65162-506-11) | Amneal Pharmaceuticals LLC | 65162-506-11 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Capsule, Extended Release | Oral | 75mg/1 | 500 Capsule, Extended Release In 1 Bottle (65162-506-50) | Amneal Pharmaceuticals LLC | 65162-506-50 | 65162-506 | ANDA091549 | ANDA | N/A |
| Indomethacin | Suspension | Oral | 25mg/5mL | 1 Bottle In 1 Carton (70954-637-10) / 237 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 70954-637-10 | 70954-637 | ANDA217883 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 12 Bottle In 1 Case (31722-542-01) / 100 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-542-01 | 31722-542 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 12 Bottle In 1 Case (31722-542-05) / 500 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-542-05 | 31722-542 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 12 Bottle In 1 Case (31722-542-10) / 1000 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-542-10 | 31722-542 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 12 Bottle In 1 Case (31722-542-30) / 30 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-542-30 | 31722-542 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 12 Bottle In 1 Case (31722-543-01) / 100 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-543-01 | 31722-543 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 12 Bottle In 1 Case (31722-543-05) / 500 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-543-05 | 31722-543 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 12 Bottle In 1 Case (31722-543-10) / 1000 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-543-10 | 31722-543 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 12 Bottle In 1 Case (31722-543-30) / 30 Capsule In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-543-30 | 31722-543 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (72865-148-01) | XLCare Pharmaceuticals Inc. | 72865-148-01 | 72865-148 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 500 Capsule In 1 Bottle (72865-148-05) | XLCare Pharmaceuticals Inc. | 72865-148-05 | 72865-148 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (72865-148-10) | XLCare Pharmaceuticals Inc. | 72865-148-10 | 72865-148 | ANDA091240 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (47781-562-01) | Alvogen Inc. | 47781-562-01 | 47781-562 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (47781-563-01) | Alvogen Inc. | 47781-563-01 | 47781-563 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (47781-564-01) | Alvogen Inc. | 47781-564-01 | 47781-564 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 100 Capsule In 1 Bottle (47781-565-01) | Alvogen Inc. | 47781-565-01 | 47781-565 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (47781-566-01) | Alvogen Inc. | 47781-566-01 | 47781-566 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 100 Capsule In 1 Bottle (47781-567-01) | Alvogen Inc. | 47781-567-01 | 47781-567 | ANDA214547 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 100 Capsule In 1 Bottle (47781-568-01) | Alvogen Inc. | 47781-568-01 | 47781-568 | ANDA214547 | ANDA | CII |
| Indomethacin | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (72865-148-30) | XLCare Pharmaceuticals Inc. | 72865-148-30 | 72865-148 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (72865-149-01) | XLCare Pharmaceuticals Inc. | 72865-149-01 | 72865-149 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (72865-149-05) | XLCare Pharmaceuticals Inc. | 72865-149-05 | 72865-149 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (72865-149-10) | XLCare Pharmaceuticals Inc. | 72865-149-10 | 72865-149 | ANDA091240 | ANDA | N/A |
| Indomethacin | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (72865-149-30) | XLCare Pharmaceuticals Inc. | 72865-149-30 | 72865-149 | ANDA091240 | ANDA | N/A |
| Ipratropium Bromide | Solution | Respiratory (Inhalation) | .5mg/2.5mL | 30 Pouch In 1 Carton (0487-9801-01) / 1 Vial, Single-Dose In 1 Pouch / 2.5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9801-01 | 0487-9801 | ANDA075562 | ANDA | N/A |
| Ipratropium Bromide | Solution | Respiratory (Inhalation) | .5mg/2.5mL | 30 Bag In 1 Box (0487-9801-02) / 1 Pouch In 1 Bag / 1 Vial, Single-Dose In 1 Pouch / 2.5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9801-02 | 0487-9801 | ANDA075562 | ANDA | N/A |
| Ipratropium Bromide | Solution | Respiratory (Inhalation) | .5mg/2.5mL | 1 Pouch In 1 Carton (0487-9801-25) / 25 Vial, Single-Dose In 1 Pouch / 2.5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9801-25 | 0487-9801 | ANDA075562 | ANDA | N/A |
| Ipratropium Bromide | Solution | Respiratory (Inhalation) | .5mg/2.5mL | 1 Pouch In 1 Carton (0487-9801-30) / 30 Vial, Single-Dose In 1 Pouch / 2.5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9801-30 | 0487-9801 | ANDA075562 | ANDA | N/A |
| Ipratropium Bromide | Solution | Respiratory (Inhalation) | .5mg/2.5mL | 2 Pouch In 1 Carton (0487-9801-60) / 30 Vial, Single-Dose In 1 Pouch / 2.5 Ml In 1 Vial, Single-Dose | Nephron Pharmaceuticals Corporation | 0487-9801-60 | 0487-9801 | ANDA075562 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (65162-284-03) | Amneal Pharmaceuticals LLC | 65162-284-03 | 65162-284 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (65162-284-09) | Amneal Pharmaceuticals LLC | 65162-284-09 | 65162-284 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (65162-284-50) | Amneal Pharmaceuticals LLC | 65162-284-50 | 65162-284 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (65162-285-03) | Amneal Pharmaceuticals LLC | 65162-285-03 | 65162-285 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 90 Tablet In 1 Bottle (65162-285-09) | Amneal Pharmaceuticals LLC | 65162-285-09 | 65162-285 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (65162-285-11) | Amneal Pharmaceuticals LLC | 65162-285-11 | 65162-285 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (65162-285-50) | Amneal Pharmaceuticals LLC | 65162-285-50 | 65162-285 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (65162-286-03) | Amneal Pharmaceuticals LLC | 65162-286-03 | 65162-286 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (65162-286-09) | Amneal Pharmaceuticals LLC | 65162-286-09 | 65162-286 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (65162-286-11) | Amneal Pharmaceuticals LLC | 65162-286-11 | 65162-286 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (65162-286-50) | Amneal Pharmaceuticals LLC | 65162-286-50 | 65162-286 | ANDA204740 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (31722-160-05) | Camber Pharmaceuticals, Inc. | 31722-160-05 | 31722-160 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (31722-730-05) | Camber Pharmaceuticals, Inc. | 31722-730-05 | 31722-730 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (31722-730-30) | Camber Pharmaceuticals, Inc. | 31722-730-30 | 31722-730 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 120 Blister Pack In 1 Carton (31722-730-31) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-730-31 | 31722-730 | ANDA202910 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 100 Capsule In 1 Bottle (0054-0375-25) | Hikma Pharmaceuticals USA Inc. | 0054-0375-25 | 0054-0375 | ANDA202827 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (0054-0370-25) | Hikma Pharmaceuticals USA Inc. | 0054-0370-25 | 0054-0370 | ANDA202827 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (0054-0371-25) | Hikma Pharmaceuticals USA Inc. | 0054-0371-25 | 0054-0371 | ANDA202827 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 100 Capsule In 1 Bottle (0054-0372-25) | Hikma Pharmaceuticals USA Inc. | 0054-0372-25 | 0054-0372 | ANDA202827 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (0054-0373-25) | Hikma Pharmaceuticals USA Inc. | 0054-0373-25 | 0054-0373 | ANDA202827 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 100 Capsule In 1 Bottle (0054-0374-25) | Hikma Pharmaceuticals USA Inc. | 0054-0374-25 | 0054-0374 | ANDA202827 | ANDA | CII |
| Lisinopril | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-455-90) | St Mary's Medical Park Pharmacy | 60760-455-90 | 60760-455 | ANDA077321 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-357-90) | St. Mary's Medical Park Pharmacy | 60760-357-90 | 60760-357 | ANDA076180 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-358-30) | St. Mary's Medical Park Pharmacy | 60760-358-30 | 60760-358 | ANDA076180 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-358-90) | St. Mary's Medical Park Pharmacy | 60760-358-90 | 60760-358 | ANDA076180 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-359-30) | St. Mary's Medical Park Pharmacy | 60760-359-30 | 60760-359 | ANDA076164 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-359-90) | St. Mary's Medical Park Pharmacy | 60760-359-90 | 60760-359 | ANDA076164 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-360-30) | St. Mary's Medical Park Pharmacy | 60760-360-30 | 60760-360 | ANDA076164 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-380-90) | St. Mary's Medical Park Pharmacy | 60760-380-90 | 60760-380 | ANDA076059 | ANDA | N/A |
| Lisinopril | Solution | Oral | 1mg/mL | 150 Ml In 1 Bottle (52652-3001-1) | Azurity Pharmaceuticals, Inc. | 52652-3001-1 | 52652-3001 | NDA208401 | NDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 90 Tablet In 1 Bottle (31722-730-90) | Camber Pharmaceuticals, Inc. | 31722-730-90 | 31722-730 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (31722-161-10) | Camber Pharmaceuticals, Inc. | 31722-161-10 | 31722-161 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (31722-731-05) | Camber Pharmaceuticals, Inc. | 31722-731-05 | 31722-731 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (31722-731-30) | Camber Pharmaceuticals, Inc. | 31722-731-30 | 31722-731 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 120 Blister Pack In 1 Carton (31722-731-31) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-731-31 | 31722-731 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 90 Tablet In 1 Bottle (31722-731-90) | Camber Pharmaceuticals, Inc. | 31722-731-90 | 31722-731 | ANDA202910 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (31722-162-05) | Camber Pharmaceuticals, Inc. | 31722-162-05 | 31722-162 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (50228-160-05) | ScieGen Pharmaceuticals, Inc. | 50228-160-05 | 50228-160 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (50228-160-30) | ScieGen Pharmaceuticals, Inc. | 50228-160-30 | 50228-160 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (50228-161-10) | ScieGen Pharmaceuticals, Inc. | 50228-161-10 | 50228-161 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (50228-161-30) | ScieGen Pharmaceuticals, Inc. | 50228-161-30 | 50228-161 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (50228-162-05) | ScieGen Pharmaceuticals, Inc. | 50228-162-05 | 50228-162 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (50228-162-30) | ScieGen Pharmaceuticals, Inc. | 50228-162-30 | 50228-162 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 500 Tablet In 1 Bottle (50228-160-05) | ScieGen Pharmaceuticals, Inc. | 50228-160-05 | 50228-160 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 75mg/1 | 30 Tablet In 1 Bottle (50228-160-30) | ScieGen Pharmaceuticals, Inc. | 50228-160-30 | 50228-160 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (50228-161-10) | ScieGen Pharmaceuticals, Inc. | 50228-161-10 | 50228-161 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (50228-161-30) | ScieGen Pharmaceuticals, Inc. | 50228-161-30 | 50228-161 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (50228-162-05) | ScieGen Pharmaceuticals, Inc. | 50228-162-05 | 50228-162 | ANDA204774 | ANDA | N/A |
| Irbesartan | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (50228-162-30) | ScieGen Pharmaceuticals, Inc. | 50228-162-30 | 50228-162 | ANDA204774 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection | Intravenous | 40mg/2mL | 1 Vial, Glass In 1 Carton (50742-401-02) / 2 Ml In 1 Vial, Glass | Ingenus Pharmaceuticals, LLC | 50742-401-02 | 50742-401 | ANDA206935 | ANDA | N/A |
| Irinotecan Hydrochloride | Injection | Intravenous | 100mg/5mL | 1 Vial, Glass In 1 Carton (50742-402-05) / 5 Ml In 1 Vial, Glass | Ingenus Pharmaceuticals, LLC | 50742-402-05 | 50742-402 | ANDA206935 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intravenous | .2mg/mL | 10 Vial In 1 Carton (70121-1604-7) / 1 Ml In 1 Vial (70121-1604-1) | Amneal Pharmaceuticals LLC | 70121-1604-7 | 70121-1604 | ANDA210576 | ANDA | N/A |
| Isoproterenol Hydrochloride | Injection, Solution | Intravenous | 1mg/5mL | 10 Vial In 1 Carton (70121-1605-7) / 5 Ml In 1 Vial (70121-1605-1) | Amneal Pharmaceuticals LLC | 70121-1605-7 | 70121-1605 | ANDA210576 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 60mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-176-01) | Ingenus Pharmaceuticals, LLC | 50742-176-01 | 50742-176 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 60mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-176-05) | Ingenus Pharmaceuticals, LLC | 50742-176-05 | 50742-176 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 120mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-177-01) | Ingenus Pharmaceuticals, LLC | 50742-177-01 | 50742-177 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 30mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (50742-175-01) | Ingenus Pharmaceuticals, LLC | 50742-175-01 | 50742-175 | ANDA210918 | ANDA | N/A |
| Isosorbide Mononitrate | Tablet, Extended Release | Oral | 30mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-175-05) | Ingenus Pharmaceuticals, LLC | 50742-175-05 | 50742-175 | ANDA210918 | ANDA | N/A |
| Isradipine | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (42806-263-01) | Epic Pharma, LLC | 42806-263-01 | 42806-263 | ANDA077169 | ANDA | N/A |
| Isradipine | Capsule | Oral | 2.5mg/1 | 500 Capsule In 1 Bottle (42806-263-05) | Epic Pharma, LLC | 42806-263-05 | 42806-263 | ANDA077169 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (0054-0021-25) | Hikma Pharmaceuticals USA Inc. | 0054-0021-25 | 0054-0021 | ANDA076832 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle, Plastic (0054-0021-29) | Hikma Pharmaceuticals USA Inc. | 0054-0021-29 | 0054-0021 | ANDA076832 | ANDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 150mg/1 | 10 Capsule, Gelatin Coated In 1 Blister Pack (0054-8526-25) | Hikma Pharmaceuticals USA Inc. | 0054-8526-25 | 0054-8526 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 300mg/1 | 10 Capsule, Gelatin Coated In 1 Blister Pack (0054-8527-25) | Hikma Pharmaceuticals USA Inc. | 0054-8527-25 | 0054-8527 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 150mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (0054-2526-25) | Hikma Pharmaceuticals USA Inc. | 0054-2526-25 | 0054-2526 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Tablet | Oral | 300mg/1 | 10 Tablet In 1 Blister Pack (0054-8528-25) | Hikma Pharmaceuticals USA Inc. | 0054-8528-25 | 0054-8528 | NDA018558 | NDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 300mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (0054-2527-25) | Hikma Pharmaceuticals USA Inc. | 0054-2527-25 | 0054-2527 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 300mg/1 | 1000 Capsule, Gelatin Coated In 1 Bottle (0054-2527-31) | Hikma Pharmaceuticals USA Inc. | 0054-2527-31 | 0054-2527 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Capsule, Gelatin Coated | Oral | 600mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (0054-2531-25) | Hikma Pharmaceuticals USA Inc. | 0054-2531-25 | 0054-2531 | NDA017812 | NDA | N/A |
| Lithium Carbonate | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (0054-4527-25) | Hikma Pharmaceuticals USA Inc. | 0054-4527-25 | 0054-4527 | NDA018558 | NDA | N/A |
| Lithium Carbonate | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (0054-4527-31) | Hikma Pharmaceuticals USA Inc. | 0054-4527-31 | 0054-4527 | NDA018558 | NDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 450mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (0054-0020-25) | Hikma Pharmaceuticals USA Inc. | 0054-0020-25 | 0054-0020 | ANDA076691 | ANDA | N/A |
| Lobster, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3362-2) | Jubilant HollisterStier LLC | 65044-3362-2 | 65044-3362 | BLA103888 | BLA | N/A |
| Lofexidine Hydrochloride | Tablet, Film Coated | Oral | .2mg/1 | 1 Bottle In 1 Carton (66993-345-37) / 36 Tablet, Film Coated In 1 Bottle | Prasco Laboratories | 66993-345-37 | 66993-345 | NDA209229 | NDA AUTHORIZED GENERIC | N/A |
| Lofexidine Hydrochloride | Tablet, Film Coated | Oral | .2mg/1 | 1 Bottle In 1 Carton (66993-345-76) / 96 Tablet, Film Coated In 1 Bottle | Prasco Laboratories | 66993-345-76 | 66993-345 | NDA209229 | NDA AUTHORIZED GENERIC | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0787-1) | Jubilant HollisterStier LLC | 65044-0787-1 | 65044-0787 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0787-2) | Jubilant HollisterStier LLC | 65044-0787-2 | 65044-0787 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0787-3) | Jubilant HollisterStier LLC | 65044-0787-3 | 65044-0787 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0787-4) | Jubilant HollisterStier LLC | 65044-0787-4 | 65044-0787 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0788-1) | Jubilant HollisterStier LLC | 65044-0788-1 | 65044-0788 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0788-2) | Jubilant HollisterStier LLC | 65044-0788-2 | 65044-0788 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0788-3) | Jubilant HollisterStier LLC | 65044-0788-3 | 65044-0788 | BLA103877 | BLA | N/A |
| Lolium Perenne Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0788-4) | Jubilant HollisterStier LLC | 65044-0788-4 | 65044-0788 | BLA103877 | BLA | N/A |
| Loperamide Hydrochloride | Capsule, Liquid Filled | Oral | 2mg/1 | 1 Blister Pack In 1 Carton (69452-176-12) / 24 Capsule, Liquid Filled In 1 Blister Pack | Bionpharma Inc. | 69452-176-12 | 69452-176 | NDA021855 | NDA | N/A |
| Loperamide Hydrochloride | Capsule, Liquid Filled | Oral | 2mg/1 | 2 Blister Pack In 1 Carton (69452-266-12) / 12 Capsule, Liquid Filled In 1 Blister Pack | Bionpharma Inc. | 69452-266-12 | 69452-266 | NDA021855 | NDA | N/A |
| Loperamide Hydrochloride | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle, Plastic (69452-271-20) | Bionpharma Inc. | 69452-271-20 | 69452-271 | ANDA215579 | ANDA | N/A |
| Loperamide Hydrochloride | Capsule | Oral | 2mg/1 | 500 Capsule In 1 Bottle, Plastic (69452-271-30) | Bionpharma Inc. | 69452-271-30 | 69452-271 | ANDA215579 | ANDA | N/A |
| Loperamide Hydrochloride | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (59746-781-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-781-01 | 59746-781 | ANDA217840 | ANDA | N/A |
| Loperamide Hydrochloride | Capsule | Oral | 2mg/1 | 500 Capsule In 1 Bottle (59746-781-05) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-781-05 | 59746-781 | ANDA217840 | ANDA | N/A |
| Loperamide Hydrochloride | Capsule | Oral | 2mg/1 | 30 Capsule In 1 Bottle (59746-781-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-781-30 | 59746-781 | ANDA217840 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-650-65) / 30 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-650-65 | 45802-650 | ANDA076301 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-650-75) / 90 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-650-75 | 45802-650 | ANDA076301 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-650-78) / 100 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-650-78 | 45802-650 | ANDA076301 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (45802-650-87) / 300 Tablet In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-650-87 | 45802-650 | ANDA076301 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (60760-569-00) | St Mary's Medical Park Pharmacy | 60760-569-00 | 60760-569 | ANDA075209 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2085-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2085-1 | 51672-2085 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2085-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2085-4 | 51672-2085 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2085-5) / 180 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2085-5 | 51672-2085 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2085-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2085-8 | 51672-2085 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2092-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2092-1 | 51672-2092 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2092-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2092-4 | 51672-2092 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2092-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2092-8 | 51672-2092 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2108-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2108-1 | 51672-2108 | ANDA201865 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2108-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2108-8 | 51672-2108 | ANDA201865 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2131-1) / 240 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2131-1 | 51672-2131 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2131-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2131-4 | 51672-2131 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2131-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2131-8 | 51672-2131 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2073-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2073-4 | 51672-2073 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2073-5) / 180 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2073-5 | 51672-2073 | ANDA076805 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (51672-2073-8) / 120 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-2073-8 | 51672-2073 | ANDA076805 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-0147-8) | Apotex Corp. | 60505-0147-8 | 60505-0147 | ANDA076471 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Bottle In 1 Carton (69452-283-17) / 60 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-283-17 | 69452-283 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Blister Pack In 1 Carton (69452-283-19) / 90 Capsule, Liquid Filled In 1 Blister Pack | Bionpharma Inc. | 69452-283-19 | 69452-283 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 180 Capsule, Liquid Filled In 1 Bottle (69452-283-25) | Bionpharma Inc. | 69452-283-25 | 69452-283 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Bottle In 1 Carton (69452-211-03) / 5 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-211-03 | 69452-211 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Blister Pack In 1 Carton (69452-211-07) / 10 Capsule, Liquid Filled In 1 Blister Pack | Bionpharma Inc. | 69452-211-07 | 69452-211 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Bottle In 1 Carton (69452-211-16) / 50 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-211-16 | 69452-211 | ANDA202538 | ANDA | N/A |
| Loratadine | Capsule, Liquid Filled | Oral | 10mg/1 | 1 Bottle In 1 Carton (69452-211-26) / 200 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-211-26 | 69452-211 | ANDA202538 | ANDA | N/A |
| Isradipine | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (42806-264-01) | Epic Pharma, LLC | 42806-264-01 | 42806-264 | ANDA077169 | ANDA | N/A |
| Isradipine | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (42806-264-05) | Epic Pharma, LLC | 42806-264-05 | 42806-264 | ANDA077169 | ANDA | N/A |
| Itraconazole | Solution | Oral | 10mg/mL | 10 Cup, Unit-Dose In 1 Tray (65162-087-34) / 10 Ml In 1 Cup, Unit-Dose (65162-087-13) | Amneal Pharmaceuticals LLC | 65162-087-34 | 65162-087 | ANDA205573 | ANDA | N/A |
| Loratadine; Pseudoephedrine Sulfate | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 120 mg/1 | 10 Blister Pack In 1 Carton (45802-122-46) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-122-46 | 45802-122 | ANDA076050 | ANDA | N/A |
| Loratadine; Pseudoephedrine Sulfate | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 120 mg/1 | 20 Blister Pack In 1 Carton (45802-122-60) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-122-60 | 45802-122 | ANDA076050 | ANDA | N/A |
| Loratadine; Pseudoephedrine Sulfate | Tablet, Film Coated, Extended Release | Oral | 5mg/1, 120 mg/1 | 30 Blister Pack In 1 Carton (45802-122-65) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-122-65 | 45802-122 | ANDA076050 | ANDA | N/A |
| Lorazepam | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (69315-904-01) | Leading Pharma, LLC | 69315-904-01 | 69315-904 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (69315-904-05) | Leading Pharma, LLC | 69315-904-05 | 69315-904 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (69315-904-10) | Leading Pharma, LLC | 69315-904-10 | 69315-904 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (69315-905-01) | Leading Pharma, LLC | 69315-905-01 | 69315-905 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (69315-905-05) | Leading Pharma, LLC | 69315-905-05 | 69315-905 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (69315-905-10) | Leading Pharma, LLC | 69315-905-10 | 69315-905 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (69315-906-01) | Leading Pharma, LLC | 69315-906-01 | 69315-906 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (69315-906-05) | Leading Pharma, LLC | 69315-906-05 | 69315-906 | ANDA078203 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (69315-906-10) | Leading Pharma, LLC | 69315-906-10 | 69315-906 | ANDA078203 | ANDA | CIV |
| Itraconazole | Solution | Oral | 10mg/mL | 150 Ml In 1 Bottle, Glass (65162-087-74) | Amneal Pharmaceuticals LLC | 65162-087-74 | 65162-087 | ANDA205573 | ANDA | N/A |
| Itraconazole | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (65162-630-03) | Amneal Pharmaceuticals LLC | 65162-630-03 | 65162-630 | ANDA205080 | ANDA | N/A |
| Ivabradine | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-053-60) | Camber Pharmaceuticals, Inc. | 31722-053-60 | 31722-053 | ANDA213366 | ANDA | N/A |
| Ivabradine | Tablet, Film Coated | Oral | 7.5mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-054-60) | Camber Pharmaceuticals, Inc. | 31722-054-60 | 31722-054 | ANDA213366 | ANDA | N/A |
| Ivabradine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (50742-362-60) | Ingenus Pharmaceuticals, LLC | 50742-362-60 | 50742-362 | ANDA214051 | ANDA | N/A |
| Ivabradine Hydrochloride | Tablet, Film Coated | Oral | 7.5mg/1 | 60 Tablet, Film Coated In 1 Bottle (50742-363-60) | Ingenus Pharmaceuticals, LLC | 50742-363-60 | 50742-363 | ANDA214051 | ANDA | N/A |
| Ketorolac Tromethamine | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-686-01) | Camber Pharmaceuticals, Inc. | 31722-686-01 | 31722-686 | ANDA216651 | ANDA | N/A |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 10 Vial In 1 Carton (0641-6000-10) / 10 Ml In 1 Vial (0641-6000-01) | Hikma Pharmaceuticals USA Inc. | 0641-6000-10 | 0641-6000 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6001-25) / 1 Ml In 1 Vial (0641-6001-01) | Hikma Pharmaceuticals USA Inc. | 0641-6001-25 | 0641-6001 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 10 Vial In 1 Carton (0641-6002-10) / 10 Ml In 1 Vial (0641-6002-01) | Hikma Pharmaceuticals USA Inc. | 0641-6002-10 | 0641-6002 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 25 Vial In 1 Carton (0641-6003-25) / 1 Ml In 1 Vial (0641-6003-01) | Hikma Pharmaceuticals USA Inc. | 0641-6003-25 | 0641-6003 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6044-25) / 1 Ml In 1 Vial (0641-6044-01) | Hikma Pharmaceuticals USA Inc. | 0641-6044-25 | 0641-6044 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 25 Vial In 1 Carton (0641-6045-25) / 1 Ml In 1 Vial (0641-6045-01) | Hikma Pharmaceuticals USA Inc. | 0641-6045-25 | 0641-6045 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 10 Vial In 1 Carton (0641-6046-10) / 10 Ml In 1 Vial (0641-6046-01) | Hikma Pharmaceuticals USA Inc. | 0641-6046-10 | 0641-6046 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 10 Vial In 1 Carton (0641-6047-10) / 10 Ml In 1 Vial (0641-6047-01) | Hikma Pharmaceuticals USA Inc. | 0641-6047-10 | 0641-6047 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6048-25) / 1 Ml In 1 Vial (0641-6048-01) | Hikma Pharmaceuticals USA Inc. | 0641-6048-25 | 0641-6048 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 25 Vial In 1 Carton (0641-6049-25) / 1 Ml In 1 Vial (0641-6049-01) | Hikma Pharmaceuticals USA Inc. | 0641-6049-25 | 0641-6049 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 10 Vial In 1 Carton (0641-6050-10) / 10 Ml In 1 Vial (0641-6050-01) | Hikma Pharmaceuticals USA Inc. | 0641-6050-10 | 0641-6050 | NDA018140 | NDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 4mg/mL | 10 Vial In 1 Carton (0641-6051-10) / 10 Ml In 1 Vial (0641-6051-01) | Hikma Pharmaceuticals USA Inc. | 0641-6051-10 | 0641-6051 | NDA018140 | NDA | CIV |
| Lorazepam | Solution, Concentrate | Oral | 2mg/mL | 1 Bottle In 1 Carton (0054-3532-44) / 30 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-3532-44 | 0054-3532 | ANDA072755 | ANDA | CIV |
| Lorazepam | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6207-25) / 1 Ml In 1 Vial (0641-6207-01) | Hikma Pharmaceuticals USA Inc. | 0641-6207-25 | 0641-6207 | NDA018140 | NDA | CIV |
| Lorazepam | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 10 Cartridge In 1 Carton (0409-1985-30) / 1 Ml In 1 Cartridge (0409-1985-03) | Hospira, Inc. | 0409-1985-30 | 0409-1985 | ANDA074243 | ANDA | CIV |
| Lorlatinib | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0227-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0227-01 | 0069-0227 | NDA210868 | NDA | N/A |
| Lorlatinib | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-0231-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0231-01 | 0069-0231 | NDA210868 | NDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-645-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-645-30 | 60760-645 | ANDA091497 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-645-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-645-90 | 60760-645 | ANDA091497 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (59746-335-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-335-01 | 59746-335 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (59746-335-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-335-10 | 59746-335 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (59746-335-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-335-30 | 59746-335 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (59746-335-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-335-90 | 59746-335 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (59746-333-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-333-01 | 59746-333 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (59746-333-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-333-10 | 59746-333 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (59746-333-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-333-30 | 59746-333 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (59746-333-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-333-90 | 59746-333 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (59746-334-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-334-01 | 59746-334 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (59746-334-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-334-10 | 59746-334 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (59746-334-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-334-30 | 59746-334 | ANDA201170 | ANDA | N/A |
| Losartan Potassium | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (59746-334-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-334-90 | 59746-334 | ANDA201170 | ANDA | N/A |
| Ketorolac Tromethamine | Injection | Intramuscular | 30mg/mL | 30 Vial In 1 Carton (0487-6232-01) / 2 Ml In 1 Vial | Nephron SC Inc. | 0487-6232-01 | 0487-6232 | ANDA211445 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (42806-327-01) | Epic Pharma, LLC | 42806-327-01 | 42806-327 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (42806-327-05) | Epic Pharma, LLC | 42806-327-05 | 42806-327 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (42806-327-10) | Epic Pharma, LLC | 42806-327-10 | 42806-327 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (42806-328-01) | Epic Pharma, LLC | 42806-328-01 | 42806-328 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (42806-328-05) | Epic Pharma, LLC | 42806-328-05 | 42806-328 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (42806-328-10) | Epic Pharma, LLC | 42806-328-10 | 42806-328 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (42806-329-01) | Epic Pharma, LLC | 42806-329-01 | 42806-329 | ANDA212990 | ANDA | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (42806-329-05) | Epic Pharma, LLC | 42806-329-05 | 42806-329 | ANDA212990 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (51407-251-10) | Golden State Medical Supply | 51407-251-10 | 51407-251 | ANDA075551 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (51407-252-10) | Golden State Medical Supply | 51407-252-10 | 51407-252 | ANDA075551 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (51407-253-10) | Golden State Medical Supply | 51407-253-10 | 51407-253 | ANDA075551 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (61442-141-01) | Carlsbad Technology, Inc. | 61442-141-01 | 61442-141 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (61442-141-05) | Carlsbad Technology, Inc. | 61442-141-05 | 61442-141 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (61442-141-10) | Carlsbad Technology, Inc. | 61442-141-10 | 61442-141 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 10mg/1 | 60 Tablet In 1 Bottle (61442-141-60) | Carlsbad Technology, Inc. | 61442-141-60 | 61442-141 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (61442-142-01) | Carlsbad Technology, Inc. | 61442-142-01 | 61442-142 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (61442-142-05) | Carlsbad Technology, Inc. | 61442-142-05 | 61442-142 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (61442-142-10) | Carlsbad Technology, Inc. | 61442-142-10 | 61442-142 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle (61442-142-60) | Carlsbad Technology, Inc. | 61442-142-60 | 61442-142 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (61442-143-01) | Carlsbad Technology, Inc. | 61442-143-01 | 61442-143 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (61442-143-05) | Carlsbad Technology, Inc. | 61442-143-05 | 61442-143 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (61442-143-10) | Carlsbad Technology, Inc. | 61442-143-10 | 61442-143 | ANDA075991 | ANDA | N/A |
| Lovastatin | Tablet | Oral | 40mg/1 | 60 Tablet In 1 Bottle (61442-143-60) | Carlsbad Technology, Inc. | 61442-143-60 | 61442-143 | ANDA075991 | ANDA | N/A |
| Lubiprostone | Capsule, Gelatin Coated | Oral | 8ug/1 | 60 Capsule, Gelatin Coated In 1 Bottle (51407-744-60) | Golden State Medical Supply, Inc. | 51407-744-60 | 51407-744 | NDA021908 | NDA AUTHORIZED GENERIC | N/A |
| Labetalol Hydrochloride | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (42806-329-10) | Epic Pharma, LLC | 42806-329-10 | 42806-329 | ANDA212990 | ANDA | N/A |
| Lacosamide | Solution | Oral | 10mg/mL | 10 Cup, Unit-Dose In 1 Tray (65162-912-48) / 5 Ml In 1 Cup, Unit-Dose (65162-912-43) | Amneal Pharmaceuticals LLC | 65162-912-48 | 65162-912 | ANDA204839 | ANDA | CV |
| Lacosamide | Solution | Oral | 10mg/mL | 200 Ml In 1 Bottle (65162-912-52) | Amneal Pharmaceuticals LLC | 65162-912-52 | 65162-912 | ANDA204839 | ANDA | CV |
| Lacosamide | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (65162-923-06) | Amneal Pharmaceuticals LLC | 65162-923-06 | 65162-923 | ANDA204857 | ANDA | CV |
| Lurasidone Hydrochloride | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-832-05) | Golden State Medical Supply, Inc. | 51407-832-05 | 51407-832 | ANDA208058 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-833-05) | Golden State Medical Supply, Inc. | 51407-833-05 | 51407-833 | ANDA208058 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (51407-836-05) | Golden State Medical Supply, Inc. | 51407-836-05 | 51407-836 | ANDA208058 | ANDA | N/A |
| Lacosamide | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-923-50) | Amneal Pharmaceuticals LLC | 65162-923-50 | 65162-923 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (65162-924-06) | Amneal Pharmaceuticals LLC | 65162-924-06 | 65162-924 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (65162-924-50) | Amneal Pharmaceuticals LLC | 65162-924-50 | 65162-924 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (65162-925-06) | Amneal Pharmaceuticals LLC | 65162-925-06 | 65162-925 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (65162-925-50) | Amneal Pharmaceuticals LLC | 65162-925-50 | 65162-925 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (65162-926-06) | Amneal Pharmaceuticals LLC | 65162-926-06 | 65162-926 | ANDA204857 | ANDA | CV |
| Lacosamide | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (65162-926-50) | Amneal Pharmaceuticals LLC | 65162-926-50 | 65162-926 | ANDA204857 | ANDA | CV |
| Lacosamide | Solution | Oral | 10mg/mL | 200 Ml In 1 Bottle, Plastic (70954-488-10) | ANI Pharmaceuticals, Inc. | 70954-488-10 | 70954-488 | ANDA216151 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-813-05) | Camber Pharmaceuticals, Inc. | 31722-813-05 | 31722-813 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 100mg/1 | 180 Tablet, Film Coated In 1 Bottle (31722-813-18) | Camber Pharmaceuticals, Inc. | 31722-813-18 | 31722-813 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-813-32) | Camber Pharmaceuticals, Inc. | 31722-813-32 | 31722-813 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-813-60) | Camber Pharmaceuticals, Inc. | 31722-813-60 | 31722-813 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 150mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-814-05) | Camber Pharmaceuticals, Inc. | 31722-814-05 | 31722-814 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 150mg/1 | 180 Tablet, Film Coated In 1 Bottle (31722-814-18) | Camber Pharmaceuticals, Inc. | 31722-814-18 | 31722-814 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-814-32) | Camber Pharmaceuticals, Inc. | 31722-814-32 | 31722-814 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-814-60) | Camber Pharmaceuticals, Inc. | 31722-814-60 | 31722-814 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-815-05) | Camber Pharmaceuticals, Inc. | 31722-815-05 | 31722-815 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 200mg/1 | 180 Tablet, Film Coated In 1 Bottle (31722-815-18) | Camber Pharmaceuticals, Inc. | 31722-815-18 | 31722-815 | ANDA204787 | ANDA | CV |
| LACOSAMIDE | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-815-32) | Camber Pharmaceuticals, Inc. | 31722-815-32 | 31722-815 | ANDA204787 | ANDA | CV |
| Magnesium Citrate | Liquid | Oral | 1.745g/29.6mL | 296 Ml In 1 Bottle, Plastic (69452-389-98) | Bionpharma, Inc. | 69452-389-98 | 69452-389 | M007 | OTC MONOGRAPH DRUG | N/A |
| Magnesium Citrate | Liquid | Oral | 1.745g/29.6mL | 296 Ml In 1 Bottle, Plastic (69452-390-98) | Bionpharma, Inc. | 69452-390-98 | 69452-390 | M007 | OTC MONOGRAPH DRUG | N/A |
| Magnesium Citrate | Liquid | Oral | 1.745g/29.6mL | 296 Ml In 1 Bottle, Plastic (69452-391-98) | Bionpharma, Inc. | 69452-391-98 | 69452-391 | M007 | OTC MONOGRAPH DRUG | N/A |
| Magnesium Hydroxide | Suspension | Oral | 400mg/5mL | 10 Tray In 1 Case (66689-053-99) / 10 Cup, Unit-Dose In 1 Tray / 30 Ml In 1 Cup, Unit-Dose | VistaPharm, LLC | 66689-053-99 | 66689-053 | M007 | OTC MONOGRAPH DRUG | N/A |
| LACOSAMIDE | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-815-60) | Camber Pharmaceuticals, Inc. | 31722-815-60 | 31722-815 | ANDA204787 | ANDA | CV |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 40mg/mL | 10 Bag In 1 Carton (25021-612-81) / 50 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-612-81 | 25021-612 | ANDA213917 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 40mg/mL | 10 Bag In 1 Carton (25021-612-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-612-82 | 25021-612 | ANDA213917 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Granule, For Solution | Oral; Topical | 1g/g | 3630 G In 1 Pouch (71569-602-80) | Jubilant, LLC | 71569-602-80 | 71569-602 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| LACOSAMIDE | Injection | Intravenous | 10mg/mL | 10 Vial, Glass In 1 Carton (31722-203-31) / 20 Ml In 1 Vial, Glass (31722-203-20) | Camber Pharmaceuticals, Inc. | 31722-203-31 | 31722-203 | ANDA216335 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-192-10) | ScieGen Pharmaceuticals Inc | 50228-192-10 | 50228-192 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-192-30) | ScieGen Pharmaceuticals Inc | 50228-192-30 | 50228-192 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-192-60) | ScieGen Pharmaceuticals Inc | 50228-192-60 | 50228-192 | ANDA205237 | ANDA | CV |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intramuscular; Intravenous | 500mg/mL | 25 Vial, Plastic In 1 Tray (0409-2168-77) / 20 Ml In 1 Vial, Plastic (0409-2168-17) | Hospira, Inc. | 0409-2168-77 | 0409-2168 | ANDA202411 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intramuscular; Intravenous | 500mg/mL | 10 Carton In 1 Package (0409-1754-10) / 1 Syringe, Plastic In 1 Carton / 10 Ml In 1 Syringe, Plastic (0409-1754-15) | Hospira, Inc. | 0409-1754-10 | 0409-1754 | ANDA075151 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 10mg/mL | 24 Pouch In 1 Case (0409-6727-23) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-6727-11) | Hospira, Inc. | 0409-6727-23 | 0409-6727 | NDA020488 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 10mg/mL | 50 Pouch In 1 Case (0409-6727-50) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-6727-55) | Hospira, Inc. | 0409-6727-50 | 0409-6727 | NDA020488 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 2g/50mL | 60 Pouch In 1 Case (0409-5239-60) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-5239-01) | Hospira, Inc. | 0409-5239-60 | 0409-5239 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 20g/500mL | 20 Pouch In 1 Case (0409-2050-20) / 1 Bag In 1 Pouch / 500 Ml In 1 Bag (0409-2050-01) | Hospira, Inc. | 0409-2050-20 | 0409-2050 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 40g/1000mL | 12 Pouch In 1 Case (0409-3164-12) / 1 Bag In 1 Pouch / 1000 Ml In 1 Bag (0409-3164-01) | Hospira, Inc. | 0409-3164-12 | 0409-3164 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 40mg/mL | 24 Pouch In 1 Case (0409-6729-23) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-6729-41) | Hospira, Inc. | 0409-6729-23 | 0409-6729 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 40mg/mL | 24 Pouch In 1 Case (0409-6729-24) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-6729-11) | Hospira, Inc. | 0409-6729-24 | 0409-6729 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 80mg/mL | 60 Pouch In 1 Case (0409-6730-60) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-6730-50) | Hospira, Inc. | 0409-6730-60 | 0409-6730 | NDA020309 | NDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection, Solution | Intravenous | 4g/100mL | 50 Pouch In 1 Case (0409-4121-50) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-4121-01) | Hospira, Inc. | 0409-4121-50 | 0409-4121 | NDA020309 | NDA | N/A |
| Magnesium Sulfate, Unspecified Form; Potassium Sulfate; Sodium Sulfate Anhydrous | Solution | Oral | 1.6g/177mL, 3.13 g/177mL, 17.5 g/177mL | 2 Bottle In 1 Carton (51672-4170-5) / 177 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., inc. | 51672-4170-5 | 51672-4170 | ANDA206431 | ANDA | N/A |
| Malathion | Lotion | Topical | .0005g/mL | 1 Bottle In 1 Carton (51672-5294-4) / 59 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5294-4 | 51672-5294 | ANDA091559 | ANDA | N/A |
| Malathion | Lotion | Topical | .0005g/mL | 1 Bottle In 1 Carton (51672-5293-4) / 59 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-5293-4 | 51672-5293 | ANDA091559 | ANDA | N/A |
| Manganese Chloride | Injection, Solution | Intravenous | .1mg/mL | 25 Vial, Plastic In 1 Tray (0409-4091-01) / 10 Ml In 1 Vial, Plastic (0409-4091-11) | Hospira, Inc. | 0409-4091-01 | 0409-4091 | NDA018962 | NDA | N/A |
| Mannitol | Injection, Solution | Intravenous | 12.5g/50mL | 25 Vial, Single-Dose In 1 Tray (0409-4031-01) / 50 Ml In 1 Vial, Single-Dose (0409-4031-16) | Hospira, Inc. | 0409-4031-01 | 0409-4031 | NDA016269 | NDA | N/A |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-193-10) | ScieGen Pharmaceuticals Inc | 50228-193-10 | 50228-193 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-193-30) | ScieGen Pharmaceuticals Inc | 50228-193-30 | 50228-193 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-193-60) | ScieGen Pharmaceuticals Inc | 50228-193-60 | 50228-193 | ANDA205237 | ANDA | CV |
| Mecamylamine Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (79739-7183-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7183-1 | 79739-7183 | ANDA204054 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-661-30) | St. Mary's Medical Park Pharmacy | 60760-661-30 | 60760-661 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-661-90) | St. Mary's Medical Park Pharmacy | 60760-661-90 | 60760-661 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (51407-629-10) | Golden State Medical Supply, Inc. | 51407-629-10 | 51407-629 | ANDA084657 | ANDA | N/A |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-194-10) | ScieGen Pharmaceuticals Inc | 50228-194-10 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-194-30) | ScieGen Pharmaceuticals Inc | 50228-194-30 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-194-60) | ScieGen Pharmaceuticals Inc | 50228-194-60 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-195-10) | ScieGen Pharmaceuticals Inc | 50228-195-10 | 50228-195 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-195-30) | ScieGen Pharmaceuticals Inc | 50228-195-30 | 50228-195 | ANDA205237 | ANDA | CV |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (59746-121-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-121-06 | 59746-121 | ANDA040659 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (59746-121-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-121-10 | 59746-121 | ANDA040659 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (59746-122-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-122-06 | 59746-122 | ANDA040659 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (59746-122-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-122-10 | 59746-122 | ANDA040659 | ANDA | N/A |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-195-60) | ScieGen Pharmaceuticals Inc | 50228-195-60 | 50228-195 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-192-10) | ScieGen Pharmaceuticals Inc | 50228-192-10 | 50228-192 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-192-30) | ScieGen Pharmaceuticals Inc | 50228-192-30 | 50228-192 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-192-60) | ScieGen Pharmaceuticals Inc | 50228-192-60 | 50228-192 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-193-10) | ScieGen Pharmaceuticals Inc | 50228-193-10 | 50228-193 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-193-30) | ScieGen Pharmaceuticals Inc | 50228-193-30 | 50228-193 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-193-60) | ScieGen Pharmaceuticals Inc | 50228-193-60 | 50228-193 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-194-10) | ScieGen Pharmaceuticals Inc | 50228-194-10 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-194-30) | ScieGen Pharmaceuticals Inc | 50228-194-30 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-194-60) | ScieGen Pharmaceuticals Inc | 50228-194-60 | 50228-194 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-195-10) | ScieGen Pharmaceuticals Inc | 50228-195-10 | 50228-195 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-195-30) | ScieGen Pharmaceuticals Inc | 50228-195-30 | 50228-195 | ANDA205237 | ANDA | CV |
| Lacosamide | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-195-60) | ScieGen Pharmaceuticals Inc | 50228-195-60 | 50228-195 | ANDA205237 | ANDA | CV |
| LACOSAMIDE | Injection | Intravenous | 10mg/mL | 10 Vial, Glass In 1 Carton (72865-235-10) / 20 Ml In 1 Vial, Glass (72865-235-01) | XLCare Pharmaceuticals Inc. | 72865-235-10 | 72865-235 | ANDA216335 | ANDA | CV |
| Medronic Acid | Injection, Powder, For Solution | Intravenous | 25mg/1 | 30 Injection, Powder, For Solution In 1 Carton (65174-660-30) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-660-30 | 65174-660 | NDA018035 | NDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 25 Vial In 1 Carton (66993-370-25) / 1 Ml In 1 Vial | Prasco Laboratories | 66993-370-25 | 66993-370 | NDA020246 | NDA AUTHORIZED GENERIC | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 1 Vial In 1 Carton (66993-370-83) / 1 Ml In 1 Vial | Prasco Laboratories | 66993-370-83 | 66993-370 | NDA020246 | NDA AUTHORIZED GENERIC | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 1 Syringe In 1 Carton (66993-371-79) / 1 Ml In 1 Syringe | Prasco Laboratories | 66993-371-79 | 66993-371 | NDA020246 | NDA AUTHORIZED GENERIC | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Syringe In 1 Carton (0548-5701-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5701-00 | 0548-5701 | ANDA077334 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Syringe In 1 Carton (0548-5711-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5711-00 | 0548-5711 | ANDA077334 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Vial, Single-Dose In 1 Carton (0548-5400-00) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5400-00 | 0548-5400 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 25 Vial, Single-Dose In 1 Carton (0548-5400-25) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5400-25 | 0548-5400 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Vial, Single-Dose In 1 Carton (0548-5410-00) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5410-00 | 0548-5410 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 25 Vial, Single-Dose In 1 Carton (0548-5410-25) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5410-25 | 0548-5410 | ANDA077235 | ANDA | N/A |
| Lactulose | Powder, For Solution | Oral | 10g/10g | 30 Pouch In 1 Carton (66220-719-30) / 10 G In 1 Pouch (66220-719-01) | Cumberland Pharmaceuticals Inc. | 66220-719-30 | 66220-719 | ANDA074712 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Vial, Single-Dose In 1 Carton (0548-5400-00) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5400-00 | 0548-5400 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 25 Vial, Single-Dose In 1 Carton (0548-5400-25) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5400-25 | 0548-5400 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Vial, Single-Dose In 1 Carton (0548-5410-00) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5410-00 | 0548-5410 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 25 Vial, Single-Dose In 1 Carton (0548-5410-25) / 1 Ml In 1 Vial, Single-Dose | Amphastar Pharmaceuticals, Inc. | 0548-5410-25 | 0548-5410 | ANDA077235 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Syringe In 1 Carton (0548-5701-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5701-00 | 0548-5701 | ANDA077334 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension, Extended Release | Intramuscular | 150mg/mL | 1 Syringe In 1 Carton (0548-5711-00) / 1 Ml In 1 Syringe | Amphastar Pharmaceuticals, Inc. | 0548-5711-00 | 0548-5711 | ANDA077334 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 1 Vial In 1 Carton (24201-150-01) / 1 Ml In 1 Vial (24201-150-00) | Hikma Pharmaceuticals USA inc. | 24201-150-01 | 24201-150 | ANDA214309 | ANDA | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 25 Vial In 1 Carton (24201-150-25) / 1 Ml In 1 Vial (24201-150-00) | Hikma Pharmaceuticals USA inc. | 24201-150-25 | 24201-150 | ANDA214309 | ANDA | N/A |
| Mefenamic Acid | Capsule | Oral | 250mg/1 | 30 Capsule In 1 Bottle (62250-677-30) | Belcher Pharmaceuticals,LLC | 62250-677-30 | 62250-677 | ANDA091608 | ANDA | N/A |
| Mefloquine Hydrochloride | Tablet | Oral | 250mg/1 | 1 Bottle In 1 Carton (0054-0025-11) / 25 Tablet In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-0025-11 | 0054-0025 | ANDA076523 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 240 Ml In 1 Bottle, Plastic (51407-910-24) | Golden State Medical Supply, Inc. | 51407-910-24 | 51407-910 | ANDA075671 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 480 Ml In 1 Bottle, Plastic (51407-910-48) | Golden State Medical Supply, Inc. | 51407-910-48 | 51407-910 | ANDA075671 | ANDA | N/A |
| Megestrol Acetate | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (60429-433-01) | Golden State Medical Supply, Inc. | 60429-433-01 | 60429-433 | ANDA072423 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 5 Tray In 1 Case (66689-020-50) / 10 Cup, Unit-Dose In 1 Tray / 10 Ml In 1 Cup, Unit-Dose (66689-020-01) | VistaPharm, LLC | 66689-020-50 | 66689-020 | ANDA075671 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 10 Tray In 1 Case (66689-020-99) / 10 Cup, Unit-Dose In 1 Tray / 10 Ml In 1 Cup, Unit-Dose (66689-020-01) | VistaPharm, LLC | 66689-020-99 | 66689-020 | ANDA075671 | ANDA | N/A |
| Lactulose | Powder, For Solution | Oral | 20g/20g | 30 Pouch In 1 Carton (66220-729-30) / 20 G In 1 Pouch (66220-729-01) | Cumberland Pharmaceuticals Inc. | 66220-729-30 | 66220-729 | ANDA074712 | ANDA | N/A |
| Lactulose | Solution | Oral; Rectal | 10g/15mL | 118 Ml In 1 Bottle (64980-592-12) | Rising Pharmaceuticals, Inc. | 64980-592-12 | 64980-592 | ANDA076645 | ANDA | N/A |
| Melaleuca Cajuputi Leaf Oil; Thymol | Cream | Topical | .0001kg/100kg, .0001 kg/100kg | 1 Tube In 1 Carton (71042-027-14) / .142 Kg In 1 Tube | OrganiCare Nature's Science, LLC | 71042-027-14 | 71042-027 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Melaleuca Cajuputi Whole; Thymol | Cream | Topical | .01g/g, .01 g/g | 1 Tube In 1 Carton (71042-028-14) / 14.2 G In 1 Tube | OrganiCare Nature's Science, LLC | 71042-028-14 | 71042-028 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Melaleuca Citrina Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1207-2) | Jubilant HollisterStier LLC | 65044-1207-2 | 65044-1207 | BLA103888 | BLA | N/A |
| Melaleuca Citrina Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1207-3) | Jubilant HollisterStier LLC | 65044-1207-3 | 65044-1207 | BLA103888 | BLA | N/A |
| Melaleuca Citrina Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1207-4) | Jubilant HollisterStier LLC | 65044-1207-4 | 65044-1207 | BLA103888 | BLA | N/A |
| Melaleuca Citrina Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1208-1) | Jubilant HollisterStier LLC | 65044-1208-1 | 65044-1208 | BLA103888 | BLA | N/A |
| Melaleuca Quinquenervia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1873-2) | Jubilant HollisterStier LLC | 65044-1873-2 | 65044-1873 | BLA103888 | BLA | N/A |
| Melaleuca Quinquenervia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1873-3) | Jubilant HollisterStier LLC | 65044-1873-3 | 65044-1873 | BLA103888 | BLA | N/A |
| Melaleuca Quinquenervia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1873-4) | Jubilant HollisterStier LLC | 65044-1873-4 | 65044-1873 | BLA103888 | BLA | N/A |
| Melaleuca Quinquenervia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1874-1) | Jubilant HollisterStier LLC | 65044-1874-1 | 65044-1874 | BLA103888 | BLA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 7 Tablet In 1 Bottle, Plastic (60760-653-07) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-653-07 | 60760-653 | ANDA077929 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-653-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-653-30 | 60760-653 | ANDA077929 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-653-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-653-60 | 60760-653 | ANDA077929 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-653-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-653-90 | 60760-653 | ANDA077929 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-610-10) | Golden State Medical Supply, Inc. | 51407-610-10 | 51407-610 | ANDA077918 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-610-90) | Golden State Medical Supply, Inc. | 51407-610-90 | 51407-610 | ANDA077918 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-611-10) | Golden State Medical Supply, Inc. | 51407-611-10 | 51407-611 | ANDA077918 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-611-90) | Golden State Medical Supply, Inc. | 51407-611-90 | 51407-611 | ANDA077918 | ANDA | N/A |
| Lactulose | Solution | Oral; Rectal | 10g/15mL | 236 Ml In 1 Bottle (64980-592-24) | Rising Pharmaceuticals, Inc. | 64980-592-24 | 64980-592 | ANDA076645 | ANDA | N/A |
| Lactulose | Solution | Oral; Rectal | 10g/15mL | 473 Ml In 1 Bottle (64980-592-48) | Rising Pharmaceuticals, Inc. | 64980-592-48 | 64980-592 | ANDA076645 | ANDA | N/A |
| Lactulose | Solution | Oral; Rectal | 10g/15mL | 946 Ml In 1 Bottle (64980-592-95) | Rising Pharmaceuticals, Inc. | 64980-592-95 | 64980-592 | ANDA076645 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 600 Tablet, Film Coated In 1 Bottle (31722-752-06) | Camber Pharmaceuticals, Inc. | 31722-752-06 | 31722-752 | ANDA203260 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-752-31) | Camber Pharmaceuticals, Inc. | 31722-752-31 | 31722-752 | ANDA203260 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Carton (31722-752-32) | Camber Pharmaceuticals, Inc. | 31722-752-32 | 31722-752 | ANDA203260 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-752-60) | Camber Pharmaceuticals, Inc. | 31722-752-60 | 31722-752 | ANDA203260 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 600 Tablet, Film Coated In 1 Bottle (31722-753-06) | Camber Pharmaceuticals, Inc. | 31722-753-06 | 31722-753 | ANDA203277 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle, Plastic (61442-126-10) | Carlsbad Technology, Inc. | 61442-126-10 | 61442-126 | ANDA077918 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-753-31) | Camber Pharmaceuticals, Inc. | 31722-753-31 | 31722-753 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Carton (31722-753-32) | Camber Pharmaceuticals, Inc. | 31722-753-32 | 31722-753 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-753-60) | Camber Pharmaceuticals, Inc. | 31722-753-60 | 31722-753 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 600 Tablet, Film Coated In 1 Bottle (31722-754-06) | Camber Pharmaceuticals, Inc. | 31722-754-06 | 31722-754 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-754-30) | Camber Pharmaceuticals, Inc. | 31722-754-30 | 31722-754 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-754-31) | Camber Pharmaceuticals, Inc. | 31722-754-31 | 31722-754 | ANDA203277 | ANDA | N/A |
| Lamivudine | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Carton (31722-754-32) | Camber Pharmaceuticals, Inc. | 31722-754-32 | 31722-754 | ANDA203277 | ANDA | N/A |
| lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 20 Blister Pack In 1 Carton (31722-001-02) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-001-02 | 31722-001 | ANDA211306 | ANDA | N/A |
| lamivudine | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-001-60) | Camber Pharmaceuticals, Inc. | 31722-001-60 | 31722-001 | ANDA211306 | ANDA | N/A |
| Lamivudine | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle, Plastic (50742-624-60) | Ingenus Pharmaceuticals, LLC | 50742-624-60 | 50742-624 | ANDA206974 | ANDA | N/A |
| Lamivudine | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle, Plastic (50742-623-60) | Ingenus Pharmaceuticals, LLC | 50742-623-60 | 50742-623 | ANDA206974 | ANDA | N/A |
| Lamivudine | Solution | Oral | 10mg/mL | 240 Ml In 1 Bottle (57237-274-24) | Rising Pharma Holdings, Inc. | 57237-274-24 | 57237-274 | ANDA077695 | ANDA | N/A |
| Lamivudine and Zidovudine | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-739-05) | Camber Pharmaceuticals, Inc. | 31722-739-05 | 31722-739 | ANDA203259 | ANDA | N/A |
| Lamivudine and Zidovudine | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-739-31) | Camber Pharmaceuticals, Inc. | 31722-739-31 | 31722-739 | ANDA203259 | ANDA | N/A |
| Lamivudine and Zidovudine | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-739-60) | Camber Pharmaceuticals, Inc. | 31722-739-60 | 31722-739 | ANDA203259 | ANDA | N/A |
| LAMIVUDINE and ZIDOVUDINE | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-506-05) | Camber Pharmaceuticals, Inc. | 31722-506-05 | 31722-506 | ANDA079124 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (52605-071-10) | POLYGEN PHARMACEUTICALS INC. | 52605-071-10 | 52605-071 | ANDA210587 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (52605-071-13) | POLYGEN PHARMACEUTICALS INC. | 52605-071-13 | 52605-071 | ANDA210587 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (52605-071-16) | POLYGEN PHARMACEUTICALS INC. | 52605-071-16 | 52605-071 | ANDA210587 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (52605-072-10) | POLYGEN PHARMACEUTICALS INC. | 52605-072-10 | 52605-072 | ANDA210587 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (52605-072-13) | POLYGEN PHARMACEUTICALS INC. | 52605-072-13 | 52605-072 | ANDA210587 | ANDA | N/A |
| Memantine Hydrochloride | Solution | Oral | 2mg/mL | 1 Bottle In 1 Carton (60505-6162-5) / 360 Ml In 1 Bottle | Apotex Corp. | 60505-6162-5 | 60505-6162 | ANDA209955 | ANDA | N/A |
| Memantine Hydrochloride | Solution | Oral | 2mg/mL | 360 Ml In 1 Bottle (13925-540-12) | Seton Pharmaceuticals | 13925-540-12 | 13925-540 | ANDA210319 | ANDA | N/A |
| LAMIVUDINE and ZIDOVUDINE | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-506-60) | Camber Pharmaceuticals, Inc. | 31722-506-60 | 31722-506 | ANDA079124 | ANDA | N/A |
| LAMIVUDINE AND ZIDOVUDINE | Tablet, Film Coated | Oral | 150mg/1, 300 mg/1 | 60 Tablet, Film Coated In 1 Bottle (72865-144-60) | XLCare Pharmaceuticals, Inc | 72865-144-60 | 72865-144 | ANDA203259 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-986-03) | Amneal Pharmaceuticals LLC | 65162-986-03 | 65162-986 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-986-09) | Amneal Pharmaceuticals LLC | 65162-986-09 | 65162-986 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 250mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-988-03) | Amneal Pharmaceuticals LLC | 65162-988-03 | 65162-988 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 250mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-988-09) | Amneal Pharmaceuticals LLC | 65162-988-09 | 65162-988 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-990-03) | Amneal Pharmaceuticals LLC | 65162-990-03 | 65162-990 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-990-09) | Amneal Pharmaceuticals LLC | 65162-990-09 | 65162-990 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-949-03) | Amneal Pharmaceuticals LLC | 65162-949-03 | 65162-949 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-949-09) | Amneal Pharmaceuticals LLC | 65162-949-09 | 65162-949 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-956-03) | Amneal Pharmaceuticals LLC | 65162-956-03 | 65162-956 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-956-09) | Amneal Pharmaceuticals LLC | 65162-956-09 | 65162-956 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-958-03) | Amneal Pharmaceuticals LLC | 65162-958-03 | 65162-958 | ANDA207497 | ANDA | N/A |
| Lamotrigine | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-958-09) | Amneal Pharmaceuticals LLC | 65162-958-09 | 65162-958 | ANDA207497 | ANDA | N/A |
| Menthol | Cream | Topical | 80mg/mL | 118.29 Ml In 1 Tube (82560-273-00) | COASTAL FORMULAS LLC | 82560-273-00 | 82560-273 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Cream | Topical | 80mg/mL | 3939.19 Ml In 1 Jug (82560-283-00) | COASTAL FORMULAS LLC | 82560-283-00 | 82560-283 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Gel | Topical | 40mg/mL | 74 Ml In 1 Bottle (80684-101-00) | Fourstar Group USA, Inc. | 80684-101-00 | 80684-101 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Liquid | Topical | 160mg/mL | 74 Ml In 1 Bottle (80684-097-00) | Fourstar Group USA, Inc. | 80684-097-00 | 80684-097 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Gel | Topical | 4.58g/100g | 57 G In 1 Tube (10578-131-02) | Indiana Botanic Gardens | 10578-131-02 | 10578-131 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Menthol | Gel | Topical | 4.58g/100g | 142 G In 1 Jar (10578-131-05) | Indiana Botanic Gardens | 10578-131-05 | 10578-131 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Menthol | Gel | Topical | 4.6g/100g | 57 G In 1 Jar (10578-135-05) | Indiana Botanic Gardens | 10578-135-05 | 10578-135 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Menthol | Cream | Topical | 3g/100g | 5 G In 1 Blister Pack (58559-002-01) | Corganics, LP | 58559-002-01 | 58559-002 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Cream | Topical | 3g/100g | 82 G In 1 Bottle, With Applicator (58559-002-02) | Corganics, LP | 58559-002-02 | 58559-002 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Cream | Topical | 3g/100g | 115 G In 1 Tube (58559-002-03) | Corganics, LP | 58559-002-03 | 58559-002 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Cream | Topical | 3g/100g | 450 G In 1 Bottle, Pump (58559-002-04) | Corganics, LP | 58559-002-04 | 58559-002 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Cream | Topical | 3g/100g | 3600 G In 1 Bottle, Pump (58559-002-05) | Corganics, LP | 58559-002-05 | 58559-002 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol | Liquid | Topical | 16mg/100mL | 1 Container In 1 Carton (69452-375-96) / 74 Ml In 1 Container | Bionpharma Inc. | 69452-375-96 | 69452-375 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-245-30) | Camber Pharmaceuticals Inc | 31722-245-30 | 31722-245 | ANDA213949 | ANDA | N/A |
| Menthol, Unspecified Form; Methyl Salicylate | Cream | Topical | 10g/100g, 15 g/100g | 1 Tube In 1 Carton (45802-174-53) / 85 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-174-53 | 45802-174 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Menthol; Methyl Salicylate | Ointment | Topical | 8g/100g, 16 g/100g | 1 Tube In 1 Package (54312-825-01) / 45 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-825-01 | 54312-825 | M017 | OTC MONOGRAPH DRUG | N/A |
| Menthol; Methyl Salicylate | Cream | Topical | 70mg/mL, 140 mg/mL | 1 Tube In 1 Package (76187-762-02) / 60 Ml In 1 Tube | Isagenix International, LLC | 76187-762-02 | 76187-762 | M017 | OTC MONOGRAPH DRUG | N/A |
| Meperidine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (30698-335-01) | Validus Pharmaceuticals LLC | 30698-335-01 | 30698-335 | NDA005010 | NDA | CII |
| Meperidine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle, Plastic (30698-337-01) | Validus Pharmaceuticals LLC | 30698-337-01 | 30698-337 | NDA005010 | NDA | CII |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-240-30) | Camber Pharmaceuticals Inc | 31722-240-30 | 31722-240 | ANDA213949 | ANDA | N/A |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-241-30) | Camber Pharmaceuticals Inc | 31722-241-30 | 31722-241 | ANDA213949 | ANDA | N/A |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-242-30) | Camber Pharmaceuticals Inc | 31722-242-30 | 31722-242 | ANDA213949 | ANDA | N/A |
| Meperidine Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 25mg/mL | 25 Vial In 1 Carton (0641-6052-25) / 1 Ml In 1 Vial (0641-6052-01) | Hikma Pharmaceuticals USA Inc. | 0641-6052-25 | 0641-6052 | ANDA080445 | ANDA | CII |
| Meperidine Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 50mg/mL | 25 Vial In 1 Carton (0641-6053-25) / 1 Ml In 1 Vial (0641-6053-01) | Hikma Pharmaceuticals USA Inc. | 0641-6053-25 | 0641-6053 | ANDA080445 | ANDA | CII |
| Meperidine Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 100mg/mL | 25 Vial In 1 Carton (0641-6054-25) / 1 Ml In 1 Vial (0641-6054-01) | Hikma Pharmaceuticals USA Inc. | 0641-6054-25 | 0641-6054 | ANDA080445 | ANDA | CII |
| Meperidine Hydrochloride | Solution | Oral | 50mg/5mL | 500 Ml In 1 Bottle (0054-3545-63) | Hikma Pharmaceuticals USA Inc. | 0054-3545-63 | 0054-3545 | ANDA088744 | ANDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 25mg/mL | 10 Syringe In 1 Cello Pack (0409-1362-01) / 1 Ml In 1 Syringe (0409-1362-11) | Hospira, Inc. | 0409-1362-01 | 0409-1362 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 50mg/mL | 10 Syringe In 1 Cello Pack (0409-1418-01) / 1 Ml In 1 Syringe (0409-1418-11) | Hospira, Inc. | 0409-1418-01 | 0409-1418 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 25mg/mL | 10 Cartridge In 1 Carton (0409-1176-30) / 1 Ml In 1 Cartridge (0409-1176-03) | Hospira, Inc. | 0409-1176-30 | 0409-1176 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 50mg/mL | 10 Cartridge In 1 Carton (0409-1178-30) / 1 Ml In 1 Cartridge (0409-1178-03) | Hospira, Inc. | 0409-1178-30 | 0409-1178 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 75mg/mL | 10 Cartridge In 1 Carton (0409-1179-30) / 1 Ml In 1 Cartridge (0409-1179-03) | Hospira, Inc. | 0409-1179-30 | 0409-1179 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 100mg/mL | 10 Cartridge In 1 Carton (0409-1180-69) / 1 Ml In 1 Cartridge (0409-1180-59) | Hospira, Inc. | 0409-1180-69 | 0409-1180 | NDA021171 | NDA | CII |
| Meperidine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 50mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-1181-30) / 30 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1181-30 | 0409-1181 | NDA021171 | NDA | CII |
| Meprobamate | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51672-4147-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4147-1 | 51672-4147 | ANDA200998 | ANDA | CIV |
| Meprobamate | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (51672-4147-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4147-3 | 51672-4147 | ANDA200998 | ANDA | CIV |
| Meprobamate | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (51672-4147-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4147-6 | 51672-4147 | ANDA200998 | ANDA | CIV |
| Meprobamate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (51672-4148-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4148-1 | 51672-4148 | ANDA200998 | ANDA | CIV |
| Meprobamate | Tablet | Oral | 400mg/1 | 1000 Tablet In 1 Bottle (51672-4148-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4148-3 | 51672-4148 | ANDA200998 | ANDA | CIV |
| Meprobamate | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (51672-4148-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4148-6 | 51672-4148 | ANDA200998 | ANDA | CIV |
| Mercaptopurine | Tablet | Oral | 50mg/1 | 25 Tablet In 1 Bottle, Plastic (0054-4581-11) | Hikma Pharmaceuticals USA Inc. | 0054-4581-11 | 0054-4581 | ANDA040528 | ANDA | N/A |
| Mercaptopurine | Tablet | Oral | 50mg/1 | 250 Tablet In 1 Bottle, Plastic (0054-4581-27) | Hikma Pharmaceuticals USA Inc. | 0054-4581-27 | 0054-4581 | ANDA040528 | ANDA | N/A |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-243-30) | Camber Pharmaceuticals Inc | 31722-243-30 | 31722-243 | ANDA213949 | ANDA | N/A |
| lamotrigine | Tablet, Film Coated, Extended Release | Oral | 250mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-244-30) | Camber Pharmaceuticals Inc | 31722-244-30 | 31722-244 | ANDA213949 | ANDA | N/A |
| Meropenem | Injection | Intravenous | 500mg/20mL | 10 Vial In 1 Carton (0143-9430-10) / 20 Ml In 1 Vial (0143-9430-01) | Hikma Pharmaceuticals USA Inc. | 0143-9430-10 | 0143-9430 | ANDA216424 | ANDA | N/A |
| Meropenem | Injection | Intravenous | 1g/30mL | 10 Vial In 1 Carton (0143-9431-10) / 30 Ml In 1 Vial (0143-9431-01) | Hikma Pharmaceuticals USA Inc. | 0143-9431-10 | 0143-9431 | ANDA216424 | ANDA | N/A |
| Meropenem | Injection, Powder, For Solution | Intravenous | 1g/20mL | 10 Vial In 1 Carton (0409-3412-10) / 20 Ml In 1 Vial (0409-3412-01) | Hospira, Inc. | 0409-3412-10 | 0409-3412 | ANDA091404 | ANDA | N/A |
| Meropenem | Injection, Powder, For Solution | Intravenous | 500mg/10mL | 10 Vial In 1 Carton (0409-1390-51) / 10 Ml In 1 Vial (0409-1390-21) | Hospira, Inc. | 0409-1390-51 | 0409-1390 | ANDA091404 | ANDA | N/A |
| Meropenem | Injection, Powder, For Solution | Intravenous | 1g/20mL | 10 Vial In 1 Carton (0409-1391-22) / 20 Ml In 1 Vial (0409-1391-21) | Hospira, Inc. | 0409-1391-22 | 0409-1391 | ANDA091404 | ANDA | N/A |
| Meropenem | Injection, Powder, For Solution | Intravenous | 500mg/10mL | 10 Vial In 1 Carton (0409-0222-10) / 10 Ml In 1 Vial (0409-0222-01) | Hospira, Inc. | 0409-0222-10 | 0409-0222 | ANDA091404 | ANDA | N/A |
| Mesalamine | Enema | Rectal | 4g/60mL | 28 Bottle In 1 Carton (45802-098-28) / 60 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-098-28 | 45802-098 | ANDA076751 | ANDA | N/A |
| Mesalamine | Enema | Rectal | 4g/60mL | 60 Ml In 1 Bottle (45802-098-46) | Padagis Israel Pharmaceuticals Ltd | 45802-098-46 | 45802-098 | ANDA076751 | ANDA | N/A |
| Mesalamine | Enema | Rectal | 4g/60mL | 7 Bottle In 1 Carton (45802-098-51) / 60 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-098-51 | 45802-098 | ANDA076751 | ANDA | N/A |
| Mesalamine | Tablet, Delayed Release | Oral | 1.2g/1 | 120 Tablet, Delayed Release In 1 Bottle (51407-274-12) | Golden State Medical Supply, Inc. | 51407-274-12 | 51407-274 | ANDA211858 | ANDA | N/A |
| Lamotrigine | Tablet, Chewable | Oral | 5mg/1 | 100 Tablet, Chewable In 1 Bottle (16571-785-01) | Rising Pharma Holdings, Inc. | 16571-785-01 | 16571-785 | ANDA090401 | ANDA | N/A |
| Lamotrigine | Tablet, Chewable | Oral | 25mg/1 | 100 Tablet, Chewable In 1 Bottle (16571-786-01) | Rising Pharma Holdings, Inc. | 16571-786-01 | 16571-786 | ANDA090401 | ANDA | N/A |
| Mesna | Injection, Solution | Intravenous | 100mg/mL | 1 Vial In 1 Carton (25021-201-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-201-10 | 25021-201 | ANDA090913 | ANDA | N/A |
| Mesna | Injection, Solution | Intravenous | 100mg/mL | 10 Vial In 1 Carton (25021-201-11) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-201-11 | 25021-201 | ANDA090913 | ANDA | N/A |
| Mesna | Injection, Solution | Intravenous | 100mg/mL | 1 Vial, Multi-Dose In 1 Carton (0143-9260-01) / 10 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9260-01 | 0143-9260 | ANDA075739 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 25mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-319-01) | ScieGen Pharmaceuticals, Inc. | 50228-319-01 | 50228-319 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 25mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-319-30) | ScieGen Pharmaceuticals, Inc. | 50228-319-30 | 50228-319 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 50mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-320-01) | ScieGen Pharmaceuticals, Inc. | 50228-320-01 | 50228-320 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 50mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-320-30) | ScieGen Pharmaceuticals, Inc. | 50228-320-30 | 50228-320 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 100mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-321-01) | ScieGen Pharmaceuticals, Inc. | 50228-321-01 | 50228-321 | ANDA206382 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 6 Tablet In 1 Bottle, Plastic (60760-093-06) | St. Mary's Medical Park Pharmacy | 60760-093-06 | 60760-093 | ANDA203695 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-093-20) | St. Mary's Medical Park Pharmacy | 60760-093-20 | 60760-093 | ANDA203695 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-093-30) | St. Mary's Medical Park Pharmacy | 60760-093-30 | 60760-093 | ANDA203695 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-093-60) | St. Mary's Medical Park Pharmacy | 60760-093-60 | 60760-093 | ANDA203695 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-093-90) | St. Mary's Medical Park Pharmacy | 60760-093-90 | 60760-093 | ANDA203695 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 6 Tablet In 1 Bottle, Plastic (60760-289-06) | St. Mary's Medical Park Pharmacy | 60760-289-06 | 60760-289 | ANDA204770 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-289-20) | St. Mary's Medical Park Pharmacy | 60760-289-20 | 60760-289 | ANDA204770 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-289-30) | St. Mary's Medical Park Pharmacy | 60760-289-30 | 60760-289 | ANDA204770 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-289-60) | St. Mary's Medical Park Pharmacy | 60760-289-60 | 60760-289 | ANDA204770 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-289-90) | St. Mary's Medical Park Pharmacy | 60760-289-90 | 60760-289 | ANDA204770 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 100mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-321-30) | ScieGen Pharmaceuticals, Inc. | 50228-321-30 | 50228-321 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 200mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-322-01) | ScieGen Pharmaceuticals, Inc. | 50228-322-01 | 50228-322 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 200mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-322-30) | ScieGen Pharmaceuticals, Inc. | 50228-322-30 | 50228-322 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 25mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-319-01) | ScieGen Pharmaceuticals, Inc. | 50228-319-01 | 50228-319 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 25mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-319-30) | ScieGen Pharmaceuticals, Inc. | 50228-319-30 | 50228-319 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 50mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-320-01) | ScieGen Pharmaceuticals, Inc. | 50228-320-01 | 50228-320 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 50mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-320-30) | ScieGen Pharmaceuticals, Inc. | 50228-320-30 | 50228-320 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 100mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-321-01) | ScieGen Pharmaceuticals, Inc. | 50228-321-01 | 50228-321 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 100mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-321-30) | ScieGen Pharmaceuticals, Inc. | 50228-321-30 | 50228-321 | ANDA206382 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (75834-500-01) | Nivagen Pharmaceuticals Inc | 75834-500-01 | 75834-500 | ANDA201991 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (75834-500-05) | Nivagen Pharmaceuticals Inc | 75834-500-05 | 75834-500 | ANDA201991 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-055-01) | Nostrum Laboratories Inc. | 29033-055-01 | 29033-055 | ANDA076756 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (29033-055-05) | Nostrum Laboratories Inc. | 29033-055-05 | 29033-055 | ANDA076756 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 1000 Tablet, Extended Release In 1 Bottle (29033-055-10) | Nostrum Laboratories Inc. | 29033-055-10 | 29033-055 | ANDA076756 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-056-01) | Nostrum Laboratories Inc. | 29033-056-01 | 29033-056 | ANDA076756 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 1000 Tablet, Extended Release In 1 Package (29033-056-10) | Nostrum Laboratories Inc. | 29033-056-10 | 29033-056 | ANDA076756 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (29033-031-06) | Nostrum Laboratories, Inc. | 29033-031-06 | 29033-031 | ANDA203832 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (29033-032-06) | Nostrum Laboratories, Inc. | 29033-032-06 | 29033-032 | ANDA203832 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 200mg/1 | 100 Tablet, Orally Disintegrating In 1 Bottle (50228-322-01) | ScieGen Pharmaceuticals, Inc. | 50228-322-01 | 50228-322 | ANDA206382 | ANDA | N/A |
| Lamotrigine | Tablet, Orally Disintegrating | Oral | 200mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (50228-322-30) | ScieGen Pharmaceuticals, Inc. | 50228-322-30 | 50228-322 | ANDA206382 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 3 Bottle In 1 Carton (16571-742-42) / 14 Capsule, Delayed Release In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-742-42 | 16571-742 | ANDA203306 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 30 Capsule, Delayed Release In 1 Bottle (16571-697-03) | Rising Pharma Holdings, Inc. | 16571-697-03 | 16571-697 | ANDA201921 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 15mg/1 | 500 Capsule, Delayed Release In 1 Bottle (16571-697-50) | Rising Pharma Holdings, Inc. | 16571-697-50 | 16571-697 | ANDA201921 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 30mg/1 | 100 Capsule, Delayed Release In 1 Bottle (16571-698-01) | Rising Pharma Holdings, Inc. | 16571-698-01 | 16571-698 | ANDA201921 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 30mg/1 | 30 Capsule, Delayed Release In 1 Bottle (16571-698-03) | Rising Pharma Holdings, Inc. | 16571-698-03 | 16571-698 | ANDA201921 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 30mg/1 | 90 Capsule, Delayed Release In 1 Bottle (16571-698-09) | Rising Pharma Holdings, Inc. | 16571-698-09 | 16571-698 | ANDA201921 | ANDA | N/A |
| Lansoprazole | Capsule, Delayed Release | Oral | 30mg/1 | 500 Capsule, Delayed Release In 1 Bottle (16571-698-50) | Rising Pharma Holdings, Inc. | 16571-698-50 | 16571-698 | ANDA201921 | ANDA | N/A |
| Latanoprost | Solution | Ophthalmic | 50ug/mL | 1 Bottle, Dropper In 1 Carton (64980-516-25) / 2.5 Ml In 1 Bottle, Dropper | Rising Pharma Holdings, Inc. | 64980-516-25 | 64980-516 | ANDA202442 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (31722-257-01) | Camber Pharmaceuticals, Inc. | 31722-257-01 | 31722-257 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 2.5mg/1 | 28 Capsule In 1 Bottle (31722-257-28) | Camber Pharmaceuticals, Inc. | 31722-257-28 | 31722-257 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (31722-258-01) | Camber Pharmaceuticals, Inc. | 31722-258-01 | 31722-258 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 5mg/1 | 28 Capsule In 1 Bottle (31722-258-28) | Camber Pharmaceuticals, Inc. | 31722-258-28 | 31722-258 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (31722-259-01) | Camber Pharmaceuticals, Inc. | 31722-259-01 | 31722-259 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 10mg/1 | 28 Capsule In 1 Bottle (31722-259-28) | Camber Pharmaceuticals, Inc. | 31722-259-28 | 31722-259 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 15mg/1 | 100 Capsule In 1 Bottle (31722-260-01) | Camber Pharmaceuticals, Inc. | 31722-260-01 | 31722-260 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 15mg/1 | 21 Capsule In 1 Bottle (31722-260-21) | Camber Pharmaceuticals, Inc. | 31722-260-21 | 31722-260 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (31722-261-01) | Camber Pharmaceuticals, Inc. | 31722-261-01 | 31722-261 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 20mg/1 | 21 Capsule In 1 Bottle (31722-261-21) | Camber Pharmaceuticals, Inc. | 31722-261-21 | 31722-261 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (31722-262-01) | Camber Pharmaceuticals, Inc. | 31722-262-01 | 31722-262 | ANDA212414 | ANDA | N/A |
| LENALIDOMIDE | Capsule | Oral | 25mg/1 | 21 Capsule In 1 Bottle (31722-262-21) | Camber Pharmaceuticals, Inc. | 31722-262-21 | 31722-262 | ANDA212414 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-358-01) | Epic Pharma LLC | 42806-358-01 | 42806-358 | ANDA074544 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (42806-358-30) | Epic Pharma LLC | 42806-358-30 | 42806-358 | ANDA074544 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 25mg/1 | 25 Tablet In 1 Bottle (42806-359-25) | Epic Pharma LLC | 42806-359-25 | 42806-359 | ANDA074544 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 12 Tablet In 1 Bottle (42806-133-21) | Epic Pharma LLC | 42806-133-21 | 42806-133 | ANDA074544 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 24 Tablet In 1 Bottle (42806-133-24) | Epic Pharma LLC | 42806-133-24 | 42806-133 | ANDA074544 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 15mg/1 | 24 Tablet In 1 Bottle (42806-134-24) | Epic Pharma LLC | 42806-134-24 | 42806-134 | ANDA074544 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-973-60) | St Marys Medical Park Pharmacy | 60760-973-60 | 60760-973 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-973-90) | St Marys Medical Park Pharmacy | 60760-973-90 | 60760-973 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-975-60) | St Marys Medical Park Pharmacy | 60760-975-60 | 60760-975 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-975-90) | St Marys Medical Park Pharmacy | 60760-975-90 | 60760-975 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-100-90) | St. Mary's Medical Park Pharmacy | 60760-100-90 | 60760-100 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (51407-059-60) | Golden State Medical Supply, Inc. | 51407-059-60 | 51407-059 | ANDA203832 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (60429-111-01) | Golden State Medical Supply, Inc. | 60429-111-01 | 60429-111 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (60429-111-10) | Golden State Medical Supply, Inc. | 60429-111-10 | 60429-111 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 100 Tablet In 1 Bottle (60429-112-01) | Golden State Medical Supply, Inc. | 60429-112-01 | 60429-112 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 500 Tablet In 1 Bottle (60429-112-05) | Golden State Medical Supply, Inc. | 60429-112-05 | 60429-112 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (60429-113-01) | Golden State Medical Supply, Inc. | 60429-113-01 | 60429-113 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 500 Tablet In 1 Bottle (60429-113-05) | Golden State Medical Supply, Inc. | 60429-113-05 | 60429-113 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Solution | Oral | 500mg/5mL | 1 Bottle In 1 Carton (66689-318-16) / 473 Ml In 1 Bottle | VistaPharm, LLC | 66689-318-16 | 66689-318 | ANDA212677 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (60505-4700-1) | Apotex Corp. | 60505-4700-1 | 60505-4700 | ANDA213356 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 90 Tablet In 1 Bottle (60505-4701-9) | Apotex Corp. | 60505-4701-9 | 60505-4701 | ANDA213356 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (50742-181-01) | Ingenus Pharmaceuticals, LLC | 50742-181-01 | 50742-181 | ANDA211132 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50742-181-30) | Ingenus Pharmaceuticals, LLC | 50742-181-30 | 50742-181 | ANDA211132 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 12 Tablet In 1 Bottle (50742-182-12) | Ingenus Pharmaceuticals, LLC | 50742-182-12 | 50742-182 | ANDA211132 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 10mg/1 | 24 Tablet In 1 Bottle (50742-182-24) | Ingenus Pharmaceuticals, LLC | 50742-182-24 | 50742-182 | ANDA211132 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 15mg/1 | 24 Tablet In 1 Bottle (50742-183-24) | Ingenus Pharmaceuticals, LLC | 50742-183-24 | 50742-183 | ANDA211132 | ANDA | N/A |
| Leucovorin Calcium | Tablet | Oral | 25mg/1 | 25 Tablet In 1 Bottle (50742-184-25) | Ingenus Pharmaceuticals, LLC | 50742-184-25 | 50742-184 | ANDA211132 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 118 Ml In 1 Bottle (65162-685-86) | Amneal Pharmaceuticals LLC | 65162-685-86 | 65162-685 | ANDA090992 | ANDA | N/A |
| Levetiracetam | Solution | Oral | 100mg/mL | 473 Ml In 1 Bottle (65162-685-90) | Amneal Pharmaceuticals LLC | 65162-685-90 | 65162-685 | ANDA090992 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (65162-528-16) | Amneal Pharmaceuticals LLC | 65162-528-16 | 65162-528 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (65162-529-16) | Amneal Pharmaceuticals LLC | 65162-529-16 | 65162-529 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (65162-538-16) | Amneal Pharmaceuticals LLC | 65162-538-16 | 65162-538 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-539-06) | Amneal Pharmaceuticals LLC | 65162-539-06 | 65162-539 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-536-05) | Camber Pharmaceuticals, Inc. | 31722-536-05 | 31722-536 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-536-10) | Camber Pharmaceuticals, Inc. | 31722-536-10 | 31722-536 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-536-12) | Camber Pharmaceuticals, Inc. | 31722-536-12 | 31722-536 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-536-30) | Camber Pharmaceuticals, Inc. | 31722-536-30 | 31722-536 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-536-60) | Camber Pharmaceuticals, Inc. | 31722-536-60 | 31722-536 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-537-05) | Camber Pharmaceuticals, Inc. | 31722-537-05 | 31722-537 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-537-10) | Camber Pharmaceuticals, Inc. | 31722-537-10 | 31722-537 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-537-12) | Camber Pharmaceuticals, Inc. | 31722-537-12 | 31722-537 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-537-30) | Camber Pharmaceuticals, Inc. | 31722-537-30 | 31722-537 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-537-60) | Camber Pharmaceuticals, Inc. | 31722-537-60 | 31722-537 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-538-05) | Camber Pharmaceuticals, Inc. | 31722-538-05 | 31722-538 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-538-12) | Camber Pharmaceuticals, Inc. | 31722-538-12 | 31722-538 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-538-30) | Camber Pharmaceuticals, Inc. | 31722-538-30 | 31722-538 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-538-60) | Camber Pharmaceuticals, Inc. | 31722-538-60 | 31722-538 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-539-05) | Camber Pharmaceuticals, Inc. | 31722-539-05 | 31722-539 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-539-12) | Camber Pharmaceuticals, Inc. | 31722-539-12 | 31722-539 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-539-30) | Camber Pharmaceuticals, Inc. | 31722-539-30 | 31722-539 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-539-60) | Camber Pharmaceuticals, Inc. | 31722-539-60 | 31722-539 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (16571-787-12) | Rising Pharma Holdings, Inc. | 16571-787-12 | 16571-787 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-787-50) | Rising Pharma Holdings, Inc. | 16571-787-50 | 16571-787 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (16571-788-12) | Rising Pharma Holdings, Inc. | 16571-788-12 | 16571-788 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-788-50) | Rising Pharma Holdings, Inc. | 16571-788-50 | 16571-788 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (16571-789-12) | Rising Pharma Holdings, Inc. | 16571-789-12 | 16571-789 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-789-50) | Rising Pharma Holdings, Inc. | 16571-789-50 | 16571-789 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-790-06) | Rising Pharma Holdings, Inc. | 16571-790-06 | 16571-790 | ANDA078993 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-604-01) | Rising Pharma Holdings, Inc. | 64980-604-01 | 64980-604 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (64980-604-12) | Rising Pharma Holdings, Inc. | 64980-604-12 | 64980-604 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (64980-604-50) | Rising Pharma Holdings, Inc. | 64980-604-50 | 64980-604 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-605-01) | Rising Pharma Holdings, Inc. | 64980-605-01 | 64980-605 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (64980-605-12) | Rising Pharma Holdings, Inc. | 64980-605-12 | 64980-605 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (64980-605-50) | Rising Pharma Holdings, Inc. | 64980-605-50 | 64980-605 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (64980-606-12) | Rising Pharma Holdings, Inc. | 64980-606-12 | 64980-606 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (64980-606-50) | Rising Pharma Holdings, Inc. | 64980-606-50 | 64980-606 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (64980-607-06) | Rising Pharma Holdings, Inc. | 64980-607-06 | 64980-607 | ANDA090767 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-05) | ScieGen Pharmaceuticals, Inc | 50228-189-05 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-30) | ScieGen Pharmaceuticals, Inc | 50228-189-30 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-60) | ScieGen Pharmaceuticals, Inc | 50228-189-60 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-05) | ScieGen Pharmaceuticals, Inc | 50228-190-05 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-30) | ScieGen Pharmaceuticals, Inc | 50228-190-30 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-60) | ScieGen Pharmaceuticals, Inc | 50228-190-60 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-05) | ScieGen Pharmaceuticals, Inc | 50228-189-05 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-30) | ScieGen Pharmaceuticals, Inc | 50228-189-30 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-189-60) | ScieGen Pharmaceuticals, Inc | 50228-189-60 | 50228-189 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-05) | ScieGen Pharmaceuticals, Inc | 50228-190-05 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-30) | ScieGen Pharmaceuticals, Inc | 50228-190-30 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-190-60) | ScieGen Pharmaceuticals, Inc | 50228-190-60 | 50228-190 | ANDA205130 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-470-05) | ScieGen Pharmaceuticals, Inc. | 50228-470-05 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-470-10) | ScieGen Pharmaceuticals, Inc. | 50228-470-10 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-470-12) | ScieGen Pharmaceuticals, Inc. | 50228-470-12 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-470-30) | ScieGen Pharmaceuticals, Inc. | 50228-470-30 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-471-05) | ScieGen Pharmaceuticals, Inc. | 50228-471-05 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-471-10) | ScieGen Pharmaceuticals, Inc. | 50228-471-10 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-471-12) | ScieGen Pharmaceuticals, Inc. | 50228-471-12 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-471-30) | ScieGen Pharmaceuticals, Inc. | 50228-471-30 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-472-05) | ScieGen Pharmaceuticals, Inc. | 50228-472-05 | 50228-472 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-472-12) | ScieGen Pharmaceuticals, Inc. | 50228-472-12 | 50228-472 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-472-30) | ScieGen Pharmaceuticals, Inc. | 50228-472-30 | 50228-472 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-473-05) | ScieGen Pharmaceuticals, Inc. | 50228-473-05 | 50228-473 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-473-30) | ScieGen Pharmaceuticals, Inc. | 50228-473-30 | 50228-473 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-473-60) | ScieGen Pharmaceuticals, Inc. | 50228-473-60 | 50228-473 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-470-05) | ScieGen Pharmaceuticals, Inc. | 50228-470-05 | 50228-470 | ANDA215069 | ANDA | N/A |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (66689-836-99) | VistaPharm, LLC | 66689-836-99 | 66689-836 | ANDA204166 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (66689-898-40) | VistaPharm, LLC | 66689-898-40 | 66689-898 | ANDA075082 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 30 Ml In 1 Bottle, Dropper (66689-694-30) | VistaPharm, LLC | 66689-694-30 | 66689-694 | ANDA040088 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 1000 Ml In 1 Bottle (66689-694-79) | VistaPharm, LLC | 66689-694-79 | 66689-694 | ANDA040088 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 4000 Ml In 1 Bottle (66689-694-88) | VistaPharm, LLC | 66689-694-88 | 66689-694 | ANDA040088 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 1000 Ml In 1 Bottle (66689-695-79) | VistaPharm, LLC | 66689-695-79 | 66689-695 | ANDA040088 | ANDA | CII |
| Methadone Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (66689-711-16) | VistaPharm, LLC | 66689-711-16 | 66689-711 | ANDA090707 | ANDA | CII |
| Methadone Hydrochloride | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (66689-712-16) | VistaPharm, LLC | 66689-712-16 | 66689-712 | ANDA090707 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (66689-820-10) | VistaPharm, LLC | 66689-820-10 | 66689-820 | ANDA040241 | ANDA | CII |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-470-10) | ScieGen Pharmaceuticals, Inc. | 50228-470-10 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-470-12) | ScieGen Pharmaceuticals, Inc. | 50228-470-12 | 50228-470 | ANDA215069 | ANDA | N/A |
| Methadone Hydrochloride | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4538-25) | Hikma Pharmaceuticals USA Inc. | 0054-4538-25 | 0054-4538 | NDA017058 | NDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 1000 Ml In 1 Bottle (0054-0391-68) | Hikma Pharmaceuticals USA | 0054-0391-68 | 0054-0391 | ANDA089897 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 1000 Ml In 1 Bottle (0054-0392-68) | Hikma Pharmaceuticals USA | 0054-0392-68 | 0054-0392 | ANDA040180 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 5mg/1 | 1 Blister Pack In 1 Carton (0054-0709-20) / 100 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0709-20 | 0054-0709 | ANDA088108 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0709-25) | Hikma Pharmaceuticals USA Inc. | 0054-0709-25 | 0054-0709 | ANDA088108 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 1 Blister Pack In 1 Carton (0054-0710-20) / 100 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0710-20 | 0054-0710 | ANDA088109 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0710-25) | Hikma Pharmaceuticals USA Inc. | 0054-0710-25 | 0054-0710 | ANDA088109 | ANDA | CII |
| Methadone Hydrochloride | Concentrate | Oral | 10mg/mL | 30 Ml In 1 Bottle, Dropper (0054-3553-44) | Hikma Pharmaceuticals USA Inc. | 0054-3553-44 | 0054-3553 | ANDA089897 | ANDA | CII |
| Methadone Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (0054-3555-63) | Hikma Pharmaceuticals USA Inc. | 0054-3555-63 | 0054-3555 | ANDA087393 | ANDA | CII |
| Methadone Hydrochloride | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (0054-3556-63) | Hikma Pharmaceuticals USA Inc. | 0054-3556-63 | 0054-3556 | ANDA087997 | ANDA | CII |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-470-30) | ScieGen Pharmaceuticals, Inc. | 50228-470-30 | 50228-470 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-471-05) | ScieGen Pharmaceuticals, Inc. | 50228-471-05 | 50228-471 | ANDA215069 | ANDA | N/A |
| Methamphetamine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0054-0389-25) | Hikma Pharmaceuticals USA Inc. | 0054-0389-25 | 0054-0389 | ANDA203846 | ANDA | CII |
| Methazolamide | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle, Plastic (0574-0790-01) | Padagis US LLC | 0574-0790-01 | 0574-0790 | ANDA040062 | ANDA | N/A |
| Methazolamide | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (0574-0791-01) | Padagis US LLC | 0574-0791-01 | 0574-0791 | ANDA040062 | ANDA | N/A |
| Methazolamide | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (51407-026-01) | Golden State Medical Supply, Inc. | 51407-026-01 | 51407-026 | ANDA040001 | ANDA | N/A |
| Methazolamide | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-027-01) | Golden State Medical Supply, Inc. | 51407-027-01 | 51407-027 | ANDA040001 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-471-10) | ScieGen Pharmaceuticals, Inc. | 50228-471-10 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-471-12) | ScieGen Pharmaceuticals, Inc. | 50228-471-12 | 50228-471 | ANDA215069 | ANDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle (51407-880-01) | Golden State Medical Supply, Inc. | 51407-880-01 | 51407-880 | ANDA210068 | ANDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle (30698-477-01) | Validus Pharmaceuticals LLC | 30698-477-01 | 30698-477 | NDA017681 | NDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle (59746-797-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-797-01 | 59746-797 | ANDA217675 | ANDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 20 Tablet In 1 Bottle (59746-797-65) | Jubilant Cadista Pharmaceuticals Inc. | 59746-797-65 | 59746-797 | ANDA217675 | ANDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle (47781-577-01) | Alvogen Inc. | 47781-577-01 | 47781-577 | NDA016151 | NDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-471-30) | ScieGen Pharmaceuticals, Inc. | 50228-471-30 | 50228-471 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-472-05) | ScieGen Pharmaceuticals, Inc. | 50228-472-05 | 50228-472 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (50228-472-12) | ScieGen Pharmaceuticals, Inc. | 50228-472-12 | 50228-472 | ANDA215069 | ANDA | N/A |
| Methimazole | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (60429-380-01) | Golden State Medical Supply, Inc. | 60429-380-01 | 60429-380 | ANDA040734 | ANDA | N/A |
| Methimazole | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60429-381-01) | Golden State Medical Supply, Inc. | 60429-381-01 | 60429-381 | ANDA040734 | ANDA | N/A |
| Methimazole | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (69452-328-20) | Bionpharma Inc. | 69452-328-20 | 69452-328 | ANDA218149 | ANDA | N/A |
| Methimazole | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (69452-329-20) | Bionpharma Inc. | 69452-329-20 | 69452-329 | ANDA218149 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-472-30) | ScieGen Pharmaceuticals, Inc. | 50228-472-30 | 50228-472 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-473-05) | ScieGen Pharmaceuticals, Inc. | 50228-473-05 | 50228-473 | ANDA215069 | ANDA | N/A |
| Methocarbamol | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-716-10) / 10 Ml In 1 Vial, Single-Dose (71288-716-11) | Meitheal Pharmaceuticals Inc. | 71288-716-10 | 71288-716 | ANDA211504 | ANDA | N/A |
| Methocarbamol | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (68475-002-25) / 10 Ml In 1 Vial (68475-002-10) | Navinta LLC | 68475-002-25 | 68475-002 | ANDA206071 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 28 Tablet In 1 Bottle, Plastic (60760-725-28) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-725-28 | 60760-725 | ANDA040489 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 40 Tablet In 1 Bottle, Plastic (60760-725-40) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-725-40 | 60760-725 | ANDA040489 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-725-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-725-90 | 60760-725 | ANDA040489 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 60 Tablet, Coated In 1 Bottle, Plastic (60760-592-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-592-60 | 60760-592 | ANDA209312 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 90 Tablet, Coated In 1 Bottle, Plastic (60760-592-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-592-90 | 60760-592 | ANDA209312 | ANDA | N/A |
| Methocarbamol | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (25021-675-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-675-10 | 25021-675 | ANDA205404 | ANDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 5 Vial In 1 Carton (70069-101-05) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-101-05 | 70069-101 | ANDA207522 | ANDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 10 Vial In 1 Carton (70069-101-10) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-101-10 | 70069-101 | ANDA207522 | ANDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (70069-101-25) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-101-25 | 70069-101 | ANDA207522 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 750mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-211-12) | AustarPharma LLC | 35561-211-12 | 35561-211 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 750mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-211-13) | AustarPharma LLC | 35561-211-13 | 35561-211 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-212-12) | AustarPharma LLC | 35561-212-12 | 35561-212 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-212-13) | AustarPharma LLC | 35561-212-13 | 35561-212 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 1000mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-349-12) | AustarPharma LLC | 35561-349-12 | 35561-349 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 1000mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-349-13) | AustarPharma LLC | 35561-349-13 | 35561-349 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 1000mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-349-12) | AustarPharma LLC | 35561-349-12 | 35561-349 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 1000mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-349-13) | AustarPharma LLC | 35561-349-13 | 35561-349 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 750mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-211-12) | AustarPharma LLC | 35561-211-12 | 35561-211 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 750mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-211-13) | AustarPharma LLC | 35561-211-13 | 35561-211 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (35561-212-12) | AustarPharma LLC | 35561-212-12 | 35561-212 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Tablet, Coated | Oral | 500mg/1 | 500 Tablet, Coated In 1 Bottle, Plastic (35561-212-13) | AustarPharma LLC | 35561-212-13 | 35561-212 | ANDA200958 | ANDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 10 Vial In 1 Carton (0641-6103-10) / 10 Ml In 1 Vial (0641-6103-01) | Hikma Pharmaceuticals USA Inc. | 0641-6103-10 | 0641-6103 | NDA011790 | NDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (0641-6103-25) / 10 Ml In 1 Vial (0641-6103-01) | Hikma Pharmaceuticals USA Inc. | 0641-6103-25 | 0641-6103 | NDA011790 | NDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 10 Vial In 1 Carton (0641-6217-10) / 10 Ml In 1 Vial (0641-6217-01) | Hikma Pharmaceuticals USA Inc. | 0641-6217-10 | 0641-6217 | NDA011790 | NDA | N/A |
| Methocarbamol | Injection | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (0641-6217-25) / 10 Ml In 1 Vial (0641-6217-01) | Hikma Pharmaceuticals USA Inc. | 0641-6217-25 | 0641-6217 | NDA011790 | NDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-473-30) | ScieGen Pharmaceuticals, Inc. | 50228-473-30 | 50228-473 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (50228-473-60) | ScieGen Pharmaceuticals, Inc. | 50228-473-60 | 50228-473 | ANDA215069 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-187-05) | XLCare Pharmaceuticals Inc. | 72865-187-05 | 72865-187 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 250mg/1 | 120 Tablet, Film Coated In 1 Bottle (72865-187-12) | XLCare Pharmaceuticals Inc. | 72865-187-12 | 72865-187 | ANDA090515 | ANDA | N/A |
| Methotrexate | Solution | Oral | 2.5mg/mL | 120 Ml In 1 Bottle (52652-2001-1) | Azurity Pharmaceuticals, Inc. | 52652-2001-1 | 52652-2001 | NDA208400 | NDA | N/A |
| Methotrexate | Solution | Oral | 2.5mg/mL | 60 Ml In 1 Bottle (52652-2001-6) | Azurity Pharmaceuticals, Inc. | 52652-2001-6 | 52652-2001 | NDA208400 | NDA | N/A |
| Methotrexate | Injection, Powder, Lyophilized, For Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 1g/1 | 1 Vial In 1 Box (0143-9367-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9367-01 | 0143-9367 | ANDA040632 | ANDA | N/A |
| Methotrexate | Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 25mg/mL | 1 Vial In 1 Box (0143-9516-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9516-01 | 0143-9516 | ANDA089343 | ANDA | N/A |
| Methotrexate | Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 25mg/mL | 1 Vial In 1 Box (0143-9517-01) / 8 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9517-01 | 0143-9517 | ANDA089342 | ANDA | N/A |
| Methotrexate | Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 25mg/mL | 1 Vial In 1 Box (0143-9518-01) / 4 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9518-01 | 0143-9518 | ANDA089341 | ANDA | N/A |
| Methotrexate | Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 25mg/mL | 10 Vial In 1 Carton (0143-9519-10) / 2 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9519-10 | 0143-9519 | ANDA089340 | ANDA | N/A |
| Methotrexate | Injection, Powder, Lyophilized, For Solution | Intra-Arterial; Intramuscular; Intrathecal; Intravenous | 1g/1 | 1 Vial In 1 Box (0143-9830-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9830-01 | 0143-9830 | ANDA040632 | ANDA | N/A |
| Methotrexate Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-121-01) | Golden State Medical Supply, Inc. | 51407-121-01 | 51407-121 | ANDA081235 | ANDA | N/A |
| Methotrexate Sodium | Tablet | Oral | 2.5mg/1 | 36 Tablet In 1 Bottle, Plastic (0054-4550-15) | Hikma Pharmaceuticals USA Inc. | 0054-4550-15 | 0054-4550 | ANDA040054 | ANDA | N/A |
| Methotrexate Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4550-25) | Hikma Pharmaceuticals USA Inc. | 0054-4550-25 | 0054-4550 | ANDA040054 | ANDA | N/A |
| Methotrexate Sodium | Injection, Solution | Intramuscular; Intrathecal; Intravenous; Subcutaneous | 25mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-124-40) / 40 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-124-40 | 61703-124 | NDA011719 | NDA | N/A |
| Methotrexate Sodium | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 25mg/mL | 5 Vial, Multi-Dose In 1 Carton (61703-350-10) / 2 Ml In 1 Vial, Multi-Dose (61703-350-09) | Hospira, Inc. | 61703-350-10 | 61703-350 | NDA011719 | NDA | N/A |
| Methotrexate Sodium | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 25mg/mL | 5 Vial, Multi-Dose In 1 Carton (61703-350-38) / 2 Ml In 1 Vial, Multi-Dose (61703-350-37) | Hospira, Inc. | 61703-350-38 | 61703-350 | NDA011719 | NDA | N/A |
| Methotrexate Sodium | Injection, Solution | Intramuscular; Intrathecal; Intravenous; Subcutaneous | 25mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-408-25) / 40 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-408-25 | 61703-408 | NDA011719 | NDA | N/A |
| Methotrexate Sodium | Injection, Solution | Intramuscular; Intrathecal; Intravenous; Subcutaneous | 25mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-408-41) / 40 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-408-41 | 61703-408 | NDA011719 | NDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-188-05) | XLCare Pharmaceuticals Inc. | 72865-188-05 | 72865-188 | ANDA090515 | ANDA | N/A |
| Methsuximide | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (0071-0525-24) | Parke-Davis Div of Pfizer Inc | 0071-0525-24 | 0071-0525 | NDA010596 | NDA | N/A |
| Methyl Salicylate | Gel | Topical | 100mg/g | 1 Tube In 1 Carton (43251-2400-1) / 56 G In 1 Tube | LaCorium Health USA Inc. | 43251-2400-1 | 43251-2400 | part348 | OTC MONOGRAPH NOT FINAL | N/A |
| Methylene Blue | Injection | Intravenous | 5mg/mL | 5 Ampule In 1 Carton (0517-0125-05) / 2 Ml In 1 Ampule (0517-0125-01) | American Regent, Inc. | 0517-0125-05 | 0517-0125 | NDA204630 | NDA | N/A |
| Methylene Blue | Injection | Intravenous | 5mg/mL | 5 Vial, Single-Dose In 1 Carton (0517-0371-05) / 2 Ml In 1 Vial, Single-Dose (0517-0371-01) | American Regent, Inc. | 0517-0371-05 | 0517-0371 | NDA204630 | NDA | N/A |
| Methylene Blue | Injection | Intravenous | 5mg/mL | 5 Ampule In 1 Carton (0517-0374-05) / 10 Ml In 1 Ampule (0517-0374-01) | American Regent, Inc. | 0517-0374-05 | 0517-0374 | NDA204630 | NDA | N/A |
| Methylene Blue | Injection | Intravenous | 5mg/mL | 5 Vial, Single-Dose In 1 Carton (0517-0381-05) / 10 Ml In 1 Vial, Single-Dose (0517-0381-01) | American Regent, Inc. | 0517-0381-05 | 0517-0381 | NDA204630 | NDA | N/A |
| Methylergonovine Maleate | Injection, Solution | Intramuscular; Intravenous | .2mg/mL | 20 Vial, Single-Dose In 1 Carton (0517-0740-20) / 1 Ml In 1 Vial, Single-Dose (0517-0740-01) | American Regent, Inc. | 0517-0740-20 | 0517-0740 | ANDA090193 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 500mg/1 | 120 Tablet, Film Coated In 1 Bottle (72865-188-12) | XLCare Pharmaceuticals Inc. | 72865-188-12 | 72865-188 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-189-05) | XLCare Pharmaceuticals Inc. | 72865-189-05 | 72865-189 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 750mg/1 | 120 Tablet, Film Coated In 1 Bottle (72865-189-12) | XLCare Pharmaceuticals Inc. | 72865-189-12 | 72865-189 | ANDA090515 | ANDA | N/A |
| Levetiracetam | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (72865-190-60) | XLCare Pharmaceuticals Inc. | 72865-190-60 | 72865-190 | ANDA090515 | ANDA | N/A |
| Methylphenidate | Patch | Transdermal | 27.5mg/mg | 1 Tray In 1 Carton (0574-2410-65) / 30 Pouch In 1 Tray / 1 Patch In 1 Pouch / 27.5 Mg In 1 Patch | PADAGIS US LLC | 0574-2410-65 | 0574-2410 | NDA021514 | NDA AUTHORIZED GENERIC | CII |
| Methylphenidate | Patch | Transdermal | 41.3mg/mg | 1 Tray In 1 Carton (0574-2415-65) / 30 Pouch In 1 Tray / 1 Patch In 1 Pouch / 41.3 Mg In 1 Patch | PADAGIS US LLC | 0574-2415-65 | 0574-2415 | NDA021514 | NDA AUTHORIZED GENERIC | CII |
| Methylphenidate | Patch | Transdermal | 55mg/mg | 1 Tray In 1 Carton (0574-2420-65) / 30 Pouch In 1 Tray / 1 Patch In 1 Pouch / 55 Mg In 1 Patch | PADAGIS US LLC | 0574-2420-65 | 0574-2420 | NDA021514 | NDA AUTHORIZED GENERIC | CII |
| Methylphenidate | Patch | Transdermal | 82.5mg/mg | 1 Tray In 1 Carton (0574-2430-65) / 30 Pouch In 1 Tray / 1 Patch In 1 Pouch / 82.5 Mg In 1 Patch | PADAGIS US LLC | 0574-2430-65 | 0574-2430 | NDA021514 | NDA AUTHORIZED GENERIC | CII |
| Levocarnitine | Solution | Oral | 1g/10mL | 118 Ml In 1 Bottle (70954-139-10) | ANI Pharmaceuticals, Inc. | 70954-139-10 | 70954-139 | ANDA211676 | ANDA | N/A |
| Levocarnitine | Solution | Oral | 1g/10mL | 118 Ml In 1 Bottle (70954-140-10) | ANI Pharmaceuticals, Inc. | 70954-140-10 | 70954-140 | ANDA211676 | ANDA | N/A |
| Levocarnitine | Tablet | Oral | 330mg/1 | 90 Blister Pack In 1 Carton (70954-492-10) / 10 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 70954-492-10 | 70954-492 | ANDA216384 | ANDA | N/A |
| Levocarnitine | Tablet | Oral | 330mg/1 | 9 Blister Pack In 1 Carton (16571-762-09) / 10 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 16571-762-09 | 16571-762 | ANDA076858 | ANDA | N/A |
| Levocarnitine | Solution | Oral | 1g/10mL | 118 Ml In 1 Bottle, Plastic (64980-503-12) | Rising Pharmaceuticals, Inc. | 64980-503-12 | 64980-503 | ANDA076851 | ANDA | N/A |
| Levocarnitine | SOLUTION | ORAL | 1g/10mL | 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) | Saptalis Pharmaceuticals, LLC | 71656-016-01 | 71656-016 | ANDA212533 | ANDA | N/A |
| Levocarnitine | SOLUTION | ORAL | 1g/10mL | 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) | Saptalis Pharmaceuticals, LLC | 71656-016-02 | 71656-016 | ANDA212533 | ANDA | N/A |
| Levocarnitine | SOLUTION | ORAL | 1g/10mL | 118 mL in 1 BOTTLE (71656-016-04) | Saptalis Pharmaceuticals, LLC | 71656-016-04 | 71656-016 | ANDA212533 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (75834-324-01) | Nivagen Pharmaceuticals, Inc. | 75834-324-01 | 75834-324 | ANDA208737 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (75834-325-01) | Nivagen Pharmaceuticals, Inc. | 75834-325-01 | 75834-325 | ANDA208737 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (75834-326-01) | Nivagen Pharmaceuticals, Inc. | 75834-326-01 | 75834-326 | ANDA208737 | ANDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (39328-154-50) | Patrin Pharma, Inc. | 39328-154-50 | 39328-154 | ANDA210764 | ANDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (39328-054-50) | Patrin Pharma, Inc. | 39328-054-50 | 39328-054 | ANDA210764 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 10mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-527-01) | Golden State Medical Supply, Inc. | 51407-527-01 | 51407-527 | ANDA210992 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 20mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-528-01) | Golden State Medical Supply, Inc. | 51407-528-01 | 51407-528 | ANDA210992 | ANDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle, Plastic (27808-058-01) | Tris Pharma Inc | 27808-058-01 | 27808-058 | ANDA091601 | ANDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle, Plastic (27808-059-01) | Tris Pharma Inc | 27808-059-01 | 27808-059 | ANDA091601 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 72mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-084-30) | Vertical Pharmaceuticals, LLC | 68025-084-30 | 68025-084 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 45mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-088-30) | Vertical Pharmaceuticals, LLC | 68025-088-30 | 68025-088 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 63mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-089-30) | Vertical Pharmaceuticals, LLC | 68025-089-30 | 68025-089 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 100 Tablet, Extended Release In 1 Bottle (68025-095-10) | Vertical Pharmaceuticals, LLC | 68025-095-10 | 68025-095 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-095-30) | Vertical Pharmaceuticals, LLC | 68025-095-30 | 68025-095 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 100 Tablet, Extended Release In 1 Bottle (68025-096-10) | Vertical Pharmaceuticals, LLC | 68025-096-10 | 68025-096 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-096-30) | Vertical Pharmaceuticals, LLC | 68025-096-30 | 68025-096 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 100 Tablet, Extended Release In 1 Bottle (68025-097-10) | Vertical Pharmaceuticals, LLC | 68025-097-10 | 68025-097 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-097-30) | Vertical Pharmaceuticals, LLC | 68025-097-30 | 68025-097 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 100 Tablet, Extended Release In 1 Bottle (68025-098-10) | Vertical Pharmaceuticals, LLC | 68025-098-10 | 68025-098 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-098-30) | Vertical Pharmaceuticals, LLC | 68025-098-30 | 68025-098 | NDA216117 | NDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (10702-163-50) | KVK-Tech, Inc. | 10702-163-50 | 10702-163 | ANDA207485 | ANDA | CII |
| Methylphenidate Hydrochloride | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (10702-164-50) | KVK-Tech, Inc. | 10702-164-50 | 10702-164 | ANDA207485 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (10702-100-01) | KVK-TECH, INC. | 10702-100-01 | 10702-100 | ANDA206932 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-101-01) | KVK-TECH, INC. | 10702-101-01 | 10702-101 | ANDA206932 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (10702-102-01) | KVK-TECH, INC. | 10702-102-01 | 10702-102 | ANDA206932 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-075-01) | KVK-Tech, Inc. | 10702-075-01 | 10702-075 | ANDA207488 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 10mg/1 | 60 Tablet In 1 Bottle (10702-075-06) | KVK-Tech, Inc. | 10702-075-06 | 10702-075 | ANDA207488 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (10702-076-01) | KVK-Tech, Inc. | 10702-076-01 | 10702-076 | ANDA207488 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle (10702-076-06) | KVK-Tech, Inc. | 10702-076-06 | 10702-076 | ANDA207488 | ANDA | CII |
| Levocarnitine | SOLUTION | ORAL | 1g/10mL | 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) | Saptalis Pharmaceuticals, LLC | 71656-016-50 | 71656-016 | ANDA212533 | ANDA | N/A |
| Levocarnitine | SOLUTION | ORAL | 1g/10mL | 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) | Saptalis Pharmaceuticals, LLC | 71656-016-51 | 71656-016 | ANDA212533 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (69230-321-01) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Consumer Care Inc | 69230-321-01 | 69230-321 | ANDA213513 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69230-321-10) | Camber Consumer Care Inc | 69230-321-10 | 69230-321 | ANDA213513 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1 Bottle In 1 Carton (69230-321-31) / 35 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-321-31 | 69230-321 | ANDA213513 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1 Bottle In 1 Carton (69230-321-32) / 55 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-321-32 | 69230-321 | ANDA213513 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1 Bottle In 1 Carton (69230-321-33) / 80 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-321-33 | 69230-321 | ANDA213513 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1 Bottle In 1 Carton (69230-321-34) / 180 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-321-34 | 69230-321 | ANDA213513 | ANDA | N/A |
| levocetirizine dihydrochloride | Solution | Oral | 2.5mg/5mL | 1 Bottle In 1 Carton (31722-659-31) / 148 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-659-31 | 31722-659 | ANDA210914 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (31722-551-05) | Camber Pharmaceuticals, Inc. | 31722-551-05 | 31722-551 | ANDA091264 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (31722-551-10) | Camber Pharmaceuticals, Inc. | 31722-551-10 | 31722-551 | ANDA091264 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 180 Tablet In 1 Bottle (31722-551-18) | Camber Pharmaceuticals, Inc. | 31722-551-18 | 31722-551 | ANDA091264 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (31722-551-30) | Camber Pharmaceuticals, Inc. | 31722-551-30 | 31722-551 | ANDA091264 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (31722-551-90) | Camber Pharmaceuticals, Inc. | 31722-551-90 | 31722-551 | ANDA091264 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-136-10) | ScieGen Pharmaceuticals, Inc. | 50228-136-10 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-136-30) | ScieGen Pharmaceuticals, Inc. | 50228-136-30 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (50228-136-90) | ScieGen Pharmaceuticals, Inc. | 50228-136-90 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (50228-136-10) | ScieGen Pharmaceuticals, Inc. | 50228-136-10 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (50228-136-30) | ScieGen Pharmaceuticals, Inc. | 50228-136-30 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levocetirizine Dihydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (50228-136-90) | ScieGen Pharmaceuticals, Inc. | 50228-136-90 | 50228-136 | ANDA203646 | ANDA | N/A |
| Levofloxacin | Solution | Oral | 25mg/mL | 100 Ml In 1 Bottle (70954-852-10) | ANI Pharmaceuticals, Inc. | 70954-852-10 | 70954-852 | ANDA091678 | ANDA | N/A |
| Levofloxacin | Solution | Oral | 25mg/mL | 200 Ml In 1 Bottle (70954-852-20) | ANI Pharmaceuticals, Inc. | 70954-852-20 | 70954-852 | ANDA091678 | ANDA | N/A |
| Levofloxacin | Solution | Oral | 25mg/mL | 480 Ml In 1 Bottle (70954-852-30) | ANI Pharmaceuticals, Inc. | 70954-852-30 | 70954-852 | ANDA091678 | ANDA | N/A |
| Levofloxacin | Solution/ Drops | Topical | 5mg/mL | 48 Bottle In 1 Case (16571-150-50) / 5 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-150-50 | 16571-150 | ANDA077700 | ANDA | N/A |
| Levoleucovorin Calcium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/1 | 1 Injection, Powder, Lyophilized, For Solution In 1 Carton (70121-1099-1) | Amneal Pharmaceuticals LLC | 70121-1099-1 | 70121-1099 | ANDA207547 | ANDA | N/A |
| Levoleucovorin Calcium | Injection, Solution | Intravenous | 10mg/mL | 1 Vial In 1 Carton (70121-1572-1) / 17.5 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1572-1 | 70121-1572 | ANDA207548 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 4mg/1 | 21 Tablet In 1 Blister Pack (59746-001-03) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-001-03 | 59746-001 | ANDA040189 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (59746-001-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-001-06 | 59746-001 | ANDA040189 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 8mg/1 | 25 Tablet In 1 Bottle (59746-002-04) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-002-04 | 59746-002 | ANDA040189 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 8mg/1 | 100 Tablet In 1 Bottle (59746-002-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-002-06 | 59746-002 | ANDA040189 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 16mg/1 | 50 Tablet In 1 Bottle (59746-003-14) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-003-14 | 59746-003 | ANDA040189 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 32mg/1 | 25 Tablet In 1 Bottle (59746-015-04) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-015-04 | 59746-015 | ANDA040189 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 1 Vial In 1 Carton (25021-820-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-820-05 | 25021-820 | ANDA201835 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 1 Vial In 1 Carton (25021-820-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-820-10 | 25021-820 | ANDA201835 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 80mg/mL | 1 Vial In 1 Carton (25021-821-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-821-05 | 25021-821 | ANDA201835 | ANDA | N/A |
| Levomilnacipran Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-455-03) | Amneal Pharmaceuticals LLC | 65162-455-03 | 65162-455 | ANDA210790 | ANDA | N/A |
| Levomilnacipran Hydrochloride | Capsule, Extended Release | Oral | 20mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-411-03) | Amneal Pharmaceuticals LLC | 65162-411-03 | 65162-411 | ANDA210790 | ANDA | N/A |
| Levomilnacipran Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-437-03) | Amneal Pharmaceuticals LLC | 65162-437-03 | 65162-437 | ANDA210790 | ANDA | N/A |
| Levomilnacipran Hydrochloride | Capsule, Extended Release | Oral | 40mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-960-03) | Amneal Pharmaceuticals LLC | 65162-960-03 | 65162-960 | ANDA210790 | ANDA | N/A |
| Levonorgestrel | Tablet | Oral | 1.5mg/1 | 1 Blister Pack In 1 Carton (50742-352-01) / 1 Tablet In 1 Blister Pack | Ingenus Pharmaceuticals, LLC | 50742-352-01 | 50742-352 | ANDA207976 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 25ug/1 | 100 Tablet In 1 Bottle (60846-801-01) | Amneal Pharmaceuticals LLC | 60846-801-01 | 60846-801 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 50ug/1 | 100 Tablet In 1 Bottle (60846-802-01) | Amneal Pharmaceuticals LLC | 60846-802-01 | 60846-802 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 75ug/1 | 100 Tablet In 1 Bottle (60846-803-01) | Amneal Pharmaceuticals LLC | 60846-803-01 | 60846-803 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 88ug/1 | 100 Tablet In 1 Bottle (60846-804-01) | Amneal Pharmaceuticals LLC | 60846-804-01 | 60846-804 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 100ug/1 | 100 Tablet In 1 Bottle (60846-805-01) | Amneal Pharmaceuticals LLC | 60846-805-01 | 60846-805 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 112ug/1 | 100 Tablet In 1 Bottle (60846-806-01) | Amneal Pharmaceuticals LLC | 60846-806-01 | 60846-806 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 125ug/1 | 100 Tablet In 1 Bottle (60846-807-01) | Amneal Pharmaceuticals LLC | 60846-807-01 | 60846-807 | NDA021210 | NDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 1 Vial, Multi-Dose In 1 Carton (0143-9182-01) / 1 Injection, Powder, For Solution In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9182-01 | 0143-9182 | ANDA202691 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, For Solution | Intramuscular; Intravenous | 40mg/1 | 25 Vial, Single-Dose In 1 Carton (0143-9753-25) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Hikma Pharmaceuticals USA Inc. | 0143-9753-25 | 0143-9753 | ANDA203125 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, For Solution | Intramuscular; Intravenous | 125mg/1 | 25 Vial, Single-Dose In 1 Carton (0143-9754-25) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (0143-9754-01) | Hikma Pharmaceuticals USA Inc. | 0143-9754-25 | 0143-9754 | ANDA203125 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, For Solution | Intramuscular; Intravenous | 500mg/1 | 1 Injection, Powder, For Solution In 1 Vial, Multi-Dose (0143-9850-01) | Hikma Pharmaceuticals USA Inc. | 0143-9850-01 | 0143-9850 | ANDA202691 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 1 Injection, Powder, For Solution In 1 Vial, Multi-Dose (0143-9851-01) | Hikma Pharmaceuticals USA Inc. | 0143-9851-01 | 0143-9851 | ANDA202691 | ANDA | N/A |
| Methyltestosterone | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (70954-255-10) | Novitium Pharma LLC | 70954-255-10 | 70954-255 | ANDA215270 | ANDA | CIII |
| Levothyroxine Sodium | Tablet | Oral | 137ug/1 | 100 Tablet In 1 Bottle (60846-808-01) | Amneal Pharmaceuticals LLC | 60846-808-01 | 60846-808 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 150ug/1 | 100 Tablet In 1 Bottle (60846-809-01) | Amneal Pharmaceuticals LLC | 60846-809-01 | 60846-809 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 175ug/1 | 100 Tablet In 1 Bottle (60846-810-01) | Amneal Pharmaceuticals LLC | 60846-810-01 | 60846-810 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 200ug/1 | 100 Tablet In 1 Bottle (60846-811-01) | Amneal Pharmaceuticals LLC | 60846-811-01 | 60846-811 | NDA021210 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | 300ug/1 | 100 Tablet In 1 Bottle (60846-812-01) | Amneal Pharmaceuticals LLC | 60846-812-01 | 60846-812 | NDA021210 | NDA | N/A |
| Metoclopramide Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-3414-01) / 2 Ml In 1 Vial, Single-Dose (0409-3414-18) | Hospira, Inc. | 0409-3414-01 | 0409-3414 | ANDA073118 | ANDA | N/A |
| Metoclopramide Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-3414-11) / 2 Ml In 1 Vial, Single-Dose (0409-3414-21) | Hospira, Inc. | 0409-3414-11 | 0409-3414 | ANDA073118 | ANDA | N/A |
| Metoclopramide Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-5255-15) / 2 Ml In 1 Vial, Single-Dose (0409-5255-10) | Hospira, Inc. | 0409-5255-15 | 0409-5255 | ANDA073118 | ANDA | N/A |
| Metoclopramide Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-5255-25) / 2 Ml In 1 Vial, Single-Dose (0409-5255-02) | Hospira, Inc. | 0409-5255-25 | 0409-5255 | ANDA073118 | ANDA | N/A |
| Metolazone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-433-01) | Golden State Medical Supply, Inc. | 51407-433-01 | 51407-433 | ANDA213827 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 1000 Tablet In 1 Bottle (43602-417-10) | Ascent Pharmaceuticals, Inc | 43602-417-10 | 43602-417 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 30 Tablet In 1 Bottle (43602-417-30) | Ascent Pharmaceuticals, Inc | 43602-417-30 | 43602-417 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 90 Tablet In 1 Bottle (43602-417-90) | Ascent Pharmaceuticals, Inc | 43602-417-90 | 43602-417 | ANDA215259 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-290-00) | Nivagen Pharmaceuticals, Inc. | 75834-290-00 | 75834-290 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 100 Tablet, Extended Release In 1 Bottle (75834-290-01) | Nivagen Pharmaceuticals, Inc. | 75834-290-01 | 75834-290 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 500 Tablet, Extended Release In 1 Bottle (75834-290-05) | Nivagen Pharmaceuticals, Inc. | 75834-290-05 | 75834-290 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-291-00) | Nivagen Pharmaceuticals, Inc. | 75834-291-00 | 75834-291 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 100 Tablet, Extended Release In 1 Bottle (75834-291-01) | Nivagen Pharmaceuticals, Inc. | 75834-291-01 | 75834-291 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 500 Tablet, Extended Release In 1 Bottle (75834-291-05) | Nivagen Pharmaceuticals, Inc. | 75834-291-05 | 75834-291 | ANDA203028 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-292-00) | Nivagen Pharmaceuticals, Inc. | 75834-292-00 | 75834-292 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (75834-292-01) | Nivagen Pharmaceuticals, Inc. | 75834-292-01 | 75834-292 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 500 Tablet, Extended Release In 1 Bottle (75834-292-05) | Nivagen Pharmaceuticals, Inc. | 75834-292-05 | 75834-292 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-293-00) | Nivagen Pharmaceuticals, Inc. | 75834-293-00 | 75834-293 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (75834-293-01) | Nivagen Pharmaceuticals, Inc. | 75834-293-01 | 75834-293 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 500 Tablet, Extended Release In 1 Bottle (75834-293-05) | Nivagen Pharmaceuticals, Inc. | 75834-293-05 | 75834-293 | ANDA203699 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 100 Tablet, Extended Release In 1 Bottle (51407-403-01) | Golden State Medical Supply, Inc. | 51407-403-01 | 51407-403 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51407-403-10) | Golden State Medical Supply, Inc. | 51407-403-10 | 51407-403 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 100 Tablet, Extended Release In 1 Bottle (51407-404-01) | Golden State Medical Supply, Inc. | 51407-404-01 | 51407-404 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51407-404-10) | Golden State Medical Supply, Inc. | 51407-404-10 | 51407-404 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (51407-405-01) | Golden State Medical Supply, Inc. | 51407-405-01 | 51407-405 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51407-405-10) | Golden State Medical Supply, Inc. | 51407-405-10 | 51407-405 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (51407-406-01) | Golden State Medical Supply, Inc. | 51407-406-01 | 51407-406 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 1000 Tablet, Extended Release In 1 Bottle (51407-406-10) | Golden State Medical Supply, Inc. | 51407-406-10 | 51407-406 | ANDA204106 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 1000 Tablet In 1 Bottle (43602-418-10) | Ascent Pharmaceuticals, Inc | 43602-418-10 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 30 Tablet In 1 Bottle (43602-418-30) | Ascent Pharmaceuticals, Inc | 43602-418-30 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 90 Tablet In 1 Bottle (43602-418-90) | Ascent Pharmaceuticals, Inc | 43602-418-90 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 1000 Tablet In 1 Bottle (43602-419-10) | Ascent Pharmaceuticals, Inc | 43602-419-10 | 43602-419 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 30 Tablet In 1 Bottle (43602-419-30) | Ascent Pharmaceuticals, Inc | 43602-419-30 | 43602-419 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 90 Tablet In 1 Bottle (43602-419-90) | Ascent Pharmaceuticals, Inc | 43602-419-90 | 43602-419 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 1000 Tablet In 1 Bottle (43602-420-10) | Ascent Pharmaceuticals, Inc | 43602-420-10 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 30 Tablet In 1 Bottle (43602-420-30) | Ascent Pharmaceuticals, Inc | 43602-420-30 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 90 Tablet In 1 Bottle (43602-420-90) | Ascent Pharmaceuticals, Inc | 43602-420-90 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 1000 Tablet In 1 Bottle (43602-421-10) | Ascent Pharmaceuticals, Inc | 43602-421-10 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 30 Tablet In 1 Bottle (43602-421-30) | Ascent Pharmaceuticals, Inc | 43602-421-30 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 90 Tablet In 1 Bottle (43602-421-90) | Ascent Pharmaceuticals, Inc | 43602-421-90 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 1000 Tablet In 1 Bottle (43602-422-10) | Ascent Pharmaceuticals, Inc | 43602-422-10 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 30 Tablet In 1 Bottle (43602-422-30) | Ascent Pharmaceuticals, Inc | 43602-422-30 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 90 Tablet In 1 Bottle (43602-422-90) | Ascent Pharmaceuticals, Inc | 43602-422-90 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (43602-423-10) | Ascent Pharmaceuticals, Inc | 43602-423-10 | 43602-423 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 30 Tablet In 1 Bottle (43602-423-30) | Ascent Pharmaceuticals, Inc | 43602-423-30 | 43602-423 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (43602-423-90) | Ascent Pharmaceuticals, Inc | 43602-423-90 | 43602-423 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 1000 Tablet In 1 Bottle (43602-424-10) | Ascent Pharmaceuticals, Inc | 43602-424-10 | 43602-424 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 30 Tablet In 1 Bottle (43602-424-30) | Ascent Pharmaceuticals, Inc | 43602-424-30 | 43602-424 | ANDA215259 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (60760-243-60) | St. Mary's Medical Park Pharmacy | 60760-243-60 | 60760-243 | ANDA200981 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 180 Tablet, Film Coated In 1 Bottle, Plastic (60760-243-98) | St. Mary's Medical Park Pharmacy | 60760-243-98 | 60760-243 | ANDA200981 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-295-90) | St. Mary's Medical Park Pharmacy | 60760-295-90 | 60760-295 | ANDA200981 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-303-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-303-05 | 25021-303 | ANDA204205 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-109-01) | Golden State Medical Supply, Inc. | 51407-109-01 | 51407-109 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle, Plastic (51407-109-10) | Golden State Medical Supply, Inc. | 51407-109-10 | 51407-109 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-110-01) | Golden State Medical Supply, Inc. | 51407-110-01 | 51407-110 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle, Plastic (51407-110-10) | Golden State Medical Supply, Inc. | 51407-110-10 | 51407-110 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (51407-111-01) | Golden State Medical Supply, Inc. | 51407-111-01 | 51407-111 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle, Plastic (51407-111-10) | Golden State Medical Supply, Inc. | 51407-111-10 | 51407-111 | ANDA076704 | ANDA | N/A |
| Metoprolol Tartrate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (30698-458-01) | Validus Pharmaceuticals LLC | 30698-458-01 | 30698-458 | NDA017963 | NDA | N/A |
| Metoprolol Tartrate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (30698-459-01) | Validus Pharmaceuticals LLC | 30698-459-01 | 30698-459 | NDA017963 | NDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 90 Tablet In 1 Bottle (43602-424-90) | Ascent Pharmaceuticals, Inc | 43602-424-90 | 43602-424 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 1000 Tablet In 1 Bottle (43602-425-10) | Ascent Pharmaceuticals, Inc | 43602-425-10 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 30 Tablet In 1 Bottle (43602-425-30) | Ascent Pharmaceuticals, Inc | 43602-425-30 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 90 Tablet In 1 Bottle (43602-425-90) | Ascent Pharmaceuticals, Inc | 43602-425-90 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 1000 Tablet In 1 Bottle (43602-426-10) | Ascent Pharmaceuticals, Inc | 43602-426-10 | 43602-426 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 30 Tablet In 1 Bottle (43602-426-30) | Ascent Pharmaceuticals, Inc | 43602-426-30 | 43602-426 | ANDA215259 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 5mg/5mL | 5 Ml In 1 Vial (0143-9873-10) | Hikma Pharmaceuticals USA Inc. | 0143-9873-10 | 0143-9873 | ANDA077761 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 5mg/5mL | 25 Vial In 1 Carton (0143-9873-25) / 5 Ml In 1 Vial (0143-9873-10) | Hikma Pharmaceuticals USA Inc. | 0143-9873-25 | 0143-9873 | ANDA077761 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 5mg/5mL | 10 Vial In 1 Carton (0143-9660-10) / 5 Ml In 1 Vial (0143-9660-01) | Hikma Pharmaceuticals USA Inc. | 0143-9660-10 | 0143-9660 | ANDA077761 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2016-10) / 5 Ml In 1 Vial, Single-Dose (0409-2016-05) | Hospira, Inc. | 0409-2016-10 | 0409-2016 | ANDA078085 | ANDA | N/A |
| Metoprolol Tartrate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1778-05) / 5 Ml In 1 Vial, Single-Dose (0409-1778-15) | Hospira, Inc. | 0409-1778-05 | 0409-1778 | ANDA078085 | ANDA | N/A |
| Metronidazole | Gel | Vaginal | 7.5mg/g | 1 Tube In 1 Carton (45802-139-70) / 70 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-139-70 | 45802-139 | ANDA211786 | ANDA | N/A |
| Metronidazole | Cream | Topical | 7.5mg/g | 1 Tube In 1 Carton (66993-960-45) / 45 G In 1 Tube | Prasco Laboratories | 66993-960-45 | 66993-960 | NDA020531 | NDA AUTHORIZED GENERIC | N/A |
| Metronidazole | Lotion | Topical | 7.5mg/g | 1 Bottle In 1 Carton (66993-961-59) / 59.7 G In 1 Bottle | Prasco Laboratories | 66993-961-59 | 66993-961 | NDA020901 | NDA AUTHORIZED GENERIC | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 60 G In 1 Tube (66993-936-61) | Prasco Laboratories | 66993-936-61 | 66993-936 | NDA021789 | NDA AUTHORIZED GENERIC | N/A |
| Metronidazole | Gel | Topical | 7.5mg/g | 1 Tube In 1 Carton (66993-962-45) / 45 G In 1 Tube | Prasco Laboratories | 66993-962-45 | 66993-962 | NDA019737 | NDA AUTHORIZED GENERIC | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 14 Tablet In 1 Bottle, Plastic (60760-539-14) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-539-14 | 60760-539 | ANDA206560 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 40 Tablet In 1 Bottle, Plastic (60760-539-40) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-539-40 | 60760-539 | ANDA206560 | ANDA | N/A |
| Metronidazole | Injection, Solution | Intravenous | 500mg/100mL | 24 Pouch In 1 Carton (25021-131-82) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-131-82 | 25021-131 | ANDA206191 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (51407-376-01) | Golden State Medical Supply, Inc. | 51407-376-01 | 51407-376 | ANDA070772 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (51407-376-05) | Golden State Medical Supply, Inc. | 51407-376-05 | 51407-376 | ANDA070772 | ANDA | N/A |
| Metronidazole | Gel | Topical | 7.5mg/g | 1 Tube In 1 Carton (51672-4116-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4116-2 | 51672-4116 | ANDA077819 | ANDA | N/A |
| Metronidazole | Gel | Topical | 7.5mg/g | 5 G In 1 Tube (51672-4116-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4116-5 | 51672-4116 | ANDA077819 | ANDA | N/A |
| Metronidazole | Gel | Topical | 7.5mg/g | 1 Tube In 1 Carton (51672-4116-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4116-6 | 51672-4116 | ANDA077819 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-4215-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4215-3 | 51672-4215 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-4215-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4215-6 | 51672-4215 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Bottle, Pump In 1 Carton (51672-4215-9) / 55 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-4215-9 | 51672-4215 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-4164-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4164-3 | 51672-4164 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (51672-4164-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-4164-6 | 51672-4164 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Bottle, Pump In 1 Carton (51672-4164-9) / 55 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-4164-9 | 51672-4164 | ANDA204651 | ANDA | N/A |
| Metronidazole | Gel | Topical | 7.5mg/g | 1 Tube In 1 Carton (0713-0637-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0637-37 | 0713-0637 | ANDA078178 | ANDA | N/A |
| Metronidazole | Gel | Topical | 10mg/g | 1 Tube In 1 Carton (0713-0574-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0574-60 | 0713-0574 | ANDA216692 | ANDA | N/A |
| Metronidazole | Gel | Vaginal | 7.5mg/g | 1 Tube, With Applicator In 1 Carton (0713-0575-71) / 70 G In 1 Tube, With Applicator | Cosette Pharmaceuticals, Inc. | 0713-0575-71 | 0713-0575 | ANDA216323 | ANDA | N/A |
| Metronidazole | Cream | Topical | 7.5mg/g | 1 Tube In 1 Carton (0713-0633-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0633-37 | 0713-0633 | ANDA077549 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 90 Tablet In 1 Package (43602-426-90) | Ascent Pharmaceuticals, Inc | 43602-426-90 | 43602-426 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 1000 Tablet In 1 Bottle (43602-427-10) | Ascent Pharmaceuticals, Inc | 43602-427-10 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 30 Tablet In 1 Bottle (43602-427-30) | Ascent Pharmaceuticals, Inc | 43602-427-30 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 90 Tablet In 1 Bottle (43602-427-90) | Ascent Pharmaceuticals, Inc | 43602-427-90 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 1000 Tablet In 1 Bottle (43602-428-10) | Ascent Pharmaceuticals, Inc | 43602-428-10 | 43602-428 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 30 Tablet In 1 Bottle (43602-428-30) | Ascent Pharmaceuticals, Inc | 43602-428-30 | 43602-428 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 90 Tablet In 1 Bottle (43602-428-90) | Ascent Pharmaceuticals, Inc | 43602-428-90 | 43602-428 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 1000 Tablet In 1 Bottle (43602-417-10) | Ascent Pharmaceuticals, Inc | 43602-417-10 | 43602-417 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 30 Tablet In 1 Bottle (43602-417-30) | Ascent Pharmaceuticals, Inc | 43602-417-30 | 43602-417 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .025mg/1 | 90 Tablet In 1 Bottle (43602-417-90) | Ascent Pharmaceuticals, Inc | 43602-417-90 | 43602-417 | ANDA215259 | ANDA | N/A |
| Metronidazole | Capsule | Oral | 375mg/1 | 100 Blister Pack In 1 Carton (0025-1942-34) / 1 Capsule In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0025-1942-34 | 0025-1942 | NDA020334 | NDA | N/A |
| Metronidazole | Capsule | Oral | 375mg/1 | 50 Capsule In 1 Bottle (0025-1942-50) | Pfizer Laboratories Div Pfizer Inc | 0025-1942-50 | 0025-1942 | NDA020334 | NDA | N/A |
| Metronidazole | Injection, Solution | Intravenous | 5mg/mL | 24 Pouch In 1 Carton (0409-0152-24) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-0152-01) | Hospira, Inc. | 0409-0152-24 | 0409-0152 | ANDA206191 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (82012-027-04) | Senores Pharmaceuticals, Inc. | 82012-027-04 | 82012-027 | ANDA202111 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (82012-028-04) | Senores Pharmaceuticals, Inc. | 82012-028-04 | 82012-028 | ANDA214089 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (51407-379-01) | Golden State Medical Supply, Inc. | 51407-379-01 | 51407-379 | ANDA074450 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (51407-380-01) | Golden State Medical Supply, Inc. | 51407-380-01 | 51407-380 | ANDA074450 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (51407-381-01) | Golden State Medical Supply, Inc. | 51407-381-01 | 51407-381 | ANDA074450 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (69315-236-01) | Leading Pharma, LLC | 69315-236-01 | 69315-236 | ANDA215876 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (69315-237-01) | Leading Pharma, LLC | 69315-237-01 | 69315-237 | ANDA215876 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (69315-238-01) | Leading Pharma, LLC | 69315-238-01 | 69315-238 | ANDA215876 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 1000 Tablet In 1 Bottle (43602-418-10) | Ascent Pharmaceuticals, Inc | 43602-418-10 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 30 Tablet In 1 Bottle (43602-418-30) | Ascent Pharmaceuticals, Inc | 43602-418-30 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .05mg/1 | 90 Tablet In 1 Bottle (43602-418-90) | Ascent Pharmaceuticals, Inc | 43602-418-90 | 43602-418 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 1000 Tablet In 1 Bottle (43602-419-10) | Ascent Pharmaceuticals, Inc | 43602-419-10 | 43602-419 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 30 Tablet In 1 Bottle (43602-419-30) | Ascent Pharmaceuticals, Inc | 43602-419-30 | 43602-419 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .075mg/1 | 90 Tablet In 1 Bottle (43602-419-90) | Ascent Pharmaceuticals, Inc | 43602-419-90 | 43602-419 | ANDA215259 | ANDA | N/A |
| Micafungin | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/1 | 1 Vial In 1 Carton (0143-9362-01) / 5 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9362-01 | 0143-9362 | ANDA213261 | ANDA | N/A |
| Micafungin | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/1 | 1 Vial In 1 Carton (0143-9361-01) / 5 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9361-01 | 0143-9361 | ANDA213261 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-028-11) / 5 Ml In 1 Vial, Single-Dose (71288-028-10) | Meitheal Pharmaceuticals Inc. | 71288-028-11 | 71288-028 | ANDA215381 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-029-11) / 5 Ml In 1 Vial, Single-Dose (71288-029-10) | Meitheal Pharmaceuticals Inc. | 71288-029-11 | 71288-029 | ANDA215381 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 1 Vial In 1 Carton (25021-190-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-190-10 | 25021-190 | ANDA213363 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial In 1 Carton (25021-190-11) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-190-11 | 25021-190 | ANDA213363 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/5mL | 1 Vial In 1 Carton (25021-191-10) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-191-10 | 25021-191 | ANDA213363 | ANDA | N/A |
| Micafungin Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/5mL | 10 Vial In 1 Carton (25021-191-11) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-191-11 | 25021-191 | ANDA213363 | ANDA | N/A |
| Miconazole Nitrate | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-2001-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2001-1 | 51672-2001 | part333C | OTC MONOGRAPH FINAL | N/A |
| Miconazole Nitrate | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-2001-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2001-2 | 51672-2001 | part333C | OTC MONOGRAPH FINAL | N/A |
| Miconazole Nitrate | Cream | Vaginal | 20mg/g | 1 Tube, With Applicator In 1 Carton (51672-2035-6) / 45 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2035-6 | 51672-2035 | ANDA074444 | ANDA | N/A |
| Miconazole Nitrate | Cream | Vaginal | 20mg/g | 1 Tube, With Applicator In 1 Carton (51672-2035-7) / 45 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2035-7 | 51672-2035 | ANDA074444 | ANDA | N/A |
| Miconazole Nitrate | Cream | Vaginal | 40mg/g | 1 Tube, With Applicator In 1 Carton (51672-2070-9) / 25 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-2070-9 | 51672-2070 | ANDA076773 | ANDA | N/A |
| Midazolam Hydrochloride | Syrup | Oral | 2mg/mL | 1 Bottle, Glass In 1 Carton (0574-0150-04) / 118 Ml In 1 Bottle, Glass | Padagis US LLC | 0574-0150-04 | 0574-0150 | ANDA076379 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-655-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-655-02 | 25021-655 | ANDA090696 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (25021-661-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-661-10 | 25021-661 | ANDA090850 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 2mg/2mL | 10 Vial In 1 Carton (70069-816-10) / 2 Ml In 1 Vial | SOMERSET THERAPEUTICS, LLC | 70069-816-10 | 70069-816 | ANDA090315 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 2mg/2mL | 25 Vial In 1 Carton (70069-816-25) / 2 Ml In 1 Vial | SOMERSET THERAPEUTICS, LLC | 70069-816-25 | 70069-816 | ANDA090315 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/5mL | 10 Vial In 1 Carton (70069-817-10) / 5 Ml In 1 Vial | SOMERSET THERAPEUTICS, LLC | 70069-817-10 | 70069-817 | ANDA090315 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (70069-818-10) / 10 Ml In 1 Vial | SOMERSET THERAPEUTICS, LLC | 70069-818-10 | 70069-818 | ANDA090316 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Multi-Dose In 1 Carton (62250-111-10) / 10 Ml In 1 Vial, Multi-Dose | Belcher Pharmaceuticals, LLC | 62250-111-10 | 62250-111 | ANDA090850 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Syringe In 1 Carton (0641-6218-10) / 1 Ml In 1 Syringe (0641-6218-01) | Hikma Pharmaceuticals USA Inc. | 0641-6218-10 | 0641-6218 | ANDA212847 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Syringe In 1 Carton (0641-6219-10) / 2 Ml In 1 Syringe (0641-6219-01) | Hikma Pharmaceuticals USA Inc. | 0641-6219-10 | 0641-6219 | ANDA212847 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 10 Syringe In 1 Carton (0641-6220-10) / 2 Ml In 1 Syringe (0641-6220-01) | Hikma Pharmaceuticals USA Inc. | 0641-6220-10 | 0641-6220 | ANDA212847 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6190-10) / 10 Ml In 1 Vial (0641-6190-01) | Hikma Pharmaceuticals USA Inc. | 0641-6190-10 | 0641-6190 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 10 Vial In 1 Carton (0641-6056-10) / 10 Ml In 1 Vial (0641-6056-01) | Hikma Pharmaceuticals USA Inc. | 0641-6056-10 | 0641-6056 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 10 Vial In 1 Carton (0641-6057-10) / 2 Ml In 1 Vial (0641-6057-01) | Hikma Pharmaceuticals USA Inc. | 0641-6057-10 | 0641-6057 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 25 Vial In 1 Carton (0641-6057-25) / 2 Ml In 1 Vial (0641-6057-01) | Hikma Pharmaceuticals USA Inc. | 0641-6057-25 | 0641-6057 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 10 Vial In 1 Carton (0641-6059-10) / 5 Ml In 1 Vial (0641-6059-01) | Hikma Pharmaceuticals USA Inc. | 0641-6059-10 | 0641-6059 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6060-10) / 10 Ml In 1 Vial (0641-6060-01) | Hikma Pharmaceuticals USA Inc. | 0641-6060-10 | 0641-6060 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6061-10) / 1 Ml In 1 Vial (0641-6061-01) | Hikma Pharmaceuticals USA Inc. | 0641-6061-10 | 0641-6061 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Carton (0641-6061-25) / 1 Ml In 1 Vial (0641-6061-01) | Hikma Pharmaceuticals USA Inc. | 0641-6061-25 | 0641-6061 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6063-10) / 2 Ml In 1 Vial (0641-6063-01) | Hikma Pharmaceuticals USA Inc. | 0641-6063-10 | 0641-6063 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Carton (0641-6063-25) / 2 Ml In 1 Vial (0641-6063-01) | Hikma Pharmaceuticals USA Inc. | 0641-6063-25 | 0641-6063 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 25 Vial In 1 Carton (0641-6209-25) / 2 Ml In 1 Vial (0641-6209-01) | Hikma Pharmaceuticals USA Inc. | 0641-6209-25 | 0641-6209 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 1mg/mL | 10 Vial In 1 Carton (0641-6210-10) / 5 Ml In 1 Vial (0641-6210-01) | Hikma Pharmaceuticals USA Inc. | 0641-6210-10 | 0641-6210 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (0641-6211-10) / 10 Ml In 1 Vial (0641-6211-01) | Hikma Pharmaceuticals USA Inc. | 0641-6211-10 | 0641-6211 | ANDA075243 | ANDA | CIV |
| Midazolam Hydrochloride | Syrup | Oral | 2mg/mL | 118 Ml In 1 Bottle, Glass (0054-3566-99) | Hikma Pharmaceuticals USA Inc. | 0054-3566-99 | 0054-3566 | ANDA075873 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Pouch In 1 Carton (0143-9379-10) / 1 Bag In 1 Pouch (0143-9379-01) / 50 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9379-10 | 0143-9379 | ANDA216159 | ANDA | CIV |
| Midazolam Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Pouch In 1 Carton (0143-9380-10) / 1 Bag In 1 Pouch (0143-9380-01) / 100 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9380-10 | 0143-9380 | ANDA216159 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2305-50) / 5 Ml In 1 Vial, Single-Dose (0409-2305-55) | Hospira, Inc. | 0409-2305-50 | 0409-2305 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2305-05) / 5 Ml In 1 Vial, Single-Dose (0409-2305-04) | Hospira, Inc. | 0409-2305-05 | 0409-2305 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-2305-17) / 2 Ml In 1 Vial, Single-Dose (0409-2305-16) | Hospira, Inc. | 0409-2305-17 | 0409-2305 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2308-49) / 1 Ml In 1 Vial, Single-Dose (0409-2308-69) | Hospira, Inc. | 0409-2308-49 | 0409-2308 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2308-50) / 2 Ml In 1 Vial, Single-Dose (0409-2308-70) | Hospira, Inc. | 0409-2308-50 | 0409-2308 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2308-01) / 1 Ml In 1 Vial, Single-Dose (0409-2308-21) | Hospira, Inc. | 0409-2308-01 | 0409-2308 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-2308-02) / 2 Ml In 1 Vial, Single-Dose (0409-2308-22) | Hospira, Inc. | 0409-2308-02 | 0409-2308 | ANDA075857 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-2587-05) / 10 Ml In 1 Vial, Multi-Dose (0409-2587-04) | Hospira, Inc. | 0409-2587-05 | 0409-2587 | ANDA075293 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-2596-03) / 5 Ml In 1 Vial, Multi-Dose (0409-2596-13) | Hospira, Inc. | 0409-2596-03 | 0409-2596 | ANDA075293 | ANDA | CIV |
| Midazolam Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-2596-05) / 10 Ml In 1 Vial, Multi-Dose (0409-2596-15) | Hospira, Inc. | 0409-2596-05 | 0409-2596 | ANDA075293 | ANDA | CIV |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-388-90) | Golden State Medical Supply, Inc. | 51407-388-90 | 51407-388 | ANDA207849 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-389-90) | Golden State Medical Supply, Inc. | 51407-389-90 | 51407-389 | ANDA207849 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-390-90) | Golden State Medical Supply, Inc. | 51407-390-90 | 51407-390 | ANDA207849 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (60505-1320-1) | Apotex Corp | 60505-1320-1 | 60505-1320 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (60505-1320-3) | Apotex Corp | 60505-1320-3 | 60505-1320 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (60505-1320-5) | Apotex Corp | 60505-1320-5 | 60505-1320 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (60505-1320-8) | Apotex Corp | 60505-1320-8 | 60505-1320 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (60505-1321-1) | Apotex Corp | 60505-1321-1 | 60505-1321 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (60505-1321-3) | Apotex Corp | 60505-1321-3 | 60505-1321 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (60505-1321-5) | Apotex Corp | 60505-1321-5 | 60505-1321 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (60505-1321-8) | Apotex Corp | 60505-1321-8 | 60505-1321 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60505-1325-1) | Apotex Corp | 60505-1325-1 | 60505-1325 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (60505-1325-3) | Apotex Corp | 60505-1325-3 | 60505-1325 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (60505-1325-5) | Apotex Corp | 60505-1325-5 | 60505-1325 | ANDA077746 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-1325-8) | Apotex Corp | 60505-1325-8 | 60505-1325 | ANDA077746 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 1000 Tablet In 1 Bottle (43602-420-10) | Ascent Pharmaceuticals, Inc | 43602-420-10 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 30 Tablet In 1 Bottle (43602-420-30) | Ascent Pharmaceuticals, Inc | 43602-420-30 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .088mg/1 | 90 Tablet In 1 Bottle (43602-420-90) | Ascent Pharmaceuticals, Inc | 43602-420-90 | 43602-420 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 1000 Tablet In 1 Bottle (43602-421-10) | Ascent Pharmaceuticals, Inc | 43602-421-10 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 30 Tablet In 1 Bottle (43602-421-30) | Ascent Pharmaceuticals, Inc | 43602-421-30 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .1mg/1 | 90 Tablet In 1 Bottle (43602-421-90) | Ascent Pharmaceuticals, Inc | 43602-421-90 | 43602-421 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 1000 Tablet In 1 Bottle (43602-422-10) | Ascent Pharmaceuticals, Inc | 43602-422-10 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 30 Tablet In 1 Bottle (43602-422-30) | Ascent Pharmaceuticals, Inc | 43602-422-30 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .112mg/1 | 90 Tablet In 1 Bottle (43602-422-90) | Ascent Pharmaceuticals, Inc | 43602-422-90 | 43602-422 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (43602-423-10) | Ascent Pharmaceuticals, Inc | 43602-423-10 | 43602-423 | ANDA215259 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (71288-200-11) / 10 Ml In 1 Vial, Single-Dose (71288-200-10) | Meitheal Pharmaceuticals Inc. | 71288-200-11 | 71288-200 | ANDA211671 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (71288-200-21) / 20 Ml In 1 Vial, Single-Dose (71288-200-20) | Meitheal Pharmaceuticals Inc. | 71288-200-21 | 71288-200 | ANDA211671 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-200-50) / 50 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-200-50 | 71288-200 | ANDA211671 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | .2mg/mL | 10 Bag In 1 Carton (25021-313-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-313-82 | 25021-313 | ANDA213585 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | .2mg/mL | 10 Bag In 1 Carton (25021-313-87) / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-313-87 | 25021-313 | ANDA213585 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (70069-807-10) / 10 Ml In 1 Vial (70069-807-01) | Somerset Therapeutics, LLC | 70069-807-10 | 70069-807 | ANDA214380 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (70069-808-10) / 20 Ml In 1 Vial (70069-808-01) | Somerset Therapeutics, LLC | 70069-808-10 | 70069-808 | ANDA214380 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial In 1 Carton (70069-809-01) / 50 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-809-01 | 70069-809 | ANDA214380 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 25 Vial In 1 Box (0143-9710-25) / 10 Ml In 1 Vial (0143-9710-10) | Hikma Pharmaceuticals USA Inc. | 0143-9710-25 | 0143-9710 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9373-10) / 10 Ml In 1 Vial (0143-9373-01) | Hikma Pharmaceuticals USA Inc. | 0143-9373-10 | 0143-9373 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9374-10) / 20 Ml In 1 Vial (0143-9374-01) | Hikma Pharmaceuticals USA Inc. | 0143-9374-10 | 0143-9374 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9326-10) / 20 Ml In 1 Vial (0143-9326-01) | Hikma Pharmaceuticals USA Inc. | 0143-9326-10 | 0143-9326 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Box (0143-9708-10) / 50 Ml In 1 Vial (0143-9708-01) | Hikma Pharmaceuticals USA Inc. | 0143-9708-10 | 0143-9708 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 20 Ml In 1 Vial (0143-9709-10) | Hikma Pharmaceuticals USA Inc. | 0143-9709-10 | 0143-9709 | ANDA077966 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 200ug/mL | 10 Container In 1 Package (0143-9718-10) / 200 Ml In 1 Container (0143-9718-01) | Hikma Pharmaceuticals USA Inc. | 0143-9718-10 | 0143-9718 | ANDA090038 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 200ug/mL | 10 Container In 1 Package (0143-9719-10) / 100 Ml In 1 Container (0143-9719-01) | Hikma Pharmaceuticals USA Inc. | 0143-9719-10 | 0143-9719 | ANDA090038 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-0212-01) / 10 Ml In 1 Vial, Single-Dose (0409-0212-10) | Hospira, Inc. | 0409-0212-01 | 0409-0212 | ANDA203280 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-0212-02) / 20 Ml In 1 Vial, Single-Dose (0409-0212-11) | Hospira, Inc. | 0409-0212-02 | 0409-0212 | ANDA203280 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0212-03) / 50 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0212-03 | 0409-0212 | ANDA203280 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | .2mg/mL | 10 Pouch In 1 Carton (0409-2045-10) / 1 Bag In 1 Pouch (0409-2045-01) / 100 Ml In 1 Bag | Hospira, Inc. | 0409-2045-10 | 0409-2045 | ANDA213585 | ANDA | N/A |
| Milrinone Lactate | Injection, Solution | Intravenous | .2mg/mL | 10 Pouch In 1 Carton (0409-1983-10) / 1 Bag In 1 Pouch (0409-1983-01) / 200 Ml In 1 Bag | Hospira, Inc. | 0409-1983-10 | 0409-1983 | ANDA213585 | ANDA | N/A |
| Mineral Oil; Petrolatum; Phenylephrine Hydrochloride | Ointment | Rectal | 14g/100g, 74.9 g/100g, .25 g/100g | 1 Tube In 1 Carton (45802-188-16) / 57 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-188-16 | 45802-188 | M015 | OTC MONOGRAPH DRUG | N/A |
| Minoxidil | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-902-01) | Golden State Medical Supply, Inc. | 51407-902-01 | 51407-902 | ANDA071839 | ANDA | N/A |
| Minoxidil | Aerosol, Foam | Topical | 50mg/g | 1 Can In 1 Package (51672-2128-4) / 60 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-2128-4 | 51672-2128 | ANDA209074 | ANDA | N/A |
| Minoxidil | Aerosol, Foam | Topical | 50mg/g | 3 Can In 1 Package (51672-2128-9) / 60 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-2128-9 | 51672-2128 | ANDA209074 | ANDA | N/A |
| Minoxidil | Aerosol, Foam | Topical | 50mg/g | 1 Can In 1 Package (51672-2129-4) / 60 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-2129-4 | 51672-2129 | ANDA209074 | ANDA | N/A |
| Minoxidil | Aerosol, Foam | Topical | 50mg/g | 2 Can In 1 Package (51672-2129-8) / 60 G In 1 Can | Taro Pharmaceuticals U.S.A., Inc. | 51672-2129-8 | 51672-2129 | ANDA209074 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 7.5mg/1 | 500 Tablet, Film Coated In 1 Bottle (66993-606-04) | Prasco Laboratories | 66993-606-04 | 66993-606 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 7.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-606-30) | Prasco Laboratories | 66993-606-30 | 66993-606 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 500 Tablet, Film Coated In 1 Bottle (66993-607-04) | Prasco Laboratories | 66993-607-04 | 66993-607 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-607-30) | Prasco Laboratories | 66993-607-30 | 66993-607 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 500 Tablet, Film Coated In 1 Bottle (66993-608-04) | Prasco Laboratories | 66993-608-04 | 66993-608 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-608-30) | Prasco Laboratories | 66993-608-30 | 66993-608 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 500 Tablet, Film Coated In 1 Bottle (66993-609-04) | Prasco Laboratories | 66993-609-04 | 66993-609 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 30 Tablet, Film Coated In 1 Bottle (66993-609-30) | Prasco Laboratories | 66993-609-30 | 66993-609 | ANDA216751 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 1000 Tablet, Film Coated In 1 Bottle, Plastic (51407-350-10) | Golden State Medical Supply, Inc. | 51407-350-10 | 51407-350 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-350-30) | Golden State Medical Supply, Inc. | 51407-350-30 | 51407-350 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (51407-351-05) | Golden State Medical Supply, Inc. | 51407-351-05 | 51407-351 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-351-30) | Golden State Medical Supply, Inc. | 51407-351-30 | 51407-351 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (51407-352-05) | Golden State Medical Supply, Inc. | 51407-352-05 | 51407-352 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-352-30) | Golden State Medical Supply, Inc. | 51407-352-30 | 51407-352 | ANDA076122 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0247-1) | Apotex Corp. | 60505-0247-1 | 60505-0247 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0247-3) | Apotex Corp. | 60505-0247-3 | 60505-0247 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-0247-5) | Apotex Corp. | 60505-0247-5 | 60505-0247 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0247-8) | Apotex Corp. | 60505-0247-8 | 60505-0247 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0248-1) | Apotex Corp. | 60505-0248-1 | 60505-0248 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0248-3) | Apotex Corp. | 60505-0248-3 | 60505-0248 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-0248-5) | Apotex Corp. | 60505-0248-5 | 60505-0248 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0248-8) | Apotex Corp. | 60505-0248-8 | 60505-0248 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0249-1) | Apotex Corp. | 60505-0249-1 | 60505-0249 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0249-3) | Apotex Corp. | 60505-0249-3 | 60505-0249 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 500 Tablet, Film Coated In 1 Bottle (60505-0249-5) | Apotex Corp. | 60505-0249-5 | 60505-0249 | ANDA077666 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0249-8) | Apotex Corp. | 60505-0249-8 | 60505-0249 | ANDA077666 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 30 Tablet In 1 Bottle (43602-423-30) | Ascent Pharmaceuticals, Inc | 43602-423-30 | 43602-423 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (43602-423-90) | Ascent Pharmaceuticals, Inc | 43602-423-90 | 43602-423 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 1000 Tablet In 1 Bottle (43602-424-10) | Ascent Pharmaceuticals, Inc | 43602-424-10 | 43602-424 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 30 Tablet In 1 Bottle (43602-424-30) | Ascent Pharmaceuticals, Inc | 43602-424-30 | 43602-424 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .137mg/1 | 90 Tablet In 1 Bottle (43602-424-90) | Ascent Pharmaceuticals, Inc | 43602-424-90 | 43602-424 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 1000 Tablet In 1 Bottle (43602-425-10) | Ascent Pharmaceuticals, Inc | 43602-425-10 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 30 Tablet In 1 Bottle (43602-425-30) | Ascent Pharmaceuticals, Inc | 43602-425-30 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .15mg/1 | 90 Tablet In 1 Bottle (43602-425-90) | Ascent Pharmaceuticals, Inc | 43602-425-90 | 43602-425 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 1000 Tablet In 1 Bottle (43602-426-10) | Ascent Pharmaceuticals, Inc | 43602-426-10 | 43602-426 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 30 Tablet In 1 Bottle (43602-426-30) | Ascent Pharmaceuticals, Inc | 43602-426-30 | 43602-426 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .175mg/1 | 90 Tablet In 1 Package (43602-426-90) | Ascent Pharmaceuticals, Inc | 43602-426-90 | 43602-426 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 1000 Tablet In 1 Bottle (43602-427-10) | Ascent Pharmaceuticals, Inc | 43602-427-10 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 30 Tablet In 1 Bottle (43602-427-30) | Ascent Pharmaceuticals, Inc | 43602-427-30 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .2mg/1 | 90 Tablet In 1 Bottle (43602-427-90) | Ascent Pharmaceuticals, Inc | 43602-427-90 | 43602-427 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 1000 Tablet In 1 Bottle (43602-428-10) | Ascent Pharmaceuticals, Inc | 43602-428-10 | 43602-428 | ANDA215259 | ANDA | N/A |
| Misoprostol | Tablet | Oral | 100ug/1 | 100 Blister Pack In 1 Carton (0025-1451-34) / 1 Tablet In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0025-1451-34 | 0025-1451 | NDA019268 | NDA | N/A |
| Misoprostol | Tablet | Oral | 100ug/1 | 60 Tablet In 1 Bottle, Unit-Dose (0025-1451-60) | Pfizer Laboratories Div Pfizer Inc | 0025-1451-60 | 0025-1451 | NDA019268 | NDA | N/A |
| Misoprostol | Tablet | Oral | 200ug/1 | 100 Tablet In 1 Bottle, Unit-Dose (0025-1461-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1461-31 | 0025-1461 | NDA019268 | NDA | N/A |
| Misoprostol | Tablet | Oral | 200ug/1 | 60 Tablet In 1 Bottle, Unit-Dose (0025-1461-60) | Pfizer Laboratories Div Pfizer Inc | 0025-1461-60 | 0025-1461 | NDA019268 | NDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-137-20) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-137-20 | 71288-137 | ANDA214505 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 20mg/40mL | 1 Vial, Single-Dose In 1 Carton (71288-138-50) / 40 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-138-50 | 71288-138 | ANDA214505 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/80mL | 1 Vial, Single-Dose In 1 Carton (71288-139-51) / 80 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-139-51 | 71288-139 | ANDA214504 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/10mL | 1 Vial In 1 Carton (25021-250-20) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-250-20 | 25021-250 | ANDA215687 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 20mg/40mL | 1 Vial In 1 Carton (25021-251-50) / 40 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-251-50 | 25021-251 | ANDA215687 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/80mL | 1 Vial In 1 Carton (25021-252-51) / 80 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-252-51 | 25021-252 | ANDA216648 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 20mg/1 | 1 Vial In 1 Box (0143-9135-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9135-01 | 0143-9135 | ANDA064117 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 20mg/40mL | 1 Vial In 1 Box, Unit-Dose (0143-9279-01) / 40 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9279-01 | 0143-9279 | ANDA064117 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/1 | 1 Vial In 1 Box (0143-9136-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9136-01 | 0143-9136 | ANDA064117 | ANDA | N/A |
| Mitomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/80mL | 1 Vial In 1 Box, Unit-Dose (0143-9280-01) / 80 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9280-01 | 0143-9280 | ANDA064117 | ANDA | N/A |
| Mitoxantrone Hydrochloride | Injection, Solution, Concentrate | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-343-18) / 10 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-343-18 | 61703-343 | ANDA076871 | ANDA | N/A |
| Mitoxantrone Hydrochloride | Injection, Solution, Concentrate | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-343-65) / 12.5 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-343-65 | 61703-343 | ANDA076871 | ANDA | N/A |
| Mitoxantrone Hydrochloride | Injection, Solution, Concentrate | Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-343-66) / 15 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-343-66 | 61703-343 | ANDA076871 | ANDA | N/A |
| Modafinil | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (51407-928-30) | Golden State Medical Supply, Inc. | 51407-928-30 | 51407-928 | ANDA077667 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (60505-2526-1) | Apotex Corp. | 60505-2526-1 | 60505-2526 | ANDA077667 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (60505-2526-3) | Apotex Corp. | 60505-2526-3 | 60505-2526 | ANDA077667 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (60505-2527-1) | Apotex Corp. | 60505-2527-1 | 60505-2527 | ANDA077667 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (60505-2527-3) | Apotex Corp. | 60505-2527-3 | 60505-2527 | ANDA077667 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle, Plastic (69452-342-13) | Bionpharma Inc. | 69452-342-13 | 69452-342 | ANDA078963 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle, Plastic (69452-342-19) | Bionpharma Inc. | 69452-342-19 | 69452-342 | ANDA078963 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle, Plastic (69452-342-20) | Bionpharma Inc. | 69452-342-20 | 69452-342 | ANDA078963 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle, Plastic (69452-343-13) | Bionpharma Inc. | 69452-343-13 | 69452-343 | ANDA078963 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 90 Tablet In 1 Bottle, Plastic (69452-343-19) | Bionpharma Inc. | 69452-343-19 | 69452-343 | ANDA078963 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle, Plastic (69452-343-20) | Bionpharma Inc. | 69452-343-20 | 69452-343 | ANDA078963 | ANDA | CIV |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 30 Tablet In 1 Bottle (43602-428-30) | Ascent Pharmaceuticals, Inc | 43602-428-30 | 43602-428 | ANDA215259 | ANDA | N/A |
| Levothyroxine Sodium | Tablet | Oral | .3mg/1 | 90 Tablet In 1 Bottle (43602-428-90) | Ascent Pharmaceuticals, Inc | 43602-428-90 | 43602-428 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 100 Tablet In 1 Bottle (31722-284-01) | Camber Pharmaceuticals, Inc. | 31722-284-01 | 31722-284 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 1000 Tablet In 1 Bottle (31722-284-10) | Camber Pharmaceuticals, Inc. | 31722-284-10 | 31722-284 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 30 Tablet In 1 Bottle (31722-284-30) | Camber Pharmaceuticals, Inc. | 31722-284-30 | 31722-284 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 90 Tablet In 1 Bottle (31722-284-90) | Camber Pharmaceuticals, Inc. | 31722-284-90 | 31722-284 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 100 Tablet In 1 Bottle (31722-285-01) | Camber Pharmaceuticals, Inc. | 31722-285-01 | 31722-285 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 1000 Tablet In 1 Bottle (31722-285-10) | Camber Pharmaceuticals, Inc. | 31722-285-10 | 31722-285 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 30 Tablet In 1 Bottle (31722-285-30) | Camber Pharmaceuticals, Inc. | 31722-285-30 | 31722-285 | ANDA215259 | ANDA | N/A |
| Mometasone | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Pump In 1 Carton (60429-664-17) / 120 Spray, Metered In 1 Bottle, Pump | Golden State Medical Supply, Inc. | 60429-664-17 | 60429-664 | ANDA091161 | ANDA | N/A |
| Mometasone | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Pump In 1 Carton (60505-0830-1) / 120 Spray, Metered In 1 Bottle, Pump | Apotex Corp. | 60505-0830-1 | 60505-0830 | ANDA091161 | ANDA | N/A |
| Mometasone Furoate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (45802-118-46) / 60 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-118-46 | 45802-118 | ANDA077180 | ANDA | N/A |
| Mometasone Furoate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (45802-118-59) / 30 Ml In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-118-59 | 45802-118 | ANDA077180 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-119-37) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-119-37 | 45802-119 | ANDA076067 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-119-42) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-119-42 | 45802-119 | ANDA076067 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-257-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-257-35 | 45802-257 | ANDA076679 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-257-42) / 45 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-257-42 | 45802-257 | ANDA076679 | ANDA | N/A |
| Mometasone Furoate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (51672-1305-3) / 30 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1305-3 | 51672-1305 | ANDA076788 | ANDA | N/A |
| Mometasone Furoate | Solution | Topical | 1mg/mL | 1 Bottle In 1 Carton (51672-1305-4) / 60 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-1305-4 | 51672-1305 | ANDA076788 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1311-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1311-1 | 51672-1311 | ANDA076624 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1311-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1311-6 | 51672-1311 | ANDA076624 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1315-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1315-1 | 51672-1315 | ANDA076679 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1315-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1315-6 | 51672-1315 | ANDA076679 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0634-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0634-15 | 0713-0634 | ANDA077447 | ANDA | N/A |
| Mometasone Furoate | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0634-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0634-37 | 0713-0634 | ANDA077447 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0635-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0635-15 | 0713-0635 | ANDA077401 | ANDA | N/A |
| Mometasone Furoate | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0635-37) / 45 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0635-37 | 0713-0635 | ANDA077401 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 90 Tablet In 1 Bottle (31722-285-90) | Camber Pharmaceuticals, Inc. | 31722-285-90 | 31722-285 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 100 Tablet In 1 Bottle (31722-286-01) | Camber Pharmaceuticals, Inc. | 31722-286-01 | 31722-286 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 1000 Tablet In 1 Bottle (31722-286-10) | Camber Pharmaceuticals, Inc. | 31722-286-10 | 31722-286 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 30 Tablet In 1 Bottle (31722-286-30) | Camber Pharmaceuticals, Inc. | 31722-286-30 | 31722-286 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 90 Tablet In 1 Bottle (31722-286-90) | Camber Pharmaceuticals, Inc. | 31722-286-90 | 31722-286 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 100 Tablet In 1 Bottle (31722-287-01) | Camber Pharmaceuticals, Inc. | 31722-287-01 | 31722-287 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 1000 Tablet In 1 Bottle (31722-287-10) | Camber Pharmaceuticals, Inc. | 31722-287-10 | 31722-287 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 30 Tablet In 1 Bottle (31722-287-30) | Camber Pharmaceuticals, Inc. | 31722-287-30 | 31722-287 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 90 Tablet In 1 Bottle (31722-287-90) | Camber Pharmaceuticals, Inc. | 31722-287-90 | 31722-287 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 100 Tablet In 1 Bottle (31722-288-01) | Camber Pharmaceuticals, Inc. | 31722-288-01 | 31722-288 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 1000 Tablet In 1 Bottle (31722-288-10) | Camber Pharmaceuticals, Inc. | 31722-288-10 | 31722-288 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 30 Tablet In 1 Bottle (31722-288-30) | Camber Pharmaceuticals, Inc. | 31722-288-30 | 31722-288 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 90 Tablet In 1 Bottle (31722-288-90) | Camber Pharmaceuticals, Inc. | 31722-288-90 | 31722-288 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 100 Tablet In 1 Bottle (31722-289-01) | Camber Pharmaceuticals, Inc. | 31722-289-01 | 31722-289 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 1000 Tablet In 1 Bottle (31722-289-10) | Camber Pharmaceuticals, Inc. | 31722-289-10 | 31722-289 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 30 Tablet In 1 Bottle (31722-289-30) | Camber Pharmaceuticals, Inc. | 31722-289-30 | 31722-289 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 90 Tablet In 1 Bottle (31722-289-90) | Camber Pharmaceuticals, Inc. | 31722-289-90 | 31722-289 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (31722-290-01) | Camber Pharmaceuticals, Inc. | 31722-290-01 | 31722-290 | ANDA215259 | ANDA | N/A |
| Morphine Sulfate | Suppository | Rectal | 5mg/1 | 12 Packet In 1 Box (0574-7110-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7110-12 | 0574-7110 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Suppository | Rectal | 10mg/1 | 12 Packet In 1 Box (0574-7112-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7112-12 | 0574-7112 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Suppository | Rectal | 20mg/1 | 12 Packet In 1 Box (0574-7114-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7114-12 | 0574-7114 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Suppository | Rectal | 30mg/1 | 12 Packet In 1 Box (0574-7116-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7116-12 | 0574-7116 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Solution | Oral | 20mg/mL | 1 Bottle, Unit-Dose In 1 Carton (27808-082-01) / 30 Ml In 1 Bottle, Unit-Dose | Tris Pharma Inc | 27808-082-01 | 27808-082 | ANDA203518 | ANDA | CII |
| Morphine Sulfate | Solution | Oral | 20mg/mL | 1 Bottle, Unit-Dose In 1 Carton (27808-082-02) / 120 Ml In 1 Bottle, Unit-Dose | Tris Pharma Inc | 27808-082-02 | 27808-082 | ANDA203518 | ANDA | CII |
| Morphine Sulfate | Injection | Epidural; Intrathecal; Intravenous | 1mg/mL | 10 Ampule In 1 Carton (0641-6019-10) / 10 Ml In 1 Ampule (0641-6019-01) | Hikma Pharmaceuticals USA Inc. | 0641-6019-10 | 0641-6019 | NDA018565 | NDA | CII |
| Morphine Sulfate | Injection | Epidural; Intrathecal; Intravenous | .5mg/mL | 10 Ampule In 1 Carton (0641-6020-10) / 10 Ml In 1 Ampule (0641-6020-01) | Hikma Pharmaceuticals USA Inc. | 0641-6020-10 | 0641-6020 | NDA018565 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Epidural; Intrathecal | 10mg/mL | 20 Ml In 1 Ampule (0641-6039-01) | Hikma Pharmaceuticals USA Inc. | 0641-6039-01 | 0641-6039 | NDA018565 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Epidural; Intrathecal | 25mg/mL | 20 Ml In 1 Ampule (0641-6040-01) | Hikma Pharmaceuticals USA Inc. | 0641-6040-01 | 0641-6040 | NDA018565 | NDA | CII |
| Morphine Sulfate | Tablet | Oral | 15mg/1 | 100 Blister Pack In 1 Carton (0054-0235-24) / 1 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0235-24 | 0054-0235 | NDA022207 | NDA | CII |
| Morphine Sulfate | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (0054-0235-25) | Hikma Pharmaceuticals USA Inc. | 0054-0235-25 | 0054-0235 | NDA022207 | NDA | CII |
| Morphine Sulfate | Tablet | Oral | 30mg/1 | 100 Blister Pack In 1 Carton (0054-0236-24) / 1 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0236-24 | 0054-0236 | NDA022207 | NDA | CII |
| Morphine Sulfate | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (0054-0236-25) | Hikma Pharmaceuticals USA Inc. | 0054-0236-25 | 0054-0236 | NDA022207 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 10mg/5mL | 100 Ml In 1 Bottle (0054-0237-49) | Hikma Pharmaceuticals USA Inc. | 0054-0237-49 | 0054-0237 | NDA022195 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (0054-0237-63) | Hikma Pharmaceuticals USA Inc. | 0054-0237-63 | 0054-0237 | NDA022195 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 20mg/5mL | 100 Ml In 1 Bottle (0054-0238-49) | Hikma Pharmaceuticals USA Inc. | 0054-0238-49 | 0054-0238 | NDA022195 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 20mg/5mL | 500 Ml In 1 Bottle (0054-0238-63) | Hikma Pharmaceuticals USA Inc. | 0054-0238-63 | 0054-0238 | NDA022195 | NDA | CII |
| Morphine Sulfate | Injection | Intravenous | 4mg/mL | 25 Vial, Single-Dose In 1 Package (0641-6125-25) / 1 Ml In 1 Vial, Single-Dose (0641-6125-01) | Hikma Pharmaceuticals USA Inc. | 0641-6125-25 | 0641-6125 | ANDA205758 | ANDA | CII |
| Morphine Sulfate | Injection | Intravenous | 8mg/mL | 25 Vial, Single-Dose In 1 Package (0641-6126-25) / 1 Ml In 1 Vial, Single-Dose (0641-6126-01) | Hikma Pharmaceuticals USA Inc. | 0641-6126-25 | 0641-6126 | ANDA205758 | ANDA | CII |
| Morphine Sulfate | Injection | Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Package (0641-6127-25) / 1 Ml In 1 Vial, Single-Dose (0641-6127-01) | Hikma Pharmaceuticals USA Inc. | 0641-6127-25 | 0641-6127 | ANDA205758 | ANDA | CII |
| Morphine Sulfate | Solution | Oral | 100mg/5mL | 15 Ml In 1 Bottle (0054-0517-41) | Hikma Pharmaceuticals USA Inc. | 0054-0517-41 | 0054-0517 | NDA022195 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 100mg/5mL | 30 Ml In 1 Bottle (0054-0517-44) | Hikma Pharmaceuticals USA Inc. | 0054-0517-44 | 0054-0517 | NDA022195 | NDA | CII |
| Morphine Sulfate | Solution | Oral | 100mg/5mL | 120 Ml In 1 Bottle (0054-0517-50) | Hikma Pharmaceuticals USA Inc. | 0054-0517-50 | 0054-0517 | NDA022195 | NDA | CII |
| Morphine Sulfate | Injection, Solution, Concentrate | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1134-03) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1134-03 | 0409-1134 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Injection, Solution, Concentrate | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1134-05) / 50 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1134-05 | 0409-1134 | N/A | UNAPPROVED DRUG OTHER | CII |
| Morphine Sulfate | Injection, Solution | Epidural; Intrathecal; Intravenous | .5mg/mL | 5 Vial, Glass In 1 Carton (0409-3814-12) / 10 Ml In 1 Vial, Glass (0409-3814-11) | Hospira, Inc. | 0409-3814-12 | 0409-3814 | ANDA073509 | ANDA | CII |
| Morphine Sulfate | Injection, Solution | Epidural; Intrathecal; Intravenous | 1mg/mL | 5 Vial, Glass In 1 Carton (0409-3815-12) / 10 Ml In 1 Vial, Glass (0409-3815-11) | Hospira, Inc. | 0409-3815-12 | 0409-3815 | ANDA073510 | ANDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 2mg/mL | 10 Cartridge In 1 Carton (0409-1890-01) / 1 Ml In 1 Cartridge (0409-1890-03) | Hospira, Inc. | 0409-1890-01 | 0409-1890 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 2mg/mL | 10 Syringe In 1 Cello Pack (0409-1890-23) / 1 Ml In 1 Syringe (0409-1890-13) | Hospira, Inc. | 0409-1890-23 | 0409-1890 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 4mg/mL | 10 Cartridge In 1 Carton (0409-1891-01) / 1 Ml In 1 Cartridge (0409-1891-03) | Hospira, Inc. | 0409-1891-01 | 0409-1891 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 4mg/mL | 10 Syringe In 1 Cello Pack (0409-1891-23) / 1 Ml In 1 Syringe (0409-1891-13) | Hospira, Inc. | 0409-1891-23 | 0409-1891 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 8mg/mL | 10 Cartridge In 1 Carton (0409-1892-01) / 1 Ml In 1 Cartridge (0409-1892-03) | Hospira, Inc. | 0409-1892-01 | 0409-1892 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 10mg/mL | 10 Cartridge In 1 Carton (0409-1893-01) / 1 Ml In 1 Cartridge (0409-1893-03) | Hospira, Inc. | 0409-1893-01 | 0409-1893 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 10mg/mL | 10 Syringe In 1 Cello Pack (0409-1893-23) / 1 Ml In 1 Syringe (0409-1893-13) | Hospira, Inc. | 0409-1893-23 | 0409-1893 | NDA202515 | NDA | CII |
| Morphine Sulfate | Injection, Solution | Intravenous | 50mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1896-20) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1896-20 | 0409-1896 | NDA202515 | NDA | CII |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1909-2) | Jubilant HollisterStier LLC | 65044-1909-2 | 65044-1909 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1909-3) | Jubilant HollisterStier LLC | 65044-1909-3 | 65044-1909 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1909-4) | Jubilant HollisterStier LLC | 65044-1909-4 | 65044-1909 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1910-1) | Jubilant HollisterStier LLC | 65044-1910-1 | 65044-1910 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1912-2) | Jubilant HollisterStier LLC | 65044-1912-2 | 65044-1912 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1912-3) | Jubilant HollisterStier LLC | 65044-1912-3 | 65044-1912 | BLA103888 | BLA | N/A |
| Morus Alba Pollen; Morus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1912-4) | Jubilant HollisterStier LLC | 65044-1912-4 | 65044-1912 | BLA103888 | BLA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (31722-290-10) | Camber Pharmaceuticals, Inc. | 31722-290-10 | 31722-290 | ANDA215259 | ANDA | N/A |
| Moxifloxacin Hydrochloride Monohydrate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (51407-321-03) / 3 Ml In 1 Bottle, Dropper | Golden State Medical Supply, Inc. | 51407-321-03 | 51407-321 | ANDA090080 | ANDA | N/A |
| Moxifloxacin Hydrochloride Monohydrate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0582-4) / 3 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0582-4 | 60505-0582 | ANDA090080 | ANDA | N/A |
| Mucor Racemosus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5144-2) | Jubilant HollisterStier LLC | 65044-5144-2 | 65044-5144 | BLA103888 | BLA | N/A |
| Mucor Racemosus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5144-3) | Jubilant HollisterStier LLC | 65044-5144-3 | 65044-5144 | BLA103888 | BLA | N/A |
| Mucor Racemosus | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5144-4) | Jubilant HollisterStier LLC | 65044-5144-4 | 65044-5144 | BLA103888 | BLA | N/A |
| Mucor Racemosus | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5145-1) | Jubilant HollisterStier LLC | 65044-5145-1 | 65044-5145 | BLA103888 | BLA | N/A |
| Mupirocin | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (45802-112-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-112-14 | 45802-112 | ANDA065123 | ANDA | N/A |
| Mupirocin | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (45802-112-22) / 22 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-112-22 | 45802-112 | ANDA065123 | ANDA | N/A |
| Mupirocin | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1312-0) / 22 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1312-0 | 51672-1312 | ANDA065170 | ANDA | N/A |
| Mupirocin | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1312-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1312-1 | 51672-1312 | ANDA065170 | ANDA | N/A |
| Mupirocin | Ointment | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1312-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1312-2 | 51672-1312 | ANDA065170 | ANDA | N/A |
| Mupirocin Calcium | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1370-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1370-1 | 51672-1370 | ANDA207116 | ANDA | N/A |
| Mupirocin Calcium | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1370-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1370-2 | 51672-1370 | ANDA207116 | ANDA | N/A |
| Mycophenolate Mofetil | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 4 Vial, Single-Dose In 1 Carton (71288-803-92) / 20 Ml In 1 Vial, Single-Dose (71288-803-91) | Meitheal Pharmaceuticals Inc. | 71288-803-92 | 71288-803 | ANDA212130 | ANDA | N/A |
| Mycophenolate Mofetil | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 4 Vial, Single-Dose In 1 Carton (71288-803-21) / 20 Ml In 1 Vial, Single-Dose (71288-803-20) | Meitheal Pharmaceuticals Inc. | 71288-803-21 | 71288-803 | ANDA212130 | ANDA | N/A |
| Mycophenolate Mofetil | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (60429-070-01) | Golden State Medical Supply, Inc. | 60429-070-01 | 60429-070 | ANDA065521 | ANDA | N/A |
| Mycophenolate Mofetil | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (60429-070-05) | Golden State Medical Supply, Inc. | 60429-070-05 | 60429-070 | ANDA065521 | ANDA | N/A |
| Mycophenolate Mofetil | Powder, For Suspension | Oral | 200mg/mL | 1 Bottle, Plastic In 1 Carton (66689-307-08) / 250 Ml In 1 Bottle, Plastic | VistaPharm, LLC | 66689-307-08 | 66689-307 | ANDA210370 | ANDA | N/A |
| Mycophenolate Mofetil | Suspension | Oral | 200mg/mL | 1 Bottle, Plastic In 1 Carton (24338-018-01) / 175 Ml In 1 Bottle, Plastic | Azurity Pharmaceuticals, Inc. | 24338-018-01 | 24338-018 | NDA216482 | NDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 30 Tablet In 1 Bottle (31722-290-30) | Camber Pharmaceuticals, Inc. | 31722-290-30 | 31722-290 | ANDA215259 | ANDA | N/A |
| Mycophenolate Mofetil | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (0054-0163-25) | Hikma Pharmaceuticals USA Inc. | 0054-0163-25 | 0054-0163 | ANDA065410 | ANDA | N/A |
| Mycophenolate Mofetil | Capsule | Oral | 250mg/1 | 500 Capsule In 1 Bottle (0054-0163-29) | Hikma Pharmaceuticals USA Inc. | 0054-0163-29 | 0054-0163 | ANDA065410 | ANDA | N/A |
| Mycophenolate Mofetil | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (0054-0166-25) | Hikma Pharmaceuticals USA Inc. | 0054-0166-25 | 0054-0166 | ANDA065413 | ANDA | N/A |
| Mycophenolate Mofetil | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (0054-0166-29) | Hikma Pharmaceuticals USA Inc. | 0054-0166-29 | 0054-0166 | ANDA065413 | ANDA | N/A |
| Mycophenolate Sodium | Tablet, Delayed Release | Oral | 180mg/1 | 120 Tablet, Delayed Release In 1 Bottle (60429-016-12) | Golden State Medical Supply, Inc. | 60429-016-12 | 60429-016 | ANDA091558 | ANDA | N/A |
| Mycophenolate Sodium | Tablet, Delayed Release | Oral | 360mg/1 | 120 Tablet, Delayed Release In 1 Bottle (60429-017-12) | Golden State Medical Supply, Inc. | 60429-017-12 | 60429-017 | ANDA091558 | ANDA | N/A |
| Mycophenolate Sodium | Tablet, Delayed Release | Oral | 180mg/1 | 120 Tablet, Delayed Release In 1 Bottle (60505-2965-7) | Apotex Corp | 60505-2965-7 | 60505-2965 | ANDA091558 | ANDA | N/A |
| Mycophenolate Sodium | Tablet, Delayed Release | Oral | 360mg/1 | 120 Tablet, Delayed Release In 1 Bottle (60505-2966-7) | Apotex Corp | 60505-2966-7 | 60505-2966 | ANDA091558 | ANDA | N/A |
| N/A | Kit | Intravenous | N/A | 1 Kit In 1 Carton (71288-126-90) * 30 Ml In 1 Vial, Single-Dose (71288-124-30) * 3 Ml In 1 Vial (71288-125-03) | Meitheal Pharmaceuticals Inc. | 71288-126-90 | 71288-126 | ANDA213460 | ANDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (71288-558-90) * 2 Ml In 1 Vial, Single-Dose (71288-556-02) * 1 Ml In 1 Syringe, Glass (71288-557-81) | Meitheal Pharmaceuticals Inc. | 71288-558-90 | 71288-558 | ANDA214540 | ANDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (71288-569-90) * 1 Vial, Multi-Dose In 1 Carton (71288-565-03) / 2.8 Ml In 1 Vial, Multi-Dose * .5 Ml In 1 Packet (71288-350-91) | Meitheal Pharmaceuticals Inc | 71288-569-90 | 71288-569 | ANDA075471 | ANDA | N/A |
| N/A | Kit | Intravenous | N/A | 1 Kit In 1 Carton (71288-132-90) * 15 Ml In 1 Vial, Single-Dose (71288-130-15) * 10 Ml In 1 Vial, Single-Use (71288-131-10) | Meitheal Pharmaceuticals Inc. | 71288-132-90 | 71288-132 | ANDA212960 | ANDA | N/A |
| N/A | Kit | Intravenous | N/A | 1 Kit In 1 Carton (71288-112-90) * 10 Ml In 1 Vial, Single-Dose (71288-111-10) * 10 Ml In 1 Vial, Single-Use (71288-110-10) | Meitheal Pharmaceuticals Inc. | 71288-112-90 | 71288-112 | ANDA209826 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (68475-503-01) * 3 Ml In 1 Vial (68475-502-01) * 30 Ml In 1 Vial, Single-Dose (68475-500-01) | Navinta LLC | 68475-503-01 | 68475-503 | ANDA210179 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Blister Pack In 1 Carton (75834-115-29) / 1 Kit In 1 Blister Pack | Nivagen Pharmaceuticals, Inc. | 75834-115-29 | 75834-115 | ANDA202015 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Packet (75834-115-84) / 1 Kit In 1 Blister Pack | Nivagen Pharmaceuticals, Inc. | 75834-115-84 | 75834-115 | ANDA202015 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Blister Pack In 1 Carton (75834-116-29) / 1 Kit In 1 Blister Pack | Nivagen Pharmaceuticals, Inc. | 75834-116-29 | 75834-116 | ANDA202016 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Packet (75834-116-84) / 1 Kit In 1 Blister Pack | Nivagen Pharmaceuticals, Inc. | 75834-116-84 | 75834-116 | ANDA202016 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (45802-507-02) * .6 G In 1 Vial * 39.4 G In 1 Jar | Padagis Israel Pharmaceuticals Ltd | 45802-507-02 | 45802-507 | ANDA202440 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (45802-507-04) * .6 G In 1 Vial * 39.4 G In 1 Bottle, Pump | Padagis Israel Pharmaceuticals Ltd | 45802-507-04 | 45802-507 | ANDA202440 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (45802-509-01) * .3 G In 1 Vial (45802-737-01) * 19.7 G In 1 Jar (45802-997-01) | Padagis Israel Pharmaceuticals Ltd | 45802-509-01 | 45802-509 | ANDA202440 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (45802-510-03) * .4 G In 1 Vial (45802-738-03) * 27.6 G In 1 Bottle, Pump (45802-998-03) | Padagis Israel Pharmaceuticals Ltd | 45802-510-03 | 45802-510 | ANDA202440 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (45802-923-41) * 60 Ml In 1 Bottle (45802-098-46) * 1 Swab In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-923-41 | 45802-923 | ANDA076751 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 4 Carton In 1 Kit (45802-929-49) / 1 Kit In 1 Carton * 60 Ml In 1 Bottle (45802-098-46) * 1 Swab In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-929-49 | 45802-929 | ANDA076751 | ANDA | N/A |
| N/A | Kit | Intravenous | N/A | 1 Kit In 1 Carton (25021-258-61) * 10 Ml In 1 Vial (25021-256-10) * 10 Ml In 1 Vial (25021-257-10) | Sagent Pharmaceuticals | 25021-258-61 | 25021-258 | ANDA209826 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 2 Tray In 1 Kit (51407-834-02) / 1 Kit In 1 Tray * 2 Tray In 1 Kit (51407-844-02) / 1 Syringe In 1 Tray / .8 Ml In 1 Syringe * 2 Packet In 1 Kit (51407-845-02) / 1 Ml In 1 Packet | Golden State Medical Supply, Inc. | 51407-834-02 | 51407-834 | BLA761154 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Tray In 1 Kit (51407-835-02) / 1 Kit In 1 Tray * 2 Tray In 1 Kit (51407-846-02) / 1 Syringe In 1 Tray / .8 Ml In 1 Syringe * 2 Packet In 1 Kit (51407-847-02) / 1 Ml In 1 Packet | Golden State Medical Supply, Inc. | 51407-835-02 | 51407-835 | BLA761154 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (0548-5850-00) * 1 Ml In 1 Vial (0548-5905-00) * 1 Ml In 1 Syringe (0548-5831-00) | Amphastar Pharmaceuticals, Inc. | 0548-5850-00 | 0548-5850 | ANDA208086 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (51672-1381-4) * 10 G In 1 Bottle, Plastic (51672-1382-2) * 40 G In 1 Jar | Taro Pharmaceuticals U.S.A., Inc. | 51672-1381-4 | 51672-1381 | ANDA208776 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (51672-1381-6) * 10 G In 1 Bottle, Plastic (51672-1382-2) * 40 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1381-6 | 51672-1381 | ANDA208776 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (51672-1381-5) * 7 G In 1 Bottle, Plastic (51672-1382-3) * 28 G In 1 Bottle, Pump | Taro Pharmaceuticals U.S.A., Inc. | 51672-1381-5 | 51672-1381 | ANDA208776 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (51672-1381-2) * 5 G In 1 Bottle, Plastic (51672-1382-1) * 20 G In 1 Jar | Taro Pharmaceuticals U.S.A., Inc. | 51672-1381-2 | 51672-1381 | ANDA208776 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Dose Pack (51672-4213-7) / 1 Kit In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4213-7 | 51672-4213 | ANDA207098 | ANDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (62935-223-05) * .375 Ml In 1 Syringe (62935-221-04) * .375 Ml In 1 Syringe (62935-224-05) | TOLMAR Inc. | 62935-223-05 | 62935-223 | NDA021379 | NDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (62935-303-30) * .5 Ml In 1 Syringe (62935-305-29) * .5 Ml In 1 Syringe (62935-304-30) | TOLMAR Inc. | 62935-303-30 | 62935-303 | NDA021488 | NDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (62935-453-45) * .375 Ml In 1 Syringe (62935-454-44) * .375 Ml In 1 Syringe (62935-455-45) | TOLMAR Inc. | 62935-453-45 | 62935-453 | NDA021731 | NDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (62935-753-75) * .25 Ml In 1 Syringe (62935-754-74) * .25 Ml In 1 Syringe (62935-755-75) | TOLMAR Inc. | 62935-753-75 | 62935-753 | NDA021343 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (62935-153-50) * .375 Ml In 1 Syringe (62935-154-50) * .375 Ml In 1 Syringe (62935-155-40) | TOLMAR Inc. | 62935-153-50 | 62935-153 | NDA213150 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-361-28) * 126 Tablet, Extended Release In 1 Blister Pack * 42 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-361-28 | 66302-361 | NDA203496 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-362-56) * 126 Tablet, Extended Release In 1 Blister Pack * 210 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-362-56 | 66302-362 | NDA203496 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-363-84) * 42 Tablet, Extended Release In 1 Blister Pack * 84 Tablet, Extended Release In 1 Blister Pack * 126 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-363-84 | 66302-363 | NDA203496 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-610-02) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-610-02 | 66302-610 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-620-03) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-620-03 | 66302-620 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-630-03) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-630-03 | 66302-630 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-640-03) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-640-03 | 66302-640 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-650-03) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-650-03 | 66302-650 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (66302-720-04) * 4 Inhalant In 1 Blister Pack * 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-720-04 | 66302-720 | NDA214324 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (52536-104-05) * 3.75 G In 1 Bottle (52536-094-05) * 147 Ml In 1 Bottle (52536-084-05) | Wilshire Pharmaceuticals, Inc. | 52536-104-05 | 52536-104 | NDA208910 | NDA AUTHORIZED GENERIC | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (52536-106-05) * 7.5 G In 1 Bottle (52536-096-05) * 145 Ml In 1 Bottle (52536-086-05) | Wilshire Pharmaceuticals, Inc. | 52536-106-05 | 52536-106 | NDA208910 | NDA AUTHORIZED GENERIC | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (52536-107-10) * 7.5 G In 1 Bottle (52536-095-10) * 295 Ml In 1 Bottle (52536-085-10) | Wilshire Pharmaceuticals, Inc. | 52536-107-10 | 52536-107 | NDA208910 | NDA AUTHORIZED GENERIC | N/A |
| N/A | Kit | Intravenous | N/A | 1 Kit In 1 Carton (10702-361-99) * 30 Ml In 1 Vial, Single-Dose (10702-366-03) * 3 Ml In 1 Vial (10702-365-03) | KVK-Tech, Inc. | 10702-361-99 | 10702-361 | ANDA209278 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (15751-3000-3) * 1 Tube In 1 Box (15751-3020-2) / 60 Ml In 1 Tube * 1 Bottle In 1 Box (15751-3030-2) / 35 Ml In 1 Bottle * 1 Bottle In 1 Box (15751-3010-5) / 150 Ml In 1 Bottle | Eminence Organic Skin Care Ltd. | 15751-3000-3 | 15751-3000 | M006 | OTC MONOGRAPH DRUG | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (59062-5000-1) * 207 Ml In 1 Bottle * 25 Cloth In 1 Package * 50 Ml In 1 Bottle, Pump (59062-4000-5) * 89 Ml In 1 Bottle, Dispensing * 266 Ml In 1 Bottle * 266 Ml In 1 Bottle | KAS Direct LLC dba BabyGanics | 59062-5000-1 | 59062-5000 | part333E | OTC MONOGRAPH FINAL | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (15751-3504-0) * 1 Tube In 1 Box (15751-3505-1) / 15 Ml In 1 Tube | Eminence Organic Skin Care | 15751-3504-0 | 15751-3504 | M020 | OTC MONOGRAPH DRUG | N/A |
| N/A | Kit | Vaginal | N/A | 1 Kit In 1 Carton (71042-007-28) * 14 G In 1 Tube (71042-008-14) * 14 G In 1 Tube (71042-009-14) | Organicare Nature's Science, LLC | 71042-007-28 | 71042-007 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| N/A | Kit | Topical; Vaginal | N/A | 1 Kit In 1 Carton (71042-011-28) * 14 G In 1 Tube (71042-012-14) * 14 G In 1 Tube (71042-013-14) | Organicare Nature's Science, LLC | 71042-011-28 | 71042-011 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (59062-5200-1) * 59 Ml In 1 Tube (59062-1100-2) * 142 G In 1 Can | KAS Direct LLC dba BabyGanics | 59062-5200-1 | 59062-5200 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (59062-5100-1) * 177 Ml In 1 Tube (59062-1000-6) * 13 G In 1 Applicator (59062-1200-1) | KAS Direct LLC dba BabyGanics | 59062-5100-1 | 59062-5100 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (60505-6270-1) * 1 Ml In 1 Vial, Glass (60505-6281-0) * 1 Ml In 1 Syringe, Glass (60505-6276-0) | Apotex Corp. | 60505-6270-1 | 60505-6270 | ANDA217776 | ANDA | N/A |
| N/A | Kit | Oral | N/A | 1 Kit In 1 Carton (60505-3615-4) * 11 Tablet, Film Coated In 1 Blister Pack (60505-3606-1) * 42 Tablet, Film Coated In 1 Blister Pack (60505-3607-1) | Apotex Corp | 60505-3615-4 | 60505-3615 | ANDA201962 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (42829-406-30) * 30 Packet In 1 Kit (42829-401-02) / 3000 Mg In 1 Packet | ASCENT CONSUMER PRODUCTS, INC. | 42829-406-30 | 42829-406 | N/A | UNAPPROVED DRUG OTHER | N/A |
| N/A | Kit | Nasal | N/A | 1 Kit In 1 Kit (42829-402-30) * 3000 Mg In 1 Packet (42829-401-01) | ASCENT CONSUMER PRODUCTS, INC. | 42829-402-30 | 42829-402 | N/A | UNAPPROVED DRUG OTHER | N/A |
| N/A | Kit | Nasal | N/A | 1 Kit In 1 Kit (42829-405-30) * 3000 Mg In 1 Packet (42829-401-01) | ASCENT CONSUMER PRODUCTS, INC. | 42829-405-30 | 42829-405 | N/A | UNAPPROVED DRUG OTHER | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-015-05) * 147 Ml In 1 Bottle * 7.5 G In 1 Bottle * 295 Ml In 1 Bottle * 3.75 G In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-015-05 | 65628-015 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-015-10) * 147 Ml In 1 Bottle * 7.5 G In 1 Bottle * 295 Ml In 1 Bottle * 3.75 G In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-015-10 | 65628-015 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-016-05) * 145 Ml In 1 Bottle * 15 G In 1 Bottle * 289 Ml In 1 Bottle * 7.5 G In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-016-05 | 65628-016 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-016-10) * 145 Ml In 1 Bottle * 15 G In 1 Bottle * 289 Ml In 1 Bottle * 7.5 G In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-016-10 | 65628-016 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-204-05) * 3.75 G In 1 Bottle * 147 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-204-05 | 65628-204 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-205-10) * 7.5 G In 1 Bottle * 295 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-205-10 | 65628-205 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-206-05) * 7.5 G In 1 Bottle * 145 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-206-05 | 65628-206 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-208-10) * 15 G In 1 Bottle * 289 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc | 65628-208-10 | 65628-208 | NDA208910 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-272-03) * 150 Ml In 1 Bottle (65628-270-05) * 300 Ml In 1 Bottle (65628-270-10) * 150 Ml In 1 Bottle (65628-271-05) * 300 Ml In 1 Bottle (65628-271-10) * 90 Ml In 1 Bottle (65628-271-03) * 90 Ml In 1 Bottle (65628-270-03) | Azurity Pharmaceuticals, Inc. | 65628-272-03 | 65628-272 | NDA213593 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-272-05) * 150 Ml In 1 Bottle (65628-270-05) * 300 Ml In 1 Bottle (65628-270-10) * 150 Ml In 1 Bottle (65628-271-05) * 300 Ml In 1 Bottle (65628-271-10) * 90 Ml In 1 Bottle (65628-271-03) * 90 Ml In 1 Bottle (65628-270-03) | Azurity Pharmaceuticals, Inc. | 65628-272-05 | 65628-272 | NDA213593 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (65628-272-10) * 150 Ml In 1 Bottle (65628-270-05) * 300 Ml In 1 Bottle (65628-270-10) * 150 Ml In 1 Bottle (65628-271-05) * 300 Ml In 1 Bottle (65628-271-10) * 90 Ml In 1 Bottle (65628-271-03) * 90 Ml In 1 Bottle (65628-270-03) | Azurity Pharmaceuticals, Inc. | 65628-272-10 | 65628-272 | NDA213593 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (24338-150-20) * 2 Ml In 1 Vial * 2 Ml In 1 Syringe, Glass | Azurity Pharmaceuticals, Inc. | 24338-150-20 | 24338-150 | NDA208956 | NDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (31722-290-90) | Camber Pharmaceuticals, Inc. | 31722-290-90 | 31722-290 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 100 Tablet In 1 Bottle (31722-291-01) | Camber Pharmaceuticals, Inc. | 31722-291-01 | 31722-291 | ANDA215259 | ANDA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9960-1) * 1.2 Ml In 1 Vial (65044-9980-2) | Jubilant HollisterStier LLC | 65044-9960-1 | 65044-9960 | BLA103882 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9986-1) * 1.2 Ml In 1 Vial (65044-9980-2) | Jubilant HollisterStier LLC | 65044-9986-1 | 65044-9986 | BLA103882 | BLA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Tray (65044-9970-1) * 1.2 Ml In 1 Vial (65044-9980-2) | Jubilant HollisterStier LLC | 65044-9970-1 | 65044-9970 | BLA103882 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Package (65174-179-01) * 3 Ml In 1 Vial (65174-046-01) * 3 Ml In 1 Vial (65174-047-01) * 10 Ml In 1 Vial (65174-131-01) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-179-01 | 65174-179 | ANDA213516 | ANDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Tray (65044-9975-1) * 1.2 Ml In 1 Vial (65044-9985-2) | Jubilant HollisterStier LLC | 65044-9975-1 | 65044-9975 | BLA103883 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9963-1) * 1.2 Ml In 1 Vial (65044-9983-2) | Jubilant HollisterStier LLC | 65044-9963-1 | 65044-9963 | BLA103884 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9989-1) * 1.2 Ml In 1 Vial (65044-9983-2) | Jubilant HollisterStier LLC | 65044-9989-1 | 65044-9989 | BLA103884 | BLA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Tray (65044-9973-1) * 1.2 Ml In 1 Vial (65044-9983-2) | Jubilant HollisterStier LLC | 65044-9973-1 | 65044-9973 | BLA103884 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9961-1) * 1.2 Ml In 1 Vial (65044-9981-2) | Jubilant HollisterStier LLC | 65044-9961-1 | 65044-9961 | BLA103885 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9987-1) * 1.2 Ml In 1 Vial (65044-9981-2) | Jubilant HollisterStier LLC | 65044-9987-1 | 65044-9987 | BLA103885 | BLA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Tray (65044-9971-1) * 1.2 Ml In 1 Vial (65044-9981-2) | Jubilant HollisterStier LLC | 65044-9971-1 | 65044-9971 | BLA103885 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9962-1) * 1.2 Ml In 1 Vial (65044-9982-2) | Jubilant HollisterStier LLC | 65044-9962-1 | 65044-9962 | BLA103886 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9988-1) * 1.2 Ml In 1 Vial (65044-9982-2) | Jubilant HollisterStier LLC | 65044-9988-1 | 65044-9988 | BLA103886 | BLA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Tray (65044-9972-1) * 1.2 Ml In 1 Vial (65044-9982-2) | Jubilant HollisterStier LLC | 65044-9972-1 | 65044-9972 | BLA103886 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9964-1) * 1.2 Ml In 1 Vial (65044-9984-2) | Jubilant HollisterStier LLC | 65044-9964-1 | 65044-9964 | BLA103887 | BLA | N/A |
| N/A | Kit | Intradermal; Percutaneous | N/A | 1 Kit In 1 Tray (65044-9994-1) * 1.2 Ml In 1 Vial (65044-9984-2) | Jubilant HollisterStier LLC | 65044-9994-1 | 65044-9994 | BLA103887 | BLA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 1000 Tablet In 1 Bottle (31722-291-10) | Camber Pharmaceuticals, Inc. | 31722-291-10 | 31722-291 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 30 Tablet In 1 Bottle (31722-291-30) | Camber Pharmaceuticals, Inc. | 31722-291-30 | 31722-291 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 90 Tablet In 1 Bottle (31722-291-90) | Camber Pharmaceuticals, Inc. | 31722-291-90 | 31722-291 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 100 Tablet In 1 Bottle (31722-292-01) | Camber Pharmaceuticals, Inc. | 31722-292-01 | 31722-292 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 1000 Tablet In 1 Bottle (31722-292-10) | Camber Pharmaceuticals, Inc. | 31722-292-10 | 31722-292 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 30 Tablet In 1 Bottle (31722-292-30) | Camber Pharmaceuticals, Inc. | 31722-292-30 | 31722-292 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 90 Tablet In 1 Bottle (31722-292-90) | Camber Pharmaceuticals, Inc. | 31722-292-90 | 31722-292 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 100 Tablet In 1 Bottle (31722-293-01) | Camber Pharmaceuticals, Inc. | 31722-293-01 | 31722-293 | ANDA215259 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (42192-714-01) * 6.6 Ml In 1 Bottle, With Applicator * 28 Ml In 1 Bottle | Acella Pharmaceuticals, LLC | 42192-714-01 | 42192-714 | N/A | UNAPPROVED DRUG OTHER | N/A |
| N/A | Kit | N/A | N/A | 3 Blister Pack In 1 Carton (42192-623-03) / 1 Kit In 1 Blister Pack | Acella Pharmaceuticals | 42192-623-03 | 42192-623 | NDA208612 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Carton (42192-623-28) / 1 Kit In 1 Blister Pack | Acella Pharmaceuticals | 42192-623-28 | 42192-623 | NDA208612 | NDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-220-23) / 1 Blister Pack In 1 Pouch (50102-220-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-220-23 | 50102-220 | ANDA206886 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-230-23) / 1 Blister Pack In 1 Pouch (50102-230-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-230-23 | 50102-230 | ANDA206866 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-254-23) / 1 Blister Pack In 1 Pouch (50102-254-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-254-23 | 50102-254 | ANDA207081 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-240-23) / 1 Blister Pack In 1 Pouch (50102-240-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-240-23 | 50102-240 | ANDA209632 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-224-23) / 1 Blister Pack In 1 Pouch (50102-224-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-224-23 | 50102-224 | ANDA207504 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Pouch In 1 Carton (50102-228-23) / 1 Blister Pack In 1 Pouch (50102-228-21) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-228-23 | 50102-228 | ANDA207505 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Carton (50102-233-11) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-233-11 | 50102-233 | ANDA205441 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Blister Pack In 1 Carton (50102-233-13) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-233-13 | 50102-233 | ANDA205441 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 3 Package In 1 Carton (50102-231-13) / 1 Blister Pack In 1 Package (50102-231-11) / 1 Kit In 1 Blister Pack (50102-231-01) | Afaxys Pharma, LLC | 50102-231-13 | 50102-231 | ANDA205762 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Carton (50102-235-11) / 1 Kit In 1 Blister Pack | Afaxys Pharma, LLC | 50102-235-11 | 50102-235 | ANDA205449 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (0548-5850-00) * 1 Ml In 1 Vial (0548-5905-00) * 1 Ml In 1 Syringe (0548-5831-00) | Amphastar Pharmaceuticals, Inc. | 0548-5850-00 | 0548-5850 | ANDA208086 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 1000 Tablet In 1 Bottle (31722-293-10) | Camber Pharmaceuticals, Inc. | 31722-293-10 | 31722-293 | ANDA215259 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (0069-0325-01) / 1 Kit In 1 Kit * .8 Ml In 1 Syringe (0069-0318-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0325-01 | 0069-0325 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0069-0325-02) / 1 Kit In 1 Kit * .8 Ml In 1 Syringe (0069-0318-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0325-02 | 0069-0325 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0069-0328-02) / 1 Kit In 1 Kit * 1 Syringe In 1 Tray / .8 Ml In 1 Syringe (0069-0317-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0328-02 | 0069-0328 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0069-0333-02) / 1 Kit In 1 Kit * 1 Syringe In 1 Tray / .4 Ml In 1 Syringe (0069-0329-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0333-02 | 0069-0333 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (0025-0325-01) / 1 Kit In 1 Kit * .8 Ml In 1 Syringe (0025-0318-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0025-0325-01 | 0025-0325 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0025-0325-02) / 1 Kit In 1 Kit * .8 Ml In 1 Syringe (0025-0318-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0025-0325-02 | 0025-0325 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0025-0328-02) / 1 Kit In 1 Kit * 1 Syringe In 1 Tray / .8 Ml In 1 Syringe (0025-0317-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0025-0328-02 | 0025-0328 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 2 Kit In 1 Carton (0025-0333-02) / 1 Kit In 1 Kit * 1 Syringe In 1 Tray / .4 Ml In 1 Syringe (0025-0329-01) * 1 Ml In 1 Packet (0069-1111-01) | Pfizer Laboratories Div Pfizer Inc | 0025-0333-02 | 0025-0333 | BLA761118 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Tray In 1 Carton (0069-0344-01) / 1 Kit In 1 Tray (0069-0344-21) * .5 Ml In 1 Vial, Glass (0069-0207-01) * .69 Ml In 1 Syringe, Glass (0069-0250-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0344-01 | 0069-0344 | BLA125769 | BLA | N/A |
| N/A | Kit | N/A | N/A | 5 Tray In 1 Carton (0069-0344-05) / 1 Kit In 1 Tray (0069-0344-21) * .5 Ml In 1 Vial, Glass (0069-0207-01) * .69 Ml In 1 Syringe, Glass (0069-0250-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0344-05 | 0069-0344 | BLA125769 | BLA | N/A |
| N/A | Kit | N/A | N/A | 10 Tray In 1 Carton (0069-0344-10) / 1 Kit In 1 Tray (0069-0344-21) * .5 Ml In 1 Vial, Glass (0069-0207-01) * .69 Ml In 1 Syringe, Glass (0069-0250-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0344-10 | 0069-0344 | BLA125769 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Carton In 1 Carton (0069-2004-04) / 1 Kit In 1 Carton (0069-2004-14) * 1 Ml In 1 Vial, Single-Dose (0069-0422-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2004-04 | 0069-2004 | BLA125786 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Carton In 1 Carton (0069-2005-05) / 1 Kit In 1 Carton (0069-2005-15) * 1 Ml In 1 Vial, Single-Dose (0069-0422-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2005-05 | 0069-2005 | BLA125786 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Carton In 1 Carton (0069-2006-06) / 1 Kit In 1 Carton (0069-2006-16) * 1 Ml In 1 Vial, Single-Dose (0069-0422-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2006-06 | 0069-2006 | BLA125786 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Carton In 1 Carton (0069-2007-07) / 1 Kit In 1 Carton (0069-2007-17) * 1 Ml In 1 Vial, Single-Dose (0069-0422-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2007-07 | 0069-2007 | BLA125786 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (0069-0471-03) * 11 Tablet, Film Coated In 1 Blister Pack * 42 Tablet, Film Coated In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-0471-03 | 0069-0471 | NDA021928 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Cartridge In 1 Carton (0013-2626-81) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2626-81 | 0013-2626 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Cartridge In 1 Carton (0013-2646-81) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2646-81 | 0013-2646 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2649-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2649-02 | 0013-2649 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2650-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2650-02 | 0013-2650 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2651-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2651-02 | 0013-2651 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2652-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2652-02 | 0013-2652 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2653-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2653-02 | 0013-2653 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2654-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2654-02 | 0013-2654 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2655-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2655-02 | 0013-2655 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2656-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2656-02 | 0013-2656 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2657-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2657-02 | 0013-2657 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 7 Cartridge In 1 Carton (0013-2658-02) / 1 Kit In 1 Cartridge | Pfizer Laboratories Div Pfizer Inc | 0013-2658-02 | 0013-2658 | BLA020280 | BLA | N/A |
| N/A | Kit | N/A | N/A | 10 Blister Pack In 1 Carton (0069-5317-20) / 1 Kit In 1 Blister Pack (0069-5317-02) * 1 Tablet, Film Coated In 1 Blister Pack (0069-2085-11) * 1 Tablet, Film Coated In 1 Blister Pack (0069-1735-11) | Pfizer Laboratories Div Pfizer Inc | 0069-5317-20 | 0069-5317 | NDA217188 | NDA | N/A |
| N/A | Kit | N/A | N/A | 10 Blister Pack In 1 Carton (0069-5321-30) / 1 Kit In 1 Blister Pack (0069-5321-03) * 2 Tablet, Film Coated In 1 Blister Pack (0069-2085-02) * 1 Tablet, Film Coated In 1 Blister Pack (0069-1735-11) | Pfizer Laboratories Div Pfizer Inc | 0069-5321-30 | 0069-5321 | NDA217188 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (0069-0600-01) / 1 Kit In 1 Kit (0069-0600-99) * .5 Ml In 1 Vial, Glass (0069-0271-01) * .5 Ml In 1 Syringe (0069-0332-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0600-01 | 0069-0600 | BLA125770 | BLA | N/A |
| N/A | Kit | N/A | N/A | 5 Kit In 1 Carton (0069-0600-05) / 1 Kit In 1 Kit (0069-0600-99) * .5 Ml In 1 Vial, Glass (0069-0271-01) * .5 Ml In 1 Syringe (0069-0332-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0600-05 | 0069-0600 | BLA125770 | BLA | N/A |
| N/A | Kit | N/A | N/A | 10 Kit In 1 Carton (0069-0600-10) / 1 Kit In 1 Kit (0069-0600-99) * .5 Ml In 1 Vial, Glass (0069-0271-01) * .5 Ml In 1 Syringe (0069-0332-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0600-10 | 0069-0600 | BLA125770 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Blister Pack In 1 Carton (0046-2575-12) / 1 Kit In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-2575-12 | 0046-2575 | NDA020527 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-205-05) * 5 Ml In 1 Vial, Glass (60793-315-01) * 5 Ml In 1 Vial, Glass (60793-218-09) | Pfizer Laboratories Div Pfizer Inc | 60793-205-05 | 60793-205 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-215-05) * 5 Ml In 1 Vial, Glass (60793-315-01) * 5 Ml In 1 Vial, Glass (60793-218-09) | Pfizer Laboratories Div Pfizer Inc | 60793-215-05 | 60793-215 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-217-20) * 20 Ml In 1 Vial, Glass (60793-221-09) * 20 Ml In 1 Vial, Glass (60793-317-01) | Pfizer Laboratories Div Pfizer Inc | 60793-217-20 | 60793-217 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-217-21) * 20 Ml In 1 Vial, Glass (60793-221-09) * 20 Ml In 1 Vial, Glass (60793-317-01) | Pfizer Laboratories Div Pfizer Inc | 60793-217-21 | 60793-217 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-217-22) * 20 Ml In 1 Vial, Glass (60793-221-09) * 20 Ml In 1 Vial, Glass (60793-317-01) | Pfizer Laboratories Div Pfizer Inc | 60793-217-22 | 60793-217 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (60793-705-05) * 5 Ml In 1 Vial, Glass (60793-315-01) * 5 Ml In 1 Vial, Glass (60793-218-09) | Pfizer Laboratories Div Pfizer Inc | 60793-705-05 | 60793-705 | BLA102865 | BLA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (0008-1179-01) * 25 Ml In 1 Vial, Single-Use (0008-1279-01) * 1.8 Ml In 1 Vial, Single-Use (0008-1125-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1179-01 | 0008-1179 | NDA022088 | NDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Kit (0069-0305-01) * 20 Ml In 1 Vial, Multi-Dose (0069-0306-01) * 20 Ml In 1 Vial (0069-0307-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0305-01 | 0069-0305 | BLA761081 | BLA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 1000mg/1 | 100 Tablet, Film Coated In 1 Bottle (79739-7078-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7078-1 | 79739-7078 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 1000mg/1 | 30 Tablet, Film Coated In 1 Bottle (79739-7078-3) | LGM PHARMA SOLUTIONS, LLC | 79739-7078-3 | 79739-7078 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 1000mg/1 | 60 Tablet, Film Coated In 1 Bottle (79739-7078-6) | LGM PHARMA SOLUTIONS, LLC | 79739-7078-6 | 79739-7078 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (79739-7076-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7076-1 | 79739-7076 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (79739-7076-5) | LGM PHARMA SOLUTIONS, LLC | 79739-7076-5 | 79739-7076 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 750mg/1 | 100 Tablet, Film Coated In 1 Bottle (79739-7077-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7077-1 | 79739-7077 | ANDA203166 | ANDA | N/A |
| Nabumetone | Tablet, Film Coated | Oral | 750mg/1 | 500 Tablet, Film Coated In 1 Bottle (79739-7077-5) | LGM PHARMA SOLUTIONS, LLC | 79739-7077-5 | 79739-7077 | ANDA203166 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 30 Tablet In 1 Bottle (31722-293-30) | Camber Pharmaceuticals, Inc. | 31722-293-30 | 31722-293 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 90 Tablet In 1 Bottle (31722-293-90) | Camber Pharmaceuticals, Inc. | 31722-293-90 | 31722-293 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 1000 Tablet In 1 Bottle (72865-244-10) | XLCare Pharmaceuticals, Inc. | 72865-244-10 | 72865-244 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .15mg/1 | 90 Tablet In 1 Bottle (72865-244-90) | XLCare Pharmaceuticals, Inc. | 72865-244-90 | 72865-244 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 1000 Tablet In 1 Bottle (72865-245-10) | XLCare Pharmaceuticals, Inc. | 72865-245-10 | 72865-245 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .175mg/1 | 90 Tablet In 1 Bottle (72865-245-90) | XLCare Pharmaceuticals, Inc. | 72865-245-90 | 72865-245 | ANDA215259 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 15 Tablet In 1 Bottle, Plastic (60760-368-15) | St. Mary's Medical Park Pharmacy | 60760-368-15 | 60760-368 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-368-60) | St. Mary's Medical Park Pharmacy | 60760-368-60 | 60760-368 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 14 Tablet In 1 Bottle, Plastic (60760-369-14) | St. Mary's Medical Park Pharmacy | 60760-369-14 | 60760-369 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-369-60) | St. Mary's Medical Park Pharmacy | 60760-369-60 | 60760-369 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-369-90) | St. Mary's Medical Park Pharmacy | 60760-369-90 | 60760-369 | ANDA078420 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .2mg/1 | 1000 Tablet In 1 Bottle (72865-246-10) | XLCare Pharmaceuticals, Inc. | 72865-246-10 | 72865-246 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .2mg/1 | 90 Tablet In 1 Bottle (72865-246-90) | XLCare Pharmaceuticals, Inc. | 72865-246-90 | 72865-246 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .3mg/1 | 1000 Tablet In 1 Bottle (72865-247-10) | XLCare Pharmaceuticals, Inc. | 72865-247-10 | 72865-247 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .3mg/1 | 90 Tablet In 1 Bottle (72865-247-90) | XLCare Pharmaceuticals, Inc. | 72865-247-90 | 72865-247 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 1000 Tablet In 1 Bottle (72865-236-10) | XLCare Pharmaceuticals, Inc. | 72865-236-10 | 72865-236 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .025mg/1 | 90 Tablet In 1 Bottle (72865-236-90) | XLCare Pharmaceuticals, Inc. | 72865-236-90 | 72865-236 | ANDA215259 | ANDA | N/A |
| Nafarelin Acetate | Spray, Metered | Nasal | 2mg/mL | 1 Bottle, Spray In 1 Carton (0025-0166-08) / 8 Ml In 1 Bottle, Spray | Pfizer Laboratories Div Pfizer Inc | 0025-0166-08 | 0025-0166 | NDA019886 | NDA | N/A |
| Nafcillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/4mL | 10 Vial In 1 Carton (25021-139-10) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-139-10 | 25021-139 | ANDA090582 | ANDA | N/A |
| Nafcillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/8mL | 10 Vial In 1 Carton (25021-140-10) / 8 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-140-10 | 25021-140 | ANDA090582 | ANDA | N/A |
| Nafcillin Sodium | Injection, Powder, For Solution | Intravenous | 10g/100mL | 10 Bottle In 1 Carton (25021-141-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-141-99 | 25021-141 | ANDA090580 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1362-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1362-1 | 51672-1362 | ANDA205975 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1362-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1362-2 | 51672-1362 | ANDA205975 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1362-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1362-3 | 51672-1362 | ANDA205975 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1362-8) / 90 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1362-8 | 51672-1362 | ANDA205975 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1368-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1368-2 | 51672-1368 | ANDA206901 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1368-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1368-3 | 51672-1368 | ANDA206901 | ANDA | N/A |
| Naftifine Hydrochloride | Cream | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1368-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1368-6 | 51672-1368 | ANDA206901 | ANDA | N/A |
| Naftifine Hydrochloride | Gel | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1376-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1376-3 | 51672-1376 | ANDA208201 | ANDA | N/A |
| Naftifine Hydrochloride | Gel | Topical | 20mg/g | 1 Tube In 1 Carton (51672-1376-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1376-6 | 51672-1376 | ANDA208201 | ANDA | N/A |
| Nalbuphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 10 Ampule In 1 Tray (0409-1463-01) / 1 Ml In 1 Ampule (0409-1463-71) | Hospira, Inc. | 0409-1463-01 | 0409-1463 | ANDA070914 | ANDA | N/A |
| Nalbuphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 10 Ampule In 1 Tray (0409-1463-49) / 1 Ml In 1 Ampule (0409-1463-69) | Hospira, Inc. | 0409-1463-49 | 0409-1463 | ANDA070914 | ANDA | N/A |
| Nalbuphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 25 Carton In 1 Case (0409-1464-01) / 1 Vial, Multi-Dose In 1 Carton (0409-1464-61) / 10 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1464-01 | 0409-1464 | ANDA070915 | ANDA | N/A |
| Nalbuphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 20mg/mL | 10 Ampule In 1 Tray (0409-1465-01) / 1 Ml In 1 Ampule (0409-1465-71) | Hospira, Inc. | 0409-1465-01 | 0409-1465 | ANDA070916 | ANDA | N/A |
| Nalbuphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 20mg/mL | 25 Carton In 1 Case (0409-1467-01) / 1 Vial, Multi-Dose In 1 Carton (0409-1467-61) / 10 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1467-01 | 0409-1467 | ANDA070918 | ANDA | N/A |
| Naloxone Hydrochloride | Spray | Nasal | 4mg/.1mL | 2 Vial, Single-Dose In 1 Carton (45802-578-84) / .1 Ml In 1 Vial, Single-Dose (45802-578-00) | Padagis Israel Pharmaceuticals Ltd | 45802-578-84 | 45802-578 | ANDA211951 | ANDA | N/A |
| Naloxone Hydrochloride | Spray | Nasal | 4mg/.1mL | 2 Vial, Single-Dose In 1 Carton (45802-811-84) / .1 Ml In 1 Vial, Single-Dose (45802-811-00) | Padagis Israel Pharmaceuticals Ltd | 45802-811-84 | 45802-811 | ANDA211951 | ANDA | N/A |
| Naloxone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Vial In 1 Carton (70069-071-10) / 1 Ml In 1 Vial (70069-071-01) | Somerset Therapeutics, LLC | 70069-071-10 | 70069-071 | ANDA207633 | ANDA | N/A |
| Naloxone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Carton In 1 Box (70069-072-10) / 1 Vial, Glass In 1 Carton (70069-072-01) / 10 Ml In 1 Vial, Glass | Somerset Therapeutics, LLC | 70069-072-10 | 70069-072 | ANDA207634 | ANDA | N/A |
| Naloxone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 25 Vial In 1 Carton (0641-6132-25) / 1 Ml In 1 Vial (0641-6132-01) | Hikma Pharmaceuticals USA Inc. | 0641-6132-25 | 0641-6132 | ANDA070299 | ANDA | N/A |
| Naloxone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 25 Vial In 1 Carton (0641-6260-25) / 1 Ml In 1 Vial (0641-6260-01) | Hikma Pharmaceuticals USA Inc. | 0641-6260-25 | 0641-6260 | ANDA070299 | ANDA | N/A |
| Naloxone Hydrochloride | Injection | Intramuscular; Intravenous; Subcutaneous | 1mg/mL | 10 Syringe In 1 Carton (0641-6205-10) / 2 Ml In 1 Syringe (0641-6205-01) | Hikma Pharmaceuticals USA Inc. | 0641-6205-10 | 0641-6205 | ANDA212300 | ANDA | N/A |
| Naloxone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-1215-01) / 1 Ml In 1 Vial, Single-Dose (0409-1215-21) | Hospira, Inc. | 0409-1215-01 | 0409-1215 | ANDA070256 | ANDA | N/A |
| Naloxone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 25 Carton In 1 Case (0409-1219-01) / 1 Vial, Multi-Dose In 1 Carton / 10 Ml In 1 Vial, Multi-Dose (0409-1219-41) | Hospira, Inc. | 0409-1219-01 | 0409-1219 | ANDA070257 | ANDA | N/A |
| Naloxone Hydrochloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | .4mg/mL | 10 Cartridge In 1 Box (0409-1782-69) / 1 Ml In 1 Cartridge (0409-1782-03) | Hospira, Inc. | 0409-1782-69 | 0409-1782 | ANDA070172 | ANDA | N/A |
| Naproxen | Suspension | Oral | 125mg/5mL | 500 Ml In 1 Bottle (70954-151-10) | Novitium Pharma LLC | 70954-151-10 | 70954-151 | ANDA211910 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 1000 Tablet In 1 Bottle (72865-237-10) | XLCare Pharmaceuticals, Inc. | 72865-237-10 | 72865-237 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .05mg/1 | 90 Tablet In 1 Bottle (72865-237-90) | XLCare Pharmaceuticals, Inc. | 72865-237-90 | 72865-237 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 1000 Tablet In 1 Bottle (72865-238-10) | XLCare Pharmaceuticals, Inc. | 72865-238-10 | 72865-238 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .075mg/1 | 90 Tablet In 1 Bottle (72865-238-90) | XLCare Pharmaceuticals, Inc. | 72865-238-90 | 72865-238 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 1000 Tablet In 1 Bottle (72865-239-10) | XLCare Pharmaceuticals, Inc. | 72865-239-10 | 72865-239 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .088mg/1 | 90 Tablet In 1 Bottle (72865-239-90) | XLCare Pharmaceuticals, Inc. | 72865-239-90 | 72865-239 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 1000 Tablet In 1 Bottle (72865-240-10) | XLCare Pharmaceuticals, Inc. | 72865-240-10 | 72865-240 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .1mg/1 | 90 Tablet In 1 Bottle (72865-240-90) | XLCare Pharmaceuticals, Inc. | 72865-240-90 | 72865-240 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 1000 Tablet In 1 Bottle (72865-241-10) | XLCare Pharmaceuticals, Inc. | 72865-241-10 | 72865-241 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .112mg/1 | 90 Tablet In 1 Bottle (72865-241-90) | XLCare Pharmaceuticals, Inc. | 72865-241-90 | 72865-241 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (72865-242-10) | XLCare Pharmaceuticals, Inc. | 72865-242-10 | 72865-242 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (72865-242-90) | XLCare Pharmaceuticals, Inc. | 72865-242-90 | 72865-242 | ANDA215259 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-644-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-644-20 | 60760-644 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-140-20) | St. Mary's Medical Park Pharmacy | 60760-140-20 | 60760-140 | ANDA078250 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 1000 Tablet In 1 Bottle (72865-243-10) | XLCare Pharmaceuticals, Inc. | 72865-243-10 | 72865-243 | ANDA215259 | ANDA | N/A |
| LEVOTHYROXINE SODIUM | Tablet | Oral | .137mg/1 | 90 Tablet In 1 Bottle (72865-243-90) | XLCare Pharmaceuticals, Inc. | 72865-243-90 | 72865-243 | ANDA215259 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 150 G In 1 Jar (65162-918-41) | Amneal Pharmaceuticals LLC | 65162-918-41 | 65162-918 | ANDA206297 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 250 G In 1 Jar (65162-918-45) | Amneal Pharmaceuticals LLC | 65162-918-45 | 65162-918 | ANDA206297 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (65162-918-30) / 30 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-918-30 | 65162-918 | ANDA206297 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 1 Tube In 1 Carton (65162-918-38) / 35.44 G In 1 Tube | Amneal Pharmaceuticals LLC | 65162-918-38 | 65162-918 | ANDA206297 | ANDA | N/A |
| Lidocaine | Ointment | Topical | 50mg/g | 50 G In 1 Jar (65162-918-53) | Amneal Pharmaceuticals LLC | 65162-918-53 | 65162-918 | ANDA206297 | ANDA | N/A |
| Lidocaine | Patch | Topical | 700mg/1 | 30 Pouch In 1 Carton (65162-791-08) / 1 Patch In 1 Pouch (65162-791-04) | Amneal Pharmaceuticals LLC | 65162-791-08 | 65162-791 | ANDA206463 | ANDA | N/A |
| Lidocaine hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 25 Vial, Multi-Dose In 1 Carton (31722-217-31) / 20 Ml In 1 Vial, Multi-Dose | Camber Pharmaceuticals, Inc. | 31722-217-31 | 31722-217 | ANDA214336 | ANDA | N/A |
| Lidocaine hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 25 Vial, Multi-Dose In 1 Carton (31722-217-32) / 50 Ml In 1 Vial, Multi-Dose | Camber Pharmaceuticals, Inc. | 31722-217-32 | 31722-217 | ANDA214336 | ANDA | N/A |
| Lidocaine hydrochloride | Injection, Solution | Infiltration; Perineural | 20mg/mL | 10 Vial, Multi-Dose In 1 Carton (31722-217-33) / 50 Ml In 1 Vial, Multi-Dose | Camber Pharmaceuticals, Inc. | 31722-217-33 | 31722-217 | ANDA214336 | ANDA | N/A |
| Naproxen | Suspension | Oral | 125mg/5mL | 473 Ml In 1 Bottle (42192-619-16) | Acella Pharmaceuticals, LLC | 42192-619-16 | 42192-619 | NDA018965 | NDA AUTHORIZED GENERIC | N/A |
| LIKMEZ (metronidazole) Oral Suspension | SUSPENSION | ORAL | 100mg/mL | 200 mL in 1 BOTTLE (71656-066-20) | Saptalis Pharmaceuticals, LLC | 71656-066-20 | 71656-066 | NDA216755 | NDA | N/A |
| LIKMEZ (metronidazole) Oral Suspension | SUSPENSION | ORAL | 100mg/mL | 75 mL in 1 BOTTLE (71656-066-75) | Saptalis Pharmaceuticals, LLC | 71656-066-75 | 71656-066 | NDA216755 | NDA | N/A |
| Linezolid | Tablet | Oral | 600mg/1 | 20 Tablet In 1 Bottle (65162-777-02) | Amneal Pharmaceuticals LLC | 65162-777-02 | 65162-777 | ANDA204536 | ANDA | N/A |
| Linezolid | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (65162-777-03) | Amneal Pharmaceuticals LLC | 65162-777-03 | 65162-777 | ANDA204536 | ANDA | N/A |
| Linezolid | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (65162-777-10) | Amneal Pharmaceuticals LLC | 65162-777-10 | 65162-777 | ANDA204536 | ANDA | N/A |
| Linezolid | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-749-01) | Camber Pharmaceuticals, Inc. | 31722-749-01 | 31722-749 | ANDA204239 | ANDA | N/A |
| Linezolid | Tablet, Film Coated | Oral | 600mg/1 | 20 Tablet, Film Coated In 1 Bottle (31722-749-20) | Camber Pharmaceuticals, Inc. | 31722-749-20 | 31722-749 | ANDA204239 | ANDA | N/A |
| Linezolid | Tablet, Film Coated | Oral | 600mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-749-30) | Camber Pharmaceuticals, Inc. | 31722-749-30 | 31722-749 | ANDA204239 | ANDA | N/A |
| Linezolid | Tablet, Film Coated | Oral | 600mg/1 | 150 Tablet, Film Coated In 1 Carton (31722-749-31) | Camber Pharmaceuticals, Inc. | 31722-749-31 | 31722-749 | ANDA204239 | ANDA | N/A |
| Linezolid | Granule, For Suspension | Oral | 100mg/5mL | 1 Bottle, Glass In 1 Carton (31722-865-25) / 150 Ml In 1 Bottle, Glass | Camber Pharmaceuticals, Inc. | 31722-865-25 | 31722-865 | ANDA211813 | ANDA | N/A |
| Linezolid | Tablet | Oral | 600mg/1 | 20 Tablet In 1 Bottle (64980-561-02) | Rising Pharma Holdings, Inc. | 64980-561-02 | 64980-561 | ANDA078845 | ANDA | N/A |
| Linezolid | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (64980-561-03) | Rising Pharma Holdings, Inc. | 64980-561-03 | 64980-561 | ANDA078845 | ANDA | N/A |
| Naproxen | Suspension | Oral | 125mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3630-63) | Hikma Pharmaceuticals USA Inc. | 0054-3630-63 | 0054-3630 | ANDA074190 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 90 Capsule In 1 Bottle (65162-023-09) | Amneal Pharmaceuticals LLC | 65162-023-09 | 65162-023 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 90 Capsule In 1 Bottle (65162-024-09) | Amneal Pharmaceuticals LLC | 65162-024-09 | 65162-024 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 90 Capsule In 1 Bottle (65162-025-09) | Amneal Pharmaceuticals LLC | 65162-025-09 | 65162-025 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (65162-026-09) | Amneal Pharmaceuticals LLC | 65162-026-09 | 65162-026 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 90 Capsule In 1 Bottle (65162-027-09) | Amneal Pharmaceuticals LLC | 65162-027-09 | 65162-027 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 90 Capsule In 1 Bottle (65162-028-09) | Amneal Pharmaceuticals LLC | 65162-028-09 | 65162-028 | ANDA202830 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 60mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-556-05) | Ascent Pharmaceuticals, Inc | 43602-556-05 | 43602-556 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 60mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-556-30) | Ascent Pharmaceuticals, Inc | 43602-556-30 | 43602-556 | ANDA217068 | ANDA | CII |
| Naproxen Sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (45802-490-71) / 50 Tablet, Film Coated In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-490-71 | 45802-490 | ANDA074661 | ANDA | N/A |
| Naproxen Sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (45802-490-75) / 90 Tablet, Film Coated In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-490-75 | 45802-490 | ANDA074661 | ANDA | N/A |
| Naproxen Sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (45802-490-78) / 100 Tablet, Film Coated In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-490-78 | 45802-490 | ANDA074661 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 14 Tablet In 1 Bottle, Plastic (60760-801-14) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801-14 | 60760-801 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-801-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801-30 | 60760-801 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-801-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801-60 | 60760-801 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-801-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801-90 | 60760-801 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 1 Bottle, Plastic In 1 Carton (21130-948-11) / 20 Capsule, Liquid Filled In 1 Bottle, Plastic | Albertsons Companies | 21130-948-11 | 21130-948 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 1 Bottle, Plastic In 1 Carton (21130-948-15) / 40 Capsule, Liquid Filled In 1 Bottle, Plastic | Albertsons Companies | 21130-948-15 | 21130-948 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 80 Capsule, Liquid Filled In 1 Bottle (21130-948-78) | Albertsons Companies | 21130-948-78 | 21130-948 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (69452-259-22) | Bionpharma Inc. | 69452-259-22 | 69452-259 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 180 Capsule, Liquid Filled In 1 Bottle (69452-259-25) | Bionpharma Inc. | 69452-259-25 | 69452-259 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 1 Bottle In 1 Carton (69452-259-78) / 80 Capsule, Liquid Filled In 1 Bottle | Bionpharma Inc. | 69452-259-78 | 69452-259 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 120 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-179-22) | Bionpharma Inc. | 69452-179-22 | 69452-179 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 180 Capsule, Liquid Filled In 1 Bottle (69452-284-25) | Bionpharma Inc. | 69452-284-25 | 69452-284 | NDA021920 | NDA | N/A |
| Naproxen Sodium | Tablet, Film Coated, Extended Release | Oral | 375mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (47781-153-01) | Alvogen Inc. | 47781-153-01 | 47781-153 | NDA020353 | NDA AUTHORIZED GENERIC | N/A |
| Naproxen Sodium | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 75 Tablet, Film Coated, Extended Release In 1 Bottle (47781-154-75) | Alvogen Inc. | 47781-154-75 | 47781-154 | NDA020353 | NDA AUTHORIZED GENERIC | N/A |
| Naproxen Sodium | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (47781-155-30) | Alvogen Inc. | 47781-155-30 | 47781-155 | NDA020353 | NDA AUTHORIZED GENERIC | N/A |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 10mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-551-05) | Ascent Pharmaceuticals, Inc | 43602-551-05 | 43602-551 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 10mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-551-30) | Ascent Pharmaceuticals, Inc | 43602-551-30 | 43602-551 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 20mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-552-05) | Ascent Pharmaceuticals, Inc | 43602-552-05 | 43602-552 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 20mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-552-30) | Ascent Pharmaceuticals, Inc | 43602-552-30 | 43602-552 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 30mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-553-05) | Ascent Pharmaceuticals, Inc | 43602-553-05 | 43602-553 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 30mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-553-30) | Ascent Pharmaceuticals, Inc | 43602-553-30 | 43602-553 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 40mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-554-05) | Ascent Pharmaceuticals, Inc | 43602-554-05 | 43602-554 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 40mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-554-30) | Ascent Pharmaceuticals, Inc | 43602-554-30 | 43602-554 | ANDA217068 | ANDA | CII |
| Naratriptan Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 1 Blister Pack In 1 Carton (69452-340-72) / 9 Tablet, Film Coated In 1 Blister Pack (69452-340-60) | Bionpharma Inc. | 69452-340-72 | 69452-340 | ANDA091441 | ANDA | N/A |
| Naratriptan Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 1 Blister Pack In 1 Carton (69452-341-72) / 9 Tablet, Film Coated In 1 Blister Pack (69452-341-60) | Bionpharma Inc. | 69452-341-72 | 69452-341 | ANDA091441 | ANDA | N/A |
| Naratriptan Hydrochloride | Tablet | Oral | 1mg/1 | 9 Tablet In 1 Bottle (0054-0278-03) | Hikma Pharmaceuticals USA Inc. | 0054-0278-03 | 0054-0278 | ANDA090381 | ANDA | N/A |
| Naratriptan Hydrochloride | Tablet | Oral | 2.5mg/1 | 9 Tablet In 1 Bottle (0054-0279-03) | Hikma Pharmaceuticals USA Inc. | 0054-0279-03 | 0054-0279 | ANDA090381 | ANDA | N/A |
| Nateglinide | Tablet, Coated | Oral | 60mg/1 | 100 Tablet, Coated In 1 Bottle (75834-205-01) | Nivagen Pharmaceuticals, Inc. | 75834-205-01 | 75834-205 | ANDA206432 | ANDA | N/A |
| Nateglinide | Tablet, Coated | Oral | 120mg/1 | 100 Tablet, Coated In 1 Bottle (75834-206-01) | Nivagen Pharmaceuticals, Inc. | 75834-206-01 | 75834-206 | ANDA206432 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-656-01) | Golden State Medical Supply, Inc. | 51407-656-01 | 51407-656 | ANDA077463 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-657-01) | Golden State Medical Supply, Inc. | 51407-657-01 | 51407-657 | ANDA077463 | ANDA | N/A |
| Nateglinide | Tablet, Coated | Oral | 60mg/1 | 100 Tablet, Coated In 1 Bottle, Plastic (60429-434-01) | Golden State Medical Supply, Inc. | 60429-434-01 | 60429-434 | ANDA077463 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 50mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-555-05) | Ascent Pharmaceuticals, Inc | 43602-555-05 | 43602-555 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 50mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-555-30) | Ascent Pharmaceuticals, Inc | 43602-555-30 | 43602-555 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 10mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-551-05) | Ascent Pharmaceuticals, Inc | 43602-551-05 | 43602-551 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 10mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-551-30) | Ascent Pharmaceuticals, Inc | 43602-551-30 | 43602-551 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 20mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-552-05) | Ascent Pharmaceuticals, Inc | 43602-552-05 | 43602-552 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 20mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-552-30) | Ascent Pharmaceuticals, Inc | 43602-552-30 | 43602-552 | ANDA217068 | ANDA | CII |
| Nebivolol Hydrochloride | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (51407-483-30) | Golden State Medical Supply, Inc. | 51407-483-30 | 51407-483 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (51407-484-30) | Golden State Medical Supply, Inc. | 51407-484-30 | 51407-484 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (51407-484-90) | Golden State Medical Supply, Inc. | 51407-484-90 | 51407-484 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (51407-485-30) | Golden State Medical Supply, Inc. | 51407-485-30 | 51407-485 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (51407-485-90) | Golden State Medical Supply, Inc. | 51407-485-90 | 51407-485 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (51407-486-30) | Golden State Medical Supply, Inc. | 51407-486-30 | 51407-486 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (51407-486-90) | Golden State Medical Supply, Inc. | 51407-486-90 | 51407-486 | ANDA203659 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 30mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-553-05) | Ascent Pharmaceuticals, Inc | 43602-553-05 | 43602-553 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 30mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-553-30) | Ascent Pharmaceuticals, Inc | 43602-553-30 | 43602-553 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 40mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-554-05) | Ascent Pharmaceuticals, Inc | 43602-554-05 | 43602-554 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 40mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-554-30) | Ascent Pharmaceuticals, Inc | 43602-554-30 | 43602-554 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 50mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-555-05) | Ascent Pharmaceuticals, Inc | 43602-555-05 | 43602-555 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 50mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-555-30) | Ascent Pharmaceuticals, Inc | 43602-555-30 | 43602-555 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 60mg/1 | 500 Tablet, Chewable In 1 Bottle (43602-556-05) | Ascent Pharmaceuticals, Inc | 43602-556-05 | 43602-556 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Tablet, Chewable | Oral | 60mg/1 | 30 Tablet, Chewable In 1 Bottle (43602-556-30) | Ascent Pharmaceuticals, Inc | 43602-556-30 | 43602-556 | ANDA217068 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 500 Capsule In 1 Bottle (43602-309-05) | Ascent Pharmaceuticals, Inc. | 43602-309-05 | 43602-309 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 60 Capsule In 1 Bottle (43602-309-60) | Ascent Pharmaceuticals, Inc. | 43602-309-60 | 43602-309 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (43602-310-05) | Ascent Pharmaceuticals, Inc. | 43602-310-05 | 43602-310 | ANDA217442 | ANDA | CII |
| Nelarabine | Injection | Intravenous | 5mg/mL | 6 Vial, Single-Dose In 1 Carton (71288-165-53) / 50 Ml In 1 Vial, Single-Dose (71288-165-52) | Meitheal Pharmaceuticals Inc | 71288-165-53 | 71288-165 | ANDA216038 | ANDA | N/A |
| Nelarabine | Injection | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-165-54) / 50 Ml In 1 Vial, Single-Dose (71288-165-52) | Meitheal Pharmaceuticals Inc | 71288-165-54 | 71288-165 | ANDA216038 | ANDA | N/A |
| Nelarabine | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-259-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-259-50 | 25021-259 | ANDA212605 | ANDA | N/A |
| Nelarabine | Injection, Solution | Intravenous | 5mg/mL | 6 Vial In 1 Carton (25021-259-51) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-259-51 | 25021-259 | ANDA212605 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (43602-310-60) | Ascent Pharmaceuticals, Inc. | 43602-310-60 | 43602-310 | ANDA217442 | ANDA | CII |
| Neomycin Sulfate | Ointment | Topical | 3.5mg/g | 1 Tube In 1 Carton (54312-019-31) / 28 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-019-31 | 54312-019 | M004 | OTC MONOGRAPH DRUG | N/A |
| Neomycin Sulfate | Ointment | Topical | 3.5mg/g | 1 Tube In 1 Carton (54312-019-35) / 14 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-019-35 | 54312-019 | M004 | OTC MONOGRAPH DRUG | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .51mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-500-11) / 10 Ml In 1 Vial, Multi-Dose (71288-500-10) | Meitheal Pharmaceuticals Inc. | 71288-500-11 | 71288-500 | ANDA212804 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1.02mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-501-11) / 10 Ml In 1 Vial, Multi-Dose (71288-501-10) | Meitheal Pharmaceuticals Inc. | 71288-501-11 | 71288-501 | ANDA212804 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Carton In 1 Package (75834-149-10) / 1 Vial, Multi-Dose In 1 Carton (75834-149-01) / 10 Ml In 1 Vial, Multi-Dose | Nivagen Pharmaceuticals, Inc. | 75834-149-10 | 75834-149 | ANDA212627 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Carton In 1 Package (75834-150-10) / 1 Vial, Multi-Dose In 1 Carton (75834-150-01) / 10 Ml In 1 Vial, Multi-Dose | Nivagen Pharmaceuticals, Inc. | 75834-150-10 | 75834-150 | ANDA212627 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection, Solution | Intravenous | .5mg/mL | 10 Vial In 1 Carton (25021-610-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-610-10 | 25021-610 | ANDA210652 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-611-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-611-10 | 25021-611 | ANDA210652 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Vial, Multi-Dose In 1 Carton (70069-805-10) / 10 Ml In 1 Vial, Multi-Dose (70069-805-01) | Somerset Therapeutics, LLC | 70069-805-10 | 70069-805 | ANDA213074 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (70069-806-10) / 10 Ml In 1 Vial, Multi-Dose (70069-806-01) | Somerset Therapeutics, LLC | 70069-806-10 | 70069-806 | ANDA213074 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Carton In 1 Package (0548-9601-00) / 1 Vial, Multi-Dose In 1 Carton / 10 Ml In 1 Vial, Multi-Dose | Amphastar Pharmaceuticals, Inc. | 0548-9601-00 | 0548-9601 | ANDA209933 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Carton In 1 Package (0548-9602-00) / 1 Vial, Multi-Dose In 1 Carton / 10 Ml In 1 Vial, Multi-Dose | Amphastar Pharmaceuticals, Inc. | 0548-9602-00 | 0548-9602 | ANDA209933 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 500 Capsule In 1 Bottle (43602-311-05) | Ascent Pharmaceuticals, Inc. | 43602-311-05 | 43602-311 | ANDA217442 | ANDA | CII |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Carton In 1 Package (0548-9601-00) / 1 Vial, Multi-Dose In 1 Carton / 10 Ml In 1 Vial, Multi-Dose | Amphastar Pharmaceuticals, Inc. | 0548-9601-00 | 0548-9601 | ANDA209933 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6150-10) / 10 Ml In 1 Vial, Multi-Dose (0641-6150-01) | Hikma Pharmaceuticals USA Inc. | 0641-6150-10 | 0641-6150 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 25 Vial, Multi-Dose In 1 Carton (0641-6150-25) / 10 Ml In 1 Vial, Multi-Dose (0641-6150-01) | Hikma Pharmaceuticals USA Inc. | 0641-6150-25 | 0641-6150 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Syringe, Plastic In 1 Carton (0641-6240-10) / 3 Ml In 1 Syringe, Plastic | Hikma Pharmaceuticals USA Inc. | 0641-6240-10 | 0641-6240 | ANDA216206 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | .5mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6264-10) / 10 Ml In 1 Vial, Multi-Dose (0641-6264-01) | Hikma Pharmaceuticals USA Inc. | 0641-6264-10 | 0641-6264 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6265-10) / 10 Ml In 1 Vial, Multi-Dose (0641-6265-01) | Hikma Pharmaceuticals USA Inc. | 0641-6265-10 | 0641-6265 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6277-10) / 10 Ml In 1 Vial, Multi-Dose (0641-6277-01) | Hikma Pharmaceuticals USA Inc. | 0641-6277-10 | 0641-6277 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (0641-6149-10) / 10 Ml In 1 Vial, Multi-Dose (0641-6149-01) | Hikma Pharmaceuticals USA Inc. | 0641-6149-10 | 0641-6149 | ANDA207042 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 25 Vial, Multi-Dose In 1 Carton (0641-6149-25) / 10 Ml In 1 Vial, Multi-Dose (0641-6149-01) | Hikma Pharmaceuticals USA Inc. | 0641-6149-25 | 0641-6149 | ANDA207042 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 60 Capsule In 1 Bottle (43602-311-60) | Ascent Pharmaceuticals, Inc. | 43602-311-60 | 43602-311 | ANDA217442 | ANDA | CII |
| Niacin | Tablet, Extended Release | Oral | 500mg/1 | 90 Tablet, Extended Release In 1 Bottle (51407-267-90) | Golden State Medical Supply, Inc. | 51407-267-90 | 51407-267 | ANDA203899 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 1000mg/1 | 90 Tablet, Extended Release In 1 Bottle (51407-268-90) | Golden State Medical Supply, Inc. | 51407-268-90 | 51407-268 | ANDA203899 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 500 Capsule In 1 Bottle (43602-312-05) | Ascent Pharmaceuticals, Inc. | 43602-312-05 | 43602-312 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 60 Capsule In 1 Bottle (43602-312-60) | Ascent Pharmaceuticals, Inc. | 43602-312-60 | 43602-312 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (43602-306-01) | Ascent Pharmaceuticals, Inc. | 43602-306-01 | 43602-306 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle (43602-307-05) | Ascent Pharmaceuticals, Inc. | 43602-307-05 | 43602-307 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 60 Capsule In 1 Bottle (43602-307-60) | Ascent Pharmaceuticals, Inc. | 43602-307-60 | 43602-307 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 500 Capsule In 1 Bottle (43602-308-05) | Ascent Pharmaceuticals, Inc. | 43602-308-05 | 43602-308 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 60 Capsule In 1 Bottle (43602-308-60) | Ascent Pharmaceuticals, Inc. | 43602-308-60 | 43602-308 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (43602-306-01) | Ascent Pharmaceuticals, Inc. | 43602-306-01 | 43602-306 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle (43602-307-05) | Ascent Pharmaceuticals, Inc. | 43602-307-05 | 43602-307 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 20mg/1 | 60 Capsule In 1 Bottle (43602-307-60) | Ascent Pharmaceuticals, Inc. | 43602-307-60 | 43602-307 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 500 Capsule In 1 Bottle (43602-308-05) | Ascent Pharmaceuticals, Inc. | 43602-308-05 | 43602-308 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 30mg/1 | 60 Capsule In 1 Bottle (43602-308-60) | Ascent Pharmaceuticals, Inc. | 43602-308-60 | 43602-308 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 500 Capsule In 1 Bottle (43602-309-05) | Ascent Pharmaceuticals, Inc. | 43602-309-05 | 43602-309 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 40mg/1 | 60 Capsule In 1 Bottle (43602-309-60) | Ascent Pharmaceuticals, Inc. | 43602-309-60 | 43602-309 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (43602-310-05) | Ascent Pharmaceuticals, Inc. | 43602-310-05 | 43602-310 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (43602-310-60) | Ascent Pharmaceuticals, Inc. | 43602-310-60 | 43602-310 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 500 Capsule In 1 Bottle (43602-311-05) | Ascent Pharmaceuticals, Inc. | 43602-311-05 | 43602-311 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 60mg/1 | 60 Capsule In 1 Bottle (43602-311-60) | Ascent Pharmaceuticals, Inc. | 43602-311-60 | 43602-311 | ANDA217442 | ANDA | CII |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 500 Capsule In 1 Bottle (43602-312-05) | Ascent Pharmaceuticals, Inc. | 43602-312-05 | 43602-312 | ANDA217442 | ANDA | CII |
| Nicardipine Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 10 Vial In 1 Carton (0517-0735-10) / 10 Ml In 1 Vial (0517-0735-01) | American Regent, Inc. | 0517-0735-10 | 0517-0735 | ANDA090534 | ANDA | N/A |
| Nicardipine Hydrochloride | Injection | Intravenous | .2mg/mL | 10 Bag In 1 Carton (0143-9633-10) / 200 Ml In 1 Bag (0143-9633-01) | Hikma Pharmaceuticals USA Inc. | 0143-9633-10 | 0143-9633 | NDA022276 | NDA | N/A |
| Nicardipine Hydrochloride | Injection | Intravenous | .1mg/mL | 10 Bag In 1 Carton (0143-9634-10) / 200 Ml In 1 Bag (0143-9634-01) | Hikma Pharmaceuticals USA Inc. | 0143-9634-10 | 0143-9634 | NDA022276 | NDA | N/A |
| Nicardipine Hydrochloride | Injection | Intravenous | 2.5mg/mL | 10 Vial In 1 Carton (0143-9542-10) / 10 Ml In 1 Vial (0143-9542-01) | Hikma Pharmaceuticals USA Inc. | 0143-9542-10 | 0143-9542 | NDA022276 | NDA | N/A |
| Nicardipine Hydrochloride | Injection | Intravenous | 25mg/10mL | 10 Vial In 1 Carton (0143-9689-10) / 10 Ml In 1 Vial (0143-9689-01) | Hikma Pharmaceuticals USA Inc. | 0143-9689-10 | 0143-9689 | NDA022276 | NDA | N/A |
| Nicotine | Gum, Chewing | Oral | 4mg/1 | 110 Blister Pack In 1 Carton (45802-651-25) / 1 Gum, Chewing In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-651-25 | 45802-651 | ANDA206393 | ANDA | N/A |
| Nicotine | Gum, Chewing | Oral | 2mg/1 | 110 Blister Pack In 1 Carton (45802-827-25) / 1 Gum, Chewing In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-827-25 | 45802-827 | ANDA206394 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 4mg/1 | 3 Container In 1 Carton (45802-873-05) / 24 Lozenge In 1 Container | Padagis Israel Pharmaceuticals Ltd | 45802-873-05 | 45802-873 | ANDA077007 | ANDA | N/A |
| Nicotine | Gum, Chewing | Oral | 2mg/1 | 110 Blister Pack In 1 Carton (45802-206-25) / 1 Gum, Chewing In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-206-25 | 45802-206 | ANDA078325 | ANDA | N/A |
| Nicotine | Gum, Chewing | Oral | 4mg/1 | 110 Blister Pack In 1 Carton (45802-001-25) / 1 Gum, Chewing In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-001-25 | 45802-001 | ANDA078326 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 4mg/1 | 3 Container In 1 Carton (45802-957-02) / 27 Lozenge In 1 Container | Padagis Israel Pharmaceuticals Ltd | 45802-957-02 | 45802-957 | ANDA203690 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 2mg/1 | 3 Container In 1 Carton (45802-344-05) / 24 Lozenge In 1 Container | Padagis Israel Pharmaceuticals Ltd | 45802-344-05 | 45802-344 | ANDA077007 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 2mg/1 | 3 Container In 1 Carton (45802-089-02) / 27 Lozenge In 1 Container | Padagis Israel Pharmaceuticals Ltd | 45802-089-02 | 45802-089 | ANDA203690 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 7mg/24h | 14 Patch In 1 Carton (60429-443-14) / 24 H In 1 Patch | Golden State Medical Supply, Inc. | 60429-443-14 | 60429-443 | NDA020076 | NDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 21mg/24h | 14 Pouch In 1 Carton (60505-7066-0) / 1 H In 1 Pouch | Apotex Corp | 60505-7066-0 | 60505-7066 | ANDA074612 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 7mg/24h | 14 Pouch In 1 Carton (60505-7064-0) / 1 H In 1 Pouch | Apotex Corp | 60505-7064-0 | 60505-7064 | ANDA074612 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 14mg/24h | 14 Pouch In 1 Carton (60505-7065-0) / 1 H In 1 Pouch | Apotex Corp | 60505-7065-0 | 60505-7065 | ANDA074612 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 7mg/24h | 14 Pouch In 1 Carton (60505-7088-0) / 1 H In 1 Pouch | Apotex Corp. | 60505-7088-0 | 60505-7088 | ANDA074612 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 14mg/24h | 14 Pouch In 1 Carton (60505-7089-0) / 1 H In 1 Pouch | Apotex Corp. | 60505-7089-0 | 60505-7089 | ANDA074612 | ANDA | N/A |
| Nicotine | Patch, Extended Release | Transdermal | 21mg/24h | 14 Pouch In 1 Carton (60505-7090-0) / 1 H In 1 Pouch | Apotex Corp. | 60505-7090-0 | 60505-7090 | ANDA074612 | ANDA | N/A |
| Lisdexamfetamine Dimesylate | Capsule | Oral | 70mg/1 | 60 Capsule In 1 Bottle (43602-312-60) | Ascent Pharmaceuticals, Inc. | 43602-312-60 | 43602-312 | ANDA217442 | ANDA | CII |
| Lisinopril | Tablet | Oral | 2.5mg/1 | 95238 Tablet In 1 Carton (31722-172-31) | Camber Pharmaceuticals, Inc. | 31722-172-31 | 31722-172 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (31722-172-01) | Camber Pharmaceuticals, Inc. | 31722-172-01 | 31722-172 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (31722-172-05) | Camber Pharmaceuticals, Inc. | 31722-172-05 | 31722-172 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 95238 Tablet In 1 Carton (31722-176-31) | Camber Pharmaceuticals, Inc. | 31722-176-31 | 31722-176 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-176-01) | Camber Pharmaceuticals, Inc. | 31722-176-01 | 31722-176 | ANDA075903 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 90mg/1 | 100 Tablet, Extended Release In 1 Bottle (51407-624-01) | Golden State Medical Supply, Inc. | 51407-624-01 | 51407-624 | ANDA202987 | ANDA | N/A |
| Nifedipine | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (69315-211-01) | Leading Pharma, LLC | 69315-211-01 | 69315-211 | ANDA073250 | ANDA | N/A |
| Nifedipine | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle, Plastic (69315-212-01) | Leading Pharma, LLC | 69315-212-01 | 69315-212 | ANDA074045 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (31722-176-10) | Camber Pharmaceuticals, Inc. | 31722-176-10 | 31722-176 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 71428 Tablet In 1 Carton (31722-177-31) | Camber Pharmaceuticals, Inc. | 31722-177-31 | 31722-177 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-177-01) | Camber Pharmaceuticals, Inc. | 31722-177-01 | 31722-177 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (31722-177-10) | Camber Pharmaceuticals, Inc. | 31722-177-10 | 31722-177 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 71428 Tablet In 1 Carton (31722-178-31) | Camber Pharmaceuticals, Inc. | 31722-178-31 | 31722-178 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-178-01) | Camber Pharmaceuticals, Inc. | 31722-178-01 | 31722-178 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (31722-178-10) | Camber Pharmaceuticals, Inc. | 31722-178-10 | 31722-178 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 30mg/1 | 71428 Tablet In 1 Carton (31722-179-31) | Camber Pharmaceuticals, Inc. | 31722-179-31 | 31722-179 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (31722-179-01) | Camber Pharmaceuticals, Inc. | 31722-179-01 | 31722-179 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (31722-179-05) | Camber Pharmaceuticals, Inc. | 31722-179-05 | 31722-179 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (72865-208-01) | XLCare Pharmaceuticals Inc. | 72865-208-01 | 72865-208 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (72865-208-05) | XLCare Pharmaceuticals Inc. | 72865-208-05 | 72865-208 | ANDA075903 | ANDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Blister Pack (0069-2650-41) | Pfizer Laboratories Div Pfizer Inc | 0069-2650-41 | 0069-2650 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (0069-2650-66) | Pfizer Laboratories Div Pfizer Inc | 0069-2650-66 | 0069-2650 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 300 Tablet, Film Coated, Extended Release In 1 Bottle (0069-2650-72) | Pfizer Laboratories Div Pfizer Inc | 0069-2650-72 | 0069-2650 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 60mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Blister Pack (0069-2660-41) | Pfizer Laboratories Div Pfizer Inc | 0069-2660-41 | 0069-2660 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 60mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (0069-2660-66) | Pfizer Laboratories Div Pfizer Inc | 0069-2660-66 | 0069-2660 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 60mg/1 | 300 Tablet, Film Coated, Extended Release In 1 Bottle (0069-2660-72) | Pfizer Laboratories Div Pfizer Inc | 0069-2660-72 | 0069-2660 | NDA019684 | NDA | N/A |
| Nifedipine | Tablet, Film Coated, Extended Release | Oral | 90mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (0069-2670-66) | Pfizer Laboratories Div Pfizer Inc | 0069-2670-66 | 0069-2670 | NDA019684 | NDA | N/A |
| Nilutamide | Tablet | Oral | 150mg/1 | 3 Blister Pack In 1 Carton (66993-212-38) / 10 Tablet In 1 Blister Pack | Prasco Laboratories | 66993-212-38 | 66993-212 | NDA020169 | NDA AUTHORIZED GENERIC | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (72865-209-01) | XLCare Pharmaceuticals Inc. | 72865-209-01 | 72865-209 | ANDA075903 | ANDA | N/A |
| Nimodipine | Solution | Oral | 30mg/5mL | 12 Package In 1 Carton (24338-230-12) / 1 Syringe, Plastic In 1 Package (24338-230-05) / 5 Ml In 1 Syringe, Plastic | Azurity Pharmaceuticals, Inc. | 24338-230-12 | 24338-230 | NDA203340 | NDA | N/A |
| Nimodipine | Solution | Oral | 60mg/10mL | 237 Ml In 1 Bottle (24338-260-08) | Azurity Pharmaceuticals, Inc. | 24338-260-08 | 24338-260 | NDA203340 | NDA | N/A |
| Nimodipine | Solution | Oral | 60mg/10mL | 12 Package In 1 Carton (24338-260-12) / 1 Syringe, Plastic In 1 Package (24338-260-10) / 10 Ml In 1 Syringe, Plastic | Azurity Pharmaceuticals, Inc. | 24338-260-12 | 24338-260 | NDA203340 | NDA | N/A |
| Nimodipine | Capsule, Liquid Filled | Oral | 30mg/1 | 3 Blister Pack In 1 Carton (69452-209-13) / 10 Capsule, Liquid Filled In 1 Blister Pack | BIONPHARMA INC. | 69452-209-13 | 69452-209 | ANDA076740 | ANDA | N/A |
| Nimodipine | Capsule, Liquid Filled | Oral | 30mg/1 | 10 Blister Pack In 1 Carton (69452-209-20) / 10 Capsule, Liquid Filled In 1 Blister Pack | BIONPHARMA INC. | 69452-209-20 | 69452-209 | ANDA076740 | ANDA | N/A |
| Nisoldipine | Tablet, Film Coated, Extended Release | Oral | 8.5mg/1 | 1 Bottle In 1 Carton (66993-472-02) / 100 Tablet, Film Coated, Extended Release In 1 Bottle | Prasco Laboratories | 66993-472-02 | 66993-472 | NDA020356 | NDA AUTHORIZED GENERIC | N/A |
| Nisoldipine | Tablet, Film Coated, Extended Release | Oral | 17mg/1 | 1 Bottle In 1 Carton (66993-473-02) / 100 Tablet, Film Coated, Extended Release In 1 Bottle | Prasco Laboratories | 66993-473-02 | 66993-473 | NDA020356 | NDA AUTHORIZED GENERIC | N/A |
| Nisoldipine | Tablet, Film Coated, Extended Release | Oral | 34mg/1 | 1 Bottle In 1 Carton (66993-475-02) / 100 Tablet, Film Coated, Extended Release In 1 Bottle | Prasco Laboratories | 66993-475-02 | 66993-475 | NDA020356 | NDA AUTHORIZED GENERIC | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (72865-209-10) | XLCare Pharmaceuticals Inc. | 72865-209-10 | 72865-209 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 45 Tablet In 1 Bottle (72865-209-45) | XLCare Pharmaceuticals Inc. | 72865-209-45 | 72865-209 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (72865-209-90) | XLCare Pharmaceuticals Inc. | 72865-209-90 | 72865-209 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (72865-210-01) | XLCare Pharmaceuticals Inc. | 72865-210-01 | 72865-210 | ANDA075903 | ANDA | N/A |
| Nitisinone | Capsule | Oral | 2mg/1 | 1 Bottle In 1 Carton (71863-119-60) / 60 Capsule In 1 Bottle | Eton Pharmaceuticals, Inc. | 71863-119-60 | 71863-119 | ANDA216201 | ANDA | N/A |
| Nitisinone | Capsule | Oral | 5mg/1 | 1 Bottle In 1 Carton (71863-120-60) / 60 Capsule In 1 Bottle | Eton Pharmaceuticals, Inc. | 71863-120-60 | 71863-120 | ANDA216201 | ANDA | N/A |
| Nitisinone | Capsule | Oral | 10mg/1 | 1 Bottle In 1 Carton (71863-121-60) / 60 Capsule In 1 Bottle | Eton Pharmaceuticals, Inc. | 71863-121-60 | 71863-121 | ANDA216201 | ANDA | N/A |
| Nitisinone | Capsule | Oral | 20mg/1 | 1 Bottle In 1 Carton (71863-122-60) / 60 Capsule In 1 Bottle | Eton Pharmaceuticals, Inc. | 71863-122-60 | 71863-122 | ANDA216201 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 240 Ml In 1 Bottle, Plastic (29033-515-32) | Nostrum Laboratories, Inc. | 29033-515-32 | 29033-515 | ANDA201355 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 480 Ml In 1 Bottle, Plastic (29033-515-34) | Nostrum Laboratories, Inc. | 29033-515-34 | 29033-515 | ANDA201355 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 240 Ml In 1 Bottle, Plastic (70408-239-32) | Nostrum Laboratories, Inc. | 70408-239-32 | 70408-239 | ANDA201355 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (72865-210-10) | XLCare Pharmaceuticals Inc. | 72865-210-10 | 72865-210 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 45 Tablet In 1 Bottle (72865-210-45) | XLCare Pharmaceuticals Inc. | 72865-210-45 | 72865-210 | ANDA075903 | ANDA | N/A |
| Nitrofurantoin | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle, Plastic (47781-306-01) | Alvogen Inc. | 47781-306-01 | 47781-306 | NDA016620 | NDA | N/A |
| Nitrofurantoin | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle, Plastic (47781-307-01) | Alvogen Inc. | 47781-307-01 | 47781-307 | NDA016620 | NDA | N/A |
| Nitrofurantoin | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle, Plastic (47781-308-01) | Alvogen Inc. | 47781-308-01 | 47781-308 | NDA016620 | NDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 5000 Tablet In 1 Bottle (72865-210-50) | XLCare Pharmaceuticals Inc. | 72865-210-50 | 72865-210 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (72865-210-90) | XLCare Pharmaceuticals Inc. | 72865-210-90 | 72865-210 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (72865-211-01) | XLCare Pharmaceuticals Inc. | 72865-211-01 | 72865-211 | ANDA075903 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 100 Capsule In 1 Bottle (59746-762-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-762-06 | 59746-762 | ANDA211013 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 1000 Capsule In 1 Bottle (59746-762-15) | Jubilant Cadista Pharmaceuticals Inc. | 59746-762-15 | 59746-762 | ANDA211013 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 100 Capsule In 1 Bottle (59746-762-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-762-01 | 59746-762 | ANDA211013 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 1000 Capsule In 1 Bottle (59746-762-36) | Jubilant Cadista Pharmaceuticals Inc. | 59746-762-36 | 59746-762 | ANDA211013 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (72865-211-10) | XLCare Pharmaceuticals Inc. | 72865-211-10 | 72865-211 | ANDA075903 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 100 Capsule In 1 Bottle (47781-303-01) | Alvogen Inc. | 47781-303-01 | 47781-303 | NDA020064 | NDA | N/A |
| Nitroglycerin | Spray | Oral | 400ug/1 | 1 Bottle In 1 Carton (45802-210-01) / 60 Spray In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-210-01 | 45802-210 | ANDA091496 | ANDA | N/A |
| Nitroglycerin | Spray | Oral | 400ug/1 | 1 Bottle In 1 Carton (45802-210-02) / 200 Spray In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-210-02 | 45802-210 | ANDA091496 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .3mg/1 | 100 Tablet In 1 Bottle (60429-839-01) | Golden State Medical Supply, Inc. | 60429-839-01 | 60429-839 | ANDA208191 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 100 Tablet In 1 Bottle (60429-840-01) | Golden State Medical Supply, Inc. | 60429-840-01 | 60429-840 | ANDA208191 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 4 Bottle In 1 Carton (60429-840-04) / 25 Tablet In 1 Bottle | Golden State Medical Supply, Inc. | 60429-840-04 | 60429-840 | ANDA208191 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .6mg/1 | 100 Tablet In 1 Bottle (60429-841-01) | Golden State Medical Supply, Inc. | 60429-841-01 | 60429-841 | ANDA208191 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .3mg/1 | 1 Bottle In 1 Carton (58151-309-01) / 100 Tablet In 1 Bottle | Viatris Specialty LLC | 58151-309-01 | 58151-309 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 1 Bottle In 1 Carton (58151-310-01) / 100 Tablet In 1 Bottle | Viatris Specialty LLC | 58151-310-01 | 58151-310 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 4 Bottle In 1 Carton (58151-310-52) / 25 Tablet In 1 Bottle (58151-310-94) | Viatris Specialty LLC | 58151-310-52 | 58151-310 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .6mg/1 | 1 Bottle In 1 Carton (58151-311-01) / 100 Tablet In 1 Bottle | Viatris Specialty LLC | 58151-311-01 | 58151-311 | NDA021134 | NDA | N/A |
| Nitroglycerin | Ointment | Rectal | 4mg/g | 1 Tube In 1 Carton (0713-0564-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0564-31 | 0713-0564 | ANDA216103 | ANDA | N/A |
| Nitroglycerin | Injection, Solution | Intravenous | 5mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-4810-25) / 10 Ml In 1 Vial, Single-Dose (0517-4810-01) | American Regent, Inc. | 0517-4810-25 | 0517-4810 | ANDA072034 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 180 Tablet In 1 Bottle (72865-211-18) | XLCare Pharmaceuticals Inc. | 72865-211-18 | 72865-211 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 45 Tablet In 1 Bottle (72865-211-45) | XLCare Pharmaceuticals Inc. | 72865-211-45 | 72865-211 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 5000 Tablet In 1 Bottle (72865-211-50) | XLCare Pharmaceuticals Inc. | 72865-211-50 | 72865-211 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (72865-211-90) | XLCare Pharmaceuticals Inc. | 72865-211-90 | 72865-211 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (72865-212-01) | XLCare Pharmaceuticals Inc. | 72865-212-01 | 72865-212 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (72865-212-05) | XLCare Pharmaceuticals Inc. | 72865-212-05 | 72865-212 | ANDA075903 | ANDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .3mg/1 | 1 Bottle In 1 Carton (0071-0417-24) / 100 Tablet In 1 Bottle | Parke-Davis Div of Pfizer Inc | 0071-0417-24 | 0071-0417 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 4 Bottle In 1 Carton (0071-0418-13) / 25 Tablet In 1 Bottle | Parke-Davis Div of Pfizer Inc | 0071-0418-13 | 0071-0418 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .4mg/1 | 1 Bottle In 1 Carton (0071-0418-24) / 100 Tablet In 1 Bottle | Parke-Davis Div of Pfizer Inc | 0071-0418-24 | 0071-0418 | NDA021134 | NDA | N/A |
| Nitroglycerin | Tablet | Sublingual | .6mg/1 | 1 Bottle In 1 Carton (0071-0419-24) / 100 Tablet In 1 Bottle | Parke-Davis Div of Pfizer Inc | 0071-0419-24 | 0071-0419 | NDA021134 | NDA | N/A |
| Norepinephrine Bitartrate | Solution | Intravenous | 32ug/mL | 10 Pouch In 1 Box (81298-9655-3) / 1 Bag In 1 Pouch (81298-9655-1) / 250 Ml In 1 Bag | Long Grove Pharmaceuticals, LLC | 81298-9655-3 | 81298-9655 | NDA214628 | NDA | N/A |
| Norepinephrine Bitartrate | Solution | Intravenous | 64ug/mL | 10 Pouch In 1 Box (81298-9658-3) / 1 Bag In 1 Pouch (81298-9658-1) / 250 Ml In 1 Bag | Long Grove Pharmaceuticals, LLC | 81298-9658-3 | 81298-9658 | NDA214628 | NDA | N/A |
| Norepinephrine Bitartrate | Solution | Intravenous | 16ug/mL | 10 Pouch In 1 Box (81298-9659-3) / 1 Bag In 1 Pouch (81298-9659-1) / 250 Ml In 1 Bag | Long Grove Pharmaceuticals, LLC | 81298-9659-3 | 81298-9659 | NDA214628 | NDA | N/A |
| Norepinephrine Bitartrate | Injection, Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-316-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-316-04 | 25021-316 | ANDA214323 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (72865-213-01) | XLCare Pharmaceuticals Inc. | 72865-213-01 | 72865-213 | ANDA075903 | ANDA | N/A |
| Norepinephrine Bitartrate | Injection | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9318-10) / 4 Ml In 1 Vial (0143-9318-01) | Hikma Pharmaceuticals USA Inc. | 0143-9318-10 | 0143-9318 | ANDA203662 | ANDA | N/A |
| Norepinephrine Bitartrate | Injection, Solution, Concentrate | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-0161-10) / 4 Ml In 1 Vial, Single-Dose (0409-0161-01) | Hospira, Inc. | 0409-0161-10 | 0409-0161 | NDA007513 | NDA | N/A |
| Norepinephrine Bitartrate | Injection, Solution, Concentrate | Intravenous | 1mg/mL | 10 Vial, Single-Dose In 1 Carton (0409-3375-04) / 4 Ml In 1 Vial, Single-Dose (0409-3375-14) | Hospira, Inc. | 0409-3375-04 | 0409-3375 | NDA007513 | NDA | N/A |
| Norethindrone | Tablet | Oral | .35mg/1 | 3 Package In 1 Carton (50102-300-13) / 1 Blister Pack In 1 Package (50102-300-11) / 28 Tablet In 1 Blister Pack (50102-300-01) | Afaxys Pharma, LLC | 50102-300-13 | 50102-300 | ANDA207304 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (72865-213-10) | XLCare Pharmaceuticals Inc. | 72865-213-10 | 72865-213 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 180 Tablet In 1 Bottle (72865-213-18) | XLCare Pharmaceuticals Inc. | 72865-213-18 | 72865-213 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 45 Tablet In 1 Bottle (72865-213-45) | XLCare Pharmaceuticals Inc. | 72865-213-45 | 72865-213 | ANDA075903 | ANDA | N/A |
| Lisinopril | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (72865-213-90) | XLCare Pharmaceuticals Inc. | 72865-213-90 | 72865-213 | ANDA075903 | ANDA | N/A |
| Lithium | SOLUTION | ORAL | 8meq/5mL | 473 mL in 1 BOTTLE (71656-072-16) | Saptalis Pharmaceuticals, LLC | 71656-072-16 | 71656-072 | ANDA217183 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 10mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-908-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-908-60 | 60760-908 | ANDA073556 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle, Plastic (60760-811-30) | St. Mary's Medical Park Pharmacy | 60760-811-30 | 60760-811 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (51672-4004-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4004-1 | 51672-4004 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 75mg/1 | 500 Capsule In 1 Bottle (51672-4004-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4004-2 | 51672-4004 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (51672-4004-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4004-5 | 51672-4004 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (51672-4004-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4004-6 | 51672-4004 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (51672-4001-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4001-1 | 51672-4001 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (51672-4001-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4001-2 | 51672-4001 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 10mg/1 | 90 Capsule In 1 Bottle (51672-4001-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4001-5 | 51672-4001 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (51672-4001-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4001-6 | 51672-4001 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 100 Capsule In 1 Bottle (51672-4002-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4002-1 | 51672-4002 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 500 Capsule In 1 Bottle (51672-4002-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4002-2 | 51672-4002 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 60 Capsule In 1 Bottle (51672-4002-4) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4002-4 | 51672-4002 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (51672-4002-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4002-5 | 51672-4002 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (51672-4002-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4002-6 | 51672-4002 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (51672-4003-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4003-1 | 51672-4003 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (51672-4003-2) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4003-2 | 51672-4003 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (51672-4003-5) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4003-5 | 51672-4003 | ANDA075520 | ANDA | N/A |
| Nortriptyline Hydrochloride | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (51672-4003-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4003-6 | 51672-4003 | ANDA075520 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (45802-048-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-048-11 | 45802-048 | ANDA062472 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (45802-048-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-048-35 | 45802-048 | ANDA062472 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (45802-059-11) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-059-11 | 45802-059 | ANDA062225 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (45802-059-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-059-35 | 45802-059 | ANDA062225 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 60 G In 1 Bottle, Plastic (0574-2008-02) | Padagis US LLC | 0574-2008-02 | 0574-2008 | ANDA064118 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 15 G In 1 Bottle, Plastic (0574-2008-15) | Padagis US LLC | 0574-2008-15 | 0574-2008 | ANDA064118 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 30 G In 1 Bottle, Plastic (0574-2008-30) | Padagis US LLC | 0574-2008-30 | 0574-2008 | ANDA064118 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 3785 Ml In 1 Bottle (51672-4117-0) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4117-0 | 51672-4117 | ANDA062876 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 1 Bottle, Dropper In 1 Carton (51672-4117-4) / 60 Ml In 1 Bottle, Dropper | Taro Pharmaceuticals U.S.A., Inc. | 51672-4117-4 | 51672-4117 | ANDA062876 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 473 Ml In 1 Bottle (51672-4117-9) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4117-9 | 51672-4117 | ANDA062876 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (51672-1289-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1289-1 | 51672-1289 | ANDA064022 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (51672-1289-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1289-2 | 51672-1289 | ANDA064022 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 5 Tray In 1 Case (66689-037-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-037-01) | VistaPharm, LLC | 66689-037-50 | 66689-037 | ANDA064142 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 10 Tray In 1 Case (66689-037-99) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-037-01) | VistaPharm, LLC | 66689-037-99 | 66689-037 | ANDA064142 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 60 Ml In 1 Bottle (66689-008-02) | VistaPharm, LLC | 66689-008-02 | 66689-008 | ANDA064142 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 237 Ml In 1 Bottle (66689-008-08) | VistaPharm, LLC | 66689-008-08 | 66689-008 | ANDA064142 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 480 Ml In 1 Bottle (66689-008-16) | VistaPharm, LLC | 66689-008-16 | 66689-008 | ANDA064142 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 473 Ml In 1 Bottle (69315-504-47) | Leading Pharma, LLC | 69315-504-47 | 69315-504 | ANDA214346 | ANDA | N/A |
| Nystatin | Suspension | Oral | 100000[USP'U]/mL | 1 Bottle In 1 Package (69315-504-60) / 60 Ml In 1 Bottle | Leading Pharma, LLC | 69315-504-60 | 69315-504 | ANDA214346 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 15 G In 1 Bottle, Plastic (69315-306-15) | Leading Pharma, LLC | 69315-306-15 | 69315-306 | ANDA208838 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 30 G In 1 Bottle, Plastic (69315-306-30) | Leading Pharma, LLC | 69315-306-30 | 69315-306 | ANDA208838 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000[USP'U]/g | 60 G In 1 Bottle, Plastic (69315-306-60) | Leading Pharma, LLC | 69315-306-60 | 69315-306 | ANDA208838 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (69315-307-15) / 15 G In 1 Tube | Leading Pharma, LLC | 69315-307-15 | 69315-307 | ANDA209082 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (69315-307-30) / 30 G In 1 Tube | Leading Pharma, LLC | 69315-307-30 | 69315-307 | ANDA209082 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (0713-0678-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0678-15 | 0713-0678 | ANDA061966 | ANDA | N/A |
| Nystatin | Cream | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (0713-0678-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0678-31 | 0713-0678 | ANDA061966 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (0713-0686-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0686-15 | 0713-0686 | ANDA209114 | ANDA | N/A |
| Nystatin | Ointment | Topical | 100000[USP'U]/g | 1 Tube In 1 Carton (0713-0686-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0686-31 | 0713-0686 | ANDA209114 | ANDA | N/A |
| Lithium | SOLUTION | ORAL | 8meq/5mL | 5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05) | Saptalis Pharmaceuticals, LLC. | 71656-072-50 | 71656-072 | ANDA217183 | ANDA | N/A |
| Lithium Carbonate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (62559-280-01) | ANI Pharmaceuticals, Inc. | 62559-280-01 | 62559-280 | NDA018027 | NDA | N/A |
| lithium carbonate | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (31722-544-01) | Camber Pharmaceuticals, Inc. | 31722-544-01 | 31722-544 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (31722-544-05) | Camber Pharmaceuticals, Inc. | 31722-544-05 | 31722-544 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 150mg/1 | 1000 Capsule In 1 Bottle (31722-544-10) | Camber Pharmaceuticals, Inc. | 31722-544-10 | 31722-544 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (31722-544-30) | Camber Pharmaceuticals, Inc. | 31722-544-30 | 31722-544 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (31722-545-01) | Camber Pharmaceuticals, Inc. | 31722-545-01 | 31722-545 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Blister Pack (31722-545-03) | Camber Pharmaceuticals, Inc. | 31722-545-03 | 31722-545 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (31722-545-05) | Camber Pharmaceuticals, Inc. | 31722-545-05 | 31722-545 | ANDA090702 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-880-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-880-14 | 45802-880 | ANDA208479 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-880-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-880-94 | 45802-880 | ANDA208479 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-880-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-880-96 | 45802-880 | ANDA208479 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-244-14) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-244-14 | 45802-244 | ANDA207380 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-244-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-244-94 | 45802-244 | ANDA207380 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (45802-244-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-244-96 | 45802-244 | ANDA207380 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1263-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1263-1 | 51672-1263 | ANDA062364 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1263-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1263-2 | 51672-1263 | ANDA062364 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Cream | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1263-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1263-3 | 51672-1263 | ANDA062364 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1272-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1272-1 | 51672-1272 | ANDA063305 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1272-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1272-2 | 51672-1272 | ANDA063305 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (51672-1272-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1272-3 | 51672-1272 | ANDA063305 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle (31722-545-10) | Camber Pharmaceuticals, Inc. | 31722-545-10 | 31722-545 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (31722-545-30) | Camber Pharmaceuticals, Inc. | 31722-545-30 | 31722-545 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 300mg/1 | 5000 Capsule In 1 Bottle (31722-545-50) | Camber Pharmaceuticals, Inc. | 31722-545-50 | 31722-545 | ANDA090702 | ANDA | N/A |
| Oatmeal | Ointment | Topical | 10mg/g | 1 Jar In 1 Box (79265-8655-1) / 113 G In 1 Jar | Babo Botanicals, Inc. | 79265-8655-1 | 79265-8655 | M016 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Lotion | Topical | 10mg/g | 85 G In 1 Tube (59062-1303-1) | KAS Direct LLC dba BabyGanics | 59062-1303-1 | 59062-1303 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Lotion/Shampoo | Topical | 10mg/mL | 14 Ml In 1 Tube (52915-010-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-010-05 | 52915-010 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Lotion/Shampoo | Topical | 10mg/mL | 562 Ml In 1 Bottle, Pump (52915-010-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-010-19 | 52915-010 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Lotion/Shampoo | Topical | 10mg/mL | 251 Ml In 1 Bottle, Plastic (52915-010-85) | ORGANIC & SUSTAINABLE BEAUTY | 52915-010-85 | 52915-010 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Cream | Topical | 10mg/mL | 57 Ml In 1 Jar (52915-120-02) | ORGANIC & SUSTAINABLE BEAUTY | 52915-120-02 | 52915-120 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Cream | Topical | 10mg/mL | 14 Ml In 1 Tube (52915-120-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-120-05 | 52915-120 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Cream | Topical | 10mg/mL | 133 Ml In 1 Container (52915-120-45) | ORGANIC & SUSTAINABLE BEAUTY | 52915-120-45 | 52915-120 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Lotion | Topical | 10mg/g | 226 G In 1 Tube (59062-1305-8) | KAS Direct LLC dba BabyGanics | 59062-1305-8 | 59062-1305 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Lotion | Topical | 50mg/g | 1 Tube In 1 Box (59062-1743-1) / 28.35 G In 1 Tube | KAS Direct LLC dba BabyGanics | 59062-1743-1 | 59062-1743 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Cream | Topical | 1.3g/1.3g | 113 G In 1 Jar (72400-203-04) | Era Organics, Inc. | 72400-203-04 | 72400-203 | M006 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Cream | Topical | 1.3g/1.3g | 227 G In 1 Jar (72400-203-08) | Era Organics, Inc. | 72400-203-08 | 72400-203 | M006 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Ointment | Topical | 10mg/mL | 10 Ml In 1 Box (82590-030-02) | Satya Organic Inc. | 82590-030-02 | 82590-030 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Ointment | Topical | 10mg/mL | 30 Ml In 1 Tube (82590-030-01) | Satya Organic Inc. | 82590-030-01 | 82590-030 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Ointment | Topical | 10mg/mL | 60 Ml In 1 Pouch (82590-030-03) | Satya Organic Inc. | 82590-030-03 | 82590-030 | M016 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (43251-9020-1) / 56 G In 1 Tube | LaCorium Health USA Inc | 43251-9020-1 | 43251-9020 | M016 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Cream | Topical | 50mg/g | 1 G In 1 Packet (43251-9020-2) | LaCorium Health USA Inc | 43251-9020-2 | 43251-9020 | M016 | OTC MONOGRAPH DRUG | N/A |
| Oatmeal | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (43251-4904-1) / 40 G In 1 Tube | LaCorium Health USA Inc. | 43251-4904-1 | 43251-4904 | part347 | OTC MONOGRAPH FINAL | N/A |
| Oatmeal | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (43251-4927-1) / 56 G In 1 Tube | LaCorium Health USA Inc | 43251-4927-1 | 43251-4927 | M016 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-859-01) | BEL STAR S A | 14141-859-01 | 14141-859 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-858-01) | BEL STAR S A | 14141-858-01 | 14141-858 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-862-01) | BEL STAR S A | 14141-862-01 | 14141-862 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-854-01) | BEL STAR S A | 14141-854-01 | 14141-854 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-855-01) | BEL STAR S A | 14141-855-01 | 14141-855 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-860-01) | BEL STAR S A | 14141-860-01 | 14141-860 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-861-01) | BEL STAR S A | 14141-861-01 | 14141-861 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate | Powder | Topical | 5g/100g | 7 G In 1 Carton (14141-857-01) | BEL STAR S A | 14141-857-01 | 14141-857 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-258-02) / 30 Ml In 1 Tube (42627-258-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-258-02 | 42627-258 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-264-02) / 30 Ml In 1 Tube (42627-264-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-264-02 | 42627-264 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-255-02) / 30 Ml In 1 Tube (42627-255-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-255-02 | 42627-255 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-256-02) / 30 Ml In 1 Tube (42627-256-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-256-02 | 42627-256 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-260-02) / 30 Ml In 1 Tube (42627-260-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-260-02 | 42627-260 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-257-02) / 30 Ml In 1 Tube (42627-257-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-257-02 | 42627-257 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-254-02) / 30 Ml In 1 Tube (42627-254-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-254-02 | 42627-254 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Titanium Dioxide | Emulsion | Topical | 7g/100mL, 4 g/100mL, 4 g/100mL | 1 Tube In 1 Carton (42627-261-02) / 30 Ml In 1 Tube (42627-261-01) | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-261-02 | 42627-261 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Zinc Oxide | Lotion | Topical | 7.5g/100mL, 5 g/100mL, 7 g/100mL | 100 Ml In 1 Bottle (70712-101-11) | BOTANICAL SCIENCE, INC. | 70712-101-11 | 70712-101 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Octisalate; Zinc Oxide | Spray | Topical | 75mg/mL, 50 mg/mL, 112 mg/mL | 177 Ml In 1 Bottle, Dispensing (59062-1207-1) | KAS Direct LLC dba BabyGanics | 59062-1207-1 | 59062-1207 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Zinc Oxide | Spray | Topical | 50mg/mL, 40 mg/mL, 112 mg/mL | 177 Ml In 1 Bottle, Dispensing (59062-1229-1) | KAS Direct LLC dba BabyGanics | 59062-1229-1 | 59062-1229 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Octisalate; Zinc Oxide | Lotion | Topical | 7.5g/100mL, 5 g/100mL, 7 g/100mL | 87 Ml In 1 Bottle (70712-102-11) | Botanical Science Technologies | 70712-102-11 | 70712-102 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-201-01) | Bel Star S.A. (Colombia) | 14141-201-01 | 14141-201 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-202-01) | Bel Star S.A. (Colombia) | 14141-202-01 | 14141-202 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-203-01) | Bel Star S.A. (Colombia) | 14141-203-01 | 14141-203 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-204-01) | Bel Star S.A. (Colombia) | 14141-204-01 | 14141-204 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-205-01) | Bel Star S.A. (Colombia) | 14141-205-01 | 14141-205 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Titanium Dioxide; Zinc Oxide | Powder | Topical | 3g/100g, 6.24 g/100g, 4.9 g/100g | 10 G In 1 Bottle (14141-206-01) | Bel Star S.A. (Colombia) | 14141-206-01 | 14141-206 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-207-01) | BEL STAR S A | 14141-207-01 | 14141-207 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-208-01) | BEL STAR S A | 14141-208-01 | 14141-208 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-209-01) | BEL STAR S A | 14141-209-01 | 14141-209 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-210-01) | BEL STAR S A | 14141-210-01 | 14141-210 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-211-01) | BEL STAR S A | 14141-211-01 | 14141-211 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Paste | Topical | 7.5g/100g, 7.84 g/100g | 9 G In 1 Case (14141-212-01) | BEL STAR S A | 14141-212-01 | 14141-212 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-218-01) | Bel Star S.A. (Colombia) | 14141-218-01 | 14141-218 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-217-01) | Bel Star S.A. (Colombia) | 14141-217-01 | 14141-217 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-219-01) | Bel Star S.A. (Colombia) | 14141-219-01 | 14141-219 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-215-01) | Bel Star S.A. (Colombia) | 14141-215-01 | 14141-215 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-216-01) | Bel Star S.A. (Colombia) | 14141-216-01 | 14141-216 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 7g/100mL, 7.2 g/100mL | 26 Ml In 1 Jar (14141-220-01) | Bel Star S.A. (Colombia) | 14141-220-01 | 14141-220 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-348-01) / 3 G In 1 Tube | BEL STAR S A | 14141-348-01 | 14141-348 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-349-01) / 3 G In 1 Tube | BEL STAR S A | 14141-349-01 | 14141-349 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-309-01) / 3 G In 1 Tube | BEL STAR S A | 14141-309-01 | 14141-309 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-306-01) / 3 G In 1 Tube | BEL STAR S A | 14141-306-01 | 14141-306 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-308-01) / 3 G In 1 Tube | BEL STAR S A | 14141-308-01 | 14141-308 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 25mg/g, 39.2 mg/g | 1 Tube In 1 Carton (14141-307-01) / 3 G In 1 Tube | BEL STAR S A | 14141-307-01 | 14141-307 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-030-01) / 30 G In 1 Tube | BEL STAR S A | 14141-030-01 | 14141-030 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-033-01) / 30 G In 1 Tube | BEL STAR S A | 14141-033-01 | 14141-033 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-026-01) / 30 G In 1 Tube | BEL STAR S A | 14141-026-01 | 14141-026 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-023-01) / 30 G In 1 Tube | BEL STAR S A | 14141-023-01 | 14141-023 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-035-01) / 30 G In 1 Tube | BEL STAR S A | 14141-035-01 | 14141-035 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-240-01) / 30 G In 1 Tube | BEL STAR S A | 14141-240-01 | 14141-240 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-139-01) / 30 G In 1 Tube | BEL STAR S A | 14141-139-01 | 14141-139 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-138-01) / 30 G In 1 Tube | BEL STAR S A | 14141-138-01 | 14141-138 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-034-01) / 30 G In 1 Tube | BEL STAR S A | 14141-034-01 | 14141-034 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-029-01) / 30 G In 1 Tube | BEL STAR S A | 14141-029-01 | 14141-029 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-024-01) / 30 G In 1 Tube | BEL STAR S A | 14141-024-01 | 14141-024 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-037-01) / 30 G In 1 Tube | BEL STAR S A | 14141-037-01 | 14141-037 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-141-01) / 30 G In 1 Tube | BEL STAR S A | 14141-141-01 | 14141-141 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-032-01) / 30 G In 1 Tube | BEL STAR S A | 14141-032-01 | 14141-032 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-242-01) / 30 G In 1 Tube | BEL STAR S A | 14141-242-01 | 14141-242 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-028-01) / 30 G In 1 Tube | BEL STAR S A | 14141-028-01 | 14141-028 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-027-01) / 30 G In 1 Tube | BEL STAR S A | 14141-027-01 | 14141-027 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-036-01) / 30 G In 1 Tube | BEL STAR S A | 14141-036-01 | 14141-036 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-031-01) / 30 G In 1 Tube | BEL STAR S A | 14141-031-01 | 14141-031 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 40mg/g, 24 mg/g | 1 Tube In 1 Box (14141-025-01) / 30 G In 1 Tube | BEL STAR S A | 14141-025-01 | 14141-025 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-329-01) / 26 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-329-01 | 14141-329 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-328-01) / 26 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-328-01 | 14141-328 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-330-01) / 26 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-330-01 | 14141-330 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-326-01) / 26 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-326-01 | 14141-326 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-327-01) / 26 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-327-01 | 14141-327 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 29.4 mg/g | 1 Tube In 1 Box (14141-344-01) / 27 G In 1 Tube | BEL STAR S A | 14141-344-01 | 14141-344 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 29.4 mg/mL | 1 Tube In 1 Box (14141-312-01) / 27 Ml In 1 Tube | BEL STAR S A | 14141-312-01 | 14141-312 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 29.4 mg/g | 1 Tube In 1 Box (14141-343-01) / 27 G In 1 Tube | BEL STAR S A | 14141-343-01 | 14141-343 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 29.4 mg/mL | 1 Tube In 1 Box (14141-311-01) / 27 Ml In 1 Tube | BEL STAR S A | 14141-311-01 | 14141-311 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 29.4 mg/g | 1 Tube In 1 Box (14141-345-01) / 27 G In 1 Tube | BEL STAR S A | 14141-345-01 | 14141-345 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 29.4 mg/mL | 1 Tube In 1 Box (14141-313-01) / 27 Ml In 1 Tube | BEL STAR S A | 14141-313-01 | 14141-313 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 29.4 mg/g | 1 Tube In 1 Box (14141-346-01) / 27 G In 1 Tube | BEL STAR S A | 14141-346-01 | 14141-346 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 29.4 mg/mL | 1 Tube In 1 Box (14141-314-01) / 27 Ml In 1 Tube | BEL STAR S A | 14141-314-01 | 14141-314 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 29.4 mg/g | 1 Tube In 1 Box (14141-347-01) / 27 G In 1 Tube | BEL STAR S A | 14141-347-01 | 14141-347 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 29.4 mg/mL | 1 Tube In 1 Box (14141-310-01) / 27 Ml In 1 Tube | BEL STAR S A | 14141-310-01 | 14141-310 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 49 mg/g | 1 Tube In 1 Box (14141-338-01) / 27 G In 1 Tube | BEL STAR S.A. | 14141-338-01 | 14141-338 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 49 mg/g | 1 Tube In 1 Box (14141-339-01) / 27 G In 1 Tube | BEL STAR S.A. | 14141-339-01 | 14141-339 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 49 mg/g | 1 Tube In 1 Box (14141-340-01) / 27 G In 1 Tube | BEL STAR S.A. | 14141-340-01 | 14141-340 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 49 mg/g | 1 Tube In 1 Box (14141-341-01) / 27 G In 1 Tube | BEL STAR S.A. | 14141-341-01 | 14141-341 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/g, 49 mg/g | 1 Tube In 1 Box (14141-342-01) / 27 G In 1 Tube | BEL STAR S.A. | 14141-342-01 | 14141-342 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Tube In 1 Box (14141-318-01) / 27 Ml In 1 Tube | Bel Star S.A. | 14141-318-01 | 14141-318 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Tube In 1 Box (14141-319-01) / 27 Ml In 1 Tube | Bel Star S.A. | 14141-319-01 | 14141-319 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Tube In 1 Box (14141-320-01) / 27 Ml In 1 Tube | Bel Star S.A. | 14141-320-01 | 14141-320 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Tube In 1 Box (14141-317-01) / 27 Ml In 1 Tube | Bel Star S.A. | 14141-317-01 | 14141-317 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Tube In 1 Box (14141-316-01) / 27 Ml In 1 Tube | Bel Star S.A. | 14141-316-01 | 14141-316 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-017-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-017-01 | 14141-017 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-018-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-018-01 | 14141-018 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-019-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-019-01 | 14141-019 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-020-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-020-01 | 14141-020 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-021-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-021-01 | 14141-021 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 60mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-022-01) / 26 Ml In 1 Bottle, Glass | Bel Star S.A. | 14141-022-01 | 14141-022 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Bottle, Glass In 1 Box (14141-325-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-325-01 | 14141-325 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Bottle, Glass In 1 Box (14141-324-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-324-01 | 14141-324 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Bottle, Glass In 1 Box (14141-322-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-322-01 | 14141-322 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Bottle, Glass In 1 Box (14141-321-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-321-01 | 14141-321 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 50mg/mL, 42 mg/mL | 1 Bottle, Glass In 1 Box (14141-323-01) / 30 Ml In 1 Bottle, Glass | BEL STAR SA | 14141-323-01 | 14141-323 | M020 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Liquid | Topical | 45mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-336-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S.A. | 14141-336-01 | 14141-336 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Liquid | Topical | 45mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-335-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S.A. | 14141-335-01 | 14141-335 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Liquid | Topical | 45mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-337-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S.A. | 14141-337-01 | 14141-337 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Liquid | Topical | 45mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-333-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S.A. | 14141-333-01 | 14141-333 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Liquid | Topical | 45mg/mL, 29.4 mg/mL | 1 Bottle, Glass In 1 Box (14141-334-01) / 30 Ml In 1 Bottle, Glass | BEL STAR S.A. | 14141-334-01 | 14141-334 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-224-01) | Bel Star S.A. (Colombia) | 14141-224-01 | 14141-224 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-223-01) | Bel Star S.A. (Colombia) | 14141-223-01 | 14141-223 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-225-01) | Bel Star S.A. (Colombia) | 14141-225-01 | 14141-225 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-221-01) | Bel Star S.A. (Colombia) | 14141-221-01 | 14141-221 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-222-01) | Bel Star S.A. (Colombia) | 14141-222-01 | 14141-222 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Emulsion | Topical | 5g/100mL, 4.2 g/100mL | 30 Ml In 1 Jar (14141-226-01) | Bel Star S.A. (Colombia) | 14141-226-01 | 14141-226 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 4g/100g, 2.4 g/100g | 30 G In 1 Tube (14141-863-01) | BEL STAR S A | 14141-863-01 | 14141-863 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 4g/100g, 2.4 g/100g | 30 G In 1 Tube (14141-869-01) | BEL STAR S A | 14141-869-01 | 14141-869 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-456-01) | BEL STAR S A | 14141-456-01 | 14141-456 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-453-01) | BEL STAR S A | 14141-453-01 | 14141-453 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-457-01) | BEL STAR S A | 14141-457-01 | 14141-457 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-452-01) | BEL STAR S A | 14141-452-01 | 14141-452 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-454-01) | BEL STAR S A | 14141-454-01 | 14141-454 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Stick | Topical | 7.5g/100g, 4.9 g/100g | 4 G In 1 Carton (14141-455-01) | BEL STAR S A | 14141-455-01 | 14141-455 | part352 | OTC MONOGRAPH FINAL | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 60 mg/mL | 1 Jar In 1 Box (15751-2235-1) / 35 Ml In 1 Jar | Eminence Organic Skin Care | 15751-2235-1 | 15751-2235 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 6g/100g, 4.5 g/100g | 1 Jar In 1 Box (15751-2272-2) / 60 G In 1 Jar | Eminence Organic Skin Care | 15751-2272-2 | 15751-2272 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 6g/100g, 4.5 g/100g | 1 Tube In 1 Box (15751-2272-5) / 15 G In 1 Tube | Eminence Organic Skin Care | 15751-2272-5 | 15751-2272 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 6g/100g, 4.5 g/100g | 1 Jar In 1 Box (15751-2272-8) / 250 G In 1 Jar | Eminence Organic Skin Care | 15751-2272-8 | 15751-2272 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 45 mg/mL | 1 Jar In 1 Box (15751-2286-2) / 60 Ml In 1 Jar | Eminence Organic Skin Care | 15751-2286-2 | 15751-2286 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 45 mg/mL | 1 Jar In 1 Box (15751-2286-4) / 125 Ml In 1 Jar | Eminence Organic Skin Care | 15751-2286-4 | 15751-2286 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 50 mg/mL | 1 Tube In 1 Box (15751-2222-5) / 147 Ml In 1 Tube | Eminence Organic Skin Care | 15751-2222-5 | 15751-2222 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 50 mg/mL | 1 Jar In 1 Box (15751-2223-1) / 15 Ml In 1 Jar | Eminence Organic Skin Care | 15751-2223-1 | 15751-2223 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 50 mg/mL | 60 Ml In 1 Jar (15751-2223-2) | Eminence Organic Skin Care | 15751-2223-2 | 15751-2223 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 50 mg/mL | 125 Ml In 1 Jar (15751-2223-4) | Eminence Organic Skin Care | 15751-2223-4 | 15751-2223 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octinoxate; Zinc Oxide | Cream | Topical | 60mg/mL, 60 mg/mL | 1 Jar In 1 Box (15751-2259-1) / 35 Ml In 1 Jar | Eminence Organic Skin Care | 15751-2259-1 | 15751-2259 | M020 | OTC MONOGRAPH DRUG | N/A |
| Octisalate; Octocrylene; Zinc Oxide | Spray | Topical | 50mg/mL, 60 mg/mL, 112 mg/mL | 177 Ml In 1 Bottle, Dispensing (59062-0120-1) | KAS Direct LLC dba Babyganics | 59062-0120-1 | 59062-0120 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 354 Ml In 1 Tube (59062-1100-1) | KAS Direct LLC dba BabyGanics | 59062-1100-1 | 59062-1100 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 59 Ml In 1 Tube (59062-1100-2) | KAS Direct LLC dba BabyGanics | 59062-1100-2 | 59062-1100 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 177 Ml In 1 Tube (59062-1100-6) | KAS Direct LLC dba BabyGanics | 59062-1100-6 | 59062-1100 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 354 Ml In 1 Tube (59062-1000-1) | KAS Direct LLC dba BabyGanics | 59062-1000-1 | 59062-1000 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 59 Ml In 1 Tube (59062-1000-2) | KAS Direct LLC dba BabyGanics | 59062-1000-2 | 59062-1000 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 177 Ml In 1 Tube (59062-1000-6) | KAS Direct LLC dba BabyGanics | 59062-1000-6 | 59062-1000 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Titanium Dioxide; Zinc Oxide | Lotion | Topical | 50mg/mL, 30 mg/mL, 60 mg/mL | 236 Ml In 1 Tube (59062-1000-8) | KAS Direct LLC dba BabyGanics | 59062-1000-8 | 59062-1000 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Zinc Oxide | Spray | Topical | 50mg/g, 150 mg/g | 2 Can In 1 Cello Pack (59062-0175-2) / 170 G In 1 Can | KAS Direct LLC dba BabyGanics | 59062-0175-2 | 59062-0175 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octisalate; Zinc Oxide | Spray | Topical | 50mg/g, 150 mg/g | 170 G In 1 Can (59062-0175-6) | KAS Direct LLC dba BabyGanics | 59062-0175-6 | 59062-0175 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 50ug/mL | 10 Vial In 1 Carton (25021-463-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-463-01 | 25021-463 | ANDA090834 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 100ug/mL | 10 Vial In 1 Carton (25021-464-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-464-01 | 25021-464 | ANDA090834 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 500ug/mL | 10 Vial In 1 Carton (25021-465-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-465-01 | 25021-465 | ANDA090834 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 200ug/mL | 1 Vial In 1 Carton (25021-466-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-466-05 | 25021-466 | ANDA091041 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 1000ug/mL | 1 Vial In 1 Carton (25021-467-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-467-05 | 25021-467 | ANDA091041 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 50ug/mL | 10 Vial, Single-Dose In 1 Carton (0641-6174-10) / 1 Ml In 1 Vial, Single-Dose (0641-6174-01) | Hikma Pharmaceuticals USA Inc. | 0641-6174-10 | 0641-6174 | ANDA076313 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 100ug/mL | 10 Vial, Single-Dose In 1 Carton (0641-6175-10) / 1 Ml In 1 Vial, Single-Dose (0641-6175-01) | Hikma Pharmaceuticals USA Inc. | 0641-6175-10 | 0641-6175 | ANDA076313 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 500ug/mL | 10 Vial, Single-Dose In 1 Carton (0641-6176-10) / 1 Ml In 1 Vial, Single-Dose (0641-6176-01) | Hikma Pharmaceuticals USA Inc. | 0641-6176-10 | 0641-6176 | ANDA076313 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 200ug/mL | 1 Vial, Multi-Dose In 1 Carton (0641-6177-01) / 5 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0641-6177-01 | 0641-6177 | ANDA076330 | ANDA | N/A |
| Octreotide Acetate | Injection, Solution | Intravenous; Subcutaneous | 1000ug/mL | 1 Vial, Multi-Dose In 1 Carton (0641-6178-01) / 5 Ml In 1 Vial, Multi-Dose | Hikma Pharmaceuticals USA Inc. | 0641-6178-01 | 0641-6178 | ANDA076330 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 100 Tablet, Coated In 1 Bottle (75834-112-01) | Nivagen Pharmaceuticals, Inc. | 75834-112-01 | 75834-112 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 500 Tablet, Coated In 1 Bottle (75834-112-05) | Nivagen Pharmaceuticals, Inc. | 75834-112-05 | 75834-112 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 50 Tablet, Coated In 1 Bottle (75834-112-50) | Nivagen Pharmaceuticals, Inc. | 75834-112-50 | 75834-112 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 100 Tablet, Coated In 1 Bottle (75834-119-01) | Nivagen Pharmaceuticals, Inc. | 75834-119-01 | 75834-119 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 500 Tablet, Coated In 1 Bottle (75834-119-05) | Nivagen Pharmaceuticals, Inc. | 75834-119-05 | 75834-119 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 50 Tablet, Coated In 1 Bottle (75834-119-50) | Nivagen Pharmaceuticals, Inc. | 75834-119-50 | 75834-119 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 100 Tablet, Coated In 1 Bottle (75834-120-01) | Nivagen Pharmaceuticals, Inc. | 75834-120-01 | 75834-120 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 500 Tablet, Coated In 1 Bottle (75834-120-05) | Nivagen Pharmaceuticals, Inc. | 75834-120-05 | 75834-120 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 50 Tablet, Coated In 1 Bottle (75834-120-50) | Nivagen Pharmaceuticals, Inc. | 75834-120-50 | 75834-120 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 100 Tablet, Coated In 1 Bottle (75834-199-01) | Nivagen Pharmaceuticals, Inc. | 75834-199-01 | 75834-199 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 500 Tablet, Coated In 1 Bottle (75834-199-05) | Nivagen Pharmaceuticals, Inc. | 75834-199-05 | 75834-199 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 200mg/1 | 50 Tablet, Coated In 1 Bottle (75834-199-50) | Nivagen Pharmaceuticals, Inc. | 75834-199-50 | 75834-199 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 100 Tablet, Coated In 1 Bottle (75834-200-01) | Nivagen Pharmaceuticals, Inc. | 75834-200-01 | 75834-200 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 500 Tablet, Coated In 1 Bottle (75834-200-05) | Nivagen Pharmaceuticals, Inc. | 75834-200-05 | 75834-200 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 300mg/1 | 50 Tablet, Coated In 1 Bottle (75834-200-50) | Nivagen Pharmaceuticals, Inc. | 75834-200-50 | 75834-200 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 100 Tablet, Coated In 1 Bottle (75834-201-01) | Nivagen Pharmaceuticals, Inc. | 75834-201-01 | 75834-201 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 500 Tablet, Coated In 1 Bottle (75834-201-05) | Nivagen Pharmaceuticals, Inc. | 75834-201-05 | 75834-201 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Tablet, Coated | Oral | 400mg/1 | 50 Tablet, Coated In 1 Bottle (75834-201-50) | Nivagen Pharmaceuticals, Inc. | 75834-201-50 | 75834-201 | ANDA091656 | ANDA | N/A |
| Ofloxacin | Solution/ Drops | Ophthalmic | 3mg/mL | 1 Bottle In 1 Carton (70069-411-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-411-01 | 70069-411 | ANDA213597 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 5 Ml In 1 Bottle, Dropper (69315-320-05) | Leading Pharma, LLC | 69315-320-05 | 69315-320 | ANDA217903 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 10 Ml In 1 Bottle, Dropper (69315-320-10) | Leading Pharma, LLC | 69315-320-10 | 69315-320 | ANDA217903 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 5 Ml In 1 Bottle, Dropper (69315-327-05) | Leading Pharma, LLC | 69315-327-05 | 69315-327 | ANDA217904 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 10 Ml In 1 Bottle, Dropper (69315-327-10) | Leading Pharma, LLC | 69315-327-10 | 69315-327 | ANDA217904 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0560-0) / 5 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0560-0 | 60505-0560 | ANDA076513 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Dropper In 1 Carton (60505-0560-1) / 10 Ml In 1 Bottle, Dropper | Apotex Corp. | 60505-0560-1 | 60505-0560 | ANDA076513 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 5 Ml In 1 Bottle, Dropper (60505-0363-1) | Apotex Corp. | 60505-0363-1 | 60505-0363 | ANDA076527 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 10 Ml In 1 Bottle, Dropper (60505-0363-2) | Apotex Corp. | 60505-0363-2 | 60505-0363 | ANDA076527 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 600mg/1 | 100 Capsule In 1 Bottle (31722-546-01) | Camber Pharmaceuticals, Inc. | 31722-546-01 | 31722-546 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 600mg/1 | 500 Capsule In 1 Bottle (31722-546-05) | Camber Pharmaceuticals, Inc. | 31722-546-05 | 31722-546 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 600mg/1 | 1000 Capsule In 1 Bottle (31722-546-10) | Camber Pharmaceuticals, Inc. | 31722-546-10 | 31722-546 | ANDA090702 | ANDA | N/A |
| lithium carbonate | Capsule | Oral | 600mg/1 | 30 Capsule In 1 Bottle (31722-546-30) | Camber Pharmaceuticals, Inc. | 31722-546-30 | 31722-546 | ANDA090702 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (66993-680-30) | Prasco Laboratories | 66993-680-30 | 66993-680 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (66993-681-30) | Prasco Laboratories | 66993-681-30 | 66993-681 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (66993-682-30) | Prasco Laboratories | 66993-682-30 | 66993-682 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (66993-683-30) | Prasco Laboratories | 66993-683-30 | 66993-683 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (66993-684-30) | Prasco Laboratories | 66993-684-30 | 66993-684 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (66993-685-30) | Prasco Laboratories | 66993-685-30 | 66993-685 | ANDA202050 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 5mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (51407-261-30) | Golden State Medical Supply, Inc. | 51407-261-30 | 51407-261 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 10mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (51407-262-30) | Golden State Medical Supply, Inc. | 51407-262-30 | 51407-262 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 15mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (51407-263-30) | Golden State Medical Supply, Inc. | 51407-263-30 | 51407-263 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 20mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (51407-264-30) | Golden State Medical Supply, Inc. | 51407-264-30 | 51407-264 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 2.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-620-10) | Golden State Medical Supply, Inc. | 60429-620-10 | 60429-620 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-620-30) | Golden State Medical Supply, Inc. | 60429-620-30 | 60429-620 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-621-10) | Golden State Medical Supply, Inc. | 60429-621-10 | 60429-621 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-621-30) | Golden State Medical Supply, Inc. | 60429-621-30 | 60429-621 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 7.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-622-10) | Golden State Medical Supply, Inc. | 60429-622-10 | 60429-622 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 7.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-622-30) | Golden State Medical Supply, Inc. | 60429-622-30 | 60429-622 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-623-10) | Golden State Medical Supply, Inc. | 60429-623-10 | 60429-623 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-623-30) | Golden State Medical Supply, Inc. | 60429-623-30 | 60429-623 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 15mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-624-10) | Golden State Medical Supply, Inc. | 60429-624-10 | 60429-624 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-624-30) | Golden State Medical Supply, Inc. | 60429-624-30 | 60429-624 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-625-10) | Golden State Medical Supply, Inc. | 60429-625-10 | 60429-625 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-625-30) | Golden State Medical Supply, Inc. | 60429-625-30 | 60429-625 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 2.5mg/1 | 10 Blister Pack In 1 Carton (60505-3110-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3110-0 | 60505-3110 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3110-3) | Apotex Corp. | 60505-3110-3 | 60505-3110 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 2.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3110-8) | Apotex Corp. | 60505-3110-8 | 60505-3110 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (60505-3111-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3111-0 | 60505-3111 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3111-8) | Apotex Corp. | 60505-3111-8 | 60505-3111 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 7.5mg/1 | 10 Blister Pack In 1 Carton (60505-3112-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3112-0 | 60505-3112 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 7.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3112-8) | Apotex Corp. | 60505-3112-8 | 60505-3112 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (60505-3113-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3113-0 | 60505-3113 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3113-8) | Apotex Corp. | 60505-3113-8 | 60505-3113 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 15mg/1 | 10 Blister Pack In 1 Carton (60505-3114-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3114-0 | 60505-3114 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3114-3) | Apotex Corp. | 60505-3114-3 | 60505-3114 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 15mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3114-8) | Apotex Corp. | 60505-3114-8 | 60505-3114 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (60505-3140-0) / 10 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3140-0 | 60505-3140 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-3140-3) | Apotex Corp. | 60505-3140-3 | 60505-3140 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-3140-8) | Apotex Corp. | 60505-3140-8 | 60505-3140 | ANDA090798 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (60505-3275-0) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Apotex Corp. | 60505-3275-0 | 60505-3275 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 5mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (60505-3275-3) | Apotex Corp. | 60505-3275-3 | 60505-3275 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 5mg/1 | 1000 Tablet, Orally Disintegrating In 1 Bottle (60505-3275-8) | Apotex Corp. | 60505-3275-8 | 60505-3275 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (60505-3276-0) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Apotex Corp. | 60505-3276-0 | 60505-3276 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 10mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (60505-3276-3) | Apotex Corp. | 60505-3276-3 | 60505-3276 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 10mg/1 | 1000 Tablet, Orally Disintegrating In 1 Bottle (60505-3276-8) | Apotex Corp. | 60505-3276-8 | 60505-3276 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 15mg/1 | 10 Blister Pack In 1 Carton (60505-3277-0) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Apotex Corp. | 60505-3277-0 | 60505-3277 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 15mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (60505-3277-3) | Apotex Corp. | 60505-3277-3 | 60505-3277 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 15mg/1 | 1000 Tablet, Orally Disintegrating In 1 Bottle (60505-3277-8) | Apotex Corp. | 60505-3277-8 | 60505-3277 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (60505-3278-0) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Apotex Corp. | 60505-3278-0 | 60505-3278 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 20mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (60505-3278-3) | Apotex Corp. | 60505-3278-3 | 60505-3278 | ANDA091265 | ANDA | N/A |
| Olanzapine | Tablet, Orally Disintegrating | Oral | 20mg/1 | 1000 Tablet, Orally Disintegrating In 1 Bottle (60505-3278-8) | Apotex Corp. | 60505-3278-8 | 60505-3278 | ANDA091265 | ANDA | N/A |
| Olanzapine | Injection, Powder, Lyophilized, For Solution | Intramuscular | 10mg/2mL | 1 Vial, Glass In 1 Carton (0517-0955-01) / 2 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-0955-01 | 0517-0955 | ANDA201741 | ANDA | N/A |
| Olea Europaea Fruit Volatile Oil; Thymol | Ointment | Topical | 3[hp_X]/100g, 6 [hp_X]/100g | 1 Tube In 1 Carton (71042-025-14) / 14.2 G In 1 Tube | Organicare Nature's Science, LLC | 71042-025-14 | 71042-025 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2050-2) | Jubilant HollisterStier LLC | 65044-2050-2 | 65044-2050 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2050-3) | Jubilant HollisterStier LLC | 65044-2050-3 | 65044-2050 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2050-4) | Jubilant HollisterStier LLC | 65044-2050-4 | 65044-2050 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2051-1) | Jubilant HollisterStier LLC | 65044-2051-1 | 65044-2051 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2053-2) | Jubilant HollisterStier LLC | 65044-2053-2 | 65044-2053 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2053-3) | Jubilant HollisterStier LLC | 65044-2053-3 | 65044-2053 | BLA103888 | BLA | N/A |
| Olea Europaea Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2053-4) | Jubilant HollisterStier LLC | 65044-2053-4 | 65044-2053 | BLA103888 | BLA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 450mg/1 | 100 Tablet, Extended Release In 1 Bottle (64980-278-01) | Rising Pharma Holdings, Inc. | 64980-278-01 | 64980-278 | ANDA205663 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (64980-205-01) | Rising Pharmaceuticals, Inc. | 64980-205-01 | 64980-205 | ANDA204779 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-205-03) | Rising Pharmaceuticals, Inc. | 64980-205-03 | 64980-205 | ANDA204779 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (64980-205-05) | Rising Pharmaceuticals, Inc. | 64980-205-05 | 64980-205 | ANDA204779 | ANDA | N/A |
| Lithium Carbonate | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle (64980-205-09) | Rising Pharmaceuticals, Inc. | 64980-205-09 | 64980-205 | ANDA204779 | ANDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 1 Blister Pack In 1 Carton (69230-325-04) / 4 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-04 | 69230-325 | ANDA211438 | ANDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 1 Blister Pack In 1 Carton (69230-325-06) / 6 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-06 | 69230-325 | ANDA211438 | ANDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 2 Blister Pack In 1 Carton (69230-325-08) / 4 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-08 | 69230-325 | ANDA211438 | ANDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 2 Blister Pack In 1 Carton (69230-325-12) / 6 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-12 | 69230-325 | ANDA211438 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-197-30) | Golden State Medical Supply, Inc. | 51407-197-30 | 51407-197 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-198-30) | Golden State Medical Supply, Inc. | 51407-198-30 | 51407-198 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-198-90) | Golden State Medical Supply, Inc. | 51407-198-90 | 51407-198 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-199-30) | Golden State Medical Supply, Inc. | 51407-199-30 | 51407-199 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-199-90) | Golden State Medical Supply, Inc. | 51407-199-90 | 51407-199 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (27808-275-01) | Tris Pharma, Inc. | 27808-275-01 | 27808-275 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (27808-275-02) | Tris Pharma, Inc. | 27808-275-02 | 27808-275 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (27808-276-01) | Tris Pharma, Inc. | 27808-276-01 | 27808-276 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (27808-276-02) | Tris Pharma, Inc. | 27808-276-02 | 27808-276 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (27808-277-01) | Tris Pharma, Inc. | 27808-277-01 | 27808-277 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (27808-277-02) | Tris Pharma, Inc. | 27808-277-02 | 27808-277 | ANDA210552 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0860-30) | Cosette Pharmaceuticals, Inc. | 0713-0860-30 | 0713-0860 | NDA021286 | NDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0861-30) | Cosette Pharmaceuticals, Inc. | 0713-0861-30 | 0713-0861 | NDA021286 | NDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (0713-0862-30) | Cosette Pharmaceuticals, Inc. | 0713-0862-30 | 0713-0862 | NDA021286 | NDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 3 Blister Pack In 1 Carton (69230-325-18) / 6 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-18 | 69230-325 | ANDA211438 | ANDA | N/A |
| Loperamide Hydrochloride and Simethicone | Tablet | Oral | 125mg/1, 2 mg/1 | 4 Blister Pack In 1 Carton (69230-325-24) / 6 Tablet In 1 Blister Pack | Camber Consumer Care Inc | 69230-325-24 | 69230-325 | ANDA211438 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 100mg/1, 25 mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-603-12) | Camber Pharmaceuticals, Inc. | 31722-603-12 | 31722-603 | ANDA091677 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 100mg/1, 25 mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-603-60) | Camber Pharmaceuticals, Inc. | 31722-603-60 | 31722-603 | ANDA091677 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 200mg/1, 50 mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-556-12) | Camber Pharmaceuticals, Inc. | 31722-556-12 | 31722-556 | ANDA091677 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 200mg/1, 50 mg/1 | 8 Blister Pack In 1 Carton (31722-556-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-556-31 | 31722-556 | ANDA091677 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 200mg/1, 50 mg/1 | 8 Blister Pack In 1 Carton (31722-556-32) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-556-32 | 31722-556 | ANDA091677 | ANDA | N/A |
| Lopinavir and ritonavir | Tablet, Film Coated | Oral | 200mg/1, 50 mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-556-60) | Camber Pharmaceuticals, Inc. | 31722-556-60 | 31722-556 | ANDA091677 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (69230-322-12) / 120 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-322-12 | 69230-322 | ANDA210409 | ANDA | N/A |
| Loratadine | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (69230-322-24) / 240 Ml In 1 Bottle | Camber Consumer Care Inc | 69230-322-24 | 69230-322 | ANDA210409 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (69230-323-01) / 10 Tablet In 1 Blister Pack (69230-323-32) | Camber Consumer Care Inc | 69230-323-01 | 69230-323 | ANDA211718 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (69230-323-10) | Camber Consumer Care Inc | 69230-323-10 | 69230-323 | ANDA211718 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-323-30) / 30 Tablet In 1 Bottle | Camber Consumer Care Inc | 69230-323-30 | 69230-323 | ANDA211718 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-323-31) / 108 Tablet In 1 Bottle | Camber Consumer Care Inc | 69230-323-31 | 69230-323 | ANDA211718 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-323-33) / 100 Tablet In 1 Bottle | Camber Consumer Care Inc | 69230-323-33 | 69230-323 | ANDA211718 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-323-34) / 300 Tablet In 1 Bottle | Camber Consumer Care Inc | 69230-323-34 | 69230-323 | ANDA211718 | ANDA | N/A |
| LORATADINE | Tablet | Oral | 10mg/1 | 1 Bottle In 1 Carton (69230-328-01) / 100 Tablet In 1 Bottle | Camber Consumer Care Inc | 69230-328-01 | 69230-328 | ANDA210722 | ANDA | N/A |
| LORATADINE | Tablet | Oral | 10mg/1 | 300 Tablet In 1 Bottle (69230-328-03) | Camber Consumer Care Inc | 69230-328-03 | 69230-328 | ANDA210722 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (16571-822-01) | Rising Pharmaceuticals, Inc | 16571-822-01 | 16571-822 | ANDA214684 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (16571-822-03) | Rising Pharmaceuticals, Inc | 16571-822-03 | 16571-822 | ANDA214684 | ANDA | N/A |
| Loratadine | Tablet | Oral | 10mg/1 | 300 Tablet In 1 Bottle (16571-822-30) | Rising Pharmaceuticals, Inc | 16571-822-30 | 16571-822 | ANDA214684 | ANDA | N/A |
| Lorazepam | Concentrate | Oral | 2mg/mL | 30 Ml In 1 Bottle, Dropper (65162-687-84) | Amneal Pharmaceuticals LLC | 65162-687-84 | 65162-687 | ANDA091383 | ANDA | CIV |
| Lorazepam | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (65162-015-10) | Amneal Pharmaceuticals LLC | 65162-015-10 | 65162-015 | ANDA078826 | ANDA | CIV |
| Lorazepam | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (65162-015-11) | Amneal Pharmaceuticals LLC | 65162-015-11 | 65162-015 | ANDA078826 | ANDA | CIV |
| Olopatadine Hydrochloride | Spray | Nasal | 665ug/1 | 1 Bottle In 1 Carton (45802-104-01) / 240 Spray In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-104-01 | 45802-104 | ANDA202853 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Plastic In 1 Carton (70069-017-01) / 5 Ml In 1 Bottle, Plastic | Somerset Therapeutics, LLC | 70069-017-01 | 70069-017 | ANDA206306 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Plastic In 1 Carton (51407-663-05) / 5 Ml In 1 Bottle, Plastic | Golden State Medical Supply, Inc. | 51407-663-05 | 51407-663 | ANDA078350 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution | Ophthalmic | 2mg/mL | 1 Bottle, Plastic In 1 Carton (21130-105-02) / 2.5 Ml In 1 Bottle, Plastic | Albertsons Companies | 21130-105-02 | 21130-105 | ANDA209752 | ANDA | N/A |
| Olopatadine Hydrochloride | Spray, Metered | Nasal | 665ug/1 | 1 Bottle In 1 Carton (60505-0845-5) / 240 Spray, Metered In 1 Bottle | Apotex Corp. | 60505-0845-5 | 60505-0845 | ANDA091572 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution/ Drops | Ophthalmic | 1mg/mL | 1 Bottle, Plastic In 1 Carton (60505-6221-0) / 5 Ml In 1 Bottle, Plastic | Apotex Corp. | 60505-6221-0 | 60505-6221 | ANDA078350 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution/ Drops | Ophthalmic | 2mg/mL | 1 Bottle, Plastic In 1 Carton (60505-6222-2) / 2.5 Ml In 1 Bottle, Plastic (60505-6222-1) | Apotex Corp. | 60505-6222-2 | 60505-6222 | ANDA090918 | ANDA | N/A |
| Olopatadine Hydrochloride | Solution/ Drops | Ophthalmic | 2mg/mL | 2 Bottle, Plastic In 1 Carton (60505-6222-3) / 2.5 Ml In 1 Bottle, Plastic | Apotex Corp. | 60505-6222-3 | 60505-6222 | ANDA090918 | ANDA | N/A |
| Lorazepam | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (65162-015-50) | Amneal Pharmaceuticals LLC | 65162-015-50 | 65162-015 | ANDA078826 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (65162-017-10) | Amneal Pharmaceuticals LLC | 65162-017-10 | 65162-017 | ANDA078826 | ANDA | CIV |
| Lorazepam | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (65162-017-11) | Amneal Pharmaceuticals LLC | 65162-017-11 | 65162-017 | ANDA078826 | ANDA | CIV |
| Omega-3-Acid Ethyl Esters | Capsule | Oral | 1g/1 | 120 Capsule In 1 Bottle, Plastic (51407-763-12) | Golden State Medical Supply, Inc. | 51407-763-12 | 51407-763 | ANDA091028 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 30 Capsule, Liquid Filled In 1 Bottle (60505-3170-3) | Apotex Corp. | 60505-3170-3 | 60505-3170 | ANDA090973 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 60 Capsule, Liquid Filled In 1 Bottle (60505-3170-6) | Apotex Corp. | 60505-3170-6 | 60505-3170 | ANDA090973 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (60505-3170-7) | Apotex Corp. | 60505-3170-7 | 60505-3170 | ANDA090973 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (60505-4462-7) | Apotex Corp. | 60505-4462-7 | 60505-4462 | ANDA090973 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 900mg/1 | 60 Capsule, Liquid Filled In 1 Bottle (69452-175-17) | Bionpharma Inc. | 69452-175-17 | 69452-175 | ANDA206455 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 900mg/1 | 120 Capsule, Liquid Filled In 1 Bottle (69452-175-22) | Bionpharma Inc. | 69452-175-22 | 69452-175 | ANDA206455 | ANDA | N/A |
| Lorazepam | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (65162-017-50) | Amneal Pharmaceuticals LLC | 65162-017-50 | 65162-017 | ANDA078826 | ANDA | CIV |
| Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-700-05) | Camber Pharmaceuticals, Inc. | 31722-700-05 | 31722-700 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-700-10) | Camber Pharmaceuticals, Inc. | 31722-700-10 | 31722-700 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-700-30) | Camber Pharmaceuticals, Inc. | 31722-700-30 | 31722-700 | ANDA203835 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 2 Carton In 1 Carton (45802-888-30) / 14 Blister Pack In 1 Carton / 1 Tablet, Delayed Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-888-30 | 45802-888 | NDA022032 | NDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 3 Carton In 1 Carton (45802-888-55) / 14 Blister Pack In 1 Carton / 1 Tablet, Delayed Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-888-55 | 45802-888 | NDA022032 | NDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (51407-813-01) | Golden State Medical Supply, Inc. | 51407-813-01 | 51407-813 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (51407-813-10) | Golden State Medical Supply, Inc. | 51407-813-10 | 51407-813 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (51407-813-30) | Golden State Medical Supply, Inc. | 51407-813-30 | 51407-813 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (51407-813-90) | Golden State Medical Supply, Inc. | 51407-813-90 | 51407-813 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-814-01) | Golden State Medical Supply, Inc. | 51407-814-01 | 51407-814 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 500 Capsule, Delayed Release Pellets In 1 Bottle (51407-814-05) | Golden State Medical Supply, Inc. | 51407-814-05 | 51407-814 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (51407-814-30) | Golden State Medical Supply, Inc. | 51407-814-30 | 51407-814 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (51407-814-90) | Golden State Medical Supply, Inc. | 51407-814-90 | 51407-814 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-816-01) | Golden State Medical Supply, Inc. | 51407-816-01 | 51407-816 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 500 Capsule, Delayed Release Pellets In 1 Bottle (51407-816-05) | Golden State Medical Supply, Inc. | 51407-816-05 | 51407-816 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (51407-816-30) | Golden State Medical Supply, Inc. | 51407-816-30 | 51407-816 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (51407-816-90) | Golden State Medical Supply, Inc. | 51407-816-90 | 51407-816 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1 Capsule, Delayed Release In 1 Pail (51407-641-00) | Golden State Medical Supply, Inc. | 51407-641-00 | 51407-641 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (51407-641-01) | Golden State Medical Supply, Inc. | 51407-641-01 | 51407-641 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (51407-641-10) | Golden State Medical Supply, Inc. | 51407-641-10 | 51407-641 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-129-01) | Golden State Medical Supply, Inc. | 51407-129-01 | 51407-129 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 1000 Capsule, Delayed Release Pellets In 1 Bottle (51407-129-10) | Golden State Medical Supply, Inc. | 51407-129-10 | 51407-129 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 30 Capsule, Delayed Release Pellets In 1 Bottle (51407-129-30) | Golden State Medical Supply, Inc. | 51407-129-30 | 51407-129 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 20mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (51407-129-90) | Golden State Medical Supply, Inc. | 51407-129-90 | 51407-129 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (51407-287-01) | Golden State Medical Supply, Inc. | 51407-287-01 | 51407-287 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (51407-287-10) | Golden State Medical Supply, Inc. | 51407-287-10 | 51407-287 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (51407-287-30) | Golden State Medical Supply, Inc. | 51407-287-30 | 51407-287 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (51407-287-90) | Golden State Medical Supply, Inc. | 51407-287-90 | 51407-287 | ANDA212977 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 50000 Capsule, Delayed Release Pellets In 1 Drum (51407-664-00) | Golden State Medical Supply, Inc. | 51407-664-00 | 51407-664 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-664-01) | Golden State Medical Supply, Inc. | 51407-664-01 | 51407-664 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 500 Capsule, Delayed Release Pellets In 1 Bottle (51407-664-05) | Golden State Medical Supply, Inc. | 51407-664-05 | 51407-664 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 100 Capsule, Delayed Release Pellets In 1 Bottle (51407-130-01) | Golden State Medical Supply, Inc. | 51407-130-01 | 51407-130 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 500 Capsule, Delayed Release Pellets In 1 Bottle (51407-130-05) | Golden State Medical Supply, Inc. | 51407-130-05 | 51407-130 | ANDA203481 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release Pellets | Oral | 40mg/1 | 90 Capsule, Delayed Release Pellets In 1 Bottle (51407-130-90) | Golden State Medical Supply, Inc. | 51407-130-90 | 51407-130 | ANDA203481 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 1 Bottle In 1 Carton (21130-018-14) / 14 Tablet, Delayed Release In 1 Bottle | Albertsons Companies | 21130-018-14 | 21130-018 | ANDA207740 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 2 Bottle In 1 Carton (21130-018-28) / 14 Tablet, Delayed Release In 1 Bottle | Albertsons Companies | 21130-018-28 | 21130-018 | ANDA207740 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 3 Bottle In 1 Carton (21130-018-42) / 14 Tablet, Delayed Release In 1 Bottle | Albertsons Companies | 21130-018-42 | 21130-018 | ANDA207740 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (60505-0065-0) | Apotex Corp | 60505-0065-0 | 60505-0065 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (60505-0065-1) | Apotex Corp | 60505-0065-1 | 60505-0065 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (60505-0065-2) | Apotex Corp | 60505-0065-2 | 60505-0065 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 30 Capsule, Delayed Release In 1 Bottle (60505-0145-0) | Apotex Corp | 60505-0145-0 | 60505-0145 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 100 Capsule, Delayed Release In 1 Bottle (60505-0145-2) | Apotex Corp | 60505-0145-2 | 60505-0145 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (60505-0146-0) | Apotex Corp | 60505-0146-0 | 60505-0146 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 500 Capsule, Delayed Release In 1 Bottle (60505-0146-1) | Apotex Corp | 60505-0146-1 | 60505-0146 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 100 Capsule, Delayed Release In 1 Bottle (60505-0146-2) | Apotex Corp | 60505-0146-2 | 60505-0146 | ANDA076048 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 5000 Capsule, Delayed Release In 1 Bottle (60505-3952-8) | Apotex Corp | 60505-3952-8 | 60505-3952 | ANDA076048 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-700-60) | Camber Pharmaceuticals, Inc. | 31722-700-60 | 31722-700 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-700-90) | Camber Pharmaceuticals, Inc. | 31722-700-90 | 31722-700 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-701-05) | Camber Pharmaceuticals, Inc. | 31722-701-05 | 31722-701 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-701-10) | Camber Pharmaceuticals, Inc. | 31722-701-10 | 31722-701 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-701-30) | Camber Pharmaceuticals, Inc. | 31722-701-30 | 31722-701 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-701-60) | Camber Pharmaceuticals, Inc. | 31722-701-60 | 31722-701 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-701-90) | Camber Pharmaceuticals, Inc. | 31722-701-90 | 31722-701 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-702-05) | Camber Pharmaceuticals, Inc. | 31722-702-05 | 31722-702 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-702-10) | Camber Pharmaceuticals, Inc. | 31722-702-10 | 31722-702 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-702-30) | Camber Pharmaceuticals, Inc. | 31722-702-30 | 31722-702 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-702-60) | Camber Pharmaceuticals, Inc. | 31722-702-60 | 31722-702 | ANDA203835 | ANDA | N/A |
| Losartan Potassium | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-702-90) | Camber Pharmaceuticals, Inc. | 31722-702-90 | 31722-702 | ANDA203835 | ANDA | N/A |
| Omeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 3 Bottle In 1 Carton (21130-398-33) / 14 Capsule, Delayed Release In 1 Bottle | Albertsons Companies | 21130-398-33 | 21130-398 | ANDA078878 | ANDA | N/A |
| Omeprazole Magnesium | Capsule, Delayed Release | Oral | 20mg/1 | 1 Bottle In 1 Carton (21130-398-52) / 14 Capsule, Delayed Release In 1 Bottle | Albertsons Companies | 21130-398-52 | 21130-398 | ANDA078878 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (72865-141-10) | XLCare Pharmaceuticals, Inc. | 72865-141-10 | 72865-141 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-141-30) | XLCare Pharmaceuticals, Inc. | 72865-141-30 | 72865-141 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle (72865-141-90) | XLCare Pharmaceuticals, Inc. | 72865-141-90 | 72865-141 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (72865-142-10) | XLCare Pharmaceuticals, Inc. | 72865-142-10 | 72865-142 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-142-30) | XLCare Pharmaceuticals, Inc. | 72865-142-30 | 72865-142 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle (72865-142-90) | XLCare Pharmaceuticals, Inc. | 72865-142-90 | 72865-142 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (72865-143-10) | XLCare Pharmaceuticals, Inc. | 72865-143-10 | 72865-143 | ANDA203835 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-143-30) | XLCare Pharmaceuticals, Inc. | 72865-143-30 | 72865-143 | ANDA203835 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 4mg/1 | 10 Tablet, Orally Disintegrating In 1 Bottle, Plastic (60760-305-10) | St Marys Medical Park Pharmacy | 60760-305-10 | 60760-305 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 8mg/1 | 10 Tablet, Orally Disintegrating In 1 Blister Pack (60760-306-10) | St Marys Medical Park Pharmacy | 60760-306-10 | 60760-306 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 4mg/1 | 3 Blister Pack In 1 Carton (60760-277-10) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | St. Mary's Medical Park Pharmacy | 60760-277-10 | 60760-277 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 4mg/1 | 10 Tablet, Orally Disintegrating In 1 Bottle, Plastic (60760-654-10) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-654-10 | 60760-654 | ANDA078152 | ANDA | N/A |
| LOSARTAN POTASSIUM | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle (72865-143-90) | XLCare Pharmaceuticals, Inc. | 72865-143-90 | 72865-143 | ANDA203835 | ANDA | N/A |
| Lubiprostone | Capsule | Oral | 8ug/1 | 60 Capsule In 1 Bottle (65162-841-06) | Amneal Pharmaceuticals LLC | 65162-841-06 | 65162-841 | ANDA209450 | ANDA | N/A |
| Lubiprostone | Capsule | Oral | 8ug/1 | 180 Capsule In 1 Bottle (65162-841-18) | Amneal Pharmaceuticals LLC | 65162-841-18 | 65162-841 | ANDA209450 | ANDA | N/A |
| Lubiprostone | Capsule | Oral | 24ug/1 | 60 Capsule In 1 Bottle (65162-842-06) | Amneal Pharmaceuticals LLC | 65162-842-06 | 65162-842 | ANDA209450 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 10 Tablet, Film Coated In 1 Bottle, Plastic (60760-658-10) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-658-10 | 60760-658 | ANDA078539 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (25021-777-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-777-02 | 25021-777 | ANDA079224 | ANDA | N/A |
| Ondansetron Hydrochloride | Solution | Oral | 4mg/5mL | 1 Bottle In 1 Carton (51672-4091-3) / 50 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A., Inc. | 51672-4091-3 | 51672-4091 | ANDA077009 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 1 Blister Pack In 1 Carton (51672-4108-0) / 100 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4108-0 | 51672-4108 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4108-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4108-6 | 51672-4108 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 1 Blister Pack In 1 Carton (51672-4108-8) / 3 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4108-8 | 51672-4108 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 1 Blister Pack In 1 Carton (51672-4109-0) / 100 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4109-0 | 51672-4109 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 30 Tablet, Film Coated In 1 Bottle (51672-4109-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4109-6 | 51672-4109 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 1 Blister Pack In 1 Carton (51672-4109-8) / 3 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4109-8 | 51672-4109 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 24mg/1 | 1 Blister Pack In 1 Carton (51672-4110-5) / 1 Tablet, Film Coated In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4110-5 | 51672-4110 | ANDA077729 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial, Single-Use In 1 Carton (60505-6130-5) / 2 Ml In 1 Vial, Single-Use (60505-6130-0) | Apotex Corp. | 60505-6130-5 | 60505-6130 | ANDA203711 | ANDA | N/A |
| Lubiprostone | Capsule | Oral | 24ug/1 | 180 Capsule In 1 Bottle (65162-842-18) | Amneal Pharmaceuticals LLC | 65162-842-18 | 65162-842 | ANDA209450 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 20mg/1 | 30 Tablet, Coated In 1 Bottle (65162-879-03) | Amneal Pharmaceuticals LLC | 65162-879-03 | 65162-879 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 20mg/1 | 90 Tablet, Coated In 1 Bottle (65162-879-09) | Amneal Pharmaceuticals LLC | 65162-879-09 | 65162-879 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 20mg/1 | 500 Tablet, Coated In 1 Bottle (65162-879-50) | Amneal Pharmaceuticals LLC | 65162-879-50 | 65162-879 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 60mg/1 | 30 Tablet, Coated In 1 Bottle (65162-082-03) | Amneal Pharmaceuticals LLC | 65162-082-03 | 65162-082 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 60mg/1 | 90 Tablet, Coated In 1 Bottle (65162-082-09) | Amneal Pharmaceuticals LLC | 65162-082-09 | 65162-082 | ANDA208002 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection | Intramuscular; Intravenous | 2mg/mL | 20 Ml In 1 Vial, Multi-Dose (0641-6286-01) | Hikma Pharmaceuticals USA Inc. | 0641-6286-01 | 0641-6286 | ANDA077541 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6078-25) / 2 Ml In 1 Vial (0641-6078-01) | Hikma Pharmaceuticals USA Inc. | 0641-6078-25 | 0641-6078 | ANDA077541 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection | Intramuscular; Intravenous | 2mg/mL | 20 Ml In 1 Carton (0641-6079-01) | Hikma Pharmaceuticals USA Inc. | 0641-6079-01 | 0641-6079 | ANDA077365 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection | Intramuscular; Intravenous | 2mg/mL | 25 Vial In 1 Carton (0641-6080-25) / 2 Ml In 1 Vial (0641-6080-01) | Hikma Pharmaceuticals USA Inc. | 0641-6080-25 | 0641-6080 | ANDA077541 | ANDA | N/A |
| Ondansetron Hydrochloride | Solution | Oral | 4mg/5mL | 1 Bottle, Glass In 1 Carton (0054-0064-47) / 50 Ml In 1 Bottle, Glass | Hikma Pharmaceuticals USA Inc. | 0054-0064-47 | 0054-0064 | ANDA076960 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4755-03) / 2 Ml In 1 Vial, Single-Dose (0409-4755-18) | Hospira, Inc. | 0409-4755-03 | 0409-4755 | ANDA077548 | ANDA | N/A |
| Ondansetron Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 2mg/mL | 1 Vial, Multi-Dose In 1 Carton (0409-4759-01) / 20 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-4759-01 | 0409-4759 | ANDA077473 | ANDA | N/A |
| Orange | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3428-2) | Jubilant HollisterStier LLC | 65044-3428-2 | 65044-3428 | BLA103888 | BLA | N/A |
| Orphenadrine Citrate | Tablet, Extended Release | Oral | 100mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (60760-810-30) | St. Mary's Medical Park Pharmacy | 60760-810-30 | 60760-810 | ANDA040284 | ANDA | N/A |
| Orphenadrine Citrate | Injection, Solution | Intramuscular; Intravenous | 30mg/mL | 10 Vial In 1 Carton (25021-651-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-651-02 | 25021-651 | ANDA090585 | ANDA | N/A |
| Orphenadrine Citrate | Injection | Intramuscular; Intravenous | 60mg/2mL | 25 Box In 1 Box (0641-6182-25) / 10 Vial In 1 Box (0641-6182-10) / 2 Ml In 1 Vial (0641-6182-01) | Hikma Pharmaceuticals USA Inc. | 0641-6182-25 | 0641-6182 | ANDA040463 | ANDA | N/A |
| Oseltamivir Phosphate | Suspension | Oral | 6mg/mL | 60 Ml In 1 Bottle (69315-174-60) | Leading Pharma, LLC | 69315-174-60 | 69315-174 | ANDA214949 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 60mg/1 | 500 Tablet, Coated In 1 Bottle (65162-082-50) | Amneal Pharmaceuticals LLC | 65162-082-50 | 65162-082 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 40mg/1 | 30 Tablet, Coated In 1 Bottle (65162-880-03) | Amneal Pharmaceuticals LLC | 65162-880-03 | 65162-880 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 40mg/1 | 90 Tablet, Coated In 1 Bottle (65162-880-09) | Amneal Pharmaceuticals LLC | 65162-880-09 | 65162-880 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 40mg/1 | 500 Tablet, Coated In 1 Bottle (65162-880-50) | Amneal Pharmaceuticals LLC | 65162-880-50 | 65162-880 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 80mg/1 | 30 Tablet, Coated In 1 Bottle (65162-881-03) | Amneal Pharmaceuticals LLC | 65162-881-03 | 65162-881 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 80mg/1 | 90 Tablet, Coated In 1 Bottle (65162-881-09) | Amneal Pharmaceuticals LLC | 65162-881-09 | 65162-881 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 80mg/1 | 500 Tablet, Coated In 1 Bottle (65162-881-50) | Amneal Pharmaceuticals LLC | 65162-881-50 | 65162-881 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 120mg/1 | 30 Tablet, Coated In 1 Bottle (65162-882-03) | Amneal Pharmaceuticals LLC | 65162-882-03 | 65162-882 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 120mg/1 | 90 Tablet, Coated In 1 Bottle (65162-882-09) | Amneal Pharmaceuticals LLC | 65162-882-09 | 65162-882 | ANDA208002 | ANDA | N/A |
| Lurasidone Hydrochloride | Tablet, Coated | Oral | 120mg/1 | 500 Tablet, Coated In 1 Bottle (65162-882-50) | Amneal Pharmaceuticals LLC | 65162-882-50 | 65162-882 | ANDA208002 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 30mg/1 | 1 Blister Pack In 1 Carton (47781-468-13) / 10 Capsule In 1 Blister Pack | Alvogen Inc. | 47781-468-13 | 47781-468 | ANDA202595 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 45mg/1 | 1 Blister Pack In 1 Carton (47781-469-13) / 10 Capsule In 1 Blister Pack | Alvogen Inc. | 47781-469-13 | 47781-469 | ANDA202595 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 75mg/1 | 1 Blister Pack In 1 Carton (47781-470-13) / 10 Capsule In 1 Blister Pack | Alvogen Inc. | 47781-470-13 | 47781-470 | ANDA202595 | ANDA | N/A |
| Oseltamivir Phosphate | Powder, For Suspension | Oral | 6mg/mL | 1 Bottle, Glass In 1 Carton (47781-384-26) / 60 Ml In 1 Bottle, Glass | Alvogen Inc. | 47781-384-26 | 47781-384 | ANDA208823 | ANDA | N/A |
| Oxacillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-162-24) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-162-24 | 25021-162 | ANDA091246 | ANDA | N/A |
| Oxacillin Sodium | Injection, Powder, For Solution | Intravenous | 10g/100mL | 10 Bottle In 1 Carton (25021-163-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-163-99 | 25021-163 | ANDA091245 | ANDA | N/A |
| Oxacillin Sodium | Injection, Powder, For Solution | Intravenous | 10g/100mL | 10 Bottle In 1 Carton (25021-163-68) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-163-68 | 25021-163 | ANDA091245 | ANDA | N/A |
| Oxacillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 1g/1 | 10 Vial In 1 Carton (25021-146-10) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-146-10 | 25021-146 | ANDA091246 | ANDA | N/A |
| Oxacillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | 2g/1 | 10 Vial In 1 Carton (25021-162-68) / 1 Injection, Powder, For Solution In 1 Vial | Sagent Pharmaceuticals | 25021-162-68 | 25021-162 | ANDA091246 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-171-11) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-171-11 | 71288-171 | ANDA217348 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-172-21) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-172-21 | 71288-172 | ANDA217348 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-149-95) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-149-95 | 71288-149 | ANDA207325 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-149-96) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-149-96 | 71288-149 | ANDA207325 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-101-10) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-101-10 | 71288-101 | ANDA207325 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-101-20) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-101-20 | 71288-101 | ANDA207325 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-233-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-233-10 | 25021-233 | ANDA203869 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (25021-233-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-233-20 | 25021-233 | ANDA203869 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (60505-6287-2) / 10 Ml In 1 Vial | Apotex Corp. | 60505-6287-2 | 60505-6287 | ANDA204368 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (60505-6287-4) / 20 Ml In 1 Vial | Apotex Corp. | 60505-6287-4 | 60505-6287 | ANDA204368 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (60505-6132-6) / 10 Ml In 1 Vial | Apotex Corp. | 60505-6132-6 | 60505-6132 | ANDA204368 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (60505-6132-7) / 20 Ml In 1 Vial | Apotex Corp. | 60505-6132-7 | 60505-6132 | ANDA204368 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 5mg/mL | 1 Vial In 1 Carton (60505-6132-8) / 40 Ml In 1 Vial | Apotex Corp. | 60505-6132-8 | 60505-6132 | ANDA204368 | ANDA | N/A |
| Mafenide Acetate | Powder, For Solution | Topical | 50g/1 | 5 Packet In 1 Carton (50742-310-25) / 1 Powder, For Solution In 1 Packet (50742-310-50) | Ingenus Pharmaceuticals, LLC | 50742-310-25 | 50742-310 | ANDA206716 | ANDA | N/A |
| Mafenide Acetate | Cream | Topical | 85mg/g | 1 Tube In 1 Carton (16571-723-12) / 113.4 G In 1 Tube | Rising Pharma Holdings, Inc. | 16571-723-12 | 16571-723 | NDA016763 | NDA | N/A |
| Oxaliplatin | Injection, Solution, Concentrate | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-363-18) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-363-18 | 61703-363 | ANDA078813 | ANDA | N/A |
| Oxaliplatin | Injection, Solution, Concentrate | Intravenous | 5mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-363-22) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-363-22 | 61703-363 | ANDA078813 | ANDA | N/A |
| Oxaprozin | Tablet | Oral | 600mg/1 | 14 Tablet In 1 Bottle, Plastic (60760-092-14) | St Mary's Medical Park Pharmacy | 60760-092-14 | 60760-092 | ANDA208633 | ANDA | N/A |
| Oxaprozin | Tablet, Film Coated | Oral | 600mg/1 | 14 Tablet, Film Coated In 1 Bottle, Plastic (60760-382-14) | ST MARY'S MEDICAL PARK PHARMACY | 60760-382-14 | 60760-382 | ANDA075855 | ANDA | N/A |
| Oxaprozin | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (0025-1381-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1381-31 | 0025-1381 | NDA018841 | NDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-061-01) | Golden State Medical Supply, Inc. | 60429-061-01 | 60429-061 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 500 Tablet, Film Coated In 1 Bottle (60429-061-05) | Golden State Medical Supply, Inc. | 60429-061-05 | 60429-061 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-062-01) | Golden State Medical Supply, Inc. | 60429-062-01 | 60429-062 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (60429-062-05) | Golden State Medical Supply, Inc. | 60429-062-05 | 60429-062 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-063-01) | Golden State Medical Supply, Inc. | 60429-063-01 | 60429-063 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 500 Tablet, Film Coated In 1 Bottle (60429-063-05) | Golden State Medical Supply, Inc. | 60429-063-05 | 60429-063 | ANDA078069 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 150mg/1 | 10 Blister Pack In 1 Carton (51672-4105-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4105-0 | 51672-4105 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (51672-4105-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4105-1 | 51672-4105 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (51672-4105-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4105-3 | 51672-4105 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 150mg/1 | 30 Tablet In 1 Bottle (51672-4105-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4105-6 | 51672-4105 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 300mg/1 | 10 Blister Pack In 1 Carton (51672-4106-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4106-0 | 51672-4106 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (51672-4106-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4106-1 | 51672-4106 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (51672-4106-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4106-3 | 51672-4106 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (51672-4106-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4106-6 | 51672-4106 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 600mg/1 | 10 Blister Pack In 1 Carton (51672-4107-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4107-0 | 51672-4107 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 600mg/1 | 100 Tablet In 1 Bottle (51672-4107-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4107-1 | 51672-4107 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 600mg/1 | 1000 Tablet In 1 Bottle (51672-4107-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4107-3 | 51672-4107 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet | Oral | 600mg/1 | 30 Tablet In 1 Bottle (51672-4107-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4107-6 | 51672-4107 | ANDA077801 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 300mg/1 | 500 Tablet, Extended Release In 1 Bottle (60505-4129-5) | Apotex Corp. | 60505-4129-5 | 60505-4129 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-4129-7) | Apotex Corp. | 60505-4129-7 | 60505-4129 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 600mg/1 | 500 Tablet, Extended Release In 1 Bottle (60505-4130-5) | Apotex Corp. | 60505-4130-5 | 60505-4130 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 600mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-4130-7) | Apotex Corp. | 60505-4130-7 | 60505-4130 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (60505-4128-5) | Apotex Corp. | 60505-4128-5 | 60505-4128 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Tablet, Extended Release | Oral | 150mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-4128-7) | Apotex Corp. | 60505-4128-7 | 60505-4128 | ANDA213369 | ANDA | N/A |
| Oxcarbazepine | Suspension | Oral | 300mg/5mL | 1 Bottle, Glass In 1 Carton (69452-125-50) / 250 Ml In 1 Bottle, Glass | Bionpharma Inc. | 69452-125-50 | 69452-125 | ANDA209652 | ANDA | N/A |
| Mafenide Acetate | Cream | Topical | 85mg/g | 453.6 G In 1 Jar (16571-723-48) | Rising Pharma Holdings, Inc. | 16571-723-48 | 16571-723 | NDA016763 | NDA | N/A |
| Mafenide Acetate | Cream | Topical | 85mg/g | 1 Tube In 1 Carton (16571-723-60) / 56.7 G In 1 Tube | Rising Pharma Holdings, Inc. | 16571-723-60 | 16571-723 | NDA016763 | NDA | N/A |
| Magnesium Hydroxide | Suspension | Oral | 2400mg/30mL | 100 Cup, Unit-Dose In 1 Box, Unit-Dose (57237-314-31) / 30 Ml In 1 Cup, Unit-Dose (57237-314-03) | Rising Pharma Holdings, Inc. | 57237-314-31 | 57237-314 | part331 | OTC MONOGRAPH FINAL | N/A |
| Oxcarbazepine | Suspension | Oral | 300mg/5mL | 250 Ml In 1 Bottle (0054-0199-59) | Hikma Pharmaceuticals USA Inc. | 0054-0199-59 | 0054-0199 | ANDA201193 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection | Intravenous | 40mg/mL | 15 Pouch In 1 Carton (70121-1719-2) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1719-2 | 70121-1719 | ANDA216597 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection | Intravenous | 40mg/mL | 24 Pouch In 1 Carton (70121-1719-9) / 1 Bag In 1 Pouch / 50 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1719-9 | 70121-1719 | ANDA216597 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection | Intravenous | 40mg/mL | 12 Pouch In 1 Carton (70121-1720-3) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1720-3 | 70121-1720 | ANDA216597 | ANDA | N/A |
| Magnesium Sulfate Heptahydrate | Injection | Intravenous | 40mg/mL | 24 Pouch In 1 Carton (70121-1720-9) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1720-9 | 70121-1720 | ANDA216597 | ANDA | N/A |
| Maraviroc | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-579-60) | Camber Pharmaceuticals, Inc. | 31722-579-60 | 31722-579 | ANDA203347 | ANDA | N/A |
| Maraviroc | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-580-60) | Camber Pharmaceuticals, Inc. | 31722-580-60 | 31722-580 | ANDA203347 | ANDA | N/A |
| Oxiconazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1359-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1359-1 | 51672-1359 | ANDA205076 | ANDA | N/A |
| Oxiconazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1359-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1359-2 | 51672-1359 | ANDA205076 | ANDA | N/A |
| Oxiconazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1359-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1359-3 | 51672-1359 | ANDA205076 | ANDA | N/A |
| Oxiconazole Nitrate | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1359-8) / 90 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1359-8 | 51672-1359 | ANDA205076 | ANDA | N/A |
| Maraviroc | Tablet, Film Coated | Oral | 150mg/1 | 60 Tablet, Film Coated In 1 Bottle (72865-231-60) | XLCare Pharmaceuticals Inc. | 72865-231-60 | 72865-231 | ANDA203347 | ANDA | N/A |
| Maraviroc | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (72865-232-60) | XLCare Pharmaceuticals Inc. | 72865-232-60 | 72865-232 | ANDA203347 | ANDA | N/A |
| Mebendazole | Tablet, Chewable | Oral | 100mg/1 | 1 Blister Pack In 1 Carton (64896-669-30) / 1 Tablet, Chewable In 1 Blister Pack | Amneal Pharmaceuticals LLC | 64896-669-30 | 64896-669 | ANDA073580 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-005-10) | Novitium Pharma LLC | 70954-005-10 | 70954-005 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (70954-005-20) | Novitium Pharma LLC | 70954-005-20 | 70954-005 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (70954-005-30) | Novitium Pharma LLC | 70954-005-30 | 70954-005 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Blister Pack In 1 Carton (70954-005-50) / 1 Tablet In 1 Blister Pack (70954-005-40) | Novitium Pharma LLC | 70954-005-50 | 70954-005 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-099-01) | Golden State Medical Supply, Inc. | 51407-099-01 | 51407-099 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (51407-099-05) | Golden State Medical Supply, Inc. | 51407-099-05 | 51407-099 | ANDA209823 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (10702-201-01) | KVK-Tech, Inc. | 10702-201-01 | 10702-201 | ANDA209335 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (10702-201-10) | KVK-Tech, Inc. | 10702-201-10 | 10702-201 | ANDA209335 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle, Plastic (10702-201-50) | KVK-Tech, Inc. | 10702-201-50 | 10702-201 | ANDA209335 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (69315-182-01) | Leading Pharma, LLC | 69315-182-01 | 69315-182 | ANDA212798 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (69315-182-05) | Leading Pharma, LLC | 69315-182-05 | 69315-182 | ANDA212798 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (69315-182-10) | Leading Pharma, LLC | 69315-182-10 | 69315-182 | ANDA212798 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (69452-119-20) | Bionpharma Inc. | 69452-119-20 | 69452-119 | ANDA210717 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (69452-120-20) | Bionpharma Inc. | 69452-120-20 | 69452-120 | ANDA210717 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (69452-121-20) | Bionpharma Inc. | 69452-121-20 | 69452-121 | ANDA210717 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 30 Tablet In 1 Bottle (65162-441-03) | Amneal Pharmaceuticals LLC | 65162-441-03 | 65162-441 | ANDA201451 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (65162-441-10) | Amneal Pharmaceuticals LLC | 65162-441-10 | 65162-441 | ANDA201451 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (65162-441-11) | Amneal Pharmaceuticals LLC | 65162-441-11 | 65162-441 | ANDA201451 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 500 Tablet In 1 Bottle (65162-441-50) | Amneal Pharmaceuticals LLC | 65162-441-50 | 65162-441 | ANDA201451 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Blister Pack (65162-441-60) | Amneal Pharmaceuticals LLC | 65162-441-60 | 65162-441 | ANDA201451 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (62559-842-10) | ANI Pharmaceuticals, Inc. | 62559-842-10 | 62559-842 | ANDA084657 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (42806-012-01) | Epic Pharma LLC | 42806-012-01 | 42806-012 | ANDA200294 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (42806-012-10) | Epic Pharma LLC | 42806-012-10 | 42806-012 | ANDA200294 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (42806-014-01) | Epic Pharma LLC | 42806-014-01 | 42806-014 | ANDA200294 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (42806-014-10) | Epic Pharma LLC | 42806-014-10 | 42806-014 | ANDA200294 | ANDA | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (57237-333-01) | Rising Pharma Holdings, Inc. | 57237-333-01 | 57237-333 | M009 | OTC MONOGRAPH DRUG | N/A |
| Meclizine Hydrochloride | Tablet, Chewable | Oral | 25mg/1 | 100 Tablet, Chewable In 1 Bottle (16571-824-01) | Rising Pharmaceuticals, Inc. | 16571-824-01 | 16571-824 | part336 | OTC MONOGRAPH FINAL | N/A |
| Meclizine Hydrochloride | Tablet, Chewable | Oral | 25mg/1 | 1000 Tablet, Chewable In 1 Bottle (16571-824-10) | Rising Pharmaceuticals, Inc. | 16571-824-10 | 16571-824 | part336 | OTC MONOGRAPH FINAL | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (16571-660-01) | Rising Pharmaceuticals, Inc. | 16571-660-01 | 16571-660 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 12.5mg/1 | 500 Tablet In 1 Bottle (16571-660-50) | Rising Pharmaceuticals, Inc. | 16571-660-50 | 16571-660 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (16571-661-01) | Rising Pharmaceuticals, Inc. | 16571-661-01 | 16571-661 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (16571-661-10) | Rising Pharmaceuticals, Inc. | 16571-661-10 | 16571-661 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (16571-662-01) | Rising Pharmaceuticals, Inc. | 16571-662-01 | 16571-662 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Meclizine Hydrochloride | Tablet, Chewable | Oral | 25mg/1 | 100 Tablet, Chewable In 1 Bottle (16571-663-01) | Rising Pharmaceuticals, Inc. | 16571-663-01 | 16571-663 | NDA010721 | NDA AUTHORIZED GENERIC | N/A |
| Medroxyprogesterone Acetate | Injection, Suspension | Intramuscular | 150mg/mL | 1 Syringe, Glass In 1 Carton (70121-1480-1) / 1 Ml In 1 Syringe, Glass | Amneal Pharmaceuticals LLC | 70121-1480-1 | 70121-1480 | ANDA215397 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 240 Ml In 1 Bottle (70954-896-10) | ANI Pharmaceuticals, Inc. | 70954-896-10 | 70954-896 | ANDA077404 | ANDA | N/A |
| Megestrol Acetate | Suspension | Oral | 40mg/mL | 480 Ml In 1 Bottle (70954-896-20) | ANI Pharmaceuticals, Inc. | 70954-896-20 | 70954-896 | ANDA077404 | ANDA | N/A |
| Meloxicam | Capsule | Oral | 5mg/1 | 30 Capsule In 1 Bottle (70954-076-10) | ANI Pharmaceuticals, Inc. | 70954-076-10 | 70954-076 | ANDA211398 | ANDA | N/A |
| Meloxicam | Capsule | Oral | 5mg/1 | 90 Capsule In 1 Bottle (70954-076-20) | ANI Pharmaceuticals, Inc. | 70954-076-20 | 70954-076 | ANDA211398 | ANDA | N/A |
| Meloxicam | Capsule | Oral | 10mg/1 | 30 Capsule In 1 Bottle (70954-077-10) | ANI Pharmaceuticals, Inc. | 70954-077-10 | 70954-077 | ANDA211398 | ANDA | N/A |
| Meloxicam | Capsule | Oral | 10mg/1 | 90 Capsule In 1 Bottle (70954-077-20) | ANI Pharmaceuticals, Inc. | 70954-077-20 | 70954-077 | ANDA211398 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (43602-623-10) | Ascent Pharmaceuticals, Inc | 43602-623-10 | 43602-623 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (43602-623-30) | Ascent Pharmaceuticals, Inc | 43602-623-30 | 43602-623 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (43602-624-10) | Ascent Pharmaceuticals, Inc | 43602-624-10 | 43602-624 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (43602-624-30) | Ascent Pharmaceuticals, Inc | 43602-624-30 | 43602-624 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (43602-623-10) | Ascent Pharmaceuticals, Inc | 43602-623-10 | 43602-623 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 30 Tablet In 1 Bottle (43602-623-30) | Ascent Pharmaceuticals, Inc | 43602-623-30 | 43602-623 | ANDA217579 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet, Coated | Oral | 30mg/1 | 100 Tablet, Coated In 1 Bottle (81140-103-10) | Protega Pharmaceuticals Inc | 81140-103-10 | 81140-103 | NDA209777 | NDA | CII |
| Oxycodone Hydrochloride | Tablet, Coated | Oral | 5mg/1 | 100 Tablet, Coated In 1 Bottle (81140-101-10) | Protega Pharmaceuticals Inc | 81140-101-10 | 81140-101 | NDA209777 | NDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 30 Ml In 1 Bottle (66689-025-30) | VistaPharm, LLC | 66689-025-30 | 66689-025 | ANDA202537 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 5 Tray In 1 Case (66689-401-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-401-01) | VistaPharm, LLC | 66689-401-50 | 66689-401 | NDA201194 | NDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (66689-403-16) | VistaPharm, LLC | 66689-403-16 | 66689-403 | NDA201194 | NDA | CII |
| Oxycodone Hydrochloride | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (10702-023-01) | KVK-TECH, INC. | 10702-023-01 | 10702-023 | ANDA202773 | ANDA | CII |
| Oxycodone Hydrochloride | Capsule | Oral | 5mg/1 | 60 Capsule In 1 Bottle (10702-023-06) | KVK-TECH, INC. | 10702-023-06 | 10702-023 | ANDA202773 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 1 Bottle, Plastic In 1 Carton (10702-171-03) / 30 Ml In 1 Bottle, Plastic | KVK-Tech, Inc. | 10702-171-03 | 10702-171 | ANDA208593 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 1 Bottle, Plastic In 1 Carton (10702-183-50) / 500 Ml In 1 Bottle, Plastic | KVK-Tech, Inc. | 10702-183-50 | 10702-183 | ANDA208593 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-056-01) | KVK-TECH,INC | 10702-056-01 | 10702-056 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (10702-056-50) | KVK-TECH,INC | 10702-056-50 | 10702-056 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (10702-057-01) | KVK-TECH,INC | 10702-057-01 | 10702-057 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (10702-057-50) | KVK-TECH,INC | 10702-057-50 | 10702-057 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (10702-008-01) | KVK-TECH,INC | 10702-008-01 | 10702-008 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (10702-008-50) | KVK-TECH,INC | 10702-008-50 | 10702-008 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (10702-009-01) | KVK-TECH,INC | 10702-009-01 | 10702-009 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (10702-009-50) | KVK-TECH,INC | 10702-009-50 | 10702-009 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (10702-018-01) | KVK-TECH,INC | 10702-018-01 | 10702-018 | ANDA091393 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (10702-018-50) | KVK-TECH,INC | 10702-018-50 | 10702-018 | ANDA091393 | ANDA | CII |
| Meloxicam | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (43602-624-10) | Ascent Pharmaceuticals, Inc | 43602-624-10 | 43602-624 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (43602-624-30) | Ascent Pharmaceuticals, Inc | 43602-624-30 | 43602-624 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (31722-226-01) | Camber Pharmaceuticals, Inc. | 31722-226-01 | 31722-226 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 7.5mg/1 | 500 Tablet In 1 Bottle (31722-226-05) | Camber Pharmaceuticals, Inc. | 31722-226-05 | 31722-226 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (31722-226-31) | Camber Pharmaceuticals, Inc. | 31722-226-31 | 31722-226 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (31722-227-01) | Camber Pharmaceuticals, Inc. | 31722-227-01 | 31722-227 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (31722-227-05) | Camber Pharmaceuticals, Inc. | 31722-227-05 | 31722-227 | ANDA217579 | ANDA | N/A |
| MELOXICAM | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (31722-227-31) | Camber Pharmaceuticals, Inc. | 31722-227-31 | 31722-227 | ANDA217579 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (16571-776-01) | Rising Pharma Holdings, Inc. | 16571-776-01 | 16571-776 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (16571-776-10) | Rising Pharma Holdings, Inc. | 16571-776-10 | 16571-776 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 500 Tablet In 1 Bottle (16571-776-50) | Rising Pharma Holdings, Inc. | 16571-776-50 | 16571-776 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (16571-777-01) | Rising Pharma Holdings, Inc. | 16571-777-01 | 16571-777 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (16571-777-10) | Rising Pharma Holdings, Inc. | 16571-777-10 | 16571-777 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (16571-777-50) | Rising Pharma Holdings, Inc. | 16571-777-50 | 16571-777 | ANDA078008 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (72865-137-01) | XLCare Pharmaceuticals, Inc. | 72865-137-01 | 72865-137 | ANDA077927 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (72865-137-10) | XLCare Pharmaceuticals, Inc. | 72865-137-10 | 72865-137 | ANDA077927 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 7.5mg/1 | 90 Tablet In 1 Bottle (72865-137-90) | XLCare Pharmaceuticals, Inc. | 72865-137-90 | 72865-137 | ANDA077927 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (72865-138-01) | XLCare Pharmaceuticals, Inc. | 72865-138-01 | 72865-138 | ANDA077927 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (72865-138-10) | XLCare Pharmaceuticals, Inc. | 72865-138-10 | 72865-138 | ANDA077927 | ANDA | N/A |
| Meloxicam | Tablet | Oral | 15mg/1 | 90 Tablet In 1 Bottle (72865-138-90) | XLCare Pharmaceuticals, Inc. | 72865-138-90 | 72865-138 | ANDA077927 | ANDA | N/A |
| MELPHALAN HYDROCHLORIDE | Kit | N/A | N/A | 1 Kit In 1 Carton (31722-362-31) * 10 Ml In 1 Vial, Single-Dose (31722-360-31) * 10 Ml In 1 Vial, Single-Use (31722-361-31) | Camber Pharmaceuticals, Inc. | 31722-362-31 | 31722-362 | ANDA215024 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 7mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-782-03) | Amneal Pharmaceuticals LLC | 65162-782-03 | 65162-782 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 7mg/1 | 90 Capsule, Extended Release In 1 Bottle (65162-782-09) | Amneal Pharmaceuticals LLC | 65162-782-09 | 65162-782 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 7mg/1 | 500 Capsule, Extended Release In 1 Bottle (65162-782-50) | Amneal Pharmaceuticals LLC | 65162-782-50 | 65162-782 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 14mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-783-03) | Amneal Pharmaceuticals LLC | 65162-783-03 | 65162-783 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 14mg/1 | 90 Capsule, Extended Release In 1 Bottle (65162-783-09) | Amneal Pharmaceuticals LLC | 65162-783-09 | 65162-783 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 14mg/1 | 500 Capsule, Extended Release In 1 Bottle (65162-783-50) | Amneal Pharmaceuticals LLC | 65162-783-50 | 65162-783 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-169-06) | Amneal Pharmaceuticals LLC | 65162-169-06 | 65162-169 | ANDA090041 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 21mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-784-03) | Amneal Pharmaceuticals LLC | 65162-784-03 | 65162-784 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 21mg/1 | 90 Capsule, Extended Release In 1 Bottle (65162-784-09) | Amneal Pharmaceuticals LLC | 65162-784-09 | 65162-784 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 21mg/1 | 500 Capsule, Extended Release In 1 Bottle (65162-784-50) | Amneal Pharmaceuticals LLC | 65162-784-50 | 65162-784 | ANDA205825 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (47781-263-01) | Alvogen, Inc. | 47781-263-01 | 47781-263 | ANDA202116 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (47781-263-05) | Alvogen, Inc. | 47781-263-05 | 47781-263 | ANDA202116 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (47781-264-01) | Alvogen, Inc. | 47781-264-01 | 47781-264 | ANDA202116 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (47781-264-05) | Alvogen, Inc. | 47781-264-05 | 47781-264 | ANDA202116 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (47781-265-01) | Alvogen, Inc. | 47781-265-01 | 47781-265 | ANDA202116 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (47781-265-05) | Alvogen, Inc. | 47781-265-05 | 47781-265 | ANDA202116 | ANDA | CII |
| Memantine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-173-06) | Amneal Pharmaceuticals LLC | 65162-173-06 | 65162-173 | ANDA090041 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 28mg/1 | 30 Capsule, Extended Release In 1 Bottle (65162-785-03) | Amneal Pharmaceuticals LLC | 65162-785-03 | 65162-785 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 28mg/1 | 90 Capsule, Extended Release In 1 Bottle (65162-785-09) | Amneal Pharmaceuticals LLC | 65162-785-09 | 65162-785 | ANDA205825 | ANDA | N/A |
| Memantine Hydrochloride | Capsule, Extended Release | Oral | 28mg/1 | 500 Capsule, Extended Release In 1 Bottle (65162-785-50) | Amneal Pharmaceuticals LLC | 65162-785-50 | 65162-785 | ANDA205825 | ANDA | N/A |
| Menthol | Liquid | Topical | 2g/100mL | 88.5 Ml In 1 Bottle, Dispensing (58418-827-03) | Epic Laboratories, LLC | 58418-827-03 | 58418-827 | M015 | OTC MONOGRAPH DRUG | N/A |
| Meperidine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (42806-050-01) | EPIC PHARMA, LLC | 42806-050-01 | 42806-050 | ANDA040331 | ANDA | CII |
| Meperidine Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (42806-050-30) | EPIC PHARMA, LLC | 42806-050-30 | 42806-050 | ANDA040331 | ANDA | CII |
| Meperidine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (42806-051-01) | EPIC PHARMA, LLC | 42806-051-01 | 42806-051 | ANDA040331 | ANDA | CII |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 165 L In 1 Cylinder (55858-001-01) | Augusta Health dba Care Home Medical | 55858-001-01 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 255 L In 1 Cylinder (55858-001-02) | Augusta Health dba Care Home Medical | 55858-001-02 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 425 L In 1 Cylinder (55858-001-03) | Augusta Health dba Care Home Medical | 55858-001-03 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 680 L In 1 Cylinder (55858-001-04) | Augusta Health dba Care Home Medical | 55858-001-04 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 1738 L In 1 Cylinder (55858-001-05) | Augusta Health dba Care Home Medical | 55858-001-05 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 3455 L In 1 Cylinder (55858-001-06) | Augusta Health dba Care Home Medical | 55858-001-06 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 7080 L In 1 Cylinder (55858-001-07) | Augusta Health dba Care Home Medical | 55858-001-07 | 55858-001 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 21 L In 1 Dewar (62481-4565-0) | Bay State Medical, Inc. | 62481-4565-0 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 1699 L In 1 Cylinder (62481-4565-4) | Bay State Medical, Inc. | 62481-4565-4 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 425 L In 1 Cylinder (62481-4565-6) | Bay State Medical, Inc. | 62481-4565-6 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 680 L In 1 Cylinder (62481-4565-7) | Bay State Medical, Inc. | 62481-4565-7 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 41 L In 1 Dewar (62481-4565-8) | Bay State Medical, Inc. | 62481-4565-8 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 31 L In 1 Dewar (62481-4565-9) | Bay State Medical, Inc. | 62481-4565-9 | 62481-4565 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 400 L In 1 Cylinder (62447-0011-1) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-1 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 660 L In 1 Cylinder (62447-0011-2) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-2 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 3540 L In 1 Cylinder (62447-0011-3) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-3 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 7100 L In 1 Cylinder (62447-0011-4) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-4 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 1000 L In 1 Cylinder (62447-0011-5) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-5 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 2000 L In 1 Cylinder (62447-0011-6) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-6 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 4000 L In 1 Cylinder (62447-0011-7) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-7 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 5000 L In 1 Cylinder (62447-0011-8) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-8 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 6000 L In 1 Cylinder (62447-0011-9) | Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply | 62447-0011-9 | 62447-0011 | NDA205767 | NDA | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 164 L In 1 Cylinder (63580-269-05) | Coastal Med-Tech Corp. | 63580-269-05 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 425 L In 1 Cylinder (63580-269-06) | Coastal Med-Tech Corp. | 63580-269-06 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 50 L In 1 Dewar (63580-269-07) | Coastal Med-Tech Corp. | 63580-269-07 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 680 L In 1 Cylinder (63580-269-08) | Coastal Med-Tech Corp. | 63580-269-08 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 7080 L In 1 Cylinder (63580-269-09) | Coastal Med-Tech Corp. | 63580-269-09 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 255 L In 1 Cylinder (63580-269-10) | Coastal Med-Tech Corp. | 63580-269-10 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 1738 L In 1 Cylinder (63580-269-11) | Coastal Med-Tech Corp. | 63580-269-11 | 63580-269 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 3133 L In 1 Cylinder (14214-0123-0) | Leading Respiratory Service Inc. | 14214-0123-0 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 1738 L In 1 Cylinder (14214-0123-1) | Leading Respiratory Service Inc. | 14214-0123-1 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 680 L In 1 Cylinder (14214-0123-2) | Leading Respiratory Service Inc. | 14214-0123-2 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 425 L In 1 Cylinder (14214-0123-3) | Leading Respiratory Service Inc. | 14214-0123-3 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 170 L In 1 Cylinder (14214-0123-4) | Leading Respiratory Service Inc. | 14214-0123-4 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 7075 L In 1 Cylinder (14214-0123-5) | Leading Respiratory Service Inc. | 14214-0123-5 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 46 L In 1 Dewar (14214-0123-6) | Leading Respiratory Service Inc. | 14214-0123-6 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 2549 L In 1 Cylinder (14214-0123-7) | Leading Respiratory Service Inc. | 14214-0123-7 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 36 L In 1 Dewar (14214-0123-8) | Leading Respiratory Service Inc. | 14214-0123-8 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxygen | Gas | Respiratory (Inhalation) | 99L/100L | 3455 L In 1 Cylinder (14214-0123-9) | Leading Respiratory Service Inc. | 14214-0123-9 | 14214-0123 | N/A | UNAPPROVED MEDICAL GAS | N/A |
| Oxymetazoline Hydrochloride | Spray | Nasal | .05g/100mL | 1 Bottle, Spray In 1 Carton (45802-410-59) / 30 Ml In 1 Bottle, Spray | Padagis Israel Pharmaceuticals Ltd | 45802-410-59 | 45802-410 | M012 | OTC MONOGRAPH DRUG | N/A |
| Oxymetazoline Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1405-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1405-2 | 51672-1405 | ANDA213584 | ANDA | N/A |
| Oxymetazoline Hydrochloride | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (51672-1405-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1405-3 | 51672-1405 | ANDA213584 | ANDA | N/A |
| Oxymetazoline Hydrochloride | Spray | Nasal | .05g/100mL | 1 Bottle, Spray In 1 Carton (51672-2030-3) / 30 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-2030-3 | 51672-2030 | part341 | OTC MONOGRAPH FINAL | N/A |
| Oxymetazoline Hydrochloride | Spray | Nasal | .05g/100mL | 1 Bottle, Spray In 1 Carton (51672-2030-5) / 15 Ml In 1 Bottle, Spray | Taro Pharmaceuticals U.S.A., Inc. | 51672-2030-5 | 51672-2030 | part341 | OTC MONOGRAPH FINAL | N/A |
| Oxymorphone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (10702-070-01) | KVK-Tech, Inc. | 10702-070-01 | 10702-070 | ANDA203601 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 5mg/1 | 60 Tablet In 1 Bottle (10702-070-06) | KVK-Tech, Inc. | 10702-070-06 | 10702-070 | ANDA203601 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (10702-071-01) | KVK-Tech, Inc. | 10702-071-01 | 10702-071 | ANDA203601 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 10mg/1 | 60 Tablet In 1 Bottle (10702-071-06) | KVK-Tech, Inc. | 10702-071-06 | 10702-071 | ANDA203601 | ANDA | CII |
| Meropenem | Injection, Powder, For Solution | Intravenous | 1g/30mL | 10 Vial, Glass In 1 Carton (70121-1453-7) / 30 Ml In 1 Vial, Glass (70121-1453-1) | Amneal Pharmaceuticals LLC | 70121-1453-7 | 70121-1453 | ANDA205883 | ANDA | N/A |
| Meropenem | Injection, Powder, For Solution | Intravenous | 500mg/20mL | 10 Vial, Glass In 1 Carton (70121-1454-7) / 20 Ml In 1 Vial, Glass (70121-1454-1) | Amneal Pharmaceuticals LLC | 70121-1454-7 | 70121-1454 | ANDA205883 | ANDA | N/A |
| Mesalamine | Enema | Rectal | 4g/60mL | 7 Bottle In 1 Box (62559-420-07) / 60 Ml In 1 Bottle (62559-420-11) | ANI Pharmaceuticals, Inc. | 62559-420-07 | 62559-420 | NDA019618 | NDA AUTHORIZED GENERIC | N/A |
| Mesalamine | Suppository | Rectal | 1000mg/1 | 5 Package In 1 Carton (64980-282-03) / 6 Suppository In 1 Package | Rising Pharmaceuticals, Inc. | 64980-282-03 | 64980-282 | ANDA207448 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (65162-553-10) | Amneal Pharmaceuticals LLC | 65162-553-10 | 65162-553 | ANDA203399 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (65162-553-50) | Amneal Pharmaceuticals LLC | 65162-553-50 | 65162-553 | ANDA203399 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (64980-472-01) | Rising Pharmaceuticals, Inc. | 64980-472-01 | 64980-472 | ANDA208774 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (64980-472-50) | Rising Pharmaceuticals, Inc. | 64980-472-50 | 64980-472 | ANDA208774 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 400mg/1 | 1000 Tablet In 1 Bottle (50228-474-10) | ScieGen Pharmaceuticals, Inc. | 50228-474-10 | 50228-474 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (50228-474-30) | ScieGen Pharmaceuticals, Inc. | 50228-474-30 | 50228-474 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (50228-323-01) | ScieGen Pharmaceuticals, Inc. | 50228-323-01 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (50228-323-05) | ScieGen Pharmaceuticals, Inc. | 50228-323-05 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (50228-323-30) | ScieGen Pharmaceuticals, Inc. | 50228-323-30 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 400mg/1 | 1000 Tablet In 1 Bottle (50228-474-10) | ScieGen Pharmaceuticals, Inc. | 50228-474-10 | 50228-474 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 400mg/1 | 30 Tablet In 1 Bottle (50228-474-30) | ScieGen Pharmaceuticals, Inc. | 50228-474-30 | 50228-474 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 100 Tablet In 1 Bottle (50228-323-01) | ScieGen Pharmaceuticals, Inc. | 50228-323-01 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 500 Tablet In 1 Bottle (50228-323-05) | ScieGen Pharmaceuticals, Inc. | 50228-323-05 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metaxalone | Tablet | Oral | 800mg/1 | 30 Tablet In 1 Bottle (50228-323-30) | ScieGen Pharmaceuticals, Inc. | 50228-323-30 | 50228-323 | ANDA207466 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 30 Tablet In 1 Bottle (65162-219-03) | Amneal Pharmaceuticals LLC | 65162-219-03 | 65162-219 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 100 Tablet In 1 Bottle (65162-219-10) | Amneal Pharmaceuticals LLC | 65162-219-10 | 65162-219 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 1000 Tablet In 1 Bottle (65162-219-11) | Amneal Pharmaceuticals LLC | 65162-219-11 | 65162-219 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 500 Tablet In 1 Bottle (65162-219-50) | Amneal Pharmaceuticals LLC | 65162-219-50 | 65162-219 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 30 Tablet In 1 Bottle (65162-220-03) | Amneal Pharmaceuticals LLC | 65162-220-03 | 65162-220 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (65162-220-10) | Amneal Pharmaceuticals LLC | 65162-220-10 | 65162-220 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 1000 Tablet In 1 Bottle (65162-220-11) | Amneal Pharmaceuticals LLC | 65162-220-11 | 65162-220 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 500 Tablet In 1 Bottle (65162-220-50) | Amneal Pharmaceuticals LLC | 65162-220-50 | 65162-220 | ANDA077880 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-178-03) | Amneal Pharmaceuticals LLC | 65162-178-03 | 65162-178 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-178-09) | Amneal Pharmaceuticals LLC | 65162-178-09 | 65162-178 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-178-10) | Amneal Pharmaceuticals LLC | 65162-178-10 | 65162-178 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 1000 Tablet, Extended Release In 1 Bottle (65162-178-11) | Amneal Pharmaceuticals LLC | 65162-178-11 | 65162-178 | ANDA078596 | ANDA | N/A |
| Oxymorphone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0054-0283-25) | Hikma Pharmaceuticals USA Inc. | 0054-0283-25 | 0054-0283 | ANDA090964 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (0054-0284-25) | Hikma Pharmaceuticals USA Inc. | 0054-0284-25 | 0054-0284 | ANDA090964 | ANDA | CII |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-178-50) | Amneal Pharmaceuticals LLC | 65162-178-50 | 65162-178 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 10000 Tablet, Extended Release In 1 Drum (65162-178-89) | Amneal Pharmaceuticals LLC | 65162-178-89 | 65162-178 | ANDA078596 | ANDA | N/A |
| Oxytocin | Injection | Intramuscular; Intravenous | 10[USP'U]/mL | 25 Vial In 1 Carton (0641-6114-25) / 1 Ml In 1 Vial (0641-6114-01) | Hikma Pharmaceuticals USA Inc. | 0641-6114-25 | 0641-6114 | NDA018243 | NDA | N/A |
| Oxytocin | Injection | Intramuscular; Intravenous | 10[USP'U]/mL | 25 Vial In 1 Carton (0641-6115-25) / 10 Ml In 1 Vial (0641-6115-01) | Hikma Pharmaceuticals USA Inc. | 0641-6115-25 | 0641-6115 | NDA018243 | NDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial In 1 Carton (25021-255-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-255-05 | 25021-255 | ANDA207326 | ANDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial In 1 Carton (25021-255-17) / 16.7 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-255-17 | 25021-255 | ANDA207326 | ANDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial In 1 Carton (25021-255-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-255-50 | 25021-255 | ANDA207326 | ANDA | N/A |
| Paclitaxel | Injection, Powder, Lyophilized, For Suspension | Intravenous | 100mg/20mL | 1 Vial, Single-Use In 1 Carton (60505-6230-4) / 20 Ml In 1 Vial, Single-Use | Apotex Corp. | 60505-6230-4 | 60505-6230 | NDA021660 | NDA AUTHORIZED GENERIC | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 300mg/50mL | 1 Vial, Multi-Dose In 1 Carton (47781-595-07) / 50 Ml In 1 Vial, Multi-Dose | Alvogen Inc. | 47781-595-07 | 47781-595 | ANDA207326 | ANDA | N/A |
| Paclitaxel | Injection, Powder, Lyophilized, For Suspension | Intravenous | 100mg/20mL | 1 Vial In 1 Carton (0517-4300-01) / 20 Ml In 1 Vial | American Regent, Inc. | 0517-4300-01 | 0517-4300 | NDA211875 | NDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-342-09) / 5 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-342-09 | 61703-342 | ANDA076131 | ANDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-342-22) / 16.7 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-342-22 | 61703-342 | ANDA076131 | ANDA | N/A |
| Paclitaxel | Injection, Solution | Intravenous | 6mg/mL | 1 Vial, Multi-Dose In 1 Carton (61703-342-50) / 50 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 61703-342-50 | 61703-342 | ANDA076131 | ANDA | N/A |
| Palbociclib | Capsule | Oral | 75mg/1 | 21 Capsule In 1 Bottle (0069-0187-21) | Pfizer Laboratories Div Pfizer Inc | 0069-0187-21 | 0069-0187 | NDA207103 | NDA | N/A |
| Palbociclib | Capsule | Oral | 100mg/1 | 21 Capsule In 1 Bottle (0069-0188-21) | Pfizer Laboratories Div Pfizer Inc | 0069-0188-21 | 0069-0188 | NDA207103 | NDA | N/A |
| Palbociclib | Capsule | Oral | 125mg/1 | 21 Capsule In 1 Bottle (0069-0189-21) | Pfizer Laboratories Div Pfizer Inc | 0069-0189-21 | 0069-0189 | NDA207103 | NDA | N/A |
| Palbociclib | Tablet, Film Coated | Oral | 125mg/1 | 3 Dose Pack In 1 Carton (0069-0688-03) / 7 Tablet, Film Coated In 1 Dose Pack (0069-0688-07) | Pfizer Laboratories Div Pfizer Inc | 0069-0688-03 | 0069-0688 | NDA212436 | NDA | N/A |
| Palbociclib | Tablet, Film Coated | Oral | 100mg/1 | 3 Dose Pack In 1 Carton (0069-0486-03) / 7 Tablet, Film Coated In 1 Dose Pack (0069-0486-07) | Pfizer Laboratories Div Pfizer Inc | 0069-0486-03 | 0069-0486 | NDA212436 | NDA | N/A |
| Palbociclib | Tablet, Film Coated | Oral | 75mg/1 | 3 Dose Pack In 1 Carton (0069-0284-03) / 7 Tablet, Film Coated In 1 Dose Pack (0069-0284-07) | Pfizer Laboratories Div Pfizer Inc | 0069-0284-03 | 0069-0284 | NDA212436 | NDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (27808-222-01) | Tris Pharma Inc | 27808-222-01 | 27808-222 | ANDA212807 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (27808-223-01) | Tris Pharma Inc | 27808-223-01 | 27808-223 | ANDA212807 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (27808-224-01) | Tris Pharma Inc | 27808-224-01 | 27808-224 | ANDA212807 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (27808-225-01) | Tris Pharma Inc | 27808-225-01 | 27808-225 | ANDA212807 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-179-03) | Amneal Pharmaceuticals LLC | 65162-179-03 | 65162-179 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-179-09) | Amneal Pharmaceuticals LLC | 65162-179-09 | 65162-179 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-179-10) | Amneal Pharmaceuticals LLC | 65162-179-10 | 65162-179 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-179-50) | Amneal Pharmaceuticals LLC | 65162-179-50 | 65162-179 | ANDA078596 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (42806-405-60) | EPIC PHARMA, LLC | 42806-405-60 | 42806-405 | ANDA209993 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (42806-406-60) | EPIC PHARMA, LLC | 42806-406-60 | 42806-406 | ANDA209993 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-313-01) | Epic Pharma, LLC | 42806-313-01 | 42806-313 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-313-05) | Epic Pharma, LLC | 42806-313-05 | 42806-313 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-313-10) | Epic Pharma, LLC | 42806-313-10 | 42806-313 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 850mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-314-01) | Epic Pharma, LLC | 42806-314-01 | 42806-314 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 850mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-314-05) | Epic Pharma, LLC | 42806-314-05 | 42806-314 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 850mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-314-10) | Epic Pharma, LLC | 42806-314-10 | 42806-314 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 1000mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-315-01) | Epic Pharma, LLC | 42806-315-01 | 42806-315 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 1000mg/1 | 500 Tablet, Film Coated In 1 Bottle (42806-315-05) | Epic Pharma, LLC | 42806-315-05 | 42806-315 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated | Oral | 1000mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-315-10) | Epic Pharma, LLC | 42806-315-10 | 42806-315 | ANDA090564 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-632-01) | Epic Pharma, LLC | 42806-632-01 | 42806-632 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-632-05) | Epic Pharma, LLC | 42806-632-05 | 42806-632 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 1000 Tablet, Extended Release In 1 Bottle (42806-632-10) | Epic Pharma, LLC | 42806-632-10 | 42806-632 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (42806-633-01) | Epic Pharma, LLC | 42806-633-01 | 42806-633 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (42806-633-05) | Epic Pharma, LLC | 42806-633-05 | 42806-633 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 750mg/1 | 1000 Tablet, Extended Release In 1 Bottle (42806-633-10) | Epic Pharma, LLC | 42806-633-10 | 42806-633 | ANDA211052 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-633-10) | Ingenus Pharmaceuticals, LLC | 50742-633-10 | 50742-633 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-633-60) | Ingenus Pharmaceuticals, LLC | 50742-633-60 | 50742-633 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 500mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-633-90) | Ingenus Pharmaceuticals, LLC | 50742-633-90 | 50742-633 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 1000mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-634-10) | Ingenus Pharmaceuticals, LLC | 50742-634-10 | 50742-634 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 1000mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-634-30) | Ingenus Pharmaceuticals, LLC | 50742-634-30 | 50742-634 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Extended Release | Oral | 1000mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-634-60) | Ingenus Pharmaceuticals, LLC | 50742-634-60 | 50742-634 | ANDA209674 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (50228-107-00) | ScieGen Pharmaceuticals Inc | 50228-107-00 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (50228-107-01) | ScieGen Pharmaceuticals Inc | 50228-107-01 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 500 Tablet In 1 Bottle (50228-107-05) | ScieGen Pharmaceuticals Inc | 50228-107-05 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 1000 Tablet In 1 Bottle (50228-107-10) | ScieGen Pharmaceuticals Inc | 50228-107-10 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 30 Tablet In 1 Bottle (50228-107-30) | ScieGen Pharmaceuticals Inc | 50228-107-30 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 60 Tablet In 1 Bottle (50228-107-60) | ScieGen Pharmaceuticals Inc | 50228-107-60 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 9000 Tablet In 1 Bottle (50228-105-00) | ScieGen Pharmaceuticals Inc | 50228-105-00 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-105-01) | ScieGen Pharmaceuticals Inc | 50228-105-01 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-105-05) | ScieGen Pharmaceuticals Inc | 50228-105-05 | 50228-105 | ANDA203769 | ANDA | N/A |
| Palonosetron Hydrochloride | Injection, Solution | Intravenous | .25mg/5mL | 1 Vial, Single-Dose In 1 Carton (71288-409-05) / 5 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-409-05 | 71288-409 | ANDA215861 | ANDA | N/A |
| Palonosetron Hydrochloride | Injection, Solution | Intravenous | .05mg/mL | 1 Vial In 1 Carton (25021-783-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-783-05 | 25021-783 | ANDA204289 | ANDA | N/A |
| Palonosetron Hydrochloride | Injection | Intravenous | .25mg/5mL | 1 Vial In 1 Carton (60505-6193-1) / 5 Ml In 1 Vial | Apotex Corp. | 60505-6193-1 | 60505-6193 | ANDA205648 | ANDA | N/A |
| Palonosetron Hydrochloride | Injection, Solution | Intravenous | .25mg/5mL | 1 Vial, Single-Dose In 1 Carton (0409-2504-10) / 5 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-2504-10 | 0409-2504 | ANDA207005 | ANDA | N/A |
| Pamabrom | Capsule | Oral | 50mg/1 | 1 Blister Pack In 1 Carton (52389-325-21) / 21 Capsule In 1 Blister Pack (52389-325-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-325-21 | 52389-325 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 4 Blister Pack In 1 Carton (52389-249-10) / 10 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-10 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 1 Blister Pack In 1 Carton (52389-249-24) / 24 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-24 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 3 Blister Pack In 1 Carton (52389-249-30) / 10 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-30 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 2 Blister Pack In 1 Carton (52389-249-48) / 24 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-48 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 5 Blister Pack In 1 Carton (52389-249-50) / 10 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-50 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamabrom | Tablet, Film Coated | Oral | 50mg/1 | 3 Blister Pack In 1 Carton (52389-249-72) / 24 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-249-72 | 52389-249 | M027 | OTC MONOGRAPH DRUG | N/A |
| Pamidronate Disodium | Injection, Solution | Intravenous | 3mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-324-18) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-324-18 | 61703-324 | ANDA075841 | ANDA | N/A |
| Pamidronate Disodium | Injection, Solution | Intravenous | 6mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-325-18) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-325-18 | 61703-325 | ANDA075841 | ANDA | N/A |
| Pamidronate Disodium | Injection, Solution | Intravenous | 9mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-326-18) / 10 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-326-18 | 61703-326 | ANDA075841 | ANDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 10 Vial, Single-Dose In 1 Carton (71288-600-11) / 10 Ml In 1 Vial, Single-Dose (71288-600-10) | Meitheal Pharmaceuticals Inc. | 71288-600-11 | 71288-600 | ANDA215860 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 30 Tablet, Delayed Release In 1 Bottle, Plastic (60760-679-30) | St Mary's Medical Park Pharmacy | 60760-679-30 | 60760-679 | ANDA202882 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (60760-639-60) | St Mary's Medical Park Pharmacy | 60760-639-60 | 60760-639 | ANDA202038 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 30 Tablet, Delayed Release In 1 Bottle, Plastic (60760-646-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-646-30 | 60760-646 | ANDA202038 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 60 Tablet, Delayed Release In 1 Bottle, Plastic (60760-151-60) | St. Mary's Medical Park Pharmacy | 60760-151-60 | 60760-151 | ANDA090074 | ANDA | N/A |
| Pantoprazole Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/10mL | 10 Vial In 1 Carton (25021-751-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-751-10 | 25021-751 | ANDA204400 | ANDA | N/A |
| Pantoprazole Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/10mL | 25 Vial In 1 Carton (25021-751-11) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-751-11 | 25021-751 | ANDA204400 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (51407-374-90) | Golden State Medical Supply, Inc. | 51407-374-90 | 51407-374 | ANDA078281 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (51407-612-90) | Golden State Medical Supply, Inc. | 51407-612-90 | 51407-612 | ANDA078281 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (51407-613-10) | Golden State Medical Supply, Inc. | 51407-613-10 | 51407-613 | ANDA078281 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (51407-613-90) | Golden State Medical Supply, Inc. | 51407-613-90 | 51407-613 | ANDA078281 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (50228-105-10) | ScieGen Pharmaceuticals Inc | 50228-105-10 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-105-30) | ScieGen Pharmaceuticals Inc | 50228-105-30 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 4200 Tablet In 1 Bottle (50228-106-00) | ScieGen Pharmaceuticals Inc | 50228-106-00 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 100 Tablet In 1 Bottle (50228-106-01) | ScieGen Pharmaceuticals Inc | 50228-106-01 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 500 Tablet In 1 Bottle (50228-106-05) | ScieGen Pharmaceuticals Inc | 50228-106-05 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 1000 Tablet In 1 Bottle (50228-106-10) | ScieGen Pharmaceuticals Inc | 50228-106-10 | 50228-106 | ANDA203769 | ANDA | N/A |
| Pantoprazole Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/1 | 10 Vial In 1 Carton (0143-9300-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9300-01) | Hikma Pharmaceuticals USA Inc. | 0143-9300-10 | 0143-9300 | NDA209463 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 40mg/1 | 10 Vial In 1 Carton (0143-9284-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9284-01) | Hikma Pharmaceuticals USA Inc. | 0143-9284-10 | 0143-9284 | NDA209463 | NDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 30 Tablet In 1 Bottle (50228-106-30) | ScieGen Pharmaceuticals Inc | 50228-106-30 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (50228-107-00) | ScieGen Pharmaceuticals Inc | 50228-107-00 | 50228-107 | ANDA203769 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (0008-0841-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0841-81 | 0008-0841 | NDA020987 | NDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (0008-0843-81) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0843-81 | 0008-0843 | NDA020987 | NDA | N/A |
| Pantoprazole Sodium | Granule, Delayed Release | Oral | 40mg/1 | 30 Packet In 1 Carton (0008-0844-02) / 1 Granule, Delayed Release In 1 Packet (0008-0844-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0844-02 | 0008-0844 | NDA022020 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 1 Vial In 1 Carton (0008-0923-51) / 10 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923-51 | 0008-0923 | NDA020988 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 10 Carton In 1 Package (0008-0923-55) / 1 Vial In 1 Carton / 10 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923-55 | 0008-0923 | NDA020988 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 25 Carton In 1 Package (0008-0923-60) / 1 Vial In 1 Carton / 10 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923-60 | 0008-0923 | NDA020988 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 10 Carton In 1 Package (0008-4001-10) / 1 Vial In 1 Carton (0008-4001-01) / 10 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4001-10 | 0008-4001 | NDA020988 | NDA | N/A |
| Pantoprazole Sodium | Injection, Powder, For Solution | Intravenous | 40mg/10mL | 25 Carton In 1 Package (0008-4001-25) / 1 Vial In 1 Carton (0008-4001-01) / 10 Ml In 1 Vial | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4001-25 | 0008-4001 | NDA020988 | NDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 100 Tablet In 1 Bottle (50228-107-01) | ScieGen Pharmaceuticals Inc | 50228-107-01 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 500 Tablet In 1 Bottle (50228-107-05) | ScieGen Pharmaceuticals Inc | 50228-107-05 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 1000 Tablet In 1 Bottle (50228-107-10) | ScieGen Pharmaceuticals Inc | 50228-107-10 | 50228-107 | ANDA203769 | ANDA | N/A |
| Papaverine Hydrochloride | Injection, Solution | Intravenous | 30mg/mL | 25 Vial In 1 Carton (0517-4002-25) / 2 Ml In 1 Vial (0517-4002-01) | American Regent, Inc. | 0517-4002-25 | 0517-4002 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Paricalcitol | Capsule | Oral | 1ug/1 | 30 Capsule In 1 Bottle, Plastic (69452-145-13) | Bionpharma Inc. | 69452-145-13 | 69452-145 | ANDA202539 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 2ug/1 | 30 Capsule In 1 Bottle, Plastic (69452-146-13) | Bionpharma Inc. | 69452-146-13 | 69452-146 | ANDA202539 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 4ug/1 | 30 Capsule In 1 Bottle, Plastic (69452-147-13) | Bionpharma Inc. | 69452-147-13 | 69452-147 | ANDA202539 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 30 Tablet In 1 Bottle (50228-107-30) | ScieGen Pharmaceuticals Inc | 50228-107-30 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 1000mg/1 | 60 Tablet In 1 Bottle (50228-107-60) | ScieGen Pharmaceuticals Inc | 50228-107-60 | 50228-107 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 9000 Tablet In 1 Bottle (50228-105-00) | ScieGen Pharmaceuticals Inc | 50228-105-00 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-105-01) | ScieGen Pharmaceuticals Inc | 50228-105-01 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-105-05) | ScieGen Pharmaceuticals Inc | 50228-105-05 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (50228-105-10) | ScieGen Pharmaceuticals Inc | 50228-105-10 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-105-30) | ScieGen Pharmaceuticals Inc | 50228-105-30 | 50228-105 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 4200 Tablet In 1 Bottle (50228-106-00) | ScieGen Pharmaceuticals Inc | 50228-106-00 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 100 Tablet In 1 Bottle (50228-106-01) | ScieGen Pharmaceuticals Inc | 50228-106-01 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 500 Tablet In 1 Bottle (50228-106-05) | ScieGen Pharmaceuticals Inc | 50228-106-05 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 1000 Tablet In 1 Bottle (50228-106-10) | ScieGen Pharmaceuticals Inc | 50228-106-10 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet | Oral | 850mg/1 | 30 Tablet In 1 Bottle (50228-106-30) | ScieGen Pharmaceuticals Inc | 50228-106-30 | 50228-106 | ANDA203769 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-01) | ScieGen Pharmaceuticals, Inc. | 50228-445-01 | 50228-445 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-05) | ScieGen Pharmaceuticals, Inc. | 50228-445-05 | 50228-445 | ANDA213334 | ANDA | N/A |
| Parkinsonia Florida Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2017-1) | Jubilant HollisterStier LLC | 65044-2017-1 | 65044-2017 | BLA103888 | BLA | N/A |
| Parkinsonia Florida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2018-2) | Jubilant HollisterStier LLC | 65044-2018-2 | 65044-2018 | BLA103888 | BLA | N/A |
| Parkinsonia Florida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2018-3) | Jubilant HollisterStier LLC | 65044-2018-3 | 65044-2018 | BLA103888 | BLA | N/A |
| Parkinsonia Florida Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2018-4) | Jubilant HollisterStier LLC | 65044-2018-4 | 65044-2018 | BLA103888 | BLA | N/A |
| Paromomycin Sulfate | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (80725-250-01) | Waylis Therapeutics LLC | 80725-250-01 | 80725-250 | ANDA065173 | ANDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 12.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-1316-3) | Apotex Corp | 60505-1316-3 | 60505-1316 | NDA020936 | NDA AUTHORIZED GENERIC | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 12.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-4377-3) | Apotex Corp | 60505-4377-3 | 60505-4377 | NDA020936 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-4378-3) | Apotex Corp | 60505-4378-3 | 60505-4378 | NDA020936 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-4379-3) | Apotex Corp | 60505-4379-3 | 60505-4379 | NDA020936 | NDA | N/A |
| Paroxetine Hydrochloride | Suspension | Oral | 10mg/5mL | 250 Ml In 1 Bottle (60505-0402-5) | Apotex Corp | 60505-0402-5 | 60505-0402 | NDA020710 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4517-3) | Apotex Corp | 60505-4517-3 | 60505-4517 | NDA020031 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4518-3) | Apotex Corp | 60505-4518-3 | 60505-4518 | NDA020031 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4519-3) | Apotex Corp | 60505-4519-3 | 60505-4519 | NDA020031 | NDA | N/A |
| Paroxetine Hydrochloride | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4520-3) | Apotex Corp | 60505-4520-3 | 60505-4520 | NDA020031 | NDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-734-10) | Golden State Medical Supply, Inc. | 60429-734-10 | 60429-734 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-734-30) | Golden State Medical Supply, Inc. | 60429-734-30 | 60429-734 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-734-90) | Golden State Medical Supply, Inc. | 60429-734-90 | 60429-734 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-735-10) | Golden State Medical Supply, Inc. | 60429-735-10 | 60429-735 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-735-30) | Golden State Medical Supply, Inc. | 60429-735-30 | 60429-735 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-735-90) | Golden State Medical Supply, Inc. | 60429-735-90 | 60429-735 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-736-10) | Golden State Medical Supply, Inc. | 60429-736-10 | 60429-736 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-736-30) | Golden State Medical Supply, Inc. | 60429-736-30 | 60429-736 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-736-90) | Golden State Medical Supply, Inc. | 60429-736-90 | 60429-736 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60429-737-10) | Golden State Medical Supply, Inc. | 60429-737-10 | 60429-737 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (60429-737-30) | Golden State Medical Supply, Inc. | 60429-737-30 | 60429-737 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (60429-737-90) | Golden State Medical Supply, Inc. | 60429-737-90 | 60429-737 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0083-1) | Apotex Corp. | 60505-0083-1 | 60505-0083 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0083-2) | Apotex Corp. | 60505-0083-2 | 60505-0083 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0083-4) | Apotex Corp. | 60505-0083-4 | 60505-0083 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0084-1) | Apotex Corp. | 60505-0084-1 | 60505-0084 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0084-2) | Apotex Corp. | 60505-0084-2 | 60505-0084 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 30mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0084-4) | Apotex Corp. | 60505-0084-4 | 60505-0084 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0097-1) | Apotex Corp. | 60505-0097-1 | 60505-0097 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0097-2) | Apotex Corp. | 60505-0097-2 | 60505-0097 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0097-4) | Apotex Corp. | 60505-0097-4 | 60505-0097 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-0101-1) | Apotex Corp. | 60505-0101-1 | 60505-0101 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Bottle (60505-0101-2) | Apotex Corp. | 60505-0101-2 | 60505-0101 | ANDA075356 | ANDA | N/A |
| Paroxetine Hydrochloride Anhydrous | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (60505-0101-4) | Apotex Corp. | 60505-0101-4 | 60505-0101 | ANDA075356 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-30) | ScieGen Pharmaceuticals, Inc. | 50228-445-30 | 50228-445 | ANDA213334 | ANDA | N/A |
| Paroxetine Hydrochloride Hemihydrate | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-1317-3) | Apotex Corp | 60505-1317-3 | 60505-1317 | NDA020936 | NDA AUTHORIZED GENERIC | N/A |
| Paroxetine Hydrochloride Hemihydrate | Tablet, Film Coated, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (60505-1318-3) | Apotex Corp | 60505-1318-3 | 60505-1318 | NDA020936 | NDA AUTHORIZED GENERIC | N/A |
| Paroxetine Mesylate | Capsule | Oral | 7.5mg/1 | 30 Capsule In 1 Bottle (0574-0279-30) | Padagis US LLC | 0574-0279-30 | 0574-0279 | NDA204516 | NDA AUTHORIZED GENERIC | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1081-2) | Jubilant HollisterStier LLC | 65044-1081-2 | 65044-1081 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1081-3) | Jubilant HollisterStier LLC | 65044-1081-3 | 65044-1081 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1081-4) | Jubilant HollisterStier LLC | 65044-1081-4 | 65044-1081 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1082-1) | Jubilant HollisterStier LLC | 65044-1082-1 | 65044-1082 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1084-2) | Jubilant HollisterStier LLC | 65044-1084-2 | 65044-1084 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1084-3) | Jubilant HollisterStier LLC | 65044-1084-3 | 65044-1084 | BLA103888 | BLA | N/A |
| Paspalum Notatum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1084-4) | Jubilant HollisterStier LLC | 65044-1084-4 | 65044-1084 | BLA103888 | BLA | N/A |
| Pazopanib | Tablet | Oral | 200mg/1 | 120 Tablet In 1 Bottle (51407-872-12) | Golden State Medical Supply, Inc. | 51407-872-12 | 51407-872 | ANDA217713 | ANDA | N/A |
| Pazopanib | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (60505-4779-5) | Apotex Corp. | 60505-4779-5 | 60505-4779 | ANDA217713 | ANDA | N/A |
| Pazopanib | Tablet | Oral | 200mg/1 | 120 Tablet In 1 Bottle (60505-4779-7) | Apotex Corp. | 60505-4779-7 | 60505-4779 | ANDA217713 | ANDA | N/A |
| Pea | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3449-2) | Jubilant HollisterStier LLC | 65044-3449-2 | 65044-3449 | BLA103888 | BLA | N/A |
| Peach | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3452-2) | Jubilant HollisterStier LLC | 65044-3452-2 | 65044-3452 | BLA103888 | BLA | N/A |
| Peanut | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3455-2) | Jubilant HollisterStier LLC | 65044-3455-2 | 65044-3455 | BLA103888 | BLA | N/A |
| Pecan | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3461-2) | Jubilant HollisterStier LLC | 65044-3461-2 | 65044-3461 | BLA103888 | BLA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-05) | ScieGen Pharmaceuticals, Inc. | 50228-446-05 | 50228-446 | ANDA213334 | ANDA | N/A |
| Pegfilgrastim | Injection, Solution | Subcutaneous | 6mg/.6mL | 1 Carton In 1 Carton (0069-0324-01) / 1 Syringe In 1 Carton / .6 Ml In 1 Syringe | Pfizer Laboratories Div Pfizer Inc | 0069-0324-01 | 0069-0324 | BLA761111 | BLA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/4mL | 1 Vial In 1 Carton (60505-6065-0) / 4 Ml In 1 Vial | Apotex Corp | 60505-6065-0 | 60505-6065 | ANDA203774 | ANDA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 1 Vial In 1 Carton (60505-6066-0) / 20 Ml In 1 Vial | Apotex Corp | 60505-6066-0 | 60505-6066 | ANDA203774 | ANDA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 1000mg/40mL | 1 Vial In 1 Carton (60505-6067-0) / 40 Ml In 1 Vial | Apotex Corp | 60505-6067-0 | 60505-6067 | ANDA209085 | ANDA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/30mL | 1 Vial In 1 Carton (60505-6068-0) / 30 Ml In 1 Vial | Apotex Corp | 60505-6068-0 | 60505-6068 | ANDA209851 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-30) | ScieGen Pharmaceuticals, Inc. | 50228-446-30 | 50228-446 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-90) | ScieGen Pharmaceuticals, Inc. | 50228-446-90 | 50228-446 | ANDA213334 | ANDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 500mg/20mL | 1 Vial, Single-Dose In 1 Carton (0409-0021-03) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0021-03 | 0409-0021 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 100mg/4mL | 1 Vial, Single-Dose In 1 Carton (0409-1045-01) / 4 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1045-01 | 0409-1045 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 1g/40mL | 1 Vial, Single-Dose In 1 Carton (0409-3532-01) / 40 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-3532-01 | 0409-3532 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 500mg/20mL | 1 Vial, Single-Dose In 1 Carton (0409-2188-01) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-2188-01 | 0409-2188 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 1g/40mL | 1 Vial, Single-Dose In 1 Carton (0409-0004-04) / 40 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0004-04 | 0409-0004 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium | Injection, Solution, Concentrate | Intravenous | 100mg/4mL | 1 Vial, Single-Dose In 1 Carton (0409-0020-02) / 4 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0020-02 | 0409-0020 | NDA214218 | NDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/50mL | 1 Vial, Single-Dose In 1 Carton (71288-167-96) / 50 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-167-96 | 71288-167 | ANDA208696 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/50mL | 1 Vial, Single-Dose In 1 Carton (71288-167-95) / 50 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-167-95 | 71288-167 | ANDA208696 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-166-10) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-166-10 | 71288-166 | ANDA208696 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-166-92) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-166-92 | 71288-166 | ANDA208696 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Dose In 1 Carton (71288-166-91) / 10 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-166-91 | 71288-166 | ANDA208696 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/50mL | 1 Vial, Single-Dose In 1 Carton (71288-167-50) / 50 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-167-50 | 71288-167 | ANDA208696 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-05) | ScieGen Pharmaceuticals, Inc. | 50228-503-05 | 50228-503 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-30) | ScieGen Pharmaceuticals, Inc. | 50228-503-30 | 50228-503 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-60) | ScieGen Pharmaceuticals, Inc. | 50228-503-60 | 50228-503 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-05) | ScieGen Pharmaceuticals, Inc. | 50228-504-05 | 50228-504 | ANDA214629 | ANDA | N/A |
| Pemetrexed Disodium Heptahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/4.2mL | 1 Vial, Single-Dose In 1 Carton (71288-145-10) / 4.2 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-145-10 | 71288-145 | ANDA215479 | ANDA | N/A |
| Pemetrexed Disodium Heptahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 1 Vial, Single-Dose In 1 Carton (71288-146-50) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-146-50 | 71288-146 | ANDA215479 | ANDA | N/A |
| Pemetrexed Disodium Heptahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/30mL | 1 Vial, Single-Dose In 1 Carton (71288-147-50) / 30 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-147-50 | 71288-147 | ANDA215479 | ANDA | N/A |
| Pemetrexed Disodium Heptahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/40mL | 1 Vial, Single-Dose In 1 Carton (71288-148-51) / 40 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-148-51 | 71288-148 | ANDA215479 | ANDA | N/A |
| Pemetrexed Tromethamine Anhydrous | Injection, Powder, Lyophilized, For Solution | Intravenous | 25mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1060-01) / 4.2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1060-01 | 0409-1060 | NDA208746 | NDA | N/A |
| Pemetrexed Tromethamine Anhydrous | Injection, Powder, Lyophilized, For Solution | Intravenous | 25mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-1061-01) / 20 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-1061-01 | 0409-1061 | NDA208746 | NDA | N/A |
| Penicillamine | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (68475-201-01) | Navinta LLC | 68475-201-01 | 68475-201 | ANDA214363 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-30) | ScieGen Pharmaceuticals, Inc. | 50228-504-30 | 50228-504 | ANDA214629 | ANDA | N/A |
| Penicillamine | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (60505-4696-1) | Apotex Corp. | 60505-4696-1 | 60505-4696 | ANDA213310 | ANDA | N/A |
| Penicillin G Benzathine | Injection, Suspension | Intramuscular | 600000[iU]/mL | 10 Syringe In 1 Package (60793-700-10) / 1 Ml In 1 Syringe (60793-700-01) | Pfizer Laboratories Div Pfizer Inc | 60793-700-10 | 60793-700 | NDA050141 | NDA | N/A |
| Penicillin G Benzathine | Injection, Suspension | Intramuscular | 1200000[iU]/2mL | 10 Syringe In 1 Package (60793-701-10) / 2 Ml In 1 Syringe (60793-701-02) | Pfizer Laboratories Div Pfizer Inc | 60793-701-10 | 60793-701 | NDA050141 | NDA | N/A |
| Penicillin G Benzathine | Injection, Suspension | Intramuscular | 2400000[iU]/4mL | 10 Syringe In 1 Package (60793-702-10) / 4 Ml In 1 Syringe (60793-702-04) | Pfizer Laboratories Div Pfizer Inc | 60793-702-10 | 60793-702 | NDA050141 | NDA | N/A |
| Penicillin G Benzathine; Penicillin G Procaine | Injection, Suspension | Intramuscular | 900000[iU]/2mL, 300000 [iU]/2mL | 10 Syringe In 1 Package (60793-602-10) / 2 Ml In 1 Syringe (60793-602-02) | Pfizer Laboratories Div Pfizer Inc | 60793-602-10 | 60793-602 | NDA050138 | NDA | N/A |
| Penicillin G Benzathine; Penicillin G Procaine | Injection, Suspension | Intramuscular | 600000[iU]/2mL, 600000 [iU]/2mL | 10 Syringe In 1 Package (60793-600-10) / 2 Ml In 1 Syringe (60793-600-02) | Pfizer Laboratories Div Pfizer Inc | 60793-600-10 | 60793-600 | NDA050138 | NDA | N/A |
| Penicillin G Benzathine; Penicillin G Procaine | Injection, Suspension | Intramuscular | 600000[iU]/2mL, 600000 [iU]/2mL | 10 Syringe In 1 Package (60793-601-10) / 2 Ml In 1 Syringe (60793-601-02) | Pfizer Laboratories Div Pfizer Inc | 60793-601-10 | 60793-601 | NDA050138 | NDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-60) | ScieGen Pharmaceuticals, Inc. | 50228-504-60 | 50228-504 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-01) | ScieGen Pharmaceuticals, Inc. | 50228-445-01 | 50228-445 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-05) | ScieGen Pharmaceuticals, Inc. | 50228-445-05 | 50228-445 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-445-30) | ScieGen Pharmaceuticals, Inc. | 50228-445-30 | 50228-445 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-05) | ScieGen Pharmaceuticals, Inc. | 50228-446-05 | 50228-446 | ANDA213334 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (0143-9836-01) | Hikma Pharmaceuticals USA Inc. | 0143-9836-01 | 0143-9836 | ANDA090549 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (0143-9836-10) | Hikma Pharmaceuticals USA Inc. | 0143-9836-10 | 0143-9836 | ANDA090549 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (0143-9837-01) | Hikma Pharmaceuticals USA Inc. | 0143-9837-01 | 0143-9837 | ANDA090549 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (0143-9837-10) | Hikma Pharmaceuticals USA Inc. | 0143-9837-10 | 0143-9837 | ANDA090549 | ANDA | N/A |
| Penicillium Chrysogenum Var. Chrysogenum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5208-2) | Jubilant HollisterStier LLC | 65044-5208-2 | 65044-5208 | BLA103888 | BLA | N/A |
| Penicillium Chrysogenum Var. Chrysogenum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5208-3) | Jubilant HollisterStier LLC | 65044-5208-3 | 65044-5208 | BLA103888 | BLA | N/A |
| Penicillium Chrysogenum Var. Chrysogenum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5208-4) | Jubilant HollisterStier LLC | 65044-5208-4 | 65044-5208 | BLA103888 | BLA | N/A |
| Penicillium Chrysogenum Var. Chrysogenum | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5209-1) | Jubilant HollisterStier LLC | 65044-5209-1 | 65044-5209 | BLA103888 | BLA | N/A |
| Pentamidine Isethionate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 300mg/300mg | 10 Vial In 1 Tray (13925-515-10) / 300 Mg In 1 Vial | Seton Pharmaceuticals | 13925-515-10 | 13925-515 | ANDA206666 | ANDA | N/A |
| Pentamidine Isethionate | Inhalant | Respiratory (Inhalation) | 300mg/300mg | 1 Vial In 1 Carton (13925-522-01) / 300 Mg In 1 Vial | Seton Pharmaceuticals | 13925-522-01 | 13925-522 | ANDA206667 | ANDA | N/A |
| Pentetic Acid | Injection, Powder, Lyophilized, For Solution | Intravenous; Respiratory (Inhalation) | 20mg/1 | 30 Injection, Powder, Lyophilized, For Solution In 1 Kit (65174-288-30) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-288-30 | 65174-288 | NDA018511 | NDA | N/A |
| Pentobarbital Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 1 Vial In 1 Carton (25021-676-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-676-20 | 25021-676 | ANDA206404 | ANDA | CII |
| Pentobarbital Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 1 Vial In 1 Carton (25021-676-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-676-50 | 25021-676 | ANDA206404 | ANDA | CII |
| Pentobarbital Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 1 Vial In 1 Carton (24201-010-20) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | 24201-010-20 | 24201-010 | ANDA203619 | ANDA | CII |
| Pentobarbital Sodium | Injection, Solution | Intramuscular; Intravenous | 50mg/mL | 1 Vial In 1 Carton (24201-010-50) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | 24201-010-50 | 24201-010 | ANDA203619 | ANDA | CII |
| Pentostatin | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0801-01) / 5 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0801-01 | 0409-0801 | NDA020122 | NDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-30) | ScieGen Pharmaceuticals, Inc. | 50228-446-30 | 50228-446 | ANDA213334 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-446-90) | ScieGen Pharmaceuticals, Inc. | 50228-446-90 | 50228-446 | ANDA213334 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (60505-0033-6) | Apotex Corp. | 60505-0033-6 | 60505-0033 | ANDA075191 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 500 Tablet, Extended Release In 1 Bottle (60505-0033-7) | Apotex Corp. | 60505-0033-7 | 60505-0033 | ANDA075191 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-05) | ScieGen Pharmaceuticals, Inc. | 50228-503-05 | 50228-503 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-30) | ScieGen Pharmaceuticals, Inc. | 50228-503-30 | 50228-503 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-503-60) | ScieGen Pharmaceuticals, Inc. | 50228-503-60 | 50228-503 | ANDA214629 | ANDA | N/A |
| Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-6580-2) | Jubilant HollisterStier LLC | 65044-6580-2 | 65044-6580 | BLA103888 | BLA | N/A |
| Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-6580-3) | Jubilant HollisterStier LLC | 65044-6580-3 | 65044-6580 | BLA103888 | BLA | N/A |
| Periplaneta Americana | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-6580-4) | Jubilant HollisterStier LLC | 65044-6580-4 | 65044-6580 | BLA103888 | BLA | N/A |
| Permethrin | Cream | Topical | 50mg/g | 1 Tube In 1 Carton (45802-269-37) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-269-37 | 45802-269 | ANDA076369 | ANDA | N/A |
| Perphenazine | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51407-694-01) | GOLDEN STATE MEDICAL SUPPLY, INC. | 51407-694-01 | 51407-694 | ANDA205232 | ANDA | N/A |
| Perphenazine | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (51407-695-01) | GOLDEN STATE MEDICAL SUPPLY, INC. | 51407-695-01 | 51407-695 | ANDA205232 | ANDA | N/A |
| Perphenazine | Tablet | Oral | 8mg/1 | 100 Tablet In 1 Bottle (51407-696-01) | GOLDEN STATE MEDICAL SUPPLY, INC. | 51407-696-01 | 51407-696 | ANDA205232 | ANDA | N/A |
| Perphenazine | Tablet | Oral | 16mg/1 | 100 Tablet In 1 Bottle (51407-697-01) | GOLDEN STATE MEDICAL SUPPLY, INC. | 51407-697-01 | 51407-697 | ANDA205232 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-162-01) | Wilshire Pharmaceuticals, Inc. | 52536-162-01 | 52536-162 | ANDA205973 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 4mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-164-01) | Wilshire Pharmaceuticals, Inc. | 52536-164-01 | 52536-164 | ANDA205973 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 8mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-168-01) | Wilshire Pharmaceuticals, Inc. | 52536-168-01 | 52536-168 | ANDA205973 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 16mg/1 | 100 Tablet, Film Coated In 1 Bottle (52536-170-01) | Wilshire Pharmaceuticals, Inc. | 52536-170-01 | 52536-170 | ANDA205973 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-05) | ScieGen Pharmaceuticals, Inc. | 50228-504-05 | 50228-504 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-30) | ScieGen Pharmaceuticals, Inc. | 50228-504-30 | 50228-504 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (50228-504-60) | ScieGen Pharmaceuticals, Inc. | 50228-504-60 | 50228-504 | ANDA214629 | ANDA | N/A |
| Metformin Hydrochloride Oral Solution | SOLUTION | ORAL | 500mg/5mL | 5 TRAY in 1 CASE (71656-017-52) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE | Saptalis Pharmaceuticals, LLC | 71656-017-52 | 71656-017 | ANDA211309 | ANDA | N/A |
| Phenazopyridine Hydrochloride | Tablet, Film Coated | Oral | 99.5mg/1 | 1 Blister Pack In 1 Carton (52389-241-24) / 24 Tablet, Film Coated In 1 Blister Pack (52389-241-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-241-24 | 52389-241 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet, Film Coated | Oral | 99.5mg/1 | 1 Blister Pack In 1 Carton (52389-241-28) / 28 Tablet, Film Coated In 1 Blister Pack (52389-241-04) | Alva-Amco Pharmacal Companies, Inc. | 52389-241-28 | 52389-241 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet, Film Coated | Oral | 99.5mg/1 | 2 Blister Pack In 1 Carton (52389-241-48) / 24 Tablet, Film Coated In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-241-48 | 52389-241 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Metformin Hydrochloride Oral Solution | SOLUTION | ORAL | 500mg/5mL | 118 mL in 1 BOTTLE (71656-017-04) | Saptalis Pharmaceuticals, LLC. | 71656-017-04 | 71656-017 | ANDA211309 | ANDA | N/A |
| Metformin Hydrochloride Oral Solution | SOLUTION | ORAL | 500mg/5mL | 473 mL in 1 BOTTLE (71656-017-16) | Saptalis Pharmaceuticals, LLC. | 71656-017-16 | 71656-017 | ANDA211309 | ANDA | N/A |
| Metformin Hydrochloride Oral Solution | SOLUTION | ORAL | 500mg/5mL | 5 TRAY in 1 CASE (71656-017-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE | Saptalis Pharmaceuticals, LLC. | 71656-017-50 | 71656-017 | ANDA211309 | ANDA | N/A |
| Metformin Hydrochloride Oral Solution | SOLUTION | ORAL | 500mg/5mL | 5 TRAY in 1 CASE (71656-017-51) / 10 CUP, UNIT-DOSE in 1 TRAY / 8.5 mL in 1 CUP, UNIT-DOSE | Saptalis Pharmaceuticals, LLC. | 71656-017-51 | 71656-017 | ANDA211309 | ANDA | N/A |
| Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 500mg/1, 15 mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-217-60) | Rising Pharma Holdings, Inc. | 57237-217-60 | 57237-217 | ANDA200823 | ANDA | N/A |
| Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 500mg/1, 15 mg/1 | 180 Tablet, Film Coated In 1 Bottle (57237-217-81) | Rising Pharma Holdings, Inc. | 57237-217-81 | 57237-217 | ANDA200823 | ANDA | N/A |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 100 Tablet In 1 Bottle (10702-045-01) | KVK-TECH, INC | 10702-045-01 | 10702-045 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 30 Tablet In 1 Bottle (10702-045-03) | KVK-TECH, INC | 10702-045-03 | 10702-045 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 1000 Tablet In 1 Bottle (10702-045-10) | KVK-TECH, INC | 10702-045-10 | 10702-045 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 100 Tablet In 1 Bottle (10702-077-01) | KVK-TECH, INC | 10702-077-01 | 10702-077 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 30 Tablet In 1 Bottle (10702-077-03) | KVK-TECH, INC | 10702-077-03 | 10702-077 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 1000 Tablet In 1 Bottle (10702-077-10) | KVK-TECH, INC | 10702-077-10 | 10702-077 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 100 Tablet In 1 Bottle (10702-078-01) | KVK-TECH, INC | 10702-078-01 | 10702-078 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 30 Tablet In 1 Bottle (10702-078-03) | KVK-TECH, INC | 10702-078-03 | 10702-078 | ANDA091042 | ANDA | CIII |
| Phendimetrazine Tartrate | Tablet | Oral | 35mg/1 | 1000 Tablet In 1 Bottle (10702-078-10) | KVK-TECH, INC | 10702-078-10 | 10702-078 | ANDA091042 | ANDA | CIII |
| Phenelzine Sulfate | Tablet, Film Coated | Oral | 15mg/1 | 60 Tablet, Film Coated In 1 Bottle (0071-0350-60) | Parke-Davis Div of Pfizer Inc | 0071-0350-60 | 0071-0350 | NDA011909 | NDA | N/A |
| Phenobarbital | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5332-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5332-1 | 51672-5332 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5332-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5332-3 | 51672-5332 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5333-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5333-1 | 51672-5333 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5333-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5333-3 | 51672-5333 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5334-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5334-1 | 51672-5334 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5334-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5334-3 | 51672-5334 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 16.2mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5326-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5326-1 | 51672-5326 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 16.2mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5326-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5326-3 | 51672-5326 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 32.4mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5327-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5327-1 | 51672-5327 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 32.4mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5327-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5327-3 | 51672-5327 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 64.8mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5328-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5328-1 | 51672-5328 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 64.8mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5328-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5328-3 | 51672-5328 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 97.2mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5329-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5329-1 | 51672-5329 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 97.2mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5329-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5329-3 | 51672-5329 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle, Plastic (51672-5331-1) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5331-1 | 51672-5331 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle, Plastic (51672-5331-3) | Taro Pharmaceuticals U.S.A. Inc. | 51672-5331-3 | 51672-5331 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 850mg/1, 15 mg/1 | 60 Tablet, Film Coated In 1 Bottle (57237-218-60) | Rising Pharma Holdings, Inc. | 57237-218-60 | 57237-218 | ANDA200823 | ANDA | N/A |
| Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet, Film Coated | Oral | 850mg/1, 15 mg/1 | 180 Tablet, Film Coated In 1 Bottle (57237-218-81) | Rising Pharma Holdings, Inc. | 57237-218-81 | 57237-218 | ANDA200823 | ANDA | N/A |
| Methadone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-946-01) | Camber Pharmaceuticals, Inc | 31722-946-01 | 31722-946 | ANDA211228 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-947-01) | Camber Pharmaceuticals, Inc | 31722-947-01 | 31722-947 | ANDA211228 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-317-01) | Epic Pharma, LLC | 42806-317-01 | 42806-317 | ANDA090065 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-318-01) | Epic Pharma, LLC | 42806-318-01 | 42806-318 | ANDA090065 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (72865-120-01) | XLCare Pharmaceuticals, Inc | 72865-120-01 | 72865-120 | ANDA211228 | ANDA | CII |
| Methadone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (72865-121-01) | XLCare Pharmaceuticals, Inc | 72865-121-01 | 72865-121 | ANDA211228 | ANDA | CII |
| Methazolamide | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (62559-240-01) | ANI Pharmaceuticals, Inc. | 62559-240-01 | 62559-240 | ANDA040001 | ANDA | N/A |
| Methazolamide | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (62559-241-01) | ANI Pharmaceuticals, Inc. | 62559-241-01 | 62559-241 | ANDA040001 | ANDA | N/A |
| Methenamine Hippurate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle (50742-142-01) | Ingenus Pharmaceuticals, LLC | 50742-142-01 | 50742-142 | ANDA210068 | ANDA | N/A |
| Methenamine; Sodium Salicylate | Tablet | Oral | 162mg/1, 162.5 mg/1 | 1 Blister Pack In 1 Box (57237-332-42) / 24 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-332-42 | 57237-332 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Methenamine; Sodium Salicylate | Tablet | Oral | 162mg/1, 162.5 mg/1 | 1 Blister Pack In 1 Box (57237-332-81) / 18 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-332-81 | 57237-332 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Methimazole | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (64980-264-01) | Rising Pharmaceuticals, Inc. | 64980-264-01 | 64980-264 | ANDA202068 | ANDA | N/A |
| Methimazole | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (64980-265-01) | Rising Pharmaceuticals, Inc. | 64980-265-01 | 64980-265 | ANDA202068 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 12 Bottle In 1 Case (31722-533-01) / 100 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-533-01 | 31722-533 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 12 Bottle In 1 Case (31722-533-05) / 500 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-533-05 | 31722-533 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 12 Bottle In 1 Case (31722-533-10) / 1000 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-533-10 | 31722-533 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 12 Bottle In 1 Case (31722-533-30) / 30 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-533-30 | 31722-533 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 12 Bottle In 1 Case (31722-533-60) / 60 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-533-60 | 31722-533 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 12 Bottle In 1 Case (31722-534-01) / 100 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-534-01 | 31722-534 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 12 Bottle In 1 Case (31722-534-05) / 500 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-534-05 | 31722-534 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 12 Bottle In 1 Case (31722-534-30) / 30 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-534-30 | 31722-534 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 12 Bottle In 1 Case (31722-534-60) / 60 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-534-60 | 31722-534 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (72865-233-01) | XLCare Pharmaceuticals Inc. | 72865-233-01 | 72865-233 | ANDA090200 | ANDA | N/A |
| Phenobarbital | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (0143-1455-01) | Hikma Pharmaceuticals USA Inc. | 0143-1455-01 | 0143-1455 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 500 Tablet In 1 Bottle (0143-1455-05) | Hikma Pharmaceuticals USA Inc. | 0143-1455-05 | 0143-1455 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (0143-1458-01) | Hikma Pharmaceuticals USA Inc. | 0143-1458-01 | 0143-1458 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (0143-1458-05) | Hikma Pharmaceuticals USA Inc. | 0143-1458-05 | 0143-1458 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (0143-1495-01) | Hikma Pharmaceuticals USA Inc. | 0143-1495-01 | 0143-1495 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (0143-1495-05) | Hikma Pharmaceuticals USA Inc. | 0143-1495-05 | 0143-1495 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (0143-1500-01) | Hikma Pharmaceuticals USA Inc. | 0143-1500-01 | 0143-1500 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (0143-1500-05) | Hikma Pharmaceuticals USA Inc. | 0143-1500-05 | 0143-1500 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital Sodium | Injection | Intramuscular; Intravenous | 65mg/mL | 25 Vial In 1 Carton (0641-0476-25) / 1 Ml In 1 Vial (0641-0476-21) | Hikma Pharmaceuticals USA Inc. | 0641-0476-25 | 0641-0476 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital Sodium | Injection | Intramuscular; Intravenous | 130mg/mL | 25 Vial In 1 Carton (0641-0477-25) / 1 Ml In 1 Vial (0641-0477-21) | Hikma Pharmaceuticals USA Inc. | 0641-0477-25 | 0641-0477 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenoxybenzamine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (70954-365-10) | Novitium Pharma LLC | 70954-365-10 | 70954-365 | ANDA215042 | ANDA | N/A |
| Phenoxybenzamine Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (66993-066-02) | Prasco Laboratories | 66993-066-02 | 66993-066 | NDA008708 | NDA AUTHORIZED GENERIC | N/A |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 30 Tablet In 1 Bottle (10702-001-03) | KVK-TECH, INC. | 10702-001-03 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 60 Tablet In 1 Bottle (10702-001-06) | KVK-TECH, INC. | 10702-001-06 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 90 Tablet In 1 Bottle (10702-001-09) | KVK-TECH, INC. | 10702-001-09 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 1000 Tablet In 1 Bottle (10702-001-10) | KVK-TECH, INC. | 10702-001-10 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 250 Tablet In 1 Bottle (10702-001-25) | KVK-TECH, INC. | 10702-001-25 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 500 Tablet In 1 Bottle (10702-001-50) | KVK-TECH, INC. | 10702-001-50 | 10702-001 | ANDA203495 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 30 Tablet In 1 Bottle (10702-067-03) | KVK-TECH, Inc. | 10702-067-03 | 10702-067 | ANDA203436 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 5000 Tablet In 1 Bottle (10702-067-05) | KVK-TECH, Inc. | 10702-067-05 | 10702-067 | ANDA203436 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 8mg/1 | 1000 Tablet In 1 Bottle (10702-067-10) | KVK-TECH, Inc. | 10702-067-10 | 10702-067 | ANDA203436 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 37.5mg/1 | 100 Tablet In 1 Bottle (10702-025-01) | KVK-TECH, Inc. | 10702-025-01 | 10702-025 | ANDA040876 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 37.5mg/1 | 30 Tablet In 1 Bottle (10702-025-03) | KVK-TECH, Inc. | 10702-025-03 | 10702-025 | ANDA040876 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 37.5mg/1 | 1000 Tablet In 1 Bottle (10702-025-10) | KVK-TECH, Inc. | 10702-025-10 | 10702-025 | ANDA040876 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 15mg/1 | 100 Capsule In 1 Bottle (10702-026-01) | KVK-Tech, Inc. | 10702-026-01 | 10702-026 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 15mg/1 | 30 Capsule In 1 Bottle (10702-026-03) | KVK-Tech, Inc. | 10702-026-03 | 10702-026 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 15mg/1 | 1000 Capsule In 1 Bottle (10702-026-10) | KVK-Tech, Inc. | 10702-026-10 | 10702-026 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (10702-027-01) | KVK-Tech, Inc. | 10702-027-01 | 10702-027 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 30 Capsule In 1 Bottle (10702-027-03) | KVK-Tech, Inc. | 10702-027-03 | 10702-027 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 1000 Capsule In 1 Bottle (10702-027-10) | KVK-Tech, Inc. | 10702-027-10 | 10702-027 | ANDA040886 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (10702-028-01) | KVK-Tech, Inc. | 10702-028-01 | 10702-028 | ANDA040875 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 30 Capsule In 1 Bottle (10702-028-03) | KVK-Tech, Inc. | 10702-028-03 | 10702-028 | ANDA040875 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 30mg/1 | 1000 Capsule In 1 Bottle (10702-028-10) | KVK-Tech, Inc. | 10702-028-10 | 10702-028 | ANDA040875 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 37.5mg/1 | 100 Capsule In 1 Bottle (10702-029-01) | KVK-TECH, Inc. | 10702-029-01 | 10702-029 | ANDA040887 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 37.5mg/1 | 30 Capsule In 1 Bottle (10702-029-03) | KVK-TECH, Inc. | 10702-029-03 | 10702-029 | ANDA040887 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 37.5mg/1 | 1000 Capsule In 1 Bottle (10702-029-10) | KVK-TECH, Inc. | 10702-029-10 | 10702-029 | ANDA040887 | ANDA | CIV |
| Methocarbamol | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (72865-233-05) | XLCare Pharmaceuticals Inc. | 72865-233-05 | 72865-233 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle (72865-234-01) | XLCare Pharmaceuticals Inc. | 72865-234-01 | 72865-234 | ANDA090200 | ANDA | N/A |
| Methocarbamol | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (72865-234-05) | XLCare Pharmaceuticals Inc. | 72865-234-05 | 72865-234 | ANDA090200 | ANDA | N/A |
| Methsuximide | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (70954-228-10) | ANI Pharmaceuticals, Inc. | 70954-228-10 | 70954-228 | ANDA217213 | ANDA | N/A |
| Phentolamine Mesylate | Injection, Powder, For Solution | Intramuscular; Intravenous | 5mg/mL | 1 Vial In 1 Box (0143-9564-01) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9564-01 | 0143-9564 | ANDA040235 | ANDA | N/A |
| Phentolamine Mesylate | Injection, Powder, For Solution | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Box (0143-9564-10) / 1 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9564-10 | 0143-9564 | ANDA040235 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-807-02) / 1 Ml In 1 Vial, Single-Dose (71288-807-01) | Meitheal Pharmaceuticals Inc. | 71288-807-02 | 71288-807 | ANDA210334 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (71288-808-76) / 5 Ml In 1 Vial, Pharmacy Bulk Package (71288-808-75) | Meitheal Pharmaceuticals Inc. | 71288-808-76 | 71288-808 | ANDA210333 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (71288-808-77) / 10 Ml In 1 Vial, Pharmacy Bulk Package | Meitheal Pharmaceuticals Inc. | 71288-808-77 | 71288-808 | ANDA210333 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 25 Vial In 1 Carton (25021-315-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-315-01 | 25021-315 | ANDA209967 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-315-98) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-315-98 | 25021-315 | ANDA209967 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection, Solution | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-315-99) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-315-99 | 25021-315 | ANDA209967 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (70069-801-25) / 1 Ml In 1 Vial (70069-801-01) | Somerset Therapeutics, LLC | 70069-801-25 | 70069-801 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 50mg/5mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (70069-802-10) / 5 Ml In 1 Vial, Pharmacy Bulk Package (70069-802-01) | Somerset Therapeutics, LLC | 70069-802-10 | 70069-802 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 100mg/10mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (70069-803-01) / 10 Ml In 1 Vial, Pharmacy Bulk Package | Somerset Therapeutics, LLC | 70069-803-01 | 70069-803 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (70069-811-25) / 1 Ml In 1 Vial (70069-811-01) | Somerset Therapeutics, LLC | 70069-811-25 | 70069-811 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 50mg/5mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (70069-812-10) / 5 Ml In 1 Vial, Pharmacy Bulk Package (70069-812-01) | Somerset Therapeutics, LLC | 70069-812-10 | 70069-812 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 100mg/10mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (70069-813-01) / 10 Ml In 1 Vial, Pharmacy Bulk Package | Somerset Therapeutics, LLC | 70069-813-01 | 70069-813 | ANDA213318 | ANDA | N/A |
| Phenylephrine Hydrochloride | Solution | Ophthalmic | 25mg/mL | 1 Bottle, Dropper In 1 Carton (69315-323-08) / 2 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-323-08 | 69315-323 | ANDA215183 | ANDA | N/A |
| Phenylephrine Hydrochloride | Solution | Ophthalmic | 25mg/mL | 1 Bottle, Dropper In 1 Carton (69315-323-15) / 15 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-323-15 | 69315-323 | ANDA215183 | ANDA | N/A |
| Phenylephrine Hydrochloride | Solution | Ophthalmic | 100mg/mL | 1 Bottle, Dropper In 1 Carton (69315-324-05) / 5 Ml In 1 Bottle, Dropper | Leading Pharma, LLC | 69315-324-05 | 69315-324 | ANDA215183 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection, Solution | Intravenous | .1mg/mL | 10 Ampule In 1 Carton (71863-202-06) / 5 Ml In 1 Ampule (71863-202-05) | Eton Pharmaceuticals, Inc. | 71863-202-06 | 71863-202 | NDA212909 | NDA | N/A |
| Phenylephrine Hydrochloride | Injection, Solution | Intravenous | .1mg/mL | 1 Vial In 1 Carton (71863-208-05) / 5 Ml In 1 Vial | Eton Pharmaceuticals, Inc. | 71863-208-05 | 71863-208 | NDA212909 | NDA | N/A |
| Methylergonovine Maleate | Tablet | Oral | .2mg/1 | 100 Tablet In 1 Bottle (16571-735-01) | Rising Pharma Holdings, Inc. | 16571-735-01 | 16571-735 | ANDA211919 | ANDA | N/A |
| Methylergonovine Maleate | Tablet | Oral | .2mg/1 | 7 Tablet In 1 Bottle (16571-735-17) | Rising Pharma Holdings, Inc. | 16571-735-17 | 16571-735 | ANDA211919 | ANDA | N/A |
| Methylergonovine Maleate | Tablet | Oral | .2mg/1 | 12 Tablet In 1 Bottle (16571-735-21) | Rising Pharma Holdings, Inc. | 16571-735-21 | 16571-735 | ANDA211919 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 100ug/mL | 10 Vial In 1 Carton (0641-6245-10) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0641-6245-10 | 0641-6245 | NDA203826 | NDA | N/A |
| Phenylephrine Hydrochloride | Injectable, Liposomal | Intravenous | 100ug/mL | 10 Vial In 1 Carton (0641-6246-10) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0641-6246-10 | 0641-6246 | NDA203826 | NDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (0641-6229-25) / 1 Ml In 1 Vial (0641-6229-01) | Hikma Pharmaceuticals USA Inc. | 0641-6229-25 | 0641-6229 | NDA203826 | NDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (0641-6188-10) / 5 Ml In 1 Vial, Pharmacy Bulk Package (0641-6188-01) | Hikma Pharmaceuticals USA Inc. | 0641-6188-10 | 0641-6188 | NDA203826 | NDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (0641-6189-10) / 10 Ml In 1 Vial, Pharmacy Bulk Package (0641-6189-01) | Hikma Pharmaceuticals USA Inc. | 0641-6189-10 | 0641-6189 | NDA203826 | NDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial In 1 Carton (0641-6142-25) / 1 Ml In 1 Vial (0641-6142-01) | Hikma Pharmaceuticals USA Inc. | 0641-6142-25 | 0641-6142 | NDA203826 | NDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 100 Tablet, Chewable In 1 Bottle (66993-372-02) | Prasco Laboratories | 66993-372-02 | 66993-372 | ANDA084427 | ANDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 100 Tablet, Chewable In 1 Bottle (51672-4146-1) | Taro Pharmaceuticals U.S.A., Inc | 51672-4146-1 | 51672-4146 | ANDA200565 | ANDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 1000 Tablet, Chewable In 1 Bottle (51672-4146-3) | Taro Pharmaceuticals U.S.A., Inc | 51672-4146-3 | 51672-4146 | ANDA200565 | ANDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 30 Tablet, Chewable In 1 Bottle (51672-4146-6) | Taro Pharmaceuticals U.S.A., Inc | 51672-4146-6 | 51672-4146 | ANDA200565 | ANDA | N/A |
| Phenytoin | Suspension | Oral | 125mg/5mL | 237 Ml In 1 Bottle (51672-4069-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4069-1 | 51672-4069 | ANDA040521 | ANDA | N/A |
| Phenytoin | Suspension | Oral | 125mg/5mL | 1 Bottle, Plastic In 1 Carton (58151-115-35) / 237 Ml In 1 Bottle, Plastic | Viatris Specialty LLC | 58151-115-35 | 58151-115 | NDA008762 | NDA | N/A |
| Phenytoin | Suspension | Oral | 125mg/5mL | 5 Tray In 1 Case (66689-036-50) / 10 Cup, Unit-Dose In 1 Tray / 4 Ml In 1 Cup, Unit-Dose (66689-036-01) | VistaPharm, LLC | 66689-036-50 | 66689-036 | ANDA040342 | ANDA | N/A |
| Phenytoin | Suspension | Oral | 125mg/5mL | 237 Ml In 1 Bottle (66689-775-08) | VistaPharm, LLC | 66689-775-08 | 66689-775 | ANDA040342 | ANDA | N/A |
| Methylergonovine Maleate | Tablet | Oral | .2mg/1 | 28 Tablet In 1 Bottle (16571-735-28) | Rising Pharma Holdings, Inc. | 16571-735-28 | 16571-735 | ANDA211919 | ANDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 100 Tablet, Chewable In 1 Bottle (0071-0007-24) | Parke-Davis Div of Pfizer Inc | 0071-0007-24 | 0071-0007 | ANDA084427 | ANDA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 100 Blister Pack In 1 Box, Unit-Dose (0071-0007-40) / 1 Tablet, Chewable In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-0007-40 | 0071-0007 | ANDA084427 | ANDA | N/A |
| Phenytoin | Suspension | Oral | 125mg/5mL | 1 Bottle, Plastic In 1 Carton (0071-2214-35) / 237 Ml In 1 Bottle, Plastic | Parke-Davis Div of Pfizer Inc | 0071-2214-35 | 0071-2214 | NDA008762 | NDA | N/A |
| Phenytoin Sodium | Capsule, Extended Release | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (51672-4111-0) / 10 Capsule, Extended Release In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4111-0 | 51672-4111 | ANDA040684 | ANDA | N/A |
| Phenytoin Sodium | Capsule, Extended Release | Oral | 100mg/1 | 100 Capsule, Extended Release In 1 Bottle (51672-4111-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4111-1 | 51672-4111 | ANDA040684 | ANDA | N/A |
| Phenytoin Sodium | Capsule, Extended Release | Oral | 100mg/1 | 1000 Capsule, Extended Release In 1 Bottle (51672-4111-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4111-3 | 51672-4111 | ANDA040684 | ANDA | N/A |
| Phenytoin Sodium | Capsule, Extended Release | Oral | 100mg/1 | 30 Capsule, Extended Release In 1 Bottle (51672-4111-6) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4111-6 | 51672-4111 | ANDA040684 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (42192-614-10) / 2 Ml In 1 Vial | Acella Pharmaceuticals, LLC | 42192-614-10 | 42192-614 | ANDA040573 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (42192-614-30) / 5 Ml In 1 Vial | Acella Pharmaceuticals, LLC | 42192-614-30 | 42192-614 | ANDA040573 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (0641-2555-10) / 5 Ml In 1 Vial (0641-2555-41) | Hikma Pharmaceuticals USA Inc. | 0641-2555-10 | 0641-2555 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0641-2555-45) / 5 Ml In 1 Vial (0641-2555-41) | Hikma Pharmaceuticals USA Inc. | 0641-2555-45 | 0641-2555 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0641-6138-25) / 2 Ml In 1 Vial (0641-6138-01) | Hikma Pharmaceuticals USA Inc. | 0641-6138-25 | 0641-6138 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 10 Vial In 1 Carton (0641-6139-10) / 5 Ml In 1 Vial (0641-6139-01) | Hikma Pharmaceuticals USA Inc. | 0641-6139-10 | 0641-6139 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0641-6139-25) / 5 Ml In 1 Vial (0641-6139-01) | Hikma Pharmaceuticals USA Inc. | 0641-6139-25 | 0641-6139 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Injection | Intramuscular; Intravenous | 50mg/mL | 25 Vial In 1 Carton (0641-0493-25) / 2 Ml In 1 Vial (0641-0493-21) | Hikma Pharmaceuticals USA Inc. | 0641-0493-25 | 0641-0493 | ANDA084307 | ANDA | N/A |
| Phenytoin Sodium | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (0071-3740-66) | Parke-Davis Div of Pfizer Inc | 0071-3740-66 | 0071-3740 | ANDA084349 | ANDA | N/A |
| Phenytoin Sodium | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (0071-0369-24) | Parke-Davis Div of Pfizer Inc | 0071-0369-24 | 0071-0369 | ANDA084349 | ANDA | N/A |
| Phenytoin Sodium | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (0071-0369-32) | Parke-Davis Div of Pfizer Inc | 0071-0369-32 | 0071-0369 | ANDA084349 | ANDA | N/A |
| Phenytoin Sodium | Capsule | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (0071-0369-40) / 1 Capsule In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-0369-40 | 0071-0369 | ANDA084349 | ANDA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0831-1) | Jubilant HollisterStier LLC | 65044-0831-1 | 65044-0831 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0831-2) | Jubilant HollisterStier LLC | 65044-0831-2 | 65044-0831 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0831-3) | Jubilant HollisterStier LLC | 65044-0831-3 | 65044-0831 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0831-4) | Jubilant HollisterStier LLC | 65044-0831-4 | 65044-0831 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0832-1) | Jubilant HollisterStier LLC | 65044-0832-1 | 65044-0832 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0832-2) | Jubilant HollisterStier LLC | 65044-0832-2 | 65044-0832 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0832-3) | Jubilant HollisterStier LLC | 65044-0832-3 | 65044-0832 | BLA103879 | BLA | N/A |
| Phleum Pratense Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0832-4) | Jubilant HollisterStier LLC | 65044-0832-4 | 65044-0832 | BLA103879 | BLA | N/A |
| Phoma Exigua Var. Exigua | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5220-2) | Jubilant HollisterStier LLC | 65044-5220-2 | 65044-5220 | BLA103888 | BLA | N/A |
| Phoma Exigua Var. Exigua | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5220-3) | Jubilant HollisterStier LLC | 65044-5220-3 | 65044-5220 | BLA103888 | BLA | N/A |
| Phoma Exigua Var. Exigua | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5220-4) | Jubilant HollisterStier LLC | 65044-5220-4 | 65044-5220 | BLA103888 | BLA | N/A |
| Phoma Exigua Var. Exigua | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5221-1) | Jubilant HollisterStier LLC | 65044-5221-1 | 65044-5221 | BLA103888 | BLA | N/A |
| Methylphenidate | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (43602-177-05) | Ascent Pharmaceuticals, Inc. | 43602-177-05 | 43602-177 | ANDA207417 | ANDA | CII |
| Methylphenidate | Solution | Oral | 5mg/5mL | 250 Ml In 1 Bottle (43602-177-25) | Ascent Pharmaceuticals, Inc. | 43602-177-25 | 43602-177 | ANDA207417 | ANDA | CII |
| Methylphenidate | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (43602-178-05) | Ascent Pharmaceuticals, Inc. | 43602-178-05 | 43602-178 | ANDA207417 | ANDA | CII |
| Methylphenidate | Solution | Oral | 10mg/5mL | 250 Ml In 1 Bottle (43602-178-25) | Ascent Pharmaceuticals, Inc. | 43602-178-25 | 43602-178 | ANDA207417 | ANDA | CII |
| Phytonadione | Injection, Emulsion | Intramuscular; Intravenous; Subcutaneous | 2mg/mL | 5 Tray In 1 Container (0409-9157-01) / 5 Ampule In 1 Tray (0409-9157-50) / .5 Ml In 1 Ampule (0409-9157-31) | Hospira, Inc. | 0409-9157-01 | 0409-9157 | ANDA087954 | ANDA | N/A |
| Phytonadione | Injection, Emulsion | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 5 Tray In 1 Container (0409-9158-01) / 5 Ampule In 1 Tray (0409-9158-50) / 1 Ml In 1 Ampule (0409-9158-31) | Hospira, Inc. | 0409-9158-01 | 0409-9158 | ANDA087955 | ANDA | N/A |
| Phytonadione | Injection, Emulsion | Intramuscular; Intravenous; Subcutaneous | 10mg/mL | 5 Tray In 1 Container (0409-9158-25) / 5 Ampule In 1 Tray (0409-9158-55) / 1 Ml In 1 Ampule (0409-9158-11) | Hospira, Inc. | 0409-9158-25 | 0409-9158 | ANDA087955 | ANDA | N/A |
| Pilocarpine Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (0574-0792-01) | Padagis US LLC | 0574-0792-01 | 0574-0792 | ANDA076746 | ANDA | N/A |
| Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (70069-181-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-181-01 | 70069-181 | ANDA210384 | ANDA | N/A |
| Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | 20mg/mL | 1 Bottle In 1 Carton (70069-191-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-191-01 | 70069-191 | ANDA210384 | ANDA | N/A |
| Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | 40mg/mL | 1 Bottle In 1 Carton (70069-201-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-201-01 | 70069-201 | ANDA210384 | ANDA | N/A |
| Pindolol | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (29033-028-01) | Nostrum Laboratories, Inc. | 29033-028-01 | 29033-028 | ANDA205415 | ANDA | N/A |
| Pindolol | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (29033-029-01) | Nostrum Laboratories, Inc. | 29033-029-01 | 29033-029 | ANDA205415 | ANDA | N/A |
| Methylphenidate | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (43602-177-05) | Ascent Pharmaceuticals, Inc. | 43602-177-05 | 43602-177 | ANDA207417 | ANDA | CII |
| Methylphenidate | Solution | Oral | 5mg/5mL | 250 Ml In 1 Bottle (43602-177-25) | Ascent Pharmaceuticals, Inc. | 43602-177-25 | 43602-177 | ANDA207417 | ANDA | CII |
| Pinus Contorta Pollen; Pinus Ponderosa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2203-2) | Jubilant HollisterStier LLC | 65044-2203-2 | 65044-2203 | BLA103888 | BLA | N/A |
| Pinus Contorta Pollen; Pinus Ponderosa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2203-3) | Jubilant HollisterStier LLC | 65044-2203-3 | 65044-2203 | BLA103888 | BLA | N/A |
| Pinus Contorta Pollen; Pinus Ponderosa Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2203-4) | Jubilant HollisterStier LLC | 65044-2203-4 | 65044-2203 | BLA103888 | BLA | N/A |
| Pinus Contorta Pollen; Pinus Ponderosa Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2204-1) | Jubilant HollisterStier LLC | 65044-2204-1 | 65044-2204 | BLA103888 | BLA | N/A |
| Methylphenidate | Solution | Oral | 10mg/5mL | 500 Ml In 1 Bottle (43602-178-05) | Ascent Pharmaceuticals, Inc. | 43602-178-05 | 43602-178 | ANDA207417 | ANDA | CII |
| Methylphenidate | Solution | Oral | 10mg/5mL | 250 Ml In 1 Bottle (43602-178-25) | Ascent Pharmaceuticals, Inc. | 43602-178-25 | 43602-178 | ANDA207417 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-231-03) | Amneal Pharmaceuticals LLC | 65162-231-03 | 65162-231 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-231-09) | Amneal Pharmaceuticals LLC | 65162-231-09 | 65162-231 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-233-03) | Amneal Pharmaceuticals LLC | 65162-233-03 | 65162-233 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-233-09) | Amneal Pharmaceuticals LLC | 65162-233-09 | 65162-233 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-235-03) | Amneal Pharmaceuticals LLC | 65162-235-03 | 65162-235 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-235-09) | Amneal Pharmaceuticals LLC | 65162-235-09 | 65162-235 | ANDA207515 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-237-03) | Amneal Pharmaceuticals LLC | 65162-237-03 | 65162-237 | ANDA207515 | ANDA | CII |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 2g/10mL, .25 g/10mL | 10 Vial In 1 Carton (25021-175-20) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-175-20 | 25021-175 | ANDA208674 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 3g/15mL, .375 g/15mL | 10 Vial In 1 Carton (25021-176-20) / 15 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-176-20 | 25021-176 | ANDA208674 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 4g/20mL, .5 g/20mL | 10 Vial In 1 Carton (25021-177-50) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-177-50 | 25021-177 | ANDA208674 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 36g/152mL, 4.5 g/152mL | 1 Bottle In 1 Carton (25021-181-99) / 152 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-181-99 | 25021-181 | ANDA208675 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 36g/180mL, 4.5 g/180mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (60505-6262-0) / 180 Ml In 1 Vial, Pharmacy Bulk Package | Apotex Corp. | 60505-6262-0 | 60505-6262 | ANDA217243 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, For Solution | Intravenous | 2g/10mL, .25 g/10mL | 10 Vial, Single-Dose In 1 Carton (60505-6156-4) / 10 Ml In 1 Vial, Single-Dose (60505-6156-0) | Apotex Corp. | 60505-6156-4 | 60505-6156 | ANDA204959 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, For Solution | Intravenous | 3g/15mL, .375 g/15mL | 10 Vial, Single-Dose In 1 Carton (60505-6157-4) / 15 Ml In 1 Vial, Single-Dose (60505-6157-0) | Apotex Corp. | 60505-6157-4 | 60505-6157 | ANDA204959 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, For Solution | Intravenous | 4g/20mL, .5 g/20mL | 10 Vial, Single-Dose In 1 Carton (60505-6159-4) / 20 Ml In 1 Vial, Single-Dose (60505-6159-0) | Apotex Corp. | 60505-6159-4 | 60505-6159 | ANDA204959 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Solution | Intravenous | 2g/50mL, 250 mg/50mL | 24 Bag In 1 Box (0206-8860-02) / 50 Ml In 1 Bag (0206-8860-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0206-8860-02 | 0206-8860 | NDA050750 | NDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Solution | Intravenous | 3g/50mL, 375 mg/50mL | 24 Bag In 1 Box (0206-8861-02) / 50 Ml In 1 Bag (0206-8861-01) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0206-8861-02 | 0206-8861 | NDA050750 | NDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 3g/15mL, .375 g/15mL | 10 Vial, Single-Use In 1 Carton (0409-3385-13) / 15 Ml In 1 Vial, Single-Use (0409-3385-11) | Hospira, Inc | 0409-3385-13 | 0409-3385 | ANDA065362 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 4g/20mL, .5 g/20mL | 10 Vial, Single-Use In 1 Carton (0409-3390-04) / 20 Ml In 1 Vial, Single-Use (0409-3390-11) | Hospira, Inc | 0409-3390-04 | 0409-3390 | ANDA065362 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 12g/60mL, 1.5 g/60mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-2999-14) / 60 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc | 0409-2999-14 | 0409-2999 | ANDA203557 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 2g/1, .25 g/1 | 10 Vial, Single-Use In 1 Carton (0409-3374-02) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Use (0409-3374-11) | Hospira, Inc | 0409-3374-02 | 0409-3374 | ANDA065363 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 3g/1, .375 g/1 | 10 Vial, Single-Use In 1 Carton (0409-3378-13) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Use (0409-3378-11) | Hospira, Inc | 0409-3378-13 | 0409-3378 | ANDA065363 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 4g/1, .5 g/1 | 10 Vial, Single-Use In 1 Carton (0409-3379-04) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Use (0409-3379-11) | Hospira, Inc | 0409-3379-04 | 0409-3379 | ANDA065363 | ANDA | N/A |
| Piperacillin Sodium; Tazobactam Sodium | Injection, Powder, Lyophilized, For Solution | Intravenous; Parenteral | 2g/10mL, .25 g/10mL | 10 Vial, Single-Use In 1 Carton (0409-3383-02) / 10 Ml In 1 Vial, Single-Use (0409-3383-11) | Hospira, Inc | 0409-3383-02 | 0409-3383 | ANDA065362 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-237-09) | Amneal Pharmaceuticals LLC | 65162-237-09 | 65162-237 | ANDA207515 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-173-01) | Camber Pharmaceutical Inc | 31722-173-01 | 31722-173 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (31722-173-05) | Camber Pharmaceutical Inc | 31722-173-05 | 31722-173 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-174-01) | Camber Pharmaceutical Inc | 31722-174-01 | 31722-174 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (31722-174-05) | Camber Pharmaceutical Inc | 31722-174-05 | 31722-174 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-175-01) | Camber Pharmaceutical Inc | 31722-175-01 | 31722-175 | ANDA207416 | ANDA | CII |
| Pirfenidone | Tablet | Oral | 267mg/1 | 270 Tablet In 1 Bottle (51407-913-27) | Golden State Medical Supply, Inc. | 51407-913-27 | 51407-913 | ANDA212709 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 90 Tablet In 1 Bottle (51407-914-90) | Golden State Medical Supply, Inc. | 51407-914-90 | 51407-914 | ANDA212709 | ANDA | N/A |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (31722-175-05) | Camber Pharmaceutical Inc | 31722-175-05 | 31722-175 | ANDA207416 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 2.5mg/1 | 100 Tablet, Chewable In 1 Bottle (31722-926-01) | Camber Pharmaceuticals Inc. | 31722-926-01 | 31722-926 | ANDA210354 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 5mg/1 | 100 Tablet, Chewable In 1 Bottle (31722-927-01) | Camber Pharmaceuticals Inc. | 31722-927-01 | 31722-927 | ANDA210354 | ANDA | CII |
| Pirfenidone | Tablet | Oral | 267mg/1 | 270 Tablet In 1 Bottle (60505-4681-7) | Apotex Corp. | 60505-4681-7 | 60505-4681 | ANDA212709 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 267mg/1 | 90 Tablet In 1 Bottle (60505-4681-9) | Apotex Corp. | 60505-4681-9 | 60505-4681 | ANDA212709 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 90 Tablet In 1 Bottle (60505-4682-9) | Apotex Corp. | 60505-4682-9 | 60505-4682 | ANDA212709 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 10mg/1 | 100 Tablet, Chewable In 1 Bottle (31722-928-01) | Camber Pharmaceuticals Inc. | 31722-928-01 | 31722-928 | ANDA210354 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-952-01) | Camber Pharmaceuticals, Inc. | 31722-952-01 | 31722-952 | ANDA211009 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-953-01) | Camber Pharmaceuticals, Inc. | 31722-953-01 | 31722-953 | ANDA211009 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-954-01) | Camber Pharmaceuticals, Inc. | 31722-954-01 | 31722-954 | ANDA211009 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-955-01) | Camber Pharmaceuticals, Inc. | 31722-955-01 | 31722-955 | ANDA211009 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 2.5mg/1 | 100 Tablet, Chewable In 1 Bottle (64980-221-01) | Rising Pharma Holdings, Inc. | 64980-221-01 | 64980-221 | ANDA205756 | ANDA | CII |
| Piroxicam | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle, Plastic (29033-012-01) | Nostrum Laboratories, Inc. | 29033-012-01 | 29033-012 | ANDA074116 | ANDA | N/A |
| Piroxicam | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle, Plastic (29033-013-01) | Nostrum Laboratories, Inc. | 29033-013-01 | 29033-013 | ANDA074118 | ANDA | N/A |
| Piroxicam | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle, Plastic (29033-013-05) | Nostrum Laboratories, Inc. | 29033-013-05 | 29033-013 | ANDA074118 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 5mg/1 | 100 Tablet, Chewable In 1 Bottle (64980-222-01) | Rising Pharma Holdings, Inc. | 64980-222-01 | 64980-222 | ANDA205756 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 10mg/1 | 100 Tablet, Chewable In 1 Bottle (64980-223-01) | Rising Pharma Holdings, Inc. | 64980-223-01 | 64980-223 | ANDA205756 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (72865-122-01) | XLCare Pharmaceuticals Inc | 72865-122-01 | 72865-122 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (72865-122-05) | XLCare Pharmaceuticals Inc | 72865-122-05 | 72865-122 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (72865-123-01) | XLCare Pharmaceuticals Inc | 72865-123-01 | 72865-123 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (72865-123-05) | XLCare Pharmaceuticals Inc | 72865-123-05 | 72865-123 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (72865-124-01) | XLCare Pharmaceuticals Inc | 72865-124-01 | 72865-124 | ANDA207416 | ANDA | CII |
| METHYLPHENIDATE HYDROCHLORIDE | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (72865-124-05) | XLCare Pharmaceuticals Inc | 72865-124-05 | 72865-124 | ANDA207416 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 18mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-133-01) | XLCare Pharmaceuticals, Inc. | 72865-133-01 | 72865-133 | ANDA211009 | ANDA | CII |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2212-2) | Jubilant HollisterStier LLC | 65044-2212-2 | 65044-2212 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2212-3) | Jubilant HollisterStier LLC | 65044-2212-3 | 65044-2212 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2212-4) | Jubilant HollisterStier LLC | 65044-2212-4 | 65044-2212 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2213-1) | Jubilant HollisterStier LLC | 65044-2213-1 | 65044-2213 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2215-2) | Jubilant HollisterStier LLC | 65044-2215-2 | 65044-2215 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2215-3) | Jubilant HollisterStier LLC | 65044-2215-3 | 65044-2215 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2215-4) | Jubilant HollisterStier LLC | 65044-2215-4 | 65044-2215 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 10 Ml In 1 Vial (65044-2216-2) | Jubilant HollisterStier LLC | 65044-2216-2 | 65044-2216 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 30 Ml In 1 Vial (65044-2216-3) | Jubilant HollisterStier LLC | 65044-2216-3 | 65044-2216 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 50 Ml In 1 Vial (65044-2216-4) | Jubilant HollisterStier LLC | 65044-2216-4 | 65044-2216 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 10 Ml In 1 Vial (65044-2217-2) | Jubilant HollisterStier LLC | 65044-2217-2 | 65044-2217 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 30 Ml In 1 Vial (65044-2217-3) | Jubilant HollisterStier LLC | 65044-2217-3 | 65044-2217 | BLA103888 | BLA | N/A |
| Plantago Lanceolata Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 50 Ml In 1 Vial (65044-2217-4) | Jubilant HollisterStier LLC | 65044-2217-4 | 65044-2217 | BLA103888 | BLA | N/A |
| Platanus Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2563-2) | Jubilant HollisterStier LLC | 65044-2563-2 | 65044-2563 | BLA103888 | BLA | N/A |
| Platanus Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2563-3) | Jubilant HollisterStier LLC | 65044-2563-3 | 65044-2563 | BLA103888 | BLA | N/A |
| Platanus Occidentalis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2563-4) | Jubilant HollisterStier LLC | 65044-2563-4 | 65044-2563 | BLA103888 | BLA | N/A |
| Platanus Occidentalis Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2564-1) | Jubilant HollisterStier LLC | 65044-2564-1 | 65044-2564 | BLA103888 | BLA | N/A |
| Pleospora Tarda | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5264-2) | Jubilant HollisterStier LLC | 65044-5264-2 | 65044-5264 | BLA103888 | BLA | N/A |
| Pleospora Tarda | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5264-3) | Jubilant HollisterStier LLC | 65044-5264-3 | 65044-5264 | BLA103888 | BLA | N/A |
| Pleospora Tarda | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5264-4) | Jubilant HollisterStier LLC | 65044-5264-4 | 65044-5264 | BLA103888 | BLA | N/A |
| Pleospora Tarda | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5265-1) | Jubilant HollisterStier LLC | 65044-5265-1 | 65044-5265 | BLA103888 | BLA | N/A |
| Plerixafor | Solution | Subcutaneous | 24mg/1.2mL | 1 Vial, Single-Dose In 1 Carton (71288-155-01) / 1.2 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-155-01 | 71288-155 | ANDA215698 | ANDA | N/A |
| Plerixafor | Injection, Solution | Subcutaneous | 20mg/mL | 1 Vial In 1 Carton (25021-416-01) / 1.2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-416-01 | 25021-416 | ANDA206644 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 27mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-134-01) | XLCare Pharmaceuticals, Inc. | 72865-134-01 | 72865-134 | ANDA211009 | ANDA | CII |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 5 Ml In 1 Vial (65044-0545-1) | Jubilant HollisterStier LLC | 65044-0545-1 | 65044-0545 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 10 Ml In 1 Vial (65044-0545-2) | Jubilant HollisterStier LLC | 65044-0545-2 | 65044-0545 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 30 Ml In 1 Vial (65044-0545-3) | Jubilant HollisterStier LLC | 65044-0545-3 | 65044-0545 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 10000[BAU]/mL | 50 Ml In 1 Vial (65044-0545-4) | Jubilant HollisterStier LLC | 65044-0545-4 | 65044-0545 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 5 Ml In 1 Vial (65044-0546-1) | Jubilant HollisterStier LLC | 65044-0546-1 | 65044-0546 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 10 Ml In 1 Vial (65044-0546-2) | Jubilant HollisterStier LLC | 65044-0546-2 | 65044-0546 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 30 Ml In 1 Vial (65044-0546-3) | Jubilant HollisterStier LLC | 65044-0546-3 | 65044-0546 | BLA103873 | BLA | N/A |
| Poa Pratensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | 100000[BAU]/mL | 50 Ml In 1 Vial (65044-0546-4) | Jubilant HollisterStier LLC | 65044-0546-4 | 65044-0546 | BLA103873 | BLA | N/A |
| Podofilox | Solution | Topical | 5mg/mL | 1 Bottle, Glass In 1 Carton (0574-0611-05) / 3.5 Ml In 1 Bottle, Glass | Padagis US LLC | 0574-0611-05 | 0574-0611 | ANDA075600 | ANDA | N/A |
| Podofilox | Gel | Topical | 5mg/g | 3.5 G In 1 Tube, With Applicator (0574-0621-05) | Padagis US LLC | 0574-0621-05 | 0574-0621 | ANDA211871 | ANDA | N/A |
| Podophyllum Resin | Tincture | Topical | 1mg/4mL | 1 Bottle, With Applicator In 1 Carton (0574-0601-15) / 15 Ml In 1 Bottle, With Applicator | Padagis US LLC | 0574-0601-15 | 0574-0601 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Polistes Spp. Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 13 Ml In 1 Vial (65044-9953-6) | Jubilant HollisterStier LLC | 65044-9953-6 | 65044-9953 | BLA103884 | BLA | N/A |
| Polistes Spp. Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 100ug/mL | 5.5 Ml In 1 Vial (65044-9943-5) | Jubilant HollisterStier LLC | 65044-9943-5 | 65044-9943 | BLA103884 | BLA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/d | 7 D In 1 Bottle (79739-7116-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7116-1 | 79739-7116 | ANDA090812 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/d | 14 D In 1 Bottle (79739-7116-2) | LGM PHARMA SOLUTIONS, LLC | 79739-7116-2 | 79739-7116 | ANDA090812 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/d | 30 D In 1 Bottle (79739-7116-3) | LGM PHARMA SOLUTIONS, LLC | 79739-7116-3 | 79739-7116 | ANDA090812 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 119 G In 1 Bottle (45802-868-01) | Padagis Israel Pharmaceuticals Ltd | 45802-868-01 | 45802-868 | ANDA090685 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 238 G In 1 Bottle (45802-868-02) | Padagis Israel Pharmaceuticals Ltd | 45802-868-02 | 45802-868 | ANDA090685 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 510 G In 1 Bottle (45802-868-03) | Padagis Israel Pharmaceuticals Ltd | 45802-868-03 | 45802-868 | ANDA090685 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 14 Packet In 1 Carton (45802-868-66) / 17 G In 1 Packet | Padagis Israel Pharmaceuticals Ltd | 45802-868-66 | 45802-868 | ANDA090685 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 36mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-135-01) | XLCare Pharmaceuticals, Inc. | 72865-135-01 | 72865-135 | ANDA211009 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Extended Release | Oral | 54mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-136-01) | XLCare Pharmaceuticals, Inc. | 72865-136-01 | 72865-136 | ANDA211009 | ANDA | CII |
| Polymyxin B Sulfate | Injection, Powder, For Solution | Intramuscular; Intrathecal; Intravenous; Ophthalmic | 500000[iU]/1 | 10 Vial In 1 Carton (0143-9941-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9941-01) | Hikma Pharmaceuticals USA Inc. | 0143-9941-10 | 0143-9941 | ANDA060716 | ANDA | N/A |
| Polymyxin B Sulfate; Trimethoprim | Solution/ Drops | Ophthalmic | 10000[iU]/mL, 1 mg/mL | 1 Bottle In 1 Carton (70069-311-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-311-01 | 70069-311 | ANDA211572 | ANDA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1435-2) | Jubilant HollisterStier LLC | 65044-1435-2 | 65044-1435 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1435-3) | Jubilant HollisterStier LLC | 65044-1435-3 | 65044-1435 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1435-4) | Jubilant HollisterStier LLC | 65044-1435-4 | 65044-1435 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1436-1) | Jubilant HollisterStier LLC | 65044-1436-1 | 65044-1436 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 10 Ml In 1 Vial (65044-1438-2) | Jubilant HollisterStier LLC | 65044-1438-2 | 65044-1438 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 30 Ml In 1 Vial (65044-1438-3) | Jubilant HollisterStier LLC | 65044-1438-3 | 65044-1438 | BLA103888 | BLA | N/A |
| Populus Deltoides Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL | 50 Ml In 1 Vial (65044-1438-4) | Jubilant HollisterStier LLC | 65044-1438-4 | 65044-1438 | BLA103888 | BLA | N/A |
| Pork | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3509-2) | Jubilant HollisterStier LLC | 65044-3509-2 | 65044-3509 | BLA103888 | BLA | N/A |
| Pork | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3510-1) | Jubilant HollisterStier LLC | 65044-3510-1 | 65044-3510 | BLA103888 | BLA | N/A |
| Posaconazole | Suspension | Oral | 40mg/mL | 1 Bottle, Glass In 1 Carton (0054-0449-49) / 105 Ml In 1 Bottle, Glass | Hikma Pharmaceuticals USA Inc. | 0054-0449-49 | 0054-0449 | ANDA208773 | ANDA | N/A |
| Potassium Acetate | Injection, Solution, Concentrate | Intravenous | 3.93g/20mL | 25 Vial, Single-Dose In 1 Tray (0409-8183-25) / 20 Ml In 1 Vial, Single-Dose (0409-8183-15) | Hospira, Inc. | 0409-8183-25 | 0409-8183 | NDA018896 | NDA | N/A |
| Potassium Acetate | Injection, Solution, Concentrate | Intravenous | 196.3mg/mL | 25 Vial, Pharmacy Bulk Package In 1 Tray (0409-3294-51) / 50 Ml In 1 Vial, Pharmacy Bulk Package (0409-3294-61) | Hospira, Inc. | 0409-3294-51 | 0409-3294 | NDA018896 | NDA | N/A |
| Potassium Acetate | Injection, Solution, Concentrate | Intravenous | 3.93g/20mL | 25 Vial, Single-Dose In 1 Tray (0409-8183-01) / 20 Ml In 1 Vial, Single-Dose (0409-8183-11) | Hospira, Inc. | 0409-8183-01 | 0409-8183 | NDA018896 | NDA | N/A |
| Potassium Acetate | Injection, Solution, Concentrate | Intravenous | 196.3mg/mL | 25 Vial, Pharmacy Bulk Package In 1 Tray (0409-3294-25) / 50 Ml In 1 Vial, Pharmacy Bulk Package (0409-3294-15) | Hospira, Inc. | 0409-3294-25 | 0409-3294 | NDA018896 | NDA | N/A |
| Potassium Chloride | Injection | Intravenous | 29.8mg/mL | 24 Bag In 1 Box (14789-107-05) / 50 Ml In 1 Bag (14789-107-08) | Nexus Pharamaceuticals Inc. | 14789-107-05 | 14789-107 | ANDA214727 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 29.8mg/mL | 24 Bag In 1 Box (14789-107-10) / 100 Ml In 1 Bag (14789-107-16) | Nexus Pharamaceuticals Inc. | 14789-107-10 | 14789-107 | ANDA214727 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 14.9mg/mL | 24 Bag In 1 Box (14789-108-05) / 50 Ml In 1 Bag (14789-108-08) | Nexus Pharamaceuticals Inc. | 14789-108-05 | 14789-108 | ANDA214727 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 14.9mg/mL | 24 Bag In 1 Box (14789-108-10) / 100 Ml In 1 Bag (14789-108-16) | Nexus Pharamaceuticals Inc. | 14789-108-10 | 14789-108 | ANDA214727 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 7.45mg/mL | 24 Bag In 1 Box (14789-109-10) / 100 Ml In 1 Bag (14789-109-16) | Nexus Pharamaceuticals Inc. | 14789-109-10 | 14789-109 | ANDA214727 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 29.8mg/mL | 25 Vial, Glass In 1 Carton (14789-136-05) / 10 Ml In 1 Vial, Glass (14789-136-07) | Nexus Pharamaceuticals Inc. | 14789-136-05 | 14789-136 | ANDA217704 | ANDA | N/A |
| Potassium Chloride | Injection | Intravenous | 29.8mg/mL | 25 Vial, Glass In 1 Carton (14789-137-05) / 20 Ml In 1 Vial, Glass (14789-137-07) | Nexus Pharamaceuticals Inc. | 14789-137-05 | 14789-137 | ANDA217704 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 10 Blister Pack In 1 Box, Unit-Dose (0574-0275-11) / 10 Tablet, Extended Release In 1 Blister Pack | Padagis US LLC | 0574-0275-11 | 0574-0275 | ANDA205993 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle, Plastic (60760-293-90) | St. Mary's Medical Park Pharmacy | 60760-293-90 | 60760-293 | NDA018279 | NDA AUTHORIZED GENERIC | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 473 Ml In 1 Bottle (27808-168-01) | Tris Pharma Inc | 27808-168-01 | 27808-168 | ANDA214076 | ANDA | N/A |
| Potassium Chloride | Solution | Oral | 40meq/15mL | 473 Ml In 1 Bottle (27808-169-01) | Tris Pharma Inc | 27808-169-01 | 27808-169 | ANDA214076 | ANDA | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 3 Tray In 1 Case (66689-047-30) / 10 Cup In 1 Tray / 15 Ml In 1 Cup (66689-047-01) | VistaPharm, LLC | 66689-047-30 | 66689-047 | NDA206814 | NDA | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 5 Tray In 1 Case (66689-047-50) / 10 Cup In 1 Tray / 15 Ml In 1 Cup (66689-047-01) | VistaPharm, LLC | 66689-047-50 | 66689-047 | NDA206814 | NDA | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 8 Tray In 1 Case (66689-047-80) / 10 Cup In 1 Tray / 15 Ml In 1 Cup (66689-047-01) | VistaPharm, LLC | 66689-047-80 | 66689-047 | NDA206814 | NDA | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 10 Tray In 1 Case (66689-047-99) / 10 Cup In 1 Tray / 15 Ml In 1 Cup (66689-047-01) | VistaPharm, LLC | 66689-047-99 | 66689-047 | NDA206814 | NDA | N/A |
| Potassium Chloride | Solution | Oral | 40meq/30mL | 3 Tray In 1 Case (66689-048-30) / 10 Cup In 1 Tray / 30 Ml In 1 Cup (66689-048-01) | VistaPharm, LLC | 66689-048-30 | 66689-048 | NDA206814 | NDA | N/A |
| Potassium Chloride | Solution | Oral | 40meq/30mL | 5 Tray In 1 Case (66689-048-50) / 10 Cup In 1 Tray / 30 Ml In 1 Cup (66689-048-01) | VistaPharm, LLC | 66689-048-50 | 66689-048 | NDA206814 | NDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 2.5mg/1 | 100 Tablet, Chewable In 1 Bottle (72865-125-01) | XLCare Pharmaceuticals, Inc. | 72865-125-01 | 72865-125 | ANDA210354 | ANDA | CII |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 5mg/1 | 100 Tablet, Chewable In 1 Bottle (72865-126-01) | XLCare Pharmaceuticals, Inc. | 72865-126-01 | 72865-126 | ANDA210354 | ANDA | CII |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 1 Bottle, Plastic In 1 Carton (60505-6184-6) / 473 Ml In 1 Bottle, Plastic | Apotex Corp | 60505-6184-6 | 60505-6184 | ANDA211067 | ANDA | N/A |
| Methylphenidate Hydrochloride | Tablet, Chewable | Oral | 10mg/1 | 100 Tablet, Chewable In 1 Bottle (72865-127-01) | XLCare Pharmaceuticals, Inc. | 72865-127-01 | 72865-127 | ANDA210354 | ANDA | CII |
| Methylprednisolone | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (42806-400-01) | Epic Pharma,LLC | 42806-400-01 | 42806-400 | ANDA204072 | ANDA | N/A |
| Methylprednisolone | Tablet | Oral | 4mg/1 | 1 Blister Pack In 1 Carton (42806-400-21) / 21 Tablet In 1 Blister Pack | Epic Pharma,LLC | 42806-400-21 | 42806-400 | ANDA204072 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Soft Tissue | 80mg/mL | 1 Vial, Single-Dose In 1 Carton (70121-1552-1) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1552-1 | 70121-1552 | ANDA210043 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Soft Tissue | 80mg/mL | 25 Vial, Single-Dose In 1 Carton (70121-1552-5) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1552-5 | 70121-1552 | ANDA210043 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 1 Vial, Single-Dose In 1 Carton (70121-1573-1) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1573-1 | 70121-1573 | ANDA210043 | ANDA | N/A |
| Potassium Chloride | Solution | Oral | 20meq/15mL | 473 Ml In 1 Bottle, Plastic (62250-713-35) | Belcher Pharmaceuticals LLC | 62250-713-35 | 62250-713 | ANDA216156 | ANDA | N/A |
| Potassium Chloride | Solution | Oral | 40meq/15mL | 473 Ml In 1 Bottle, Plastic (62250-714-35) | Belcher Pharmaceuticals LLC | 62250-714-35 | 62250-714 | ANDA216156 | ANDA | N/A |
| Potassium Chloride | Powder, For Solution | Oral | 1.5g/1.58g | 30 Pouch In 1 Carton (62250-690-32) / 1.58 G In 1 Pouch (62250-690-34) | Belcher Pharmaceuticals LLC | 62250-690-32 | 62250-690 | ANDA212183 | ANDA | N/A |
| Potassium Chloride | Powder, For Solution | Oral | 1.5g/1.58g | 100 Pouch In 1 Carton (62250-690-33) / 1.58 G In 1 Pouch (62250-690-34) | Belcher Pharmaceuticals LLC | 62250-690-33 | 62250-690 | ANDA212183 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 25 Vial, Single-Dose In 1 Carton (70121-1573-5) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1573-5 | 70121-1573 | ANDA210043 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Soft Tissue | 80mg/mL | 1 Vial, Single-Dose In 1 Carton (70121-1574-1) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1574-1 | 70121-1574 | ANDA210043 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Soft Tissue | 80mg/mL | 25 Vial, Single-Dose In 1 Carton (70121-1574-5) / 1 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1574-5 | 70121-1574 | ANDA210043 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 1 Vial, Multi-Dose In 1 Carton (70121-1609-1) / 10 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1609-1 | 70121-1609 | ANDA216502 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 40mg/mL | 25 Vial, Multi-Dose In 1 Carton (70121-1609-5) / 10 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1609-5 | 70121-1609 | ANDA216502 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 80mg/mL | 1 Vial, Multi-Dose In 1 Carton (70121-1610-1) / 5 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1610-1 | 70121-1610 | ANDA216502 | ANDA | N/A |
| Methylprednisolone Acetate | Injection, Suspension | Intra-Articular; Intra-Articular; Intralesional; Intramuscular; Intrasynovial; Soft Tissue | 80mg/mL | 25 Vial, Multi-Dose In 1 Carton (70121-1610-5) / 5 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1610-5 | 70121-1610 | ANDA216502 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 40mg/mL | 25 Vial In 1 Carton (70121-1000-5) / 1 Ml In 1 Vial (70121-1000-1) | Amneal Pharmaceuticals LLC | 70121-1000-5 | 70121-1000 | ANDA207549 | ANDA | N/A |
| Methylprednisolone Sodium Succinate | Injection, Powder, Lyophilized, For Solution | Intramuscular; Intravenous | 125mg/2mL | 25 Vial In 1 Carton (70121-1001-5) / 2 Ml In 1 Vial (70121-1001-1) | Amneal Pharmaceuticals LLC | 70121-1001-5 | 70121-1001 | ANDA207549 | ANDA | N/A |
| Metoclopramide Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (62559-295-01) | ANI Pharmaceuticals, Inc. | 62559-295-01 | 62559-295 | NDA017854 | NDA AUTHORIZED GENERIC | N/A |
| Metoclopramide Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (62559-296-01) | ANI Pharmaceuticals, Inc. | 62559-296-01 | 62559-296 | NDA017854 | NDA AUTHORIZED GENERIC | N/A |
| Metoclopramide Hydrochloride | Solution | Oral | 5mg/5mL | 473 Ml In 1 Bottle, Plastic (62559-190-16) | ANI Pharmaceuticals, Inc. | 62559-190-16 | 62559-190 | ANDA071402 | ANDA | N/A |
| Metoclopramide Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (62559-165-01) | ANI Pharmaceuticals, Inc. | 62559-165-01 | 62559-165 | NDA017854 | NDA | N/A |
| Metoclopramide Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (62559-166-01) | ANI Pharmaceuticals, Inc. | 62559-166-01 | 62559-166 | NDA017854 | NDA | N/A |
| Metolazone | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (50742-349-01) | Ingenus Pharmaceuticals LLC | 50742-349-01 | 50742-349 | ANDA215616 | ANDA | N/A |
| Metolazone | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (50742-350-01) | Ingenus Pharmaceuticals LLC | 50742-350-01 | 50742-350 | ANDA215616 | ANDA | N/A |
| Metolazone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (50742-351-01) | Ingenus Pharmaceuticals LLC | 50742-351-01 | 50742-351 | ANDA215616 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-589-01) | Camber Pharmaceuticals, Inc. | 31722-589-01 | 31722-589 | ANDA205541 | ANDA | N/A |
| Potassium Chloride | Injection, Solution, Concentrate | Intravenous | 149mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6635-01) / 5 Ml In 1 Vial, Single-Dose (0409-6635-18) | Hospira, Inc. | 0409-6635-01 | 0409-6635 | ANDA080205 | ANDA | N/A |
| Potassium Chloride | Injection, Solution, Concentrate | Intravenous | 149mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6651-06) / 10 Ml In 1 Vial, Single-Dose (0409-6651-19) | Hospira, Inc. | 0409-6651-06 | 0409-6651 | ANDA080205 | ANDA | N/A |
| Potassium Chloride | Injection, Solution, Concentrate | Intravenous | 149mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6653-05) / 20 Ml In 1 Vial, Single-Dose (0409-6653-18) | Hospira, Inc. | 0409-6653-05 | 0409-6653 | ANDA080205 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-589-05) | Camber Pharmaceuticals, Inc. | 31722-589-05 | 31722-589 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (31722-589-10) | Camber Pharmaceuticals, Inc. | 31722-589-10 | 31722-589 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 25mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-589-30) | Camber Pharmaceuticals, Inc. | 31722-589-30 | 31722-589 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-590-01) | Camber Pharmaceuticals, Inc. | 31722-590-01 | 31722-590 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-590-05) | Camber Pharmaceuticals, Inc. | 31722-590-05 | 31722-590 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (31722-590-10) | Camber Pharmaceuticals, Inc. | 31722-590-10 | 31722-590 | ANDA205541 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 5meq/1 | 100 Tablet, Extended Release In 1 Bottle (51407-449-01) | Golden State Medical Supply, Inc. | 51407-449-01 | 51407-449 | ANDA203546 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 100 Tablet, Extended Release In 1 Bottle (51407-450-01) | Golden State Medical Supply, Inc. | 51407-450-01 | 51407-450 | ANDA203546 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 100 Tablet, Extended Release In 1 Bottle (51407-451-01) | Golden State Medical Supply, Inc. | 51407-451-01 | 51407-451 | ANDA203546 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-590-30) | Camber Pharmaceuticals, Inc. | 31722-590-30 | 31722-590 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-591-01) | Camber Pharmaceuticals, Inc. | 31722-591-01 | 31722-591 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-591-05) | Camber Pharmaceuticals, Inc. | 31722-591-05 | 31722-591 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (31722-591-10) | Camber Pharmaceuticals, Inc. | 31722-591-10 | 31722-591 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 100mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-591-30) | Camber Pharmaceuticals, Inc. | 31722-591-30 | 31722-591 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (31722-592-01) | Camber Pharmaceuticals, Inc. | 31722-592-01 | 31722-592 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (31722-592-05) | Camber Pharmaceuticals, Inc. | 31722-592-05 | 31722-592 | ANDA205541 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (31722-592-10) | Camber Pharmaceuticals, Inc. | 31722-592-10 | 31722-592 | ANDA205541 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 100 Tablet, Extended Release In 1 Bottle (69452-193-20) | Bionpharma Inc. | 69452-193-20 | 69452-193 | ANDA212799 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 500 Tablet, Extended Release In 1 Bottle (69452-193-30) | Bionpharma Inc. | 69452-193-30 | 69452-193 | ANDA212799 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 100 Tablet, Extended Release In 1 Bottle (69452-194-20) | Bionpharma Inc. | 69452-194-20 | 69452-194 | ANDA212799 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 500 Tablet, Extended Release In 1 Bottle (69452-194-30) | Bionpharma Inc. | 69452-194-30 | 69452-194 | ANDA212799 | ANDA | N/A |
| METOPROLOL SUCCINATE | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (31722-592-30) | Camber Pharmaceuticals, Inc. | 31722-592-30 | 31722-592 | ANDA205541 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-615-01) | Ingenus Pharmaceuticals, LLC | 50742-615-01 | 50742-615 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-615-05) | Ingenus Pharmaceuticals, LLC | 50742-615-05 | 50742-615 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-615-10) | Ingenus Pharmaceuticals, LLC | 50742-615-10 | 50742-615 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-615-90) | Ingenus Pharmaceuticals, LLC | 50742-615-90 | 50742-615 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 25mg/1 | 115384 Tablet, Extended Release In 1 Drum (50742-615-99) | Ingenus Pharmaceuticals, LLC | 50742-615-99 | 50742-615 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-616-01) | Ingenus Pharmaceuticals, LLC | 50742-616-01 | 50742-616 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-616-05) | Ingenus Pharmaceuticals, LLC | 50742-616-05 | 50742-616 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-616-10) | Ingenus Pharmaceuticals, LLC | 50742-616-10 | 50742-616 | ANDA204106 | ANDA | N/A |
| Potassium Iodide | Solution | Oral | 1g/mL | 237 Ml In 1 Bottle (75834-280-08) | Nivagen Pharmaceuticals, Inc. | 75834-280-08 | 75834-280 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Potassium Iodide | Solution | Oral | 1g/mL | 30 Ml In 1 Bottle, With Applicator (75834-280-30) | Nivagen Pharmaceuticals, Inc. | 75834-280-30 | 75834-280 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-616-90) | Ingenus Pharmaceuticals, LLC | 50742-616-90 | 50742-616 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 50mg/1 | 57692 Tablet, Extended Release In 1 Drum (50742-616-99) | Ingenus Pharmaceuticals, LLC | 50742-616-99 | 50742-616 | ANDA204106 | ANDA | N/A |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | Injection, Solution | Intravenous | 236mg/mL, 224 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-2051-25) / 5 Ml In 1 Vial, Single-Dose (0517-2051-01) | American Regent, Inc. | 0517-2051-25 | 0517-2051 | ANDA216274 | ANDA | N/A |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | Injection, Solution | Intravenous | 236mg/mL, 224 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-2102-25) / 15 Ml In 1 Vial, Single-Dose (0517-2102-01) | American Regent, Inc. | 0517-2102-25 | 0517-2102 | ANDA216274 | ANDA | N/A |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | Injection, Solution | Intravenous | 236mg/mL, 224 mg/mL | 25 Vial, Pharmacy Bulk Package In 1 Tray (0517-2505-25) / 50 Ml In 1 Vial, Pharmacy Bulk Package (0517-2505-01) | American Regent, Inc. | 0517-2505-25 | 0517-2505 | ANDA216274 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-617-01) | Ingenus Pharmaceuticals, LLC | 50742-617-01 | 50742-617 | ANDA204106 | ANDA | N/A |
| Potato | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3518-2) | Jubilant HollisterStier LLC | 65044-3518-2 | 65044-3518 | BLA103888 | BLA | N/A |
| Poultry, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3173-2) | Jubilant HollisterStier LLC | 65044-3173-2 | 65044-3173 | BLA103888 | BLA | N/A |
| Poultry, Unspecified | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3174-1) | Jubilant HollisterStier LLC | 65044-3174-1 | 65044-3174 | BLA103888 | BLA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-617-05) | Ingenus Pharmaceuticals, LLC | 50742-617-05 | 50742-617 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-617-10) | Ingenus Pharmaceuticals, LLC | 50742-617-10 | 50742-617 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-617-90) | Ingenus Pharmaceuticals, LLC | 50742-617-90 | 50742-617 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 100mg/1 | 32362 Tablet, Extended Release In 1 Drum (50742-617-99) | Ingenus Pharmaceuticals, LLC | 50742-617-99 | 50742-617 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-618-01) | Ingenus Pharmaceuticals, LLC | 50742-618-01 | 50742-618 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 500 Tablet, Extended Release In 1 Bottle (50742-618-05) | Ingenus Pharmaceuticals, LLC | 50742-618-05 | 50742-618 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-618-10) | Ingenus Pharmaceuticals, LLC | 50742-618-10 | 50742-618 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-618-90) | Ingenus Pharmaceuticals, LLC | 50742-618-90 | 50742-618 | ANDA204106 | ANDA | N/A |
| Metoprolol Succinate | Tablet, Extended Release | Oral | 200mg/1 | 16181 Tablet, Extended Release In 1 Drum (50742-618-99) | Ingenus Pharmaceuticals, LLC | 50742-618-99 | 50742-618 | ANDA204106 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-100-01) | Rising Pharma Holdings, Inc. | 57237-100-01 | 57237-100 | ANDA077739 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-100-99) | Rising Pharma Holdings, Inc. | 57237-100-99 | 57237-100 | ANDA077739 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-101-01) | Rising Pharma Holdings, Inc. | 57237-101-01 | 57237-101 | ANDA077739 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (60429-085-90) | Golden State Medical Supply, Inc. | 60429-085-90 | 60429-085 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 90 Tablet In 1 Bottle (60429-086-90) | Golden State Medical Supply, Inc. | 60429-086-90 | 60429-086 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (60429-087-90) | Golden State Medical Supply, Inc. | 60429-087-90 | 60429-087 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (60429-089-90) | Golden State Medical Supply, Inc. | 60429-089-90 | 60429-089 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 90 Tablet In 1 Bottle (60429-090-90) | Golden State Medical Supply, Inc. | 60429-090-90 | 60429-090 | ANDA203855 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-101-99) | Rising Pharma Holdings, Inc. | 57237-101-99 | 57237-101 | ANDA077739 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-102-01) | Rising Pharma Holdings, Inc. | 57237-102-01 | 57237-102 | ANDA077739 | ANDA | N/A |
| Metoprolol Tartrate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-102-99) | Rising Pharma Holdings, Inc. | 57237-102-99 | 57237-102 | ANDA077739 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (16571-664-01) | Rising Pharma Holdings, Inc. | 16571-664-01 | 16571-664 | ANDA203974 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (16571-664-50) | Rising Pharma Holdings, Inc. | 16571-664-50 | 16571-664 | ANDA203974 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (16571-665-01) | Rising Pharma Holdings, Inc. | 16571-665-01 | 16571-665 | ANDA203974 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (16571-665-50) | Rising Pharma Holdings, Inc. | 16571-665-50 | 16571-665 | ANDA203974 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (64980-235-01) | Rising Pharmaceuticals, Inc. | 64980-235-01 | 64980-235 | ANDA205245 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (64980-235-05) | Rising Pharmaceuticals, Inc. | 64980-235-05 | 64980-235 | ANDA205245 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 250mg/1 | 250 Tablet In 1 Bottle (64980-235-25) | Rising Pharmaceuticals, Inc. | 64980-235-25 | 64980-235 | ANDA205245 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (64980-236-01) | Rising Pharmaceuticals, Inc. | 64980-236-01 | 64980-236 | ANDA205245 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (64980-236-05) | Rising Pharmaceuticals, Inc. | 64980-236-05 | 64980-236 | ANDA205245 | ANDA | N/A |
| Metronidazole | Tablet | Oral | 500mg/1 | 50 Tablet In 1 Bottle (64980-236-50) | Rising Pharmaceuticals, Inc. | 64980-236-50 | 64980-236 | ANDA205245 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (62559-820-01) | ANI Pharmaceuticals, Inc. | 62559-820-01 | 62559-820 | ANDA074450 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (62559-821-01) | ANI Pharmaceuticals, Inc. | 62559-821-01 | 62559-821 | ANDA074450 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (62559-822-01) | ANI Pharmaceuticals, Inc. | 62559-822-01 | 62559-822 | ANDA074450 | ANDA | N/A |
| Mexiletine hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (31722-036-01) | Camber Pharmaceuticals, Inc. | 31722-036-01 | 31722-036 | ANDA216463 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (50742-239-01) | Ingenus Pharmaceuticals, LLC | 50742-239-01 | 50742-239 | ANDA214352 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (50742-240-01) | Ingenus Pharmaceuticals, LLC | 50742-240-01 | 50742-240 | ANDA214352 | ANDA | N/A |
| Mexiletine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (50742-241-01) | Ingenus Pharmaceuticals, LLC | 50742-241-01 | 50742-241 | ANDA214352 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (64980-433-01) | Rising Pharmaceuticals, Inc. | 64980-433-01 | 64980-433 | ANDA207613 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (64980-434-01) | Rising Pharmaceuticals, Inc. | 64980-434-01 | 64980-434 | ANDA207613 | ANDA | N/A |
| Midodrine Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (64980-435-01) | Rising Pharmaceuticals, Inc. | 64980-435-01 | 64980-435 | ANDA207613 | ANDA | N/A |
| Miglustat | Capsule | Oral | 100mg/1 | 6 Blister Pack In 1 Carton (43975-310-83) / 15 Capsule In 1 Blister Pack (43975-310-08) | ANI Pharmaceuticals, Inc. | 43975-310-83 | 43975-310 | ANDA208342 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 12.5mg/1 | 60 Tablet In 1 Bottle (65162-091-06) | Amneal Pharmaceuticals LLC | 65162-091-06 | 65162-091 | ANDA205081 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 25mg/1 | 60 Tablet In 1 Bottle (65162-092-06) | Amneal Pharmaceuticals LLC | 65162-092-06 | 65162-092 | ANDA205081 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (65162-093-06) | Amneal Pharmaceuticals LLC | 65162-093-06 | 65162-093 | ANDA205081 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-093-50) | Amneal Pharmaceuticals LLC | 65162-093-50 | 65162-093 | ANDA205081 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (65162-094-06) | Amneal Pharmaceuticals LLC | 65162-094-06 | 65162-094 | ANDA205081 | ANDA | N/A |
| Milnacipran Hydrochloride | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (65162-094-50) | Amneal Pharmaceuticals LLC | 65162-094-50 | 65162-094 | ANDA205081 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 7.5mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-007-05) | Rising Pharma Holdings, Inc. | 57237-007-05 | 57237-007 | ANDA076921 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-444-30) | Golden State Medical Supply, Inc. | 51407-444-30 | 51407-444 | ANDA205927 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (51407-445-30) | Golden State Medical Supply, Inc. | 51407-445-30 | 51407-445 | ANDA205927 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4642-3) | Apotex Corp. | 60505-4642-3 | 60505-4642 | ANDA205897 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4643-3) | Apotex Corp. | 60505-4643-3 | 60505-4643 | ANDA205897 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Coated | Oral | 5mg/1 | 30 Tablet, Coated In 1 Bottle (0713-0881-30) | Cosette Pharmaceuticals, Inc. | 0713-0881-30 | 0713-0881 | NDA022307 | NDA | N/A |
| Prasugrel Hydrochloride | Tablet, Coated | Oral | 10mg/1 | 30 Tablet, Coated In 1 Bottle (0713-0882-30) | Cosette Pharmaceuticals, Inc. | 0713-0882-30 | 0713-0882 | NDA022307 | NDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 7.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-007-30) | Rising Pharma Holdings, Inc. | 57237-007-30 | 57237-007 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-008-05) | Rising Pharma Holdings, Inc. | 57237-008-05 | 57237-008 | ANDA076921 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (60505-0168-1) | Apotex Corp. | 60505-0168-1 | 60505-0168 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 10mg/1 | 40000 Tablet In 1 Bottle (60505-0168-4) | Apotex Corp. | 60505-0168-4 | 60505-0168 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (60505-0168-5) | Apotex Corp. | 60505-0168-5 | 60505-0168 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (60505-0168-7) | Apotex Corp. | 60505-0168-7 | 60505-0168 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (60505-0168-9) | Apotex Corp. | 60505-0168-9 | 60505-0168 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (60505-0169-1) | Apotex Corp. | 60505-0169-1 | 60505-0169 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 20mg/1 | 20000 Tablet In 1 Bottle (60505-0169-2) | Apotex Corp. | 60505-0169-2 | 60505-0169 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (60505-0169-5) | Apotex Corp. | 60505-0169-5 | 60505-0169 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (60505-0169-7) | Apotex Corp. | 60505-0169-7 | 60505-0169 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (60505-0169-9) | Apotex Corp. | 60505-0169-9 | 60505-0169 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle (60505-0170-1) | Apotex Corp. | 60505-0170-1 | 60505-0170 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (60505-0170-5) | Apotex Corp. | 60505-0170-5 | 60505-0170 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (60505-0170-7) | Apotex Corp. | 60505-0170-7 | 60505-0170 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 40mg/1 | 9000 Tablet In 1 Bottle (60505-0170-8) | Apotex Corp. | 60505-0170-8 | 60505-0170 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (60505-0170-9) | Apotex Corp. | 60505-0170-9 | 60505-0170 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle (60505-1323-1) | Apotex Corp. | 60505-1323-1 | 60505-1323 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (60505-1323-5) | Apotex Corp. | 60505-1323-5 | 60505-1323 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (60505-1323-7) | Apotex Corp. | 60505-1323-7 | 60505-1323 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 80mg/1 | 5000 Tablet In 1 Bottle (60505-1323-8) | Apotex Corp. | 60505-1323-8 | 60505-1323 | ANDA076341 | ANDA | N/A |
| Pravastatin Sodium | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (60505-1323-9) | Apotex Corp. | 60505-1323-9 | 60505-1323 | ANDA076341 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (70954-019-10) | Novitium Pharma LLC | 70954-019-10 | 70954-019 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 1mg/1 | 1000 Capsule In 1 Bottle (70954-019-20) | Novitium Pharma LLC | 70954-019-20 | 70954-019 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 1mg/1 | 100 Blister Pack In 1 Carton (70954-019-40) / 1 Capsule In 1 Blister Pack (70954-019-30) | Novitium Pharma LLC | 70954-019-40 | 70954-019 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 1mg/1 | 90 Capsule In 1 Bottle (70954-019-50) | Novitium Pharma LLC | 70954-019-50 | 70954-019 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (70954-020-10) | Novitium Pharma LLC | 70954-020-10 | 70954-020 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 2mg/1 | 1000 Capsule In 1 Bottle (70954-020-20) | Novitium Pharma LLC | 70954-020-20 | 70954-020 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 2mg/1 | 100 Blister Pack In 1 Carton (70954-020-40) / 1 Capsule In 1 Blister Pack (70954-020-30) | Novitium Pharma LLC | 70954-020-40 | 70954-020 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (70954-021-10) | Novitium Pharma LLC | 70954-021-10 | 70954-021 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 5mg/1 | 250 Capsule In 1 Bottle (70954-021-20) | Novitium Pharma LLC | 70954-021-20 | 70954-021 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 5mg/1 | 100 Blister Pack In 1 Carton (70954-021-40) / 1 Capsule In 1 Blister Pack (70954-021-30) | Novitium Pharma LLC | 70954-021-40 | 70954-021 | ANDA210971 | ANDA | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 1mg/1 | 90 Capsule In 1 Bottle (66993-431-85) | Prasco Laboratories | 66993-431-85 | 66993-431 | NDA017442 | NDA AUTHORIZED GENERIC | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 2mg/1 | 90 Capsule In 1 Bottle (66993-432-85) | Prasco Laboratories | 66993-432-85 | 66993-432 | NDA017442 | NDA AUTHORIZED GENERIC | N/A |
| Prazosin Hydrochloride | Capsule | Oral | 5mg/1 | 90 Capsule In 1 Bottle (66993-433-85) | Prasco Laboratories | 66993-433-85 | 66993-433 | NDA017442 | NDA AUTHORIZED GENERIC | N/A |
| Prednisolone Sodium Phosphate | Tablet, Orally Disintegrating | Oral | 10mg/1 | 2 Blister Pack In 1 Carton (66993-844-35) / 6 Tablet, Orally Disintegrating In 1 Blister Pack (66993-844-51) | Prasco Laboratories | 66993-844-35 | 66993-844 | NDA021959 | NDA AUTHORIZED GENERIC | N/A |
| Prednisolone Sodium Phosphate | Tablet, Orally Disintegrating | Oral | 15mg/1 | 2 Blister Pack In 1 Carton (66993-845-35) / 6 Tablet, Orally Disintegrating In 1 Blister Pack (66993-845-51) | Prasco Laboratories | 66993-845-35 | 66993-845 | NDA021959 | NDA AUTHORIZED GENERIC | N/A |
| Prednisolone Sodium Phosphate | Tablet, Orally Disintegrating | Oral | 30mg/1 | 2 Blister Pack In 1 Carton (66993-846-35) / 6 Tablet, Orally Disintegrating In 1 Blister Pack (66993-846-51) | Prasco Laboratories | 66993-846-35 | 66993-846 | NDA021959 | NDA AUTHORIZED GENERIC | N/A |
| Prednisolone Sodium Phosphate | Solution | Oral | 5mg/5mL | 120 Ml In 1 Bottle (13925-166-04) | Seton Pharmaceuticals, LLC | 13925-166-04 | 13925-166 | NDA019157 | NDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 12 Tablet In 1 Bottle, Plastic (60760-715-12) | St. Mary's Medical Park Pharmacy | 60760-715-12 | 60760-715 | ANDA210525 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 21 Tablet In 1 Bottle, Plastic (60760-715-21) | St. Mary's Medical Park Pharmacy | 60760-715-21 | 60760-715 | ANDA210525 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 21 Tablet In 1 Bottle, Plastic (60760-932-21) | St. Mary's Medical Park Pharmacy | 60760-932-21 | 60760-932 | ANDA211495 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-921-10) | Golden State Medical Supply, Inc. | 51407-921-10 | 51407-921 | ANDA080292 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-922-10) | Golden State Medical Supply, Inc. | 51407-922-10 | 51407-922 | ANDA088832 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-923-05) | Golden State Medical Supply, Inc. | 51407-923-05 | 51407-923 | ANDA083677 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-355-01) | Golden State Medical Supply, Inc. | 51407-355-01 | 51407-355 | ANDA087800 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-355-10) | Golden State Medical Supply, Inc. | 51407-355-10 | 51407-355 | ANDA087800 | ANDA | N/A |
| Prednisone | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-356-01) | Golden State Medical Supply, Inc. | 51407-356-01 | 51407-356 | ANDA087801 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-357-10) | Golden State Medical Supply, Inc. | 51407-357-10 | 51407-357 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-358-05) | Golden State Medical Supply, Inc. | 51407-358-05 | 51407-358 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-359-05) | Golden State Medical Supply, Inc. | 51407-359-05 | 51407-359 | ANDA087342 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 15mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-008-30) | Rising Pharma Holdings, Inc. | 57237-008-30 | 57237-008 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-009-05) | Rising Pharma Holdings, Inc. | 57237-009-05 | 57237-009 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 30mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-009-30) | Rising Pharma Holdings, Inc. | 57237-009-30 | 57237-009 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-010-05) | Rising Pharma Holdings, Inc. | 57237-010-05 | 57237-010 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Film Coated | Oral | 45mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-010-30) | Rising Pharma Holdings, Inc. | 57237-010-30 | 57237-010 | ANDA076921 | ANDA | N/A |
| Mirtazapine | Tablet, Orally Disintegrating | Oral | 15mg/1 | 5 Blister Pack In 1 Carton (57237-011-06) / 6 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-011-06 | 57237-011 | ANDA077376 | ANDA | N/A |
| Mirtazapine | Tablet, Orally Disintegrating | Oral | 30mg/1 | 5 Blister Pack In 1 Carton (57237-012-06) / 6 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-012-06 | 57237-012 | ANDA077376 | ANDA | N/A |
| Mirtazapine | Tablet, Orally Disintegrating | Oral | 45mg/1 | 5 Blister Pack In 1 Carton (57237-013-06) / 6 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-013-06 | 57237-013 | ANDA077376 | ANDA | N/A |
| Misoprostol | Tablet | Oral | 100ug/1 | 60 Tablet In 1 Bottle (70954-443-10) | ANI Pharmaceuticals, Inc. | 70954-443-10 | 70954-443 | ANDA076095 | ANDA | N/A |
| Misoprostol | Tablet | Oral | 100ug/1 | 120 Tablet In 1 Bottle (70954-443-20) | ANI Pharmaceuticals, Inc. | 70954-443-20 | 70954-443 | ANDA076095 | ANDA | N/A |
| Misoprostol | Tablet | Oral | 200ug/1 | 60 Tablet In 1 Bottle (70954-444-10) | ANI Pharmaceuticals, Inc. | 70954-444-10 | 70954-444 | ANDA076095 | ANDA | N/A |
| Misoprostol | Tablet | Oral | 200ug/1 | 100 Tablet In 1 Bottle (70954-444-20) | ANI Pharmaceuticals, Inc. | 70954-444-20 | 70954-444 | ANDA076095 | ANDA | N/A |
| Modafinil | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (57237-154-01) | Rising Pharma Holdings, Inc. | 57237-154-01 | 57237-154 | ANDA202566 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (57237-154-30) | Rising Pharma Holdings, Inc. | 57237-154-30 | 57237-154 | ANDA202566 | ANDA | CIV |
| Modafinil | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (57237-154-90) | Rising Pharma Holdings, Inc. | 57237-154-90 | 57237-154 | ANDA202566 | ANDA | CIV |
| Prednisone | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (59746-782-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-782-01 | 59746-782 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (59746-782-30) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-782-30 | 59746-782 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (59746-783-01) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-783-01 | 59746-783 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (59746-171-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-171-06 | 59746-171 | ANDA040611 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (59746-171-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-171-10 | 59746-171 | ANDA040611 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (59746-172-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-172-06 | 59746-172 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (59746-172-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-172-10 | 59746-172 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (59746-173-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-173-06 | 59746-173 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (59746-173-09) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-173-09 | 59746-173 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (59746-173-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-173-10 | 59746-173 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (59746-175-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-175-06 | 59746-175 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (59746-175-09) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-175-09 | 59746-175 | ANDA040362 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (59746-175-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-175-10 | 59746-175 | ANDA040362 | ANDA | N/A |
| Prednisone | Solution | Oral | 5mg/5mL | 120 Ml In 1 Bottle (0054-3722-50) | Hikma Pharmaceuticals USA Inc. | 0054-3722-50 | 0054-3722 | ANDA088703 | ANDA | N/A |
| Prednisone | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (0054-3722-63) | Hikma Pharmaceuticals USA Inc. | 0054-3722-63 | 0054-3722 | ANDA088703 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (0054-8724-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8724-25 | 0054-8724 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 10 Blister Pack In 1 Carton (0054-8739-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8739-25 | 0054-8739 | ANDA087800 | ANDA | N/A |
| Prednisone | Tablet | Oral | 2.5mg/1 | 10 Blister Pack In 1 Carton (0054-8740-25) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-8740-25 | 0054-8740 | ANDA087801 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (0054-9817-25) | Hikma Pharmaceuticals USA Inc. | 0054-9817-25 | 0054-9817 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (0054-9817-29) | Hikma Pharmaceuticals USA Inc. | 0054-9817-29 | 0054-9817 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (0054-9818-25) | Hikma Pharmaceuticals USA Inc. | 0054-9818-25 | 0054-9818 | ANDA087342 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (0054-9818-29) | Hikma Pharmaceuticals USA Inc. | 0054-9818-29 | 0054-9818 | ANDA087342 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0054-9828-25) | Hikma Pharmaceuticals USA Inc. | 0054-9828-25 | 0054-9828 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (0054-9828-31) | Hikma Pharmaceuticals USA Inc. | 0054-9828-31 | 0054-9828 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4728-25) | Hikma Pharmaceuticals USA Inc. | 0054-4728-25 | 0054-4728 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle, Plastic (0054-4728-31) | Hikma Pharmaceuticals USA Inc. | 0054-4728-31 | 0054-4728 | ANDA080352 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4741-25) | Hikma Pharmaceuticals USA Inc. | 0054-4741-25 | 0054-4741 | ANDA087800 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle, Plastic (0054-4741-31) | Hikma Pharmaceuticals USA Inc. | 0054-4741-31 | 0054-4741 | ANDA087800 | ANDA | N/A |
| Prednisone | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-4742-25) | Hikma Pharmaceuticals USA Inc. | 0054-4742-25 | 0054-4742 | ANDA087801 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (0054-0017-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0017-20 | 0054-0017 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0017-25) | Hikma Pharmaceuticals USA Inc. | 0054-0017-25 | 0054-0017 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle, Plastic (0054-0017-29) | Hikma Pharmaceuticals USA Inc. | 0054-0017-29 | 0054-0017 | ANDA084122 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (0054-0018-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0018-20 | 0054-0018 | ANDA087342 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0018-25) | Hikma Pharmaceuticals USA Inc. | 0054-0018-25 | 0054-0018 | ANDA087342 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle, Plastic (0054-0018-29) | Hikma Pharmaceuticals USA Inc. | 0054-0018-29 | 0054-0018 | ANDA087342 | ANDA | N/A |
| Prednisone | Tablet | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (0054-0019-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0019-20 | 0054-0019 | ANDA084283 | ANDA | N/A |
| Prednisone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0019-25) | Hikma Pharmaceuticals USA Inc. | 0054-0019-25 | 0054-0019 | ANDA084283 | ANDA | N/A |
| Prednisone | Solution, Concentrate | Oral | 5mg/mL | 30 Ml In 1 Bottle, Glass (0054-3721-44) | Hikma Pharmaceuticals USA Inc. | 0054-3721-44 | 0054-3721 | ANDA088810 | ANDA | N/A |
| Pregabalin | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (75834-300-05) | Nivagen Pharmaceuticals, Inc. | 75834-300-05 | 75834-300 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle (75834-300-60) | Nivagen Pharmaceuticals, Inc. | 75834-300-60 | 75834-300 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (75834-300-90) | Nivagen Pharmaceuticals, Inc. | 75834-300-90 | 75834-300 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (75834-301-05) | Nivagen Pharmaceuticals, Inc. | 75834-301-05 | 75834-301 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 60 Capsule In 1 Bottle (75834-301-60) | Nivagen Pharmaceuticals, Inc. | 75834-301-60 | 75834-301 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (75834-301-90) | Nivagen Pharmaceuticals, Inc. | 75834-301-90 | 75834-301 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 500 Capsule In 1 Bottle (75834-302-05) | Nivagen Pharmaceuticals, Inc. | 75834-302-05 | 75834-302 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 60 Capsule In 1 Bottle (75834-302-60) | Nivagen Pharmaceuticals, Inc. | 75834-302-60 | 75834-302 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (75834-302-90) | Nivagen Pharmaceuticals, Inc. | 75834-302-90 | 75834-302 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (75834-303-05) | Nivagen Pharmaceuticals, Inc. | 75834-303-05 | 75834-303 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle (75834-303-60) | Nivagen Pharmaceuticals, Inc. | 75834-303-60 | 75834-303 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (75834-303-90) | Nivagen Pharmaceuticals, Inc. | 75834-303-90 | 75834-303 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 500 Capsule In 1 Bottle (75834-296-05) | Nivagen Pharmaceuticals, Inc. | 75834-296-05 | 75834-296 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 60 Capsule In 1 Bottle (75834-296-60) | Nivagen Pharmaceuticals, Inc. | 75834-296-60 | 75834-296 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (75834-296-90) | Nivagen Pharmaceuticals, Inc. | 75834-296-90 | 75834-296 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (75834-297-05) | Nivagen Pharmaceuticals, Inc. | 75834-297-05 | 75834-297 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (75834-297-60) | Nivagen Pharmaceuticals, Inc. | 75834-297-60 | 75834-297 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (75834-297-90) | Nivagen Pharmaceuticals, Inc. | 75834-297-90 | 75834-297 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 500 Capsule In 1 Bottle (75834-298-05) | Nivagen Pharmaceuticals, Inc. | 75834-298-05 | 75834-298 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle (75834-298-60) | Nivagen Pharmaceuticals, Inc. | 75834-298-60 | 75834-298 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (75834-298-90) | Nivagen Pharmaceuticals, Inc. | 75834-298-90 | 75834-298 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (75834-299-05) | Nivagen Pharmaceuticals, Inc. | 75834-299-05 | 75834-299 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle (75834-299-60) | Nivagen Pharmaceuticals, Inc. | 75834-299-60 | 75834-299 | ANDA212988 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (75834-299-90) | Nivagen Pharmaceuticals, Inc. | 75834-299-90 | 75834-299 | ANDA212988 | ANDA | CV |
| Modafinil | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (57237-155-01) | Rising Pharma Holdings, Inc. | 57237-155-01 | 57237-155 | ANDA202566 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (57237-155-30) | Rising Pharma Holdings, Inc. | 57237-155-30 | 57237-155 | ANDA202566 | ANDA | CIV |
| Modafinil | Tablet | Oral | 200mg/1 | 90 Tablet In 1 Bottle (57237-155-90) | Rising Pharma Holdings, Inc. | 57237-155-90 | 57237-155 | ANDA202566 | ANDA | CIV |
| Molindone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-336-01) | EPIC PHARMA, LLC | 42806-336-01 | 42806-336 | ANDA090453 | ANDA | N/A |
| Molindone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-337-01) | EPIC PHARMA, LLC | 42806-337-01 | 42806-337 | ANDA090453 | ANDA | N/A |
| Molindone Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (42806-338-01) | EPIC PHARMA, LLC | 42806-338-01 | 42806-338 | ANDA090453 | ANDA | N/A |
| Mometasone Furoate | Spray, Metered | Nasal | 50ug/1 | 1 Bottle, Pump In 1 Carton (65162-891-29) / 120 Spray, Metered In 1 Bottle, Pump | Amneal Pharmaceuticals LLC | 65162-891-29 | 65162-891 | ANDA207989 | ANDA | N/A |
| Montelukast | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (72865-175-10) | XLCare Pharmaceuticals Inc. | 72865-175-10 | 72865-175 | ANDA202843 | ANDA | N/A |
| Montelukast | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-175-30) | XLCare Pharmaceuticals Inc. | 72865-175-30 | 72865-175 | ANDA202843 | ANDA | N/A |
| Montelukast | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (72865-175-90) | XLCare Pharmaceuticals Inc. | 72865-175-90 | 72865-175 | ANDA202843 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 4mg/1 | 30 Tablet, Chewable In 1 Bottle (65162-771-03) | Amneal Pharmaceuticals LLC | 65162-771-03 | 65162-771 | ANDA205107 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 5mg/1 | 30 Tablet, Chewable In 1 Bottle (65162-772-03) | Amneal Pharmaceuticals LLC | 65162-772-03 | 65162-772 | ANDA205107 | ANDA | N/A |
| Montelukast Sodium | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (65162-732-03) | Amneal Pharmaceuticals LLC | 65162-732-03 | 65162-732 | ANDA204604 | ANDA | N/A |
| Montelukast Sodium | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (65162-732-09) | Amneal Pharmaceuticals LLC | 65162-732-09 | 65162-732 | ANDA204604 | ANDA | N/A |
| Montelukast Sodium | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-732-11) | Amneal Pharmaceuticals LLC | 65162-732-11 | 65162-732 | ANDA204604 | ANDA | N/A |
| Montelukast Sodium | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (16571-100-09) | Rising Pharma Holdings, Inc. | 16571-100-09 | 16571-100 | ANDA209012 | ANDA | N/A |
| Montelukast Sodium | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (16571-100-10) | Rising Pharma Holdings, Inc. | 16571-100-10 | 16571-100 | ANDA209012 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 4mg/1 | 30 Tablet, Chewable In 1 Bottle (57237-212-30) | Rising Pharma Holdings, Inc. | 57237-212-30 | 57237-212 | ANDA202096 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 4mg/1 | 90 Tablet, Chewable In 1 Bottle (57237-212-90) | Rising Pharma Holdings, Inc. | 57237-212-90 | 57237-212 | ANDA202096 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 5mg/1 | 30 Tablet, Chewable In 1 Bottle (57237-213-30) | Rising Pharma Holdings, Inc. | 57237-213-30 | 57237-213 | ANDA202096 | ANDA | N/A |
| Montelukast Sodium | Tablet, Chewable | Oral | 5mg/1 | 90 Tablet, Chewable In 1 Bottle (57237-213-90) | Rising Pharma Holdings, Inc. | 57237-213-90 | 57237-213 | ANDA202096 | ANDA | N/A |
| Montelukast Sodium | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-255-30) | Rising Pharma Holdings, Inc. | 57237-255-30 | 57237-255 | ANDA202468 | ANDA | N/A |
| Montelukast Sodium | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-255-90) | Rising Pharma Holdings, Inc. | 57237-255-90 | 57237-255 | ANDA202468 | ANDA | N/A |
| Morphine | Solution | Oral | 1g/100mL | 118 Ml In 1 Bottle (62559-153-04) | ANI Pharmaceuticals, Inc. | 62559-153-04 | 62559-153 | N/A | UNAPPROVED DRUG OTHER | CII |
| Moxifloxacin | Tablet, Film Coated | Oral | 400mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-845-05) | Camber Pharmaceuticals, Inc. | 31722-845-05 | 31722-845 | ANDA204836 | ANDA | N/A |
| Moxifloxacin | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-845-30) | Camber Pharmaceuticals, Inc. | 31722-845-30 | 31722-845 | ANDA204836 | ANDA | N/A |
| Moxifloxacin Hydrochloride | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-156-30) | Rising Pharma Holdings, Inc. | 57237-156-30 | 57237-156 | ANDA202632 | ANDA | N/A |
| Mycophenolate Mofetil | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 4 Vial In 1 Carton (70121-1584-4) / 20 Ml In 1 Vial (70121-1584-1) | Amneal Pharmaceuticals LLC | 70121-1584-4 | 70121-1584 | ANDA211374 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Carton (70121-1482-2) * 3 Ml In 1 Vial (70121-3639-1) * 30 Ml In 1 Vial, Single-Dose (70121-1668-1) | Amneal Pharmaceuticals LLC | 70121-1482-2 | 70121-1482 | ANDA211229 | ANDA | N/A |
| N/A | Kit | Subcutaneous | N/A | 1 Kit In 1 Carton (70121-2537-6) * 1 Ml In 1 Packet (70121-2538-9) * 1 Vial, Multi-Dose In 1 Carton (70121-1695-2) / 2.8 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-2537-6 | 70121-2537 | ANDA215336 | ANDA | N/A |
| Pregabalin | Solution | Oral | 20mg/mL | 1 Bottle, Plastic In 1 Carton (39328-090-16) / 473 Ml In 1 Bottle, Plastic | Patrin Pharma, Inc. | 39328-090-16 | 39328-090 | ANDA212604 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-509-60) | St Mary's Medical Park Pharmacy | 60760-509-60 | 60760-509 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle (60760-591-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-591-60 | 60760-591 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle, Plastic (60760-485-60) | St. Mary's Medical Park Pharmacy | 60760-485-60 | 60760-485 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-485-90) | St. Mary's Medical Park Pharmacy | 60760-485-90 | 60760-485 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-486-90) | St. Mary's Medical Park Pharmacy | 60760-486-90 | 60760-486 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (51407-574-90) | Golden State Medical Supply, Inc. | 51407-574-90 | 51407-574 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (51407-575-90) | Golden State Medical Supply, Inc. | 51407-575-90 | 51407-575 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (51407-576-90) | Golden State Medical Supply, Inc. | 51407-576-90 | 51407-576 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (51407-577-90) | Golden State Medical Supply, Inc. | 51407-577-90 | 51407-577 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (51407-578-90) | Golden State Medical Supply, Inc. | 51407-578-90 | 51407-578 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (51407-579-90) | Golden State Medical Supply, Inc. | 51407-579-90 | 51407-579 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (51407-580-90) | Golden State Medical Supply, Inc. | 51407-580-90 | 51407-580 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (51407-581-90) | Golden State Medical Supply, Inc. | 51407-581-90 | 51407-581 | ANDA208677 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (58151-247-93) | Viatris Specialty LLC | 58151-247-93 | 58151-247 | NDA209501 | NDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (27808-235-01) | Tris Pharma Inc | 27808-235-01 | 27808-235 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (27808-236-01) | Tris Pharma Inc | 27808-236-01 | 27808-236 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (27808-237-01) | Tris Pharma Inc | 27808-237-01 | 27808-237 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (27808-238-01) | Tris Pharma Inc | 27808-238-01 | 27808-238 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (27808-239-01) | Tris Pharma Inc | 27808-239-01 | 27808-239 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (27808-240-01) | Tris Pharma Inc | 27808-240-01 | 27808-240 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (27808-241-01) | Tris Pharma Inc | 27808-241-01 | 27808-241 | ANDA214322 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (60505-3793-9) | ApotexCorp | 60505-3793-9 | 60505-3793 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (60505-3794-9) | ApotexCorp | 60505-3794-9 | 60505-3794 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (60505-3795-9) | ApotexCorp | 60505-3795-9 | 60505-3795 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (60505-3796-9) | ApotexCorp | 60505-3796-9 | 60505-3796 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (60505-3797-9) | ApotexCorp | 60505-3797-9 | 60505-3797 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (60505-3798-9) | ApotexCorp | 60505-3798-9 | 60505-3798 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (60505-3799-9) | ApotexCorp | 60505-3799-9 | 60505-3799 | ANDA211685 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (60505-3800-9) | ApotexCorp | 60505-3800-9 | 60505-3800 | ANDA211685 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (47781-379-30) | Alvogen Inc. | 47781-379-30 | 47781-379 | ANDA211593 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (47781-380-30) | Alvogen Inc. | 47781-380-30 | 47781-380 | ANDA211593 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (47781-381-30) | Alvogen Inc. | 47781-381-30 | 47781-381 | ANDA211593 | ANDA | CV |
| N/A | Kit | Intrathecal | N/A | 1 Ampule In 1 Box (70121-2501-1) / 1 Kit In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2501-1 | 70121-2501 | NDA020075 | NDA | N/A |
| N/A | Kit | Intrathecal | N/A | 2 Ampule In 1 Box (70121-2502-2) / 1 Kit In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2502-2 | 70121-2502 | NDA020075 | NDA | N/A |
| N/A | Kit | Intrathecal | N/A | 1 Ampule In 1 Box (70121-2503-1) / 1 Kit In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2503-1 | 70121-2503 | NDA020075 | NDA | N/A |
| N/A | Kit | Intrathecal | N/A | 2 Ampule In 1 Box (70121-2504-2) / 1 Kit In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2504-2 | 70121-2504 | NDA020075 | NDA | N/A |
| N/A | Kit | Intrathecal | N/A | 2 Ampule In 1 Box (70121-2505-2) / 1 Kit In 1 Ampule | Amneal Pharmaceuticals LLC | 70121-2505-2 | 70121-2505 | NDA020075 | NDA | N/A |
| N/A | Kit | Oral | N/A | 5 Carton In 1 Tray (65162-558-15) / 1 Blister Pack In 1 Carton (65162-558-58) / 1 Kit In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-558-15 | 65162-558 | ANDA214292 | ANDA | N/A |
| N/A | Kit | N/A | N/A | 1 Kit In 1 Blister Pack (66220-422-01) | Cumberland Pharmaceuticals Inc. | 66220-422-01 | 66220-422 | NDA050824 | NDA | N/A |
| N/A | Kit | N/A | N/A | 10 Blister Pack In 1 Carton (66220-422-02) / 1 Kit In 1 Blister Pack | Cumberland Pharmaceuticals Inc. | 66220-422-02 | 66220-422 | NDA050824 | NDA | N/A |
| N/A | Kit | N/A | N/A | 14 Blister Pack In 1 Carton (57237-001-14) / 1 Kit In 1 Blister Pack (57237-001-01) | Rising Pharma Holdings, Inc. | 57237-001-14 | 57237-001 | ANDA206006 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-465-01) | ScieGen Pharmaceuticals Inc | 50228-465-01 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-465-05) | ScieGen Pharmaceuticals Inc | 50228-465-05 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-465-30) | ScieGen Pharmaceuticals Inc | 50228-465-30 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle (50228-466-01) | ScieGen Pharmaceuticals Inc | 50228-466-01 | 50228-466 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (50228-466-05) | ScieGen Pharmaceuticals Inc | 50228-466-05 | 50228-466 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 30 Tablet In 1 Bottle (50228-466-30) | ScieGen Pharmaceuticals Inc | 50228-466-30 | 50228-466 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-465-01) | ScieGen Pharmaceuticals Inc | 50228-465-01 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-465-05) | ScieGen Pharmaceuticals Inc | 50228-465-05 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-465-30) | ScieGen Pharmaceuticals Inc | 50228-465-30 | 50228-465 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle (50228-466-01) | ScieGen Pharmaceuticals Inc | 50228-466-01 | 50228-466 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (50228-466-05) | ScieGen Pharmaceuticals Inc | 50228-466-05 | 50228-466 | ANDA078420 | ANDA | N/A |
| Nabumetone | Tablet | Oral | 750mg/1 | 30 Tablet In 1 Bottle (50228-466-30) | ScieGen Pharmaceuticals Inc | 50228-466-30 | 50228-466 | ANDA078420 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (65162-188-10) | Amneal Pharmaceuticals LLC | 65162-188-10 | 65162-188 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle (65162-188-11) | Amneal Pharmaceuticals LLC | 65162-188-11 | 65162-188 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (65162-188-50) | Amneal Pharmaceuticals LLC | 65162-188-50 | 65162-188 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 100 Tablet In 1 Bottle (65162-189-10) | Amneal Pharmaceuticals LLC | 65162-189-10 | 65162-189 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 1000 Tablet In 1 Bottle (65162-189-11) | Amneal Pharmaceuticals LLC | 65162-189-11 | 65162-189 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 500 Tablet In 1 Bottle (65162-189-50) | Amneal Pharmaceuticals LLC | 65162-189-50 | 65162-189 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (65162-190-10) | Amneal Pharmaceuticals LLC | 65162-190-10 | 65162-190 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (65162-190-11) | Amneal Pharmaceuticals LLC | 65162-190-11 | 65162-190 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (65162-190-50) | Amneal Pharmaceuticals LLC | 65162-190-50 | 65162-190 | ANDA075927 | ANDA | N/A |
| Naproxen | Tablet, Delayed Release | Oral | 375mg/1 | 100 Tablet, Delayed Release In 1 Bottle (70954-925-10) | ANI Pharmaceuticals, Inc. | 70954-925-10 | 70954-925 | ANDA218497 | ANDA | N/A |
| Naproxen | Tablet, Delayed Release | Oral | 500mg/1 | 100 Tablet, Delayed Release In 1 Bottle (70954-928-10) | ANI Pharmaceuticals, Inc. | 70954-928-10 | 70954-928 | ANDA218497 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (50228-434-01) | ScieGen Pharmaceuticals, Inc. | 50228-434-01 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (50228-434-05) | ScieGen Pharmaceuticals, Inc. | 50228-434-05 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle (50228-434-10) | ScieGen Pharmaceuticals, Inc. | 50228-434-10 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle (50228-434-30) | ScieGen Pharmaceuticals, Inc. | 50228-434-30 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 100 Tablet In 1 Bottle (50228-435-01) | ScieGen Pharmaceuticals, Inc. | 50228-435-01 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 500 Tablet In 1 Bottle (50228-435-05) | ScieGen Pharmaceuticals, Inc. | 50228-435-05 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 1000 Tablet In 1 Bottle (50228-435-10) | ScieGen Pharmaceuticals, Inc. | 50228-435-10 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 30 Tablet In 1 Bottle (50228-435-30) | ScieGen Pharmaceuticals, Inc. | 50228-435-30 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-436-01) | ScieGen Pharmaceuticals, Inc. | 50228-436-01 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-436-05) | ScieGen Pharmaceuticals, Inc. | 50228-436-05 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (50228-436-10) | ScieGen Pharmaceuticals, Inc. | 50228-436-10 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-436-30) | ScieGen Pharmaceuticals, Inc. | 50228-436-30 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (50228-434-01) | ScieGen Pharmaceuticals, Inc. | 50228-434-01 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (50228-434-05) | ScieGen Pharmaceuticals, Inc. | 50228-434-05 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle (50228-434-10) | ScieGen Pharmaceuticals, Inc. | 50228-434-10 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle (50228-434-30) | ScieGen Pharmaceuticals, Inc. | 50228-434-30 | 50228-434 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 100 Tablet In 1 Bottle (50228-435-01) | ScieGen Pharmaceuticals, Inc. | 50228-435-01 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 500 Tablet In 1 Bottle (50228-435-05) | ScieGen Pharmaceuticals, Inc. | 50228-435-05 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 1000 Tablet In 1 Bottle (50228-435-10) | ScieGen Pharmaceuticals, Inc. | 50228-435-10 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 375mg/1 | 30 Tablet In 1 Bottle (50228-435-30) | ScieGen Pharmaceuticals, Inc. | 50228-435-30 | 50228-435 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (50228-436-01) | ScieGen Pharmaceuticals, Inc. | 50228-436-01 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (50228-436-05) | ScieGen Pharmaceuticals, Inc. | 50228-436-05 | 50228-436 | ANDA212517 | ANDA | N/A |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (0071-1012-68) | Parke-Davis Div of Pfizer Inc | 0071-1012-68 | 0071-1012 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 100 Blister Pack In 1 Carton (0071-1013-41) / 1 Capsule In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-1013-41 | 0071-1013 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (0071-1013-68) | Parke-Davis Div of Pfizer Inc | 0071-1013-68 | 0071-1013 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 100 Blister Pack In 1 Carton (0071-1014-41) / 1 Capsule In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-1014-41 | 0071-1014 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (0071-1014-68) | Parke-Davis Div of Pfizer Inc | 0071-1014-68 | 0071-1014 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (0071-1015-41) / 1 Capsule In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-1015-41 | 0071-1015 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (0071-1015-68) | Parke-Davis Div of Pfizer Inc | 0071-1015-68 | 0071-1015 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 100 Blister Pack In 1 Carton (0071-1016-41) / 1 Capsule In 1 Blister Pack | Parke-Davis Div of Pfizer Inc | 0071-1016-41 | 0071-1016 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (0071-1016-68) | Parke-Davis Div of Pfizer Inc | 0071-1016-68 | 0071-1016 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (0071-1017-68) | Parke-Davis Div of Pfizer Inc | 0071-1017-68 | 0071-1017 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (0071-1018-68) | Parke-Davis Div of Pfizer Inc | 0071-1018-68 | 0071-1018 | NDA021446 | NDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (0071-1019-68) | Parke-Davis Div of Pfizer Inc | 0071-1019-68 | 0071-1019 | NDA021446 | NDA | CV |
| Pregabalin | Solution | Oral | 20mg/mL | 473 Ml In 1 Bottle (0071-1020-01) | Parke-Davis Div of Pfizer Inc | 0071-1020-01 | 0071-1020 | NDA022488 | NDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0071-1026-01) | Parke-Davis Div of Pfizer Inc | 0071-1026-01 | 0071-1026 | NDA209501 | NDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0071-1027-01) | Parke-Davis Div of Pfizer Inc | 0071-1027-01 | 0071-1027 | NDA209501 | NDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0071-1029-01) | Parke-Davis Div of Pfizer Inc | 0071-1029-01 | 0071-1029 | NDA209501 | NDA | CV |
| Naproxen | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (50228-436-10) | ScieGen Pharmaceuticals, Inc. | 50228-436-10 | 50228-436 | ANDA212517 | ANDA | N/A |
| Naproxen | Tablet | Oral | 500mg/1 | 30 Tablet In 1 Bottle (50228-436-30) | ScieGen Pharmaceuticals, Inc. | 50228-436-30 | 50228-436 | ANDA212517 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-637-01) | Golden State Medical Supply, Inc. | 51407-637-01 | 51407-637 | ANDA084903 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (51407-637-05) | Golden State Medical Supply, Inc. | 51407-637-05 | 51407-637 | ANDA084903 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (51407-638-01) | Golden State Medical Supply, Inc. | 51407-638-01 | 51407-638 | ANDA084903 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (80005-117-11) | Carnegie Pharmaceuticals LLC | 80005-117-11 | 80005-117 | ANDA218366 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (80005-117-14) | Carnegie Pharmaceuticals LLC | 80005-117-14 | 80005-117 | ANDA218366 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (80005-117-15) | Carnegie Pharmaceuticals LLC | 80005-117-15 | 80005-117 | ANDA218366 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (80005-118-11) | Carnegie Pharmaceuticals LLC | 80005-118-11 | 80005-118 | ANDA218366 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (80005-118-14) | Carnegie Pharmaceuticals LLC | 80005-118-14 | 80005-118 | ANDA218366 | ANDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 1 Bottle, Plastic In 1 Box (69230-305-20) / 20 Capsule, Liquid Filled In 1 Bottle, Plastic | Camber Consumer Care | 69230-305-20 | 69230-305 | ANDA208363 | ANDA | N/A |
| Naproxen Sodium | Capsule, Liquid Filled | Oral | 220mg/1 | 1 Bottle, Plastic In 1 Box (69230-305-80) / 80 Capsule, Liquid Filled In 1 Bottle, Plastic | Camber Consumer Care | 69230-305-80 | 69230-305 | ANDA208363 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (69230-329-01) / 100 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-329-01 | 69230-329 | ANDA211065 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (69230-329-02) / 200 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-329-02 | 69230-329 | ANDA211065 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 500 Tablet, Film Coated In 1 Bottle (69230-329-05) | Camber Consumer Care Inc | 69230-329-05 | 69230-329 | ANDA211065 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69230-329-10) | Camber Consumer Care Inc | 69230-329-10 | 69230-329 | ANDA211065 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (69230-329-24) / 24 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-329-24 | 69230-329 | ANDA211065 | ANDA | N/A |
| Naproxen sodium | Tablet, Film Coated | Oral | 220mg/1 | 1 Bottle In 1 Carton (69230-329-50) / 50 Tablet, Film Coated In 1 Bottle | Camber Consumer Care Inc | 69230-329-50 | 69230-329 | ANDA211065 | ANDA | N/A |
| Procainamide Hydrochloride | Injection | Intramuscular; Intravenous | 500mg/mL | 10 Vial, Multi-Dose In 1 Carton (14789-900-02) / 2 Ml In 1 Vial, Multi-Dose | Nexus Pharmaceuticals LLC | 14789-900-02 | 14789-900 | ANDA206332 | ANDA | N/A |
| Procainamide Hydrochloride | Injection | Intramuscular; Intravenous | 100mg/mL | 10 Vial, Multi-Dose In 1 Carton (14789-901-10) / 10 Ml In 1 Vial, Multi-Dose | Nexus Pharmaceuticals LLC | 14789-901-10 | 14789-901 | ANDA206332 | ANDA | N/A |
| Procainamide Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Carton In 1 Case (0409-1902-01) / 1 Vial, Multi-Dose In 1 Carton (0409-1902-11) / 10 Ml In 1 Vial, Multi-Dose | Hospira, Inc. | 0409-1902-01 | 0409-1902 | ANDA089069 | ANDA | N/A |
| Prochlorperazine | Suppository | Rectal | 25mg/1 | 12 Packet In 1 Carton (0574-7226-12) / 1 Suppository In 1 Packet | Padagis US LLC | 0574-7226-12 | 0574-7226 | ANDA040246 | ANDA | N/A |
| Prochlorperazine | Suppository | Rectal | 25mg/1 | 1000 Blister Pack In 1 Carton (0713-0135-10) / 1 Suppository In 1 Blister Pack | Cosette Pharmaceuticals, Inc. | 0713-0135-10 | 0713-0135 | ANDA040058 | ANDA | N/A |
| Prochlorperazine | Suppository | Rectal | 25mg/1 | 12 Blister Pack In 1 Carton (0713-0135-12) / 1 Suppository In 1 Blister Pack | Cosette Pharmaceuticals, Inc. | 0713-0135-12 | 0713-0135 | ANDA040058 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (14789-700-02) / 2 Ml In 1 Vial, Single-Dose (14789-700-07) | Nexus Pharmaceuticals Inc. | 14789-700-02 | 14789-700 | ANDA204860 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (25021-790-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-790-02 | 25021-790 | ANDA214107 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Carton (25021-790-03) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-790-03 | 25021-790 | ANDA214107 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Package (0713-0351-09) / 2 Ml In 1 Vial (0713-0351-02) | Cosette Pharmaceuticals, Inc. | 0713-0351-09 | 0713-0351 | ANDA213626 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Package (0713-0351-25) / 2 Ml In 1 Vial (0713-0351-02) | Cosette Pharmaceuticals, Inc. | 0713-0351-25 | 0713-0351 | ANDA213626 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 100 Tablet In 1 Bottle (50228-432-01) | ScieGen Pharmaceuticals, Inc. | 50228-432-01 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 500 Tablet In 1 Bottle (50228-432-05) | ScieGen Pharmaceuticals, Inc. | 50228-432-05 | 50228-432 | ANDA212199 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Syringe In 1 Carton (0641-6225-10) / 2 Ml In 1 Syringe (0641-6225-01) | Hikma Pharmaceuticals USA Inc. | 0641-6225-10 | 0641-6225 | ANDA213630 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Carton (0641-6135-25) / 2 Ml In 1 Vial (0641-6135-01) | Hikma Pharmaceuticals USA Inc. | 0641-6135-25 | 0641-6135 | ANDA089903 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 1000 Tablet In 1 Bottle (50228-432-10) | ScieGen Pharmaceuticals, Inc. | 50228-432-10 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 30 Tablet In 1 Bottle (50228-432-30) | ScieGen Pharmaceuticals, Inc. | 50228-432-30 | 50228-432 | ANDA212199 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (69452-309-20) | Bionpharma Inc. | 69452-309-20 | 69452-309 | ANDA217478 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69452-309-32) | Bionpharma Inc. | 69452-309-32 | 69452-309 | ANDA217478 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (69452-310-20) | Bionpharma Inc. | 69452-310-20 | 69452-310 | ANDA217478 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (69452-310-32) | Bionpharma Inc. | 69452-310-32 | 69452-310 | ANDA217478 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (59746-113-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-113-06 | 59746-113 | ANDA040268 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (59746-113-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-113-10 | 59746-113 | ANDA040268 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (59746-115-06) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-115-06 | 59746-115 | ANDA040268 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (59746-115-10) | JUBILANT CADISTA PHARMACEUTICALS INC. | 59746-115-10 | 59746-115 | ANDA040268 | ANDA | N/A |
| Progesterone | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (69452-148-20) | Bionpharma Inc. | 69452-148-20 | 69452-148 | ANDA200900 | ANDA | N/A |
| Progesterone | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (69452-149-20) | Bionpharma Inc. | 69452-149-20 | 69452-149 | ANDA200900 | ANDA | N/A |
| Progesterone | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (69452-233-20) | Bionpharma Inc. | 69452-233-20 | 69452-233 | ANDA200900 | ANDA | N/A |
| Progesterone | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (69452-234-20) | Bionpharma Inc. | 69452-234-20 | 69452-234 | ANDA200900 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 100 Tablet In 1 Bottle (50228-433-01) | ScieGen Pharmaceuticals, Inc. | 50228-433-01 | 50228-433 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 500 Tablet In 1 Bottle (50228-433-05) | ScieGen Pharmaceuticals, Inc. | 50228-433-05 | 50228-433 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 1000 Tablet In 1 Bottle (50228-433-10) | ScieGen Pharmaceuticals, Inc. | 50228-433-10 | 50228-433 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 30 Tablet In 1 Bottle (50228-433-30) | ScieGen Pharmaceuticals, Inc. | 50228-433-30 | 50228-433 | ANDA212199 | ANDA | N/A |
| Progesterone | Injection | Intramuscular | 50mg/1 | 10 Injection In 1 Box (0143-9725-01) | Hikma Pharmaceuticals USA Inc. | 0143-9725-01 | 0143-9725 | ANDA091033 | ANDA | N/A |
| Promethazine Hydrochloride | Solution | Oral | 6.25mg/5mL | 473 Ml In 1 Bottle (29033-500-34) | Nostrum Laboratories, Inc. | 29033-500-34 | 29033-500 | ANDA040891 | ANDA | N/A |
| Promethazine Hydrochloride | Solution | Oral | 6.25mg/5mL | 473 Ml In 1 Bottle (70408-146-34) | Nostrum Laboratories, Inc. | 70408-146-34 | 70408-146 | ANDA040891 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 12.5mg/1 | 12 Blister Pack In 1 Carton (45802-758-30) / 1 Suppository In 1 Blister Pack (45802-758-00) | Padagis Israel Pharmaceuticals Ltd | 45802-758-30 | 45802-758 | ANDA040500 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 25mg/1 | 12 Blister Pack In 1 Carton (45802-759-30) / 1 Suppository In 1 Blister Pack (45802-759-00) | Padagis Israel Pharmaceuticals Ltd | 45802-759-30 | 45802-759 | ANDA040500 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-456-20) | St. Mary's Medical Park Pharmacy | 60760-456-20 | 60760-456 | ANDA040596 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 12.5mg/1 | 12 Blister Pack In 1 Carton (51672-5296-1) / 1 Suppository In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-5296-1 | 51672-5296 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 25mg/1 | 12 Blister Pack In 1 Carton (51672-5297-1) / 1 Suppository In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-5297-1 | 51672-5297 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Syrup | Oral | 6.25mg/5mL | 473 Ml In 1 Bottle (27808-051-02) | Tris Pharma Inc | 27808-051-02 | 27808-051 | ANDA091675 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (10702-002-01) | KVK-Tech, Inc. | 10702-002-01 | 10702-002 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 12.5mg/1 | 1000 Tablet In 1 Bottle (10702-002-10) | KVK-Tech, Inc. | 10702-002-10 | 10702-002 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (10702-003-01) | KVK-Tech, Inc. | 10702-003-01 | 10702-003 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (10702-003-10) | KVK-Tech, Inc. | 10702-003-10 | 10702-003 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (10702-003-50) | KVK-Tech, Inc. | 10702-003-50 | 10702-003 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (10702-004-01) | KVK-Tech, Inc. | 10702-004-01 | 10702-004 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (10702-004-10) | KVK-Tech, Inc. | 10702-004-10 | 10702-004 | ANDA040712 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 25mg/1 | 1000 Suppository In 1 Box (0713-0526-10) | Cosette Pharmaceuticals, Inc. | 0713-0526-10 | 0713-0526 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 25mg/1 | 12 Suppository In 1 Box (0713-0526-12) | Cosette Pharmaceuticals, Inc. | 0713-0526-12 | 0713-0526 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 12.5mg/1 | 1000 Suppository In 1 Box (0713-0536-10) | Cosette Pharmaceuticals, Inc. | 0713-0536-10 | 0713-0536 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 12.5mg/1 | 12 Suppository In 1 Box (0713-0536-12) | Cosette Pharmaceuticals, Inc. | 0713-0536-12 | 0713-0536 | ANDA040428 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 50mg/1 | 1000 Suppository In 1 Box (0713-0132-10) | Cosette Pharmaceuticals, Inc. | 0713-0132-10 | 0713-0132 | ANDA087165 | ANDA | N/A |
| Promethazine Hydrochloride | Suppository | Rectal | 50mg/1 | 12 Suppository In 1 Box (0713-0132-12) | Cosette Pharmaceuticals, Inc. | 0713-0132-12 | 0713-0132 | ANDA087165 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 100 Tablet In 1 Bottle (50228-432-01) | ScieGen Pharmaceuticals, Inc. | 50228-432-01 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 500 Tablet In 1 Bottle (50228-432-05) | ScieGen Pharmaceuticals, Inc. | 50228-432-05 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 1000 Tablet In 1 Bottle (50228-432-10) | ScieGen Pharmaceuticals, Inc. | 50228-432-10 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 275mg/1 | 30 Tablet In 1 Bottle (50228-432-30) | ScieGen Pharmaceuticals, Inc. | 50228-432-30 | 50228-432 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 100 Tablet In 1 Bottle (50228-433-01) | ScieGen Pharmaceuticals, Inc. | 50228-433-01 | 50228-433 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 500 Tablet In 1 Bottle (50228-433-05) | ScieGen Pharmaceuticals, Inc. | 50228-433-05 | 50228-433 | ANDA212199 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 1000 Tablet In 1 Bottle (50228-433-10) | ScieGen Pharmaceuticals, Inc. | 50228-433-10 | 50228-433 | ANDA212199 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Ampule In 1 Carton (0641-6082-25) / 1 Ml In 1 Ampule (0641-6082-01) | Hikma Pharmaceuticals USA Inc. | 0641-6082-25 | 0641-6082 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Ampule In 1 Carton (0641-6083-25) / 1 Ml In 1 Ampule (0641-6083-01) | Hikma Pharmaceuticals USA Inc. | 0641-6083-25 | 0641-6083 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Vial In 1 Carton (0641-6084-25) / 1 Ml In 1 Vial (0641-6084-01) | Hikma Pharmaceuticals USA Inc. | 0641-6084-25 | 0641-6084 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Vial In 1 Carton (0641-6085-25) / 1 Ml In 1 Vial (0641-6085-01) | Hikma Pharmaceuticals USA Inc. | 0641-6085-25 | 0641-6085 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Vial, Single-Dose In 1 Package (0641-0929-25) / 1 Ml In 1 Vial, Single-Dose (0641-0929-21) | Hikma Pharmaceuticals USA Inc. | 0641-0929-25 | 0641-0929 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Ampule In 1 Carton (0641-0948-35) / 1 Ml In 1 Ampule (0641-0948-31) | Hikma Pharmaceuticals USA Inc. | 0641-0948-35 | 0641-0948 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Ampule In 1 Carton (0641-0949-35) / 1 Ml In 1 Ampule (0641-0949-31) | Hikma Pharmaceuticals USA Inc. | 0641-0949-35 | 0641-0949 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Vial In 1 Carton (0641-0955-25) / 1 Ml In 1 Vial (0641-0955-21) | Hikma Pharmaceuticals USA Inc. | 0641-0955-25 | 0641-0955 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Vial In 1 Carton (0641-0956-25) / 1 Ml In 1 Vial (0641-0956-21) | Hikma Pharmaceuticals USA Inc. | 0641-0956-25 | 0641-0956 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Ampule In 1 Carton (0641-1495-35) / 1 Ml In 1 Ampule (0641-1495-31) | Hikma Pharmaceuticals USA Inc. | 0641-1495-35 | 0641-1495 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular | 50mg/mL | 25 Ampule In 1 Package (0641-1496-35) / 1 Ml In 1 Ampule (0641-1496-31) | Hikma Pharmaceuticals USA Inc. | 0641-1496-35 | 0641-1496 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Vial In 1 Carton (0641-6208-25) / 1 Ml In 1 Vial (0641-6208-01) | Hikma Pharmaceuticals USA Inc. | 0641-6208-25 | 0641-6208 | ANDA083312 | ANDA | N/A |
| Promethazine Hydrochloride | Injection | Intramuscular; Intravenous | 25mg/mL | 25 Vial, Single-Dose In 1 Package (0641-0928-25) / 1 Ml In 1 Vial, Single-Dose (0641-0928-21) | Hikma Pharmaceuticals USA Inc. | 0641-0928-25 | 0641-0928 | ANDA083312 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 225mg/1 | 60 Capsule, Extended Release In 1 Bottle, Plastic (51407-477-60) | Golden State Medical Supply, Inc. | 51407-477-60 | 51407-477 | ANDA212928 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 325mg/1 | 60 Capsule, Extended Release In 1 Bottle, Plastic (51407-478-60) | Golden State Medical Supply, Inc. | 51407-478-60 | 51407-478 | ANDA212928 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 425mg/1 | 60 Capsule, Extended Release In 1 Bottle, Plastic (51407-479-60) | Golden State Medical Supply, Inc. | 51407-479-60 | 51407-479 | ANDA212928 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 150mg/1 | 100 Tablet, Coated In 1 Bottle (51407-015-01) | Golden State Medical Supply, Inc. | 51407-015-01 | 51407-015 | ANDA076550 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 225mg/1 | 100 Tablet, Coated In 1 Bottle (51407-016-01) | Golden State Medical Supply, Inc. | 51407-016-01 | 51407-016 | ANDA076550 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 300mg/1 | 100 Tablet, Coated In 1 Bottle (51407-017-01) | Golden State Medical Supply, Inc. | 51407-017-01 | 51407-017 | ANDA076550 | ANDA | N/A |
| Naproxen Sodium | Tablet | Oral | 550mg/1 | 30 Tablet In 1 Bottle (50228-433-30) | ScieGen Pharmaceuticals, Inc. | 50228-433-30 | 50228-433 | ANDA212199 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (16571-758-01) | Rising Pharmaceuticals, Inc. | 16571-758-01 | 16571-758 | ANDA205544 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 60mg/1 | 90 Tablet In 1 Bottle (16571-758-09) | Rising Pharmaceuticals, Inc. | 16571-758-09 | 16571-758 | ANDA205544 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 60mg/1 | 500 Tablet In 1 Bottle (16571-758-50) | Rising Pharmaceuticals, Inc. | 16571-758-50 | 16571-758 | ANDA205544 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (16571-759-01) | Rising Pharmaceuticals, Inc. | 16571-759-01 | 16571-759 | ANDA205544 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 120mg/1 | 90 Tablet In 1 Bottle (16571-759-09) | Rising Pharmaceuticals, Inc. | 16571-759-09 | 16571-759 | ANDA205544 | ANDA | N/A |
| Nateglinide | Tablet | Oral | 120mg/1 | 500 Tablet In 1 Bottle (16571-759-50) | Rising Pharmaceuticals, Inc. | 16571-759-50 | 16571-759 | ANDA205544 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (31722-585-01) | Camber Pharmaceuticals, Inc. | 31722-585-01 | 31722-585 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (31722-585-30) | Camber Pharmaceuticals, Inc. | 31722-585-30 | 31722-585 | ANDA203825 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 25 Vial In 1 Carton (25021-608-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-608-20 | 25021-608 | ANDA075102 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 20 Vial In 1 Carton (25021-608-50) / 50 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-608-50 | 25021-608 | ANDA075102 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-608-51) / 100 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-608-51 | 25021-608 | ANDA075102 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Syringe, Plastic In 1 Bag (80700-113-11) / 10 Ml In 1 Syringe, Plastic (80700-113-10) | Genixus | 80700-113-11 | 80700-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 25 Syringe, Plastic In 1 Bag (80700-113-12) / 10 Ml In 1 Syringe, Plastic (80700-113-10) | Genixus | 80700-113-12 | 80700-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Syringe, Plastic In 1 Bag (80700-113-21) / 20 Ml In 1 Syringe, Plastic (80700-113-20) | Genixus | 80700-113-21 | 80700-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 25 Syringe, Plastic In 1 Bag (80700-113-22) / 20 Ml In 1 Syringe, Plastic (80700-113-20) | Genixus | 80700-113-22 | 80700-113 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial, Single-Use In 1 Carton (0641-6194-10) / 20 Ml In 1 Vial, Single-Use (0641-6194-01) | Hikma Pharmaceuticals USA Inc. | 0641-6194-10 | 0641-6194 | ANDA074848 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 20 Vial, Single-Use In 1 Carton (0641-6195-20) / 50 Ml In 1 Vial, Single-Use (0641-6195-01) | Hikma Pharmaceuticals USA Inc. | 0641-6195-20 | 0641-6195 | ANDA074848 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial, Single-Use In 1 Carton (0641-6196-10) / 100 Ml In 1 Vial, Single-Use (0641-6196-01) | Hikma Pharmaceuticals USA Inc. | 0641-6196-10 | 0641-6196 | ANDA074848 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial In 1 Carton (0069-0209-10) / 20 Ml In 1 Vial (0069-0209-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0209-10 | 0069-0209 | ANDA205576 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 20 Vial In 1 Carton (0069-0234-20) / 50 Ml In 1 Vial | Pfizer Laboratories Div Pfizer Inc | 0069-0234-20 | 0069-0234 | ANDA205576 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial In 1 Carton (0069-0248-10) / 100 Ml In 1 Vial | Pfizer Laboratories Div Pfizer Inc | 0069-0248-10 | 0069-0248 | ANDA205576 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 10 Vial In 1 Tray (0409-4699-24) / 100 Ml In 1 Vial (0409-4699-54) | Hospira, Inc. | 0409-4699-24 | 0409-4699 | ANDA077908 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 5 Vial In 1 Carton (0409-4699-30) / 20 Ml In 1 Vial (0409-4699-50) | Hospira, Inc. | 0409-4699-30 | 0409-4699 | ANDA077908 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 20 Vial In 1 Tray (0409-4699-33) / 50 Ml In 1 Vial (0409-4699-53) | Hospira, Inc. | 0409-4699-33 | 0409-4699 | ANDA077908 | ANDA | N/A |
| Propofol | Injection, Emulsion | Intravenous | 10mg/mL | 25 Vial In 1 Tray (0409-6010-25) / 20 Ml In 1 Vial (0409-6010-02) | Hospira, Inc. | 0409-6010-25 | 0409-6010 | ANDA077908 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-262-60) | St. Mary's Medical Park Pharmacy | 60760-262-60 | 60760-262 | ANDA070218 | ANDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (60760-538-30) | St. Mary's Medical Park Pharmacy | 60760-538-30 | 60760-538 | NDA018553 | NDA AUTHORIZED GENERIC | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (60760-589-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-589-30 | 60760-589 | ANDA078703 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-545-60) | St. Mary's Medical Park Pharmacy | 60760-545-60 | 60760-545 | ANDA070322 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-235-01) | Golden State Medical Supply, Inc. | 51407-235-01 | 51407-235 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-235-10) | Golden State Medical Supply, Inc. | 51407-235-10 | 51407-235 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-236-01) | Golden State Medical Supply, Inc. | 51407-236-01 | 51407-236 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-236-10) | Golden State Medical Supply, Inc. | 51407-236-10 | 51407-236 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 40mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-237-01) | Golden State Medical Supply, Inc. | 51407-237-01 | 51407-237 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle, Plastic (51407-237-10) | Golden State Medical Supply, Inc. | 51407-237-10 | 51407-237 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-238-01) | Golden State Medical Supply, Inc. | 51407-238-01 | 51407-238 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle, Plastic (51407-238-05) | Golden State Medical Supply, Inc. | 51407-238-05 | 51407-238 | ANDA070213 | ANDA | N/A |
| Propranolol Hydrochloride | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-239-01) | Golden State Medical Supply, Inc. | 51407-239-01 | 51407-239 | ANDA070213 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 2.5mg/1 | 12 Blister Pack In 1 Carton (31722-585-32) / 10 Tablet In 1 Blister Pack (31722-585-31) | Camber Pharmaceuticals, Inc. | 31722-585-32 | 31722-585 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 2.5mg/1 | 15 Blister Pack In 1 Carton (31722-585-34) / 10 Tablet In 1 Blister Pack (31722-585-33) | Camber Pharmaceuticals, Inc. | 31722-585-34 | 31722-585 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-586-01) | Camber Pharmaceuticals, Inc. | 31722-586-01 | 31722-586 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (31722-586-30) | Camber Pharmaceuticals, Inc. | 31722-586-30 | 31722-586 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (31722-586-32) / 10 Tablet In 1 Blister Pack (31722-586-31) | Camber Pharmaceuticals, Inc. | 31722-586-32 | 31722-586 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 5mg/1 | 18 Blister Pack In 1 Carton (31722-586-34) / 7 Tablet In 1 Blister Pack (31722-586-33) | Camber Pharmaceuticals, Inc. | 31722-586-34 | 31722-586 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (31722-586-90) | Camber Pharmaceuticals, Inc. | 31722-586-90 | 31722-586 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-587-01) | Camber Pharmaceuticals, Inc. | 31722-587-01 | 31722-587 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (31722-587-30) | Camber Pharmaceuticals, Inc. | 31722-587-30 | 31722-587 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (31722-587-32) / 10 Tablet In 1 Blister Pack (31722-587-31) | Camber Pharmaceuticals, Inc. | 31722-587-32 | 31722-587 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 10mg/1 | 18 Blister Pack In 1 Carton (31722-587-34) / 7 Tablet In 1 Blister Pack (31722-587-33) | Camber Pharmaceuticals, Inc. | 31722-587-34 | 31722-587 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (31722-587-90) | Camber Pharmaceuticals, Inc. | 31722-587-90 | 31722-587 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-588-01) | Camber Pharmaceuticals, Inc. | 31722-588-01 | 31722-588 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (31722-588-30) | Camber Pharmaceuticals, Inc. | 31722-588-30 | 31722-588 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (31722-588-32) / 10 Tablet In 1 Blister Pack (31722-588-31) | Camber Pharmaceuticals, Inc. | 31722-588-32 | 31722-588 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 20mg/1 | 18 Blister Pack In 1 Carton (31722-588-34) / 7 Tablet In 1 Blister Pack (31722-588-33) | Camber Pharmaceuticals, Inc. | 31722-588-34 | 31722-588 | ANDA203825 | ANDA | N/A |
| Nebivolol | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (31722-588-90) | Camber Pharmaceuticals, Inc. | 31722-588-90 | 31722-588 | ANDA203825 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 2.5mg/1 | 30 Tablet In 1 Bottle (62559-275-30) | ANI Pharmaceuticals, Inc. | 62559-275-30 | 62559-275 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 2.5mg/1 | 2300 Tablet In 1 Bottle (62559-275-83) | ANI Pharmaceuticals, Inc. | 62559-275-83 | 62559-275 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (62559-276-30) | ANI Pharmaceuticals, Inc. | 62559-276-30 | 62559-276 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 5mg/1 | 1100 Tablet In 1 Bottle (62559-276-71) | ANI Pharmaceuticals, Inc. | 62559-276-71 | 62559-276 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (62559-276-90) | ANI Pharmaceuticals, Inc. | 62559-276-90 | 62559-276 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (62559-277-05) | ANI Pharmaceuticals, Inc. | 62559-277-05 | 62559-277 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (62559-277-30) | ANI Pharmaceuticals, Inc. | 62559-277-30 | 62559-277 | ANDA203659 | ANDA | N/A |
| Propranolol Hydrochloride | Solution | Oral | 20mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3727-63) | Hikma Pharmaceuticals USA Inc. | 0054-3727-63 | 0054-3727 | ANDA070979 | ANDA | N/A |
| Propranolol Hydrochloride | Solution | Oral | 40mg/5mL | 500 Ml In 1 Bottle, Plastic (0054-3730-63) | Hikma Pharmaceuticals USA Inc. | 0054-3730-63 | 0054-3730 | ANDA070690 | ANDA | N/A |
| Propranolol Hydrochloride | Injection | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9872-10) / 1 Ml In 1 Vial (0143-9872-01) | Hikma Pharmaceuticals USA Inc. | 0143-9872-10 | 0143-9872 | ANDA077760 | ANDA | N/A |
| Prosopis Juliflora Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1876-2) | Jubilant HollisterStier LLC | 65044-1876-2 | 65044-1876 | BLA103888 | BLA | N/A |
| Prosopis Juliflora Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1876-3) | Jubilant HollisterStier LLC | 65044-1876-3 | 65044-1876 | BLA103888 | BLA | N/A |
| Prosopis Juliflora Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1876-4) | Jubilant HollisterStier LLC | 65044-1876-4 | 65044-1876 | BLA103888 | BLA | N/A |
| Prosopis Juliflora Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1877-1) | Jubilant HollisterStier LLC | 65044-1877-1 | 65044-1877 | BLA103888 | BLA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (62559-277-90) | ANI Pharmaceuticals, Inc. | 62559-277-90 | 62559-277 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (62559-278-05) | ANI Pharmaceuticals, Inc. | 62559-278-05 | 62559-278 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (62559-278-30) | ANI Pharmaceuticals, Inc. | 62559-278-30 | 62559-278 | ANDA203659 | ANDA | N/A |
| Nebivolol Hydrochloride | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (62559-278-90) | ANI Pharmaceuticals, Inc. | 62559-278-90 | 62559-278 | ANDA203659 | ANDA | N/A |
| Nelarabine | Injection | Intravenous | 5mg/mL | 6 Vial, Single-Dose In 1 Carton (70121-1743-4) / 50 Ml In 1 Vial, Single-Dose (70121-1743-1) | Amneal Pharmaceuticals LLC | 70121-1743-4 | 70121-1743 | ANDA216346 | ANDA | N/A |
| Neostigmine Methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (70121-1479-7) / 10 Ml In 1 Vial, Multi-Dose (70121-1479-1) | Amneal Pharmaceuticals LLC | 70121-1479-7 | 70121-1479 | ANDA210051 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (0054-0210-25) | Hikma Pharmaceuticals USA Inc. | 0054-0210-25 | 0054-0210 | ANDA078913 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (0054-0211-25) | Hikma Pharmaceuticals USA Inc. | 0054-0211-25 | 0054-0211 | ANDA078913 | ANDA | N/A |
| Pseudoephedrine Hydrochloride | Tablet, Film Coated | Oral | 30mg/1 | 24 Blister Pack In 1 Carton (45802-432-62) / 1 Tablet, Film Coated In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-432-62 | 45802-432 | M012 | OTC MONOGRAPH DRUG | N/A |
| Pseudoephedrine Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 120mg/1 | 10 Blister Pack In 1 Carton (45802-107-52) / 1 Tablet, Film Coated, Extended Release In 1 Blister Pack | Padagis Israel Pharmaceuticals Ltd | 45802-107-52 | 45802-107 | ANDA075153 | ANDA | N/A |
| Pyrazinamide | Tablet | Oral | 500mg/1 | 60 Tablet In 1 Bottle (70954-484-10) | Novitium Pharma LLC | 70954-484-10 | 70954-484 | ANDA080157 | ANDA | N/A |
| Pyrazinamide | Tablet | Oral | 500mg/1 | 90 Tablet In 1 Bottle (70954-484-20) | Novitium Pharma LLC | 70954-484-20 | 70954-484 | ANDA080157 | ANDA | N/A |
| Pyrazinamide | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (70954-484-30) | Novitium Pharma LLC | 70954-484-30 | 70954-484 | ANDA080157 | ANDA | N/A |
| Pyrazinamide | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (70954-484-40) | Novitium Pharma LLC | 70954-484-40 | 70954-484 | ANDA080157 | ANDA | N/A |
| Pyridostigmine Bromide | Solution | Oral | 60mg/5mL | 473 Ml In 1 Bottle (70954-148-10) | Novitium Pharma LLC | 70954-148-10 | 70954-148 | ANDA211694 | ANDA | N/A |
| Pyridostigmine Bromide | Solution | Oral | 60mg/5mL | 1 Tray In 1 Case (66689-406-10) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (66689-406-01) | VistaPharm, LLC | 66689-406-10 | 66689-406 | ANDA211694 | ANDA | N/A |
| neostigmine methylsulfate | Injection | Intravenous | .5mg/mL | 10 Vial, Multi-Dose In 1 Carton (31722-994-31) / 10 Ml In 1 Vial, Multi-Dose | Camber Pharmaceuticals Inc. | 31722-994-31 | 31722-994 | ANDA212512 | ANDA | N/A |
| Pyridostigmine Bromide | Solution | Oral | 60mg/5mL | 473 Ml In 1 Bottle (42192-626-16) | Acella Pharmaceuticals, LLC | 42192-626-16 | 42192-626 | ANDA212405 | ANDA | N/A |
| Pyridostigmine Bromide | Tablet, Extended Release | Oral | 180mg/1 | 30 Tablet, Extended Release In 1 Bottle (47781-335-30) | Alvogen, Inc. | 47781-335-30 | 47781-335 | ANDA204737 | ANDA | N/A |
| neostigmine methylsulfate | Injection | Intravenous | 1mg/mL | 10 Vial, Multi-Dose In 1 Carton (31722-995-31) / 10 Ml In 1 Vial, Multi-Dose | Camber Pharmaceuticals Inc. | 31722-995-31 | 31722-995 | ANDA212512 | ANDA | N/A |
| Nevirapine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (65162-209-06) | Amneal Pharmaceuticals LLC | 65162-209-06 | 65162-209 | ANDA078195 | ANDA | N/A |
| Pyrimethamine | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (47781-925-01) | Alvogen Inc. | 47781-925-01 | 47781-925 | ANDA211271 | ANDA | N/A |
| Pyrimethamine | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (47781-925-30) | Alvogen Inc. | 47781-925-30 | 47781-925 | ANDA211271 | ANDA | N/A |
| Pyrimethamine | Tablet | Oral | 25mg/1 | 3 Blister Pack In 1 Carton (47781-925-31) / 10 Tablet In 1 Blister Pack (47781-925-13) | Alvogen Inc. | 47781-925-31 | 47781-925 | ANDA211271 | ANDA | N/A |
| Quahog, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3191-2) | Jubilant HollisterStier LLC | 65044-3191-2 | 65044-3191 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-2035-2) | Jubilant HollisterStier LLC | 65044-2035-2 | 65044-2035 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-2035-3) | Jubilant HollisterStier LLC | 65044-2035-3 | 65044-2035 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-2035-4) | Jubilant HollisterStier LLC | 65044-2035-4 | 65044-2035 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-2036-1) | Jubilant HollisterStier LLC | 65044-2036-1 | 65044-2036 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-2038-2) | Jubilant HollisterStier LLC | 65044-2038-2 | 65044-2038 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-2038-3) | Jubilant HollisterStier LLC | 65044-2038-3 | 65044-2038 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-2038-4) | Jubilant HollisterStier LLC | 65044-2038-4 | 65044-2038 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-2039-2) | Jubilant HollisterStier LLC | 65044-2039-2 | 65044-2039 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-2039-3) | Jubilant HollisterStier LLC | 65044-2039-3 | 65044-2039 | BLA103888 | BLA | N/A |
| Quercus Alba Pollen; Quercus Rubra Pollen; Quercus Virginiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-2039-4) | Jubilant HollisterStier LLC | 65044-2039-4 | 65044-2039 | BLA103888 | BLA | N/A |
| Quercus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2014-2) | Jubilant HollisterStier LLC | 65044-2014-2 | 65044-2014 | BLA103888 | BLA | N/A |
| Quercus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2014-3) | Jubilant HollisterStier LLC | 65044-2014-3 | 65044-2014 | BLA103888 | BLA | N/A |
| Quercus Rubra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2014-4) | Jubilant HollisterStier LLC | 65044-2014-4 | 65044-2014 | BLA103888 | BLA | N/A |
| Quercus Rubra Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2015-1) | Jubilant HollisterStier LLC | 65044-2015-1 | 65044-2015 | BLA103888 | BLA | N/A |
| Nevirapine | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (31722-505-01) | Camber Pharmaceuticals, Inc. | 31722-505-01 | 31722-505 | ANDA078584 | ANDA | N/A |
| Nevirapine | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (31722-505-05) | Camber Pharmaceuticals, Inc. | 31722-505-05 | 31722-505 | ANDA078584 | ANDA | N/A |
| Nevirapine | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (31722-505-10) | Camber Pharmaceuticals, Inc. | 31722-505-10 | 31722-505 | ANDA078584 | ANDA | N/A |
| Nevirapine | Tablet | Oral | 200mg/1 | 60 Tablet In 1 Bottle (31722-505-60) | Camber Pharmaceuticals, Inc. | 31722-505-60 | 31722-505 | ANDA078584 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 500mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-321-03) | Amneal Pharmaceuticals LLC | 65162-321-03 | 65162-321 | ANDA203578 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 500mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-321-09) | Amneal Pharmaceuticals LLC | 65162-321-09 | 65162-321 | ANDA203578 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 500mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-321-50) | Amneal Pharmaceuticals LLC | 65162-321-50 | 65162-321 | ANDA203578 | ANDA | N/A |
| Niacin | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (65162-322-03) | Amneal Pharmaceuticals LLC | 65162-322-03 | 65162-322 | ANDA204178 | ANDA | N/A |
| Niacin | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 90 Tablet, Film Coated, Extended Release In 1 Bottle (65162-322-09) | Amneal Pharmaceuticals LLC | 65162-322-09 | 65162-322 | ANDA204178 | ANDA | N/A |
| Niacin | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (65162-322-50) | Amneal Pharmaceuticals LLC | 65162-322-50 | 65162-322 | ANDA204178 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 1000mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-323-03) | Amneal Pharmaceuticals LLC | 65162-323-03 | 65162-323 | ANDA203578 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 1000mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-323-09) | Amneal Pharmaceuticals LLC | 65162-323-09 | 65162-323 | ANDA203578 | ANDA | N/A |
| Niacin | Tablet, Extended Release | Oral | 1000mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-323-50) | Amneal Pharmaceuticals LLC | 65162-323-50 | 65162-323 | ANDA203578 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 20mg/1 | 90 Capsule In 1 Bottle (62559-205-90) | ANI Pharmaceuticals, Inc. | 62559-205-90 | 62559-205 | ANDA074670 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 30mg/1 | 90 Capsule In 1 Bottle (62559-206-90) | ANI Pharmaceuticals, Inc. | 62559-206-90 | 62559-206 | ANDA074670 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-799-60) | Golden State Medical Supply, Inc. | 51407-799-60 | 51407-799 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-800-60) | Golden State Medical Supply, Inc. | 51407-800-60 | 51407-800 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-801-60) | Golden State Medical Supply, Inc. | 51407-801-60 | 51407-801 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-802-60) | Golden State Medical Supply, Inc. | 51407-802-60 | 51407-802 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (51407-803-60) | Golden State Medical Supply, Inc. | 51407-803-60 | 51407-803 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (51407-066-01) | Golden State Medical Supply, Inc. | 51407-066-01 | 51407-066 | ANDA090120 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (51407-066-10) | Golden State Medical Supply, Inc. | 51407-066-10 | 51407-066 | ANDA090120 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (51407-067-01) | Golden State Medical Supply, Inc. | 51407-067-01 | 51407-067 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (51407-067-10) | Golden State Medical Supply, Inc. | 51407-067-10 | 51407-067 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (51407-068-01) | Golden State Medical Supply, Inc. | 51407-068-01 | 51407-068 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (51407-068-10) | Golden State Medical Supply, Inc. | 51407-068-10 | 51407-068 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (51407-069-01) | Golden State Medical Supply, Inc. | 51407-069-01 | 51407-069 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (51407-069-05) | Golden State Medical Supply, Inc. | 51407-069-05 | 51407-069 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (51407-070-05) | Golden State Medical Supply, Inc. | 51407-070-05 | 51407-070 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 300mg/1 | 60 Tablet In 1 Bottle (51407-070-60) | Golden State Medical Supply, Inc. | 51407-070-60 | 51407-070 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (51407-071-01) | Golden State Medical Supply, Inc. | 51407-071-01 | 51407-071 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 400mg/1 | 500 Tablet In 1 Bottle (51407-071-05) | Golden State Medical Supply, Inc. | 51407-071-05 | 51407-071 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 50mg/1 | 60 Tablet, Extended Release In 1 Bottle (51407-073-60) | Golden State Medical Supply, Inc. | 51407-073-60 | 51407-073 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 150mg/1 | 60 Tablet, Extended Release In 1 Bottle (51407-074-60) | Golden State Medical Supply, Inc. | 51407-074-60 | 51407-074 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 200mg/1 | 60 Tablet, Extended Release In 1 Bottle (51407-075-60) | Golden State Medical Supply, Inc. | 51407-075-60 | 51407-075 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 300mg/1 | 60 Tablet, Extended Release In 1 Bottle (51407-076-60) | Golden State Medical Supply, Inc. | 51407-076-60 | 51407-076 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 400mg/1 | 60 Tablet, Extended Release In 1 Bottle (51407-077-60) | Golden State Medical Supply, Inc. | 51407-077-60 | 51407-077 | ANDA208947 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 20mg/1 | 100 Capsule In 1 Bottle (42806-501-01) | Epic Pharma, LLC | 42806-501-01 | 42806-501 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 20mg/1 | 500 Capsule In 1 Bottle (42806-501-05) | Epic Pharma, LLC | 42806-501-05 | 42806-501 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 20mg/1 | 90 Capsule In 1 Bottle (42806-501-09) | Epic Pharma, LLC | 42806-501-09 | 42806-501 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 20mg/1 | 1000 Capsule In 1 Bottle (42806-501-10) | Epic Pharma, LLC | 42806-501-10 | 42806-501 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (42806-502-01) | Epic Pharma, LLC | 42806-502-01 | 42806-502 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 30mg/1 | 500 Capsule In 1 Bottle (42806-502-05) | Epic Pharma, LLC | 42806-502-05 | 42806-502 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 30mg/1 | 90 Capsule In 1 Bottle (42806-502-09) | Epic Pharma, LLC | 42806-502-09 | 42806-502 | ANDA074928 | ANDA | N/A |
| Nicardipine Hydrochloride | Capsule | Oral | 30mg/1 | 1000 Capsule In 1 Bottle (42806-502-10) | Epic Pharma, LLC | 42806-502-10 | 42806-502 | ANDA074928 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 2mg/1 | 1 Bottle, Plastic In 1 Box (57237-320-42) / 24 Lozenge In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 57237-320-42 | 57237-320 | ANDA207868 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 2mg/1 | 3 Bottle, Plastic In 1 Box (57237-320-72) / 24 Lozenge In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 57237-320-72 | 57237-320 | ANDA207868 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 4mg/1 | 1 Bottle, Plastic In 1 Box (57237-321-42) / 24 Lozenge In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 57237-321-42 | 57237-321 | ANDA207868 | ANDA | N/A |
| Nicotine | Lozenge | Oral | 4mg/1 | 3 Bottle, Plastic In 1 Box (57237-321-72) / 24 Lozenge In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 57237-321-72 | 57237-321 | ANDA207868 | ANDA | N/A |
| Nicotine | Gum, Chewing | Oral | 2mg/1 | 100 Blister Pack In 1 Carton (57237-322-01) / 1 Gum, Chewing In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-322-01 | 57237-322 | ANDA078699 | ANDA | N/A |
| Nicotine | Gum, Chewing | Oral | 4mg/1 | 100 Blister Pack In 1 Carton (57237-323-01) / 1 Gum, Chewing In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-323-01 | 57237-323 | ANDA078697 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 30mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-260-01) | Ingenus Pharmaceuticals, LLC | 50742-260-01 | 50742-260 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 30mg/1 | 300 Tablet, Extended Release In 1 Bottle (50742-260-03) | Ingenus Pharmaceuticals, LLC | 50742-260-03 | 50742-260 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 30mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-260-30) | Ingenus Pharmaceuticals, LLC | 50742-260-30 | 50742-260 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 60mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-261-01) | Ingenus Pharmaceuticals, LLC | 50742-261-01 | 50742-261 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 60mg/1 | 300 Tablet, Extended Release In 1 Bottle (50742-261-03) | Ingenus Pharmaceuticals, LLC | 50742-261-03 | 50742-261 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 60mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-261-30) | Ingenus Pharmaceuticals, LLC | 50742-261-30 | 50742-261 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 30mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-620-01) | Ingenus Pharmaceuticals, LLC | 50742-620-01 | 50742-620 | ANDA202987 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 90mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-262-01) | Ingenus Pharmaceuticals, LLC | 50742-262-01 | 50742-262 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 90mg/1 | 300 Tablet, Extended Release In 1 Bottle (50742-262-03) | Ingenus Pharmaceuticals, LLC | 50742-262-03 | 50742-262 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 90mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-262-30) | Ingenus Pharmaceuticals, LLC | 50742-262-30 | 50742-262 | ANDA210614 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 60mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-621-01) | Ingenus Pharmaceuticals, LLC | 50742-621-01 | 50742-621 | ANDA202987 | ANDA | N/A |
| Nifedipine | Tablet, Extended Release | Oral | 90mg/1 | 100 Tablet, Extended Release In 1 Bottle (50742-622-01) | Ingenus Pharmaceuticals, LLC | 50742-622-01 | 50742-622 | ANDA202987 | ANDA | N/A |
| Nilutamide | Tablet | Oral | 150mg/1 | 3 Blister Pack In 1 Carton (62559-173-31) / 10 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-173-31 | 62559-173 | ANDA207631 | ANDA | N/A |
| Nitazoxanide | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (64980-526-03) | Rising Pharmaceuticals, Inc. | 64980-526-03 | 64980-526 | ANDA213820 | ANDA | N/A |
| Nitazoxanide | Tablet, Film Coated | Oral | 500mg/1 | 12 Tablet, Film Coated In 1 Bottle (64980-526-21) | Rising Pharmaceuticals, Inc. | 64980-526-21 | 64980-526 | ANDA213820 | ANDA | N/A |
| Nitazoxanide | Tablet, Film Coated | Oral | 500mg/1 | 6 Tablet, Film Coated In 1 Bottle (64980-526-60) | Rising Pharmaceuticals, Inc. | 64980-526-60 | 64980-526 | ANDA213820 | ANDA | N/A |
| Nitazoxanide | Tablet, Film Coated | Oral | 500mg/1 | 18 Tablet, Film Coated In 1 Bottle (64980-526-81) | Rising Pharmaceuticals, Inc. | 64980-526-81 | 64980-526 | ANDA213820 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (0054-0222-25) | Hikma Pharmaceuticals USA Inc. | 0054-0222-25 | 0054-0222 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 300mg/1 | 10 Blister Pack In 1 Carton (0054-0223-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0223-20 | 0054-0223 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 300mg/1 | 60 Tablet In 1 Bottle (0054-0223-21) | Hikma Pharmaceuticals USA Inc. | 0054-0223-21 | 0054-0223 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (0054-0229-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0229-20 | 0054-0229 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (0054-0229-25) | Hikma Pharmaceuticals USA Inc. | 0054-0229-25 | 0054-0229 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (0054-0229-31) | Hikma Pharmaceuticals USA Inc. | 0054-0229-31 | 0054-0229 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 400mg/1 | 100 Tablet In 1 Bottle (0054-0230-25) | Hikma Pharmaceuticals USA Inc. | 0054-0230-25 | 0054-0230 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 25mg/1 | 10 Blister Pack In 1 Carton (0054-0220-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0220-20 | 0054-0220 | ANDA090120 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (0054-0220-25) | Hikma Pharmaceuticals USA Inc. | 0054-0220-25 | 0054-0220 | ANDA090120 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (0054-0220-31) | Hikma Pharmaceuticals USA Inc. | 0054-0220-31 | 0054-0220 | ANDA090120 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (0054-0221-20) / 10 Tablet In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0221-20 | 0054-0221 | ANDA090749 | ANDA | N/A |
| Quetiapine Fumarate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (0054-0221-25) | Hikma Pharmaceuticals USA Inc. | 0054-0221-25 | 0054-0221 | ANDA090749 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 230 Ml In 1 Bottle, Glass (65162-689-88) | Amneal Pharmaceuticals LLC | 65162-689-88 | 65162-689 | ANDA201679 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 230 Ml In 1 Bottle (70954-496-10) | ANI Pharmaceuticals, Inc. | 70954-496-10 | 70954-496 | ANDA216385 | ANDA | N/A |
| Nitrofurantoin | Suspension | Oral | 25mg/5mL | 1 Bottle In 1 Carton (16571-740-24) / 230 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-740-24 | 16571-740 | NDA009175 | NDA AUTHORIZED GENERIC | N/A |
| Nitrofurantoin | Suspension | Oral | 50mg/5mL | 1 Bottle In 1 Carton (16571-888-06) / 60 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 16571-888-06 | 16571-888 | NDA009175 | NDA AUTHORIZED GENERIC | N/A |
| Nitrofurantoin Monohydrate | Suspension | Oral | 25mg/5mL | 1 Bottle In 1 Carton (64980-593-24) / 230 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-593-24 | 64980-593 | ANDA212607 | ANDA | N/A |
| Nitrofurantoin; Nitrofurantoin Monohydrate | Capsule | Oral | 25mg/1, 75 mg/1 | 100 Capsule In 1 Bottle (65162-478-10) | Amneal Pharmaceuticals LLC | 65162-478-10 | 65162-478 | ANDA207372 | ANDA | N/A |
| Nitroglycerin | Patch | Transdermal | 20mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-513-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-513-30 | 50742-513 | NDA020145 | NDA | N/A |
| Nitroglycerin | Patch | Transdermal | 40mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-514-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-514-30 | 50742-514 | NDA020145 | NDA | N/A |
| Nitroglycerin | Patch | Transdermal | 60mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-515-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-515-30 | 50742-515 | NDA020145 | NDA | N/A |
| Nitroglycerin | Patch | Transdermal | 80mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-516-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-516-30 | 50742-516 | NDA020145 | NDA | N/A |
| Nitroglycerin | Patch | Transdermal | 120mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-517-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-517-30 | 50742-517 | NDA020145 | NDA | N/A |
| Nitroglycerin | Patch | Transdermal | 160mg/1 | 30 Pouch In 1 Box, Unit-Dose (50742-518-30) / 1 Patch In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-518-30 | 50742-518 | NDA020145 | NDA | N/A |
| Norepinephrine Bitartrate | Injection, Solution, Concentrate | Intravenous | 1mg/mL | 10 Vial In 1 Carton (70121-1576-7) / 4 Ml In 1 Vial (70121-1576-1) | Amneal Pharmaceuticals LLC | 70121-1576-7 | 70121-1576 | ANDA210839 | ANDA | N/A |
| Norethindrone Acetate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (65162-475-03) | Amneal Pharmaceuticals LLC | 65162-475-03 | 65162-475 | ANDA200275 | ANDA | N/A |
| Norethindrone Acetate | Tablet | Oral | 5mg/1 | 50 Tablet In 1 Bottle (65162-475-05) | Amneal Pharmaceuticals LLC | 65162-475-05 | 65162-475 | ANDA200275 | ANDA | N/A |
| Norethindrone Acetate | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (65162-475-09) | Amneal Pharmaceuticals LLC | 65162-475-09 | 65162-475 | ANDA200275 | ANDA | N/A |
| Norethindrone Acetate | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-475-50) | Amneal Pharmaceuticals LLC | 65162-475-50 | 65162-475 | ANDA200275 | ANDA | N/A |
| Norethindrone Acetate | Tablet | Oral | 5mg/1 | 50 Tablet In 1 Bottle (50742-267-50) | Ingenus Pharmaceuticals, LLC | 50742-267-50 | 50742-267 | ANDA206490 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 15 G In 1 Bottle (42806-186-15) | Epic Pharma, LLC | 42806-186-15 | 42806-186 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 30 G In 1 Bottle (42806-186-30) | Epic Pharma, LLC | 42806-186-30 | 42806-186 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 60 G In 1 Bottle (42806-186-60) | Epic Pharma, LLC | 42806-186-60 | 42806-186 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 15 G In 1 Bottle (42806-178-15) | Epic Pharma, LLC | 42806-178-15 | 42806-178 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 30 G In 1 Bottle (42806-178-30) | Epic Pharma, LLC | 42806-178-30 | 42806-178 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 60 G In 1 Bottle (42806-178-60) | Epic Pharma, LLC | 42806-178-60 | 42806-178 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 15 G In 1 Bottle (42806-185-15) | Epic Pharma, LLC | 42806-185-15 | 42806-185 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 30 G In 1 Bottle (42806-185-30) | Epic Pharma, LLC | 42806-185-30 | 42806-185 | ANDA210532 | ANDA | N/A |
| Nystatin | Powder | Topical | 100000U/g | 60 G In 1 Bottle (42806-185-60) | Epic Pharma, LLC | 42806-185-60 | 42806-185 | ANDA210532 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (64980-325-15) / 15 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-325-15 | 64980-325 | ANDA206785 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (64980-325-30) / 30 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-325-30 | 64980-325 | ANDA206785 | ANDA | N/A |
| Nystatin; Triamcinolone Acetonide | Ointment | Topical | 100000[USP'U]/g, 1 mg/g | 1 Tube In 1 Carton (64980-325-60) / 60 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-325-60 | 64980-325 | ANDA206785 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 1 Bottle, Dropper In 1 Carton (64980-432-01) / 10 Ml In 1 Bottle, Dropper | Rising Pharma Holdings, Inc. | 64980-432-01 | 64980-432 | ANDA215038 | ANDA | N/A |
| Ofloxacin | Solution | Auricular (Otic) | 3mg/mL | 1 Bottle, Dropper In 1 Carton (64980-432-05) / 5 Ml In 1 Bottle, Dropper | Rising Pharma Holdings, Inc. | 64980-432-05 | 64980-432 | ANDA215038 | ANDA | N/A |
| Quinapril Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0527-23) | Parke-Davis Div of Pfizer Inc | 0071-0527-23 | 0071-0527 | NDA019885 | NDA | N/A |
| Quinapril Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0530-23) | Parke-Davis Div of Pfizer Inc | 0071-0530-23 | 0071-0530 | NDA019885 | NDA | N/A |
| Quinapril Hydrochloride | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0532-23) | Parke-Davis Div of Pfizer Inc | 0071-0532-23 | 0071-0532 | NDA019885 | NDA | N/A |
| Quinapril Hydrochloride | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (0071-0535-23) | Parke-Davis Div of Pfizer Inc | 0071-0535-23 | 0071-0535 | NDA019885 | NDA | N/A |
| Quinidine Gluconate | Tablet, Extended Release | Oral | 324mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (51407-288-01) | Golden State Medical Supply | 51407-288-01 | 51407-288 | ANDA089338 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Plastic In 1 Carton (64980-515-01) / 10 Ml In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 64980-515-01 | 64980-515 | ANDA078559 | ANDA | N/A |
| Ofloxacin | Solution | Ophthalmic | 3mg/mL | 1 Bottle, Plastic In 1 Carton (64980-515-05) / 5 Ml In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 64980-515-05 | 64980-515 | ANDA078559 | ANDA | N/A |
| Olanzapine | Injection, Powder, For Solution | Intramuscular | 10mg/2mL | 1 Vial In 1 Carton (31722-308-01) / 2 Ml In 1 Vial | Camber Pharmaceuticals, Inc. | 31722-308-01 | 31722-308 | ANDA217466 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-079-03) | Amneal Pharmaceuticals LLC | 65162-079-03 | 65162-079 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-079-09) | Amneal Pharmaceuticals LLC | 65162-079-09 | 65162-079 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-079-50) | Amneal Pharmaceuticals LLC | 65162-079-50 | 65162-079 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-080-03) | Amneal Pharmaceuticals LLC | 65162-080-03 | 65162-080 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-080-09) | Amneal Pharmaceuticals LLC | 65162-080-09 | 65162-080 | ANDA207480 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 500 Tablet, Delayed Release In 1 Bottle (51407-184-05) | Golden State Medical Supply, Inc. | 51407-184-05 | 51407-184 | ANDA090678 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 30 Tablet, Delayed Release In 1 Bottle (51407-184-30) | Golden State Medical Supply, Inc. | 51407-184-30 | 51407-184 | ANDA090678 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (51407-184-90) | Golden State Medical Supply, Inc. | 51407-184-90 | 51407-184 | ANDA090678 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 30 Tablet, Delayed Release In 1 Bottle, Plastic (80725-243-30) | Waylis Therapeutics LLC | 80725-243-30 | 80725-243 | NDA020973 | NDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-080-50) | Amneal Pharmaceuticals LLC | 65162-080-50 | 65162-080 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-081-03) | Amneal Pharmaceuticals LLC | 65162-081-03 | 65162-081 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-081-09) | Amneal Pharmaceuticals LLC | 65162-081-09 | 65162-081 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-081-50) | Amneal Pharmaceuticals LLC | 65162-081-50 | 65162-081 | ANDA207480 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 5mg/1 | 30 Tablet, Coated In 1 Bottle (64980-601-03) | Rising Pharma Holdings, Inc. | 64980-601-03 | 64980-601 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 5mg/1 | 90 Tablet, Coated In 1 Bottle (64980-601-09) | Rising Pharma Holdings, Inc. | 64980-601-09 | 64980-601 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 20mg/1 | 30 Tablet, Coated In 1 Bottle (64980-602-03) | Rising Pharma Holdings, Inc. | 64980-602-03 | 64980-602 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 20mg/1 | 90 Tablet, Coated In 1 Bottle (64980-602-09) | Rising Pharma Holdings, Inc. | 64980-602-09 | 64980-602 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 40mg/1 | 30 Tablet, Coated In 1 Bottle (64980-603-03) | Rising Pharma Holdings, Inc. | 64980-603-03 | 64980-603 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Coated | Oral | 40mg/1 | 90 Tablet, Coated In 1 Bottle (64980-603-09) | Rising Pharma Holdings, Inc. | 64980-603-09 | 64980-603 | ANDA208659 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-339-10) | ScieGen Pharmaceuticals, Inc. | 50228-339-10 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-339-30) | ScieGen Pharmaceuticals, Inc. | 50228-339-30 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-339-90) | ScieGen Pharmaceuticals, Inc. | 50228-339-90 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-340-10) | ScieGen Pharmaceuticals, Inc. | 50228-340-10 | 50228-340 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-340-30) | ScieGen Pharmaceuticals, Inc. | 50228-340-30 | 50228-340 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-340-90) | ScieGen Pharmaceuticals, Inc. | 50228-340-90 | 50228-340 | ANDA208130 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-481-90) | St. Mary's Medical Park Pharmacy | 60760-481-90 | 60760-481 | ANDA091604 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-341-10) | ScieGen Pharmaceuticals, Inc. | 50228-341-10 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-341-30) | ScieGen Pharmaceuticals, Inc. | 50228-341-30 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-341-90) | ScieGen Pharmaceuticals, Inc. | 50228-341-90 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-339-10) | ScieGen Pharmaceuticals, Inc. | 50228-339-10 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-339-30) | ScieGen Pharmaceuticals, Inc. | 50228-339-30 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-339-90) | ScieGen Pharmaceuticals, Inc. | 50228-339-90 | 50228-339 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-340-10) | ScieGen Pharmaceuticals, Inc. | 50228-340-10 | 50228-340 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-340-30) | ScieGen Pharmaceuticals, Inc. | 50228-340-30 | 50228-340 | ANDA208130 | ANDA | N/A |
| Ramipril | Capsule | Oral | 1.25mg/1 | 100 Capsule In 1 Bottle (0054-0106-25) | Hikma Pharmaceuticals USA Inc. | 0054-0106-25 | 0054-0106 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 10 Blister Pack In 1 Carton (0054-0107-20) / 10 Capsule In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0107-20 | 0054-0107 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (0054-0107-25) | Hikma Pharmaceuticals USA Inc. | 0054-0107-25 | 0054-0107 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 500 Capsule In 1 Bottle (0054-0107-29) | Hikma Pharmaceuticals USA Inc. | 0054-0107-29 | 0054-0107 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (0054-0108-20) / 10 Capsule In 1 Blister Pack | Hikma Pharmaceuticals USA Inc. | 0054-0108-20 | 0054-0108 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (0054-0108-25) | Hikma Pharmaceuticals USA Inc. | 0054-0108-25 | 0054-0108 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (0054-0108-29) | Hikma Pharmaceuticals USA Inc. | 0054-0108-29 | 0054-0108 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (0054-0109-25) | Hikma Pharmaceuticals USA Inc. | 0054-0109-25 | 0054-0109 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (0054-0109-29) | Hikma Pharmaceuticals USA Inc. | 0054-0109-29 | 0054-0109 | ANDA077900 | ANDA | N/A |
| Ramipril | Capsule | Oral | 1.25mg/1 | 100 Capsule In 1 Bottle (61570-110-01) | Pfizer Laboratories Div Pfizer Inc | 61570-110-01 | 61570-110 | NDA019901 | NDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (61570-111-01) | Pfizer Laboratories Div Pfizer Inc | 61570-111-01 | 61570-111 | NDA019901 | NDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (61570-112-01) | Pfizer Laboratories Div Pfizer Inc | 61570-112-01 | 61570-112 | NDA019901 | NDA | N/A |
| Ramipril | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (61570-120-01) | Pfizer Laboratories Div Pfizer Inc | 61570-120-01 | 61570-120 | NDA019901 | NDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-340-90) | ScieGen Pharmaceuticals, Inc. | 50228-340-90 | 50228-340 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-341-10) | ScieGen Pharmaceuticals, Inc. | 50228-341-10 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-341-30) | ScieGen Pharmaceuticals, Inc. | 50228-341-30 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olmesartan Medoxomil | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-341-90) | ScieGen Pharmaceuticals, Inc. | 50228-341-90 | 50228-341 | ANDA208130 | ANDA | N/A |
| Olopatadine Hydrochloride | Spray, Metered | Nasal | 665ug/1 | 1 Bottle, Spray In 1 Carton (65162-890-23) / 665 Spray, Metered In 1 Bottle, Spray | Amneal Pharmaceuticals LLC | 65162-890-23 | 65162-890 | ANDA210901 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 60 Capsule, Liquid Filled In 1 Bottle (65162-034-06) | Amneal Pharmaceuticals LLC | 65162-034-06 | 65162-034 | ANDA204940 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (65162-034-16) | Amneal Pharmaceuticals LLC | 65162-034-16 | 65162-034 | ANDA204940 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 360 Capsule, Liquid Filled In 1 Bottle (65162-034-32) | Amneal Pharmaceuticals LLC | 65162-034-32 | 65162-034 | ANDA204940 | ANDA | N/A |
| Omega-3-acid ethyl esters | Capsule, Liquid Filled | Oral | 1g/1 | 500 Capsule, Liquid Filled In 1 Bottle (31722-936-05) | Camber Pharmaceuticals, Inc. | 31722-936-05 | 31722-936 | ANDA207420 | ANDA | N/A |
| Omega-3-acid ethyl esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (31722-936-12) | Camber Pharmaceuticals, Inc. | 31722-936-12 | 31722-936 | ANDA207420 | ANDA | N/A |
| Omega-3-Acid Ethyl Esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (42806-552-12) | EPIC PHARMA, LLC | 42806-552-12 | 42806-552 | ANDA210093 | ANDA | N/A |
| Omega-3-acid ethyl esters | Capsule, Liquid Filled | Oral | 1g/1 | 500 Capsule, Liquid Filled In 1 Bottle (72865-139-05) | XLCare Pharmaceuticals, Inc. | 72865-139-05 | 72865-139 | ANDA207420 | ANDA | N/A |
| Omega-3-acid ethyl esters | Capsule, Liquid Filled | Oral | 1g/1 | 120 Capsule, Liquid Filled In 1 Bottle (72865-139-12) | XLCare Pharmaceuticals, Inc. | 72865-139-12 | 72865-139 | ANDA207420 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 500 Tablet, Delayed Release In 1 Bottle (69230-318-05) | Camber Consumer Care Inc | 69230-318-05 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (69230-318-10) | Camber Consumer Care Inc | 69230-318-10 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 1 Blister Pack In 1 Carton (69230-318-32) / 14 Tablet, Delayed Release In 1 Blister Pack | Camber Consumer Care Inc | 69230-318-32 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 2 Blister Pack In 1 Carton (69230-318-33) / 14 Tablet, Delayed Release In 1 Blister Pack | Camber Consumer Care Inc | 69230-318-33 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 3 Blister Pack In 1 Carton (69230-318-34) / 14 Tablet, Delayed Release In 1 Blister Pack | Camber Consumer Care Inc | 69230-318-34 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 1 Bottle In 1 Carton (69230-318-35) / 14 Tablet, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-318-35 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 2 Bottle In 1 Carton (69230-318-36) / 14 Tablet, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-318-36 | 69230-318 | ANDA211732 | ANDA | N/A |
| Omeprazole | Tablet, Delayed Release | Oral | 20mg/1 | 3 Bottle In 1 Carton (69230-318-37) / 14 Tablet, Delayed Release In 1 Bottle | Camber Consumer Care Inc | 69230-318-37 | 69230-318 | ANDA211732 | ANDA | N/A |
| omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 100 Capsule, Delayed Release In 1 Bottle (31722-527-01) | Camber Pharmaceuticals, Inc. | 31722-527-01 | 31722-527 | ANDA204012 | ANDA | N/A |
| omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-527-30) | Camber Pharmaceuticals, Inc. | 31722-527-30 | 31722-527 | ANDA204012 | ANDA | N/A |
| omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (31722-528-01) | Camber Pharmaceuticals, Inc. | 31722-528-01 | 31722-528 | ANDA204012 | ANDA | N/A |
| omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (31722-528-30) | Camber Pharmaceuticals, Inc. | 31722-528-30 | 31722-528 | ANDA204012 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 100 Capsule, Delayed Release In 1 Bottle (57237-160-01) | Rising Pharma Holdings, Inc. | 57237-160-01 | 57237-160 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 10mg/1 | 30 Capsule, Delayed Release In 1 Bottle (57237-160-30) | Rising Pharma Holdings, Inc. | 57237-160-30 | 57237-160 | ANDA203270 | ANDA | N/A |
| Rasagiline Mesylate | Tablet | Oral | .5mg/1 | 30 Tablet In 1 Bottle, Plastic (47781-683-30) | Alvogen, Inc. | 47781-683-30 | 47781-683 | ANDA201970 | ANDA | N/A |
| Rasagiline Mesylate | Tablet | Oral | 1mg/1 | 30 Tablet In 1 Bottle, Plastic (47781-690-30) | Alvogen, Inc. | 47781-690-30 | 47781-690 | ANDA201970 | ANDA | N/A |
| Raxtozinameran | Injection, Suspension | Intramuscular | .048mg/.48mL | 10 Vial, Single-Dose In 1 Carton (0069-2362-10) / .48 Ml In 1 Vial, Single-Dose (0069-2362-01) | Pfizer Laboratories Div Pfizer Inc | 0069-2362-10 | 0069-2362 | BLA125742 | BLA | N/A |
| Recombinant Stabilized Rsv A Prefusion F Antigen; Recombinant Stabilized Rsv B Prefusion F Antigen | Injection, Powder, Lyophilized, For Solution | Intramuscular | .06mg/.5mL, .06 mg/.5mL | 1 Vial In 1 Carton (0069-2465-01) / .5 Ml In 1 Vial (0069-2465-19) | Pfizer Laboratories Div Pfizer Inc | 0069-2465-01 | 0069-2465 | BLA125769 | BLA | N/A |
| Recombinant Stabilized Rsv A Prefusion F Antigen; Recombinant Stabilized Rsv B Prefusion F Antigen | Injection, Powder, Lyophilized, For Solution | Intramuscular | .06mg/.5mL, .06 mg/.5mL | 10 Vial In 1 Carton (0069-2465-10) / .5 Ml In 1 Vial (0069-2465-19) | Pfizer Laboratories Div Pfizer Inc | 0069-2465-10 | 0069-2465 | BLA125769 | BLA | N/A |
| Regadenoson | Injection, Solution | Intravenous | .08mg/mL | 1 Syringe, Plastic In 1 Carton (71288-201-85) / 5 Ml In 1 Syringe, Plastic | Meitheal Pharmaceuticals Inc. | 71288-201-85 | 71288-201 | ANDA212806 | ANDA | N/A |
| Regadenoson | Injection, Solution | Intravenous | .08mg/mL | 1 Syringe, Plastic In 1 Carton (60505-6116-0) / 5 Ml In 1 Syringe, Plastic | Apotex Corp. | 60505-6116-0 | 60505-6116 | ANDA207604 | ANDA | N/A |
| Regadenoson Anhydrous | Injection, Solution | Intravenous | .08mg/mL | 1 Syringe, Plastic In 1 Carton (0641-6253-01) / 5 Ml In 1 Syringe, Plastic | Hikma Pharmaceuticals USA Inc. | 0641-6253-01 | 0641-6253 | ANDA215827 | ANDA | N/A |
| Regadenoson Anhydrous | Injection, Solution | Intravenous | .08mg/mL | 10 Carton In 1 Package (0409-1401-01) / 1 Syringe, Plastic In 1 Carton / 5 Ml In 1 Syringe, Plastic (0409-1401-05) | Hospira, Inc. | 0409-1401-01 | 0409-1401 | ANDA214349 | ANDA | N/A |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/1 | 10 Vial, Glass In 1 Carton (75834-230-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Glass (75834-230-01) | Nivagen Pharmaceuticals, Inc. | 75834-230-10 | 75834-230 | ANDA215635 | ANDA | CII |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/1 | 10 Vial, Glass In 1 Carton (75834-231-10) / 2 Injection, Powder, Lyophilized, For Solution In 1 Vial, Glass (75834-231-01) | Nivagen Pharmaceuticals, Inc. | 75834-231-10 | 75834-231 | ANDA215635 | ANDA | CII |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/1 | 10 Vial, Glass In 1 Carton (75834-232-10) / 5 Injection, Powder, Lyophilized, For Solution In 1 Vial, Glass (75834-232-01) | Nivagen Pharmaceuticals, Inc. | 75834-232-10 | 75834-232 | ANDA215635 | ANDA | CII |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0143-9391-10) / 3 Ml In 1 Vial (0143-9391-01) | Hikma Pharmaceuticals USA Inc. | 0143-9391-10 | 0143-9391 | ANDA210594 | ANDA | CII |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 2mg/2mL | 10 Vial In 1 Carton (0143-9392-10) / 5 Ml In 1 Vial (0143-9392-01) | Hikma Pharmaceuticals USA Inc. | 0143-9392-10 | 0143-9392 | ANDA210594 | ANDA | CII |
| Remifentanil Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 5mg/5mL | 10 Vial In 1 Carton (0143-9393-10) / 10 Ml In 1 Vial (0143-9393-01) | Hikma Pharmaceuticals USA Inc. | 0143-9393-10 | 0143-9393 | ANDA210594 | ANDA | CII |
| Repaglinide | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (0574-0240-01) | Padagis US LLC | 0574-0240-01 | 0574-0240 | ANDA201189 | ANDA | N/A |
| Repaglinide | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (0574-0241-01) | Padagis US LLC | 0574-0241-01 | 0574-0241 | ANDA201189 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 100 Capsule, Delayed Release In 1 Bottle (57237-161-01) | Rising Pharma Holdings, Inc. | 57237-161-01 | 57237-161 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 30 Capsule, Delayed Release In 1 Bottle (57237-161-30) | Rising Pharma Holdings, Inc. | 57237-161-30 | 57237-161 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 500 Capsule, Delayed Release In 1 Bottle (57237-161-50) | Rising Pharma Holdings, Inc. | 57237-161-50 | 57237-161 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 90 Capsule, Delayed Release In 1 Bottle (57237-161-90) | Rising Pharma Holdings, Inc. | 57237-161-90 | 57237-161 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 20mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (57237-161-99) | Rising Pharma Holdings, Inc. | 57237-161-99 | 57237-161 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 100 Capsule, Delayed Release In 1 Bottle (57237-162-01) | Rising Pharma Holdings, Inc. | 57237-162-01 | 57237-162 | ANDA203270 | ANDA | N/A |
| Rhizopus Stolonifer | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5232-1) | Jubilant HollisterStier LLC | 65044-5232-1 | 65044-5232 | BLA103888 | BLA | N/A |
| Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5230-2) | Jubilant HollisterStier LLC | 65044-5230-2 | 65044-5230 | BLA103888 | BLA | N/A |
| Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5230-3) | Jubilant HollisterStier LLC | 65044-5230-3 | 65044-5230 | BLA103888 | BLA | N/A |
| Rhizopus Stolonifer | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5230-4) | Jubilant HollisterStier LLC | 65044-5230-4 | 65044-5230 | BLA103888 | BLA | N/A |
| Ribavirin | Powder, For Solution | Respiratory (Inhalation) | 6g/1 | 4 Vial In 1 Carton (68475-003-04) / 1 Powder, For Solution In 1 Vial | Navinta LLC | 68475-003-04 | 68475-003 | ANDA207366 | ANDA | N/A |
| Rifabutin | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (70954-041-10) | Novitium Pharma LLC | 70954-041-10 | 70954-041 | ANDA215041 | ANDA | N/A |
| Rifabutin | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (0013-5301-17) | Pfizer Laboratories Div Pfizer Inc | 0013-5301-17 | 0013-5301 | NDA050689 | NDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 1000 Capsule, Delayed Release In 1 Bottle (57237-162-10) | Rising Pharma Holdings, Inc. | 57237-162-10 | 57237-162 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 30 Capsule, Delayed Release In 1 Bottle (57237-162-30) | Rising Pharma Holdings, Inc. | 57237-162-30 | 57237-162 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 500 Capsule, Delayed Release In 1 Bottle (57237-162-50) | Rising Pharma Holdings, Inc. | 57237-162-50 | 57237-162 | ANDA203270 | ANDA | N/A |
| Omeprazole | Capsule, Delayed Release | Oral | 40mg/1 | 90 Capsule, Delayed Release In 1 Bottle (57237-162-90) | Rising Pharma Holdings, Inc. | 57237-162-90 | 57237-162 | ANDA203270 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 20mg/1, 1100 mg/1 | 500 Capsule In 1 Bottle (50228-363-05) | ScieGen Pharmaceuticals, Inc. | 50228-363-05 | 50228-363 | ANDA207476 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 20mg/1, 1100 mg/1 | 30 Capsule In 1 Bottle (50228-363-30) | ScieGen Pharmaceuticals, Inc. | 50228-363-30 | 50228-363 | ANDA207476 | ANDA | N/A |
| Rifampin | Injection, Powder, Lyophilized, For Solution | Intravenous | 600mg/1 | 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9230-01) | Hikma Pharmaceuticals USA Inc. | 0143-9230-01 | 0143-9230 | ANDA205039 | ANDA | N/A |
| Rimegepant Sulfate | Tablet, Orally Disintegrating | Oral | 75mg/1 | 1 Blister Pack In 1 Carton (72618-3000-2) / 8 Tablet, Orally Disintegrating In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 72618-3000-2 | 72618-3000 | NDA212728 | NDA | N/A |
| Rimegepant Sulfate | Tablet, Orally Disintegrating | Oral | 75mg/1 | 4 Dose Pack In 1 Carton (72618-3001-2) / 1 Blister Pack In 1 Dose Pack (72618-3001-1) / 2 Tablet, Orally Disintegrating In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 72618-3001-2 | 72618-3001 | NDA212728 | NDA | N/A |
| Risedronate Sodium | Tablet, Film Coated | Oral | 150mg/1 | 1 Blister Pack In 1 Carton (60505-3097-2) / 1 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3097-2 | 60505-3097 | ANDA090877 | ANDA | N/A |
| Risedronate Sodium | Tablet, Film Coated | Oral | 150mg/1 | 1 Blister Pack In 1 Carton (60505-3097-4) / 3 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3097-4 | 60505-3097 | ANDA090877 | ANDA | N/A |
| Risedronate Sodium | Tablet, Film Coated | Oral | 35mg/1 | 1 Blister Pack In 1 Carton (60505-3165-0) / 4 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3165-0 | 60505-3165 | ANDA090877 | ANDA | N/A |
| Risedronate Sodium | Tablet, Film Coated | Oral | 35mg/1 | 3 Blister Pack In 1 Carton (60505-3165-2) / 4 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3165-2 | 60505-3165 | ANDA090877 | ANDA | N/A |
| Risedronate Sodium | Tablet, Film Coated | Oral | 75mg/1 | 1 Blister Pack In 1 Carton (60505-3096-2) / 2 Tablet, Film Coated In 1 Blister Pack | Apotex Corp. | 60505-3096-2 | 60505-3096 | ANDA090877 | ANDA | N/A |
| Risperidone | Solution | Oral | 1mg/mL | 30 Ml In 1 Bottle, Unit-Dose (27808-002-01) | Tris Pharma Inc | 27808-002-01 | 27808-002 | ANDA079059 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | .5mg/1 | 7 Blister Pack In 1 Carton (59746-010-22) / 4 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-010-22 | 59746-010 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | .5mg/1 | 3 Blister Pack In 1 Carton (59746-010-32) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-010-32 | 59746-010 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | 1mg/1 | 7 Blister Pack In 1 Carton (59746-020-22) / 4 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-020-22 | 59746-020 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | 1mg/1 | 3 Blister Pack In 1 Carton (59746-020-32) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-020-32 | 59746-020 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | 2mg/1 | 7 Blister Pack In 1 Carton (59746-030-22) / 4 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-030-22 | 59746-030 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | 3mg/1 | 7 Blister Pack In 1 Carton (59746-040-22) / 4 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-040-22 | 59746-040 | ANDA090839 | ANDA | N/A |
| Risperidone | Tablet, Orally Disintegrating | Oral | 4mg/1 | 7 Blister Pack In 1 Carton (59746-050-22) / 4 Tablet, Orally Disintegrating In 1 Blister Pack | Jubilant Cadista Pharmaceuticals Inc. | 59746-050-22 | 59746-050 | ANDA090839 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 40mg/1, 1100 mg/1 | 500 Capsule In 1 Bottle (50228-364-05) | ScieGen Pharmaceuticals, Inc. | 50228-364-05 | 50228-364 | ANDA207476 | ANDA | N/A |
| Ritlecitinib Tosylate | Capsule | Oral | 50mg/1 | 28 Capsule In 1 Bottle (0069-0334-28) | Pfizer Laboratories Div Pfizer Inc | 0069-0334-28 | 0069-0334 | NDA215830 | NDA | N/A |
| Rituximab | Injection, Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Use In 1 Carton (0069-0238-01) / 10 Ml In 1 Vial, Single-Use | Pfizer Laboratories Div Pfizer Inc | 0069-0238-01 | 0069-0238 | BLA761103 | BLA | N/A |
| Rituximab | Injection, Solution | Intravenous | 500mg/50mL | 1 Vial, Single-Use In 1 Carton (0069-0249-01) / 50 Ml In 1 Vial, Single-Use | Pfizer Laboratories Div Pfizer Inc | 0069-0249-01 | 0069-0249 | BLA761103 | BLA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 40mg/1, 1100 mg/1 | 30 Capsule In 1 Bottle (50228-364-30) | ScieGen Pharmaceuticals, Inc. | 50228-364-30 | 50228-364 | ANDA207476 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 20mg/1, 1100 mg/1 | 500 Capsule In 1 Bottle (50228-363-05) | ScieGen Pharmaceuticals, Inc. | 50228-363-05 | 50228-363 | ANDA207476 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 20mg/1, 1100 mg/1 | 30 Capsule In 1 Bottle (50228-363-30) | ScieGen Pharmaceuticals, Inc. | 50228-363-30 | 50228-363 | ANDA207476 | ANDA | N/A |
| Rivastigmine | Patch, Extended Release | Transdermal | 13.3mg/1 | 30 Pouch In 1 Carton (47781-405-03) / 1 Patch, Extended Release In 1 Pouch (47781-405-11) | Alvogen Inc. | 47781-405-03 | 47781-405 | ANDA204403 | ANDA | N/A |
| Rivastigmine | Patch, Extended Release | Transdermal | 4.6mg/1 | 30 Pouch In 1 Carton (47781-304-03) / 1 Patch, Extended Release In 1 Pouch (47781-304-11) | Alvogen Inc. | 47781-304-03 | 47781-304 | ANDA204403 | ANDA | N/A |
| Rivastigmine | Patch, Extended Release | Transdermal | 9.5mg/1 | 30 Pouch In 1 Carton (47781-305-03) / 1 Patch, Extended Release In 1 Pouch (47781-305-11) | Alvogen Inc. | 47781-305-03 | 47781-305 | ANDA204403 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 1.5mg/1 | 500 Capsule In 1 Bottle, Plastic (75834-133-05) | Nivagen Pharmaceuticals, Inc. | 75834-133-05 | 75834-133 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 1.5mg/1 | 60 Capsule In 1 Bottle, Plastic (75834-133-60) | Nivagen Pharmaceuticals, Inc. | 75834-133-60 | 75834-133 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 3mg/1 | 500 Capsule In 1 Bottle, Plastic (75834-134-05) | Nivagen Pharmaceuticals, Inc. | 75834-134-05 | 75834-134 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 3mg/1 | 60 Capsule In 1 Bottle, Plastic (75834-134-60) | Nivagen Pharmaceuticals, Inc. | 75834-134-60 | 75834-134 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 4.5mg/1 | 500 Capsule In 1 Bottle, Plastic (75834-135-05) | Nivagen Pharmaceuticals, Inc. | 75834-135-05 | 75834-135 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 4.5mg/1 | 60 Capsule In 1 Bottle, Plastic (75834-135-60) | Nivagen Pharmaceuticals, Inc. | 75834-135-60 | 75834-135 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 6mg/1 | 500 Capsule In 1 Bottle, Plastic (75834-136-05) | Nivagen Pharmaceuticals, Inc. | 75834-136-05 | 75834-136 | ANDA203844 | ANDA | N/A |
| Rivastigmine Tartrate | Capsule | Oral | 6mg/1 | 60 Capsule In 1 Bottle, Plastic (75834-136-60) | Nivagen Pharmaceuticals, Inc. | 75834-136-60 | 75834-136 | ANDA203844 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 5mg/1 | 1 Blister Pack In 1 Carton (51407-679-03) / 3 Tablet, Orally Disintegrating In 1 Blister Pack (51407-679-11) | Golden State Medical Supply, Inc. | 51407-679-03 | 51407-679 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 5mg/1 | 3 Blister Pack In 1 Carton (51407-679-18) / 6 Tablet, Orally Disintegrating In 1 Blister Pack (51407-679-06) | Golden State Medical Supply, Inc. | 51407-679-18 | 51407-679 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 10mg/1 | 1 Blister Pack In 1 Carton (51407-680-03) / 3 Tablet, Orally Disintegrating In 1 Blister Pack (51407-680-11) | Golden State Medical Supply, Inc. | 51407-680-03 | 51407-680 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 10mg/1 | 3 Blister Pack In 1 Carton (51407-680-18) / 6 Tablet, Orally Disintegrating In 1 Blister Pack (51407-680-06) | Golden State Medical Supply, Inc. | 51407-680-18 | 51407-680 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 5mg/1 | 4 Blister Pack In 1 Carton (51407-681-12) / 3 Tablet In 1 Blister Pack (51407-681-03) | Golden State Medical Supply, Inc. | 51407-681-12 | 51407-681 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 5mg/1 | 3 Blister Pack In 1 Carton (51407-681-18) / 6 Tablet In 1 Blister Pack (51407-681-06) | Golden State Medical Supply, Inc. | 51407-681-18 | 51407-681 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 10mg/1 | 4 Blister Pack In 1 Carton (51407-682-12) / 3 Tablet In 1 Blister Pack (51407-682-03) | Golden State Medical Supply, Inc. | 51407-682-12 | 51407-682 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 10mg/1 | 3 Blister Pack In 1 Carton (51407-682-18) / 6 Tablet In 1 Blister Pack (51407-682-06) | Golden State Medical Supply, Inc. | 51407-682-18 | 51407-682 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 5mg/1 | 6 Blister Pack In 1 Carton (69452-156-73) / 3 Tablet, Orally Disintegrating In 1 Blister Pack (69452-156-74) | Bionpharma Inc., | 69452-156-73 | 69452-156 | ANDA204722 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 10mg/1 | 6 Blister Pack In 1 Carton (69452-157-73) / 3 Tablet, Orally Disintegrating In 1 Blister Pack (69452-157-74) | Bionpharma Inc., | 69452-157-73 | 69452-157 | ANDA204722 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 40mg/1, 1100 mg/1 | 500 Capsule In 1 Bottle (50228-364-05) | ScieGen Pharmaceuticals, Inc. | 50228-364-05 | 50228-364 | ANDA207476 | ANDA | N/A |
| Omeprazole; Sodium Bicarbonate | Capsule | Oral | 40mg/1, 1100 mg/1 | 30 Capsule In 1 Bottle (50228-364-30) | ScieGen Pharmaceuticals, Inc. | 50228-364-30 | 50228-364 | ANDA207476 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 4mg/1 | 3 Blister Pack In 1 Carton (57237-077-10) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-077-10 | 57237-077 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 4mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (57237-077-30) | Rising Pharma Holdings, Inc. | 57237-077-30 | 57237-077 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 8mg/1 | 3 Blister Pack In 1 Carton (57237-078-10) / 10 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-078-10 | 57237-078 | ANDA090469 | ANDA | N/A |
| Ondansetron | Tablet, Orally Disintegrating | Oral | 8mg/1 | 30 Tablet, Orally Disintegrating In 1 Bottle (57237-078-30) | Rising Pharma Holdings, Inc. | 57237-078-30 | 57237-078 | ANDA090469 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-700-06) / 5 Ml In 1 Vial, Multi-Dose (71288-700-05) | Meitheal Pharmaceuticals Inc. | 71288-700-06 | 71288-700 | ANDA213453 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (71288-718-11) / 10 Ml In 1 Vial, Multi-Dose (71288-718-10) | Meitheal Pharmaceuticals Inc. | 71288-718-11 | 71288-718 | ANDA213453 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-662-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-662-05 | 25021-662 | ANDA091458 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-662-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-662-10 | 25021-662 | ANDA091458 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-687-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-687-05 | 25021-687 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Carton (25021-687-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-687-10 | 25021-687 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Box (0143-9250-10) / 5 Ml In 1 Vial (0143-9250-01) | Hikma Pharmaceuticals USA Inc. | 0143-9250-10 | 0143-9250 | ANDA204679 | ANDA | N/A |
| Rocuronium Bromide | Injection | Intravenous | 10mg/mL | 10 Vial In 1 Box (0143-9251-10) / 10 Ml In 1 Vial (0143-9251-01) | Hikma Pharmaceuticals USA Inc. | 0143-9251-10 | 0143-9251 | ANDA204679 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-5160-10) / 10 Ml In 1 Vial, Multi-Dose (0409-5160-01) | Hospira, Inc. | 0409-5160-10 | 0409-5160 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-3189-10) / 5 Ml In 1 Vial, Multi-Dose (0409-3189-05) | Hospira, Inc. | 0409-3189-10 | 0409-3189 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-7037-10) / 10 Ml In 1 Vial, Multi-Dose (0409-7037-01) | Hospira, Inc. | 0409-7037-10 | 0409-7037 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Carton (0409-1403-10) / 5 Ml In 1 Vial, Multi-Dose (0409-1403-05) | Hospira, Inc. | 0409-1403-10 | 0409-1403 | ANDA205656 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-9558-49) / 5 Ml In 1 Vial, Multi-Dose (0409-9558-69) | Hospira, Inc. | 0409-9558-49 | 0409-9558 | ANDA078519 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-9558-50) / 10 Ml In 1 Vial, Multi-Dose (0409-9558-70) | Hospira, Inc. | 0409-9558-50 | 0409-9558 | ANDA078519 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-9558-05) / 5 Ml In 1 Vial, Multi-Dose (0409-9558-11) | Hospira, Inc. | 0409-9558-05 | 0409-9558 | ANDA078519 | ANDA | N/A |
| Rocuronium Bromide | Injection, Solution | Intravenous | 10mg/mL | 10 Vial, Multi-Dose In 1 Box (0409-9558-10) / 10 Ml In 1 Vial, Multi-Dose (0409-9558-31) | Hospira, Inc. | 0409-9558-10 | 0409-9558 | ANDA078519 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | .25mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-356-20) | Bionpharma Inc. | 69452-356-20 | 69452-356 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | .5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-357-20) | Bionpharma Inc. | 69452-357-20 | 69452-357 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | 1mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-358-20) | Bionpharma Inc. | 69452-358-20 | 69452-358 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-359-20) | Bionpharma Inc. | 69452-359-20 | 69452-359 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | 3mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-360-20) | Bionpharma Inc. | 69452-360-20 | 69452-360 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-361-20) | Bionpharma Inc. | 69452-361-20 | 69452-361 | ANDA079229 | ANDA | N/A |
| Ropinirole Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (69452-362-20) | Bionpharma Inc. | 69452-362-20 | 69452-362 | ANDA079229 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-738-21) / 20 Ml In 1 Vial, Single-Dose (71288-738-20) | Meitheal Pharmaceuticals Inc. | 71288-738-21 | 71288-738 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Perineural | 2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-732-11) / 10 Ml In 1 Vial, Single-Dose (71288-732-10) | Meitheal Pharmaceuticals Inc. | 71288-732-11 | 71288-732 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Perineural | 2mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-733-21) / 20 Ml In 1 Vial, Single-Dose (71288-733-20) | Meitheal Pharmaceuticals Inc. | 71288-733-21 | 71288-733 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Perineural | 5mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-734-21) / 20 Ml In 1 Vial, Single-Dose (71288-734-20) | Meitheal Pharmaceuticals Inc. | 71288-734-21 | 71288-734 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration; Perineural | 5mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-735-31) / 30 Ml In 1 Vial, Single-Dose (71288-735-30) | Meitheal Pharmaceuticals Inc. | 71288-735-31 | 71288-735 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Perineural | 7.5mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-736-21) / 20 Ml In 1 Vial, Single-Dose (71288-736-20) | Meitheal Pharmaceuticals Inc. | 71288-736-21 | 71288-736 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (71288-737-11) / 10 Ml In 1 Vial, Single-Dose (71288-737-10) | Meitheal Pharmaceuticals Inc. | 71288-737-11 | 71288-737 | ANDA218713 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 5mg/mL | 10 Bag In 1 Carton (25021-652-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-652-82 | 25021-652 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 5mg/mL | 10 Bag In 1 Carton (25021-652-87) / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-652-87 | 25021-652 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 2mg/mL | 10 Bag In 1 Carton (25021-671-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-671-82 | 25021-671 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 2mg/mL | 10 Bag In 1 Carton (25021-671-87) / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-671-87 | 25021-671 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 2mg/mL | 10 Bag In 1 Carton (25021-671-66) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-671-66 | 25021-671 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection, Solution | Epidural; Infiltration | 2mg/mL | 10 Bag In 1 Carton (25021-671-67) / 200 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-671-67 | 25021-671 | ANDA206166 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 10 Vial In 1 Carton (70069-062-10) / 20 Ml In 1 Vial (70069-062-01) | Somerset Therapeutics, LLC | 70069-062-10 | 70069-062 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 25 Vial In 1 Carton (70069-062-25) / 20 Ml In 1 Vial (70069-062-01) | Somerset Therapeutics, LLC | 70069-062-25 | 70069-062 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 25 Vial In 1 Carton (70069-063-25) / 20 Ml In 1 Vial (70069-063-01) | Somerset Therapeutics, LLC | 70069-063-25 | 70069-063 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 1 Vial In 1 Carton (70069-064-01) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-064-01 | 70069-064 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 10 Vial In 1 Carton (70069-064-10) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-064-10 | 70069-064 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 25 Vial In 1 Carton (70069-064-25) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-064-25 | 70069-064 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Perineural | 7.5mg/mL | 25 Vial In 1 Carton (70069-065-25) / 20 Ml In 1 Vial (70069-065-01) | Somerset Therapeutics, LLC | 70069-065-25 | 70069-065 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 10mg/mL | 10 Vial In 1 Carton (70069-066-10) / 10 Ml In 1 Vial (70069-066-01) | Somerset Therapeutics, LLC | 70069-066-10 | 70069-066 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 10mg/mL | 25 Vial In 1 Vial (70069-066-25) / 10 Ml In 1 Vial (70069-066-01) | Somerset Therapeutics, LLC | 70069-066-25 | 70069-066 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 10mg/mL | 10 Vial In 1 Carton (70069-067-10) / 20 Ml In 1 Vial (70069-067-01) | Somerset Therapeutics, LLC | 70069-067-10 | 70069-067 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 10mg/mL | 25 Vial In 1 Carton (70069-067-25) / 20 Ml In 1 Vial (70069-067-01) | Somerset Therapeutics, LLC | 70069-067-25 | 70069-067 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 10 Vial In 1 Carton (70069-061-10) / 10 Ml In 1 Vial (70069-061-01) | Somerset Therapeutics, LLC | 70069-061-10 | 70069-061 | ANDA207636 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 25 Vial In 1 Carton (70069-061-25) / 10 Ml In 1 Vial (70069-061-01) | Somerset Therapeutics, LLC | 70069-061-25 | 70069-061 | ANDA207636 | ANDA | N/A |
| Ondansetron Hydrochloride | Solution | Oral | 4mg/5mL | 10 Cup, Unit-Dose In 1 Tray (65162-691-19) / 5 Ml In 1 Cup, Unit-Dose (65162-691-37) | Amneal Pharmaceuticals LLC | 65162-691-19 | 65162-691 | ANDA091483 | ANDA | N/A |
| Ondansetron Hydrochloride | Solution | Oral | 4mg/5mL | 50 Ml In 1 Bottle (65162-691-79) | Amneal Pharmaceuticals LLC | 65162-691-79 | 65162-691 | ANDA091483 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-075-30) | Rising Pharma Holdings, Inc. | 57237-075-30 | 57237-075 | ANDA078539 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 4mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-075-50) | Rising Pharma Holdings, Inc. | 57237-075-50 | 57237-075 | ANDA078539 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-076-30) | Rising Pharma Holdings, Inc. | 57237-076-30 | 57237-076 | ANDA078539 | ANDA | N/A |
| Ondansetron Hydrochloride | Tablet, Film Coated | Oral | 8mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-076-50) | Rising Pharma Holdings, Inc. | 57237-076-50 | 57237-076 | ANDA078539 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 30mg/1 | 10 Capsule In 1 Carton (31722-630-31) | Camber Pharmaceuticals, Inc. | 31722-630-31 | 31722-630 | ANDA209438 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 45mg/1 | 10 Capsule In 1 Carton (31722-631-31) | Camber Pharmaceuticals, Inc. | 31722-631-31 | 31722-631 | ANDA209438 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration | 2mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9263-10) / 20 Ml In 1 Vial, Single-Dose (0143-9263-01) | Hikma Pharmaceuticals USA Inc. | 0143-9263-10 | 0143-9263 | ANDA214074 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration | 5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9264-10) / 30 Ml In 1 Vial, Single-Dose (0143-9264-01) | Hikma Pharmaceuticals USA Inc. | 0143-9264-10 | 0143-9264 | ANDA214074 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 7.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9265-10) / 20 Ml In 1 Vial, Single-Dose (0143-9265-01) | Hikma Pharmaceuticals USA Inc. | 0143-9265-10 | 0143-9265 | ANDA214074 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural | 10mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9266-10) / 20 Ml In 1 Vial, Single-Dose (0143-9266-01) | Hikma Pharmaceuticals USA Inc. | 0143-9266-10 | 0143-9266 | ANDA214074 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 75mg/1 | 10 Capsule In 1 Carton (31722-632-31) | Camber Pharmaceuticals, Inc. | 31722-632-31 | 31722-632 | ANDA209438 | ANDA | N/A |
| Oseltamivir phosphate | Powder, For Suspension | Oral | 6mg/mL | 360 Ml In 1 Bottle (31722-108-60) | Camber Pharmaceuticals, Inc. | 31722-108-60 | 31722-108 | ANDA209590 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 30mg/1 | 10 Capsule In 1 Bottle (42806-553-11) | EPIC PHARMA, LLC | 42806-553-11 | 42806-553 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 30mg/1 | 10 Capsule In 1 Blister Pack (42806-553-50) | EPIC PHARMA, LLC | 42806-553-50 | 42806-553 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (42806-553-80) | EPIC PHARMA, LLC | 42806-553-80 | 42806-553 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 45mg/1 | 10 Capsule In 1 Bottle (42806-554-11) | EPIC PHARMA, LLC | 42806-554-11 | 42806-554 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 45mg/1 | 10 Capsule In 1 Blister Pack (42806-554-50) | EPIC PHARMA, LLC | 42806-554-50 | 42806-554 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 45mg/1 | 100 Capsule In 1 Bottle (42806-554-80) | EPIC PHARMA, LLC | 42806-554-80 | 42806-554 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 75mg/1 | 10 Capsule In 1 Bottle (42806-555-11) | EPIC PHARMA, LLC | 42806-555-11 | 42806-555 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 75mg/1 | 10 Capsule In 1 Blister Pack (42806-555-50) | EPIC PHARMA, LLC | 42806-555-50 | 42806-555 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Capsule | Oral | 75mg/1 | 100 Capsule In 1 Bottle (42806-555-80) | EPIC PHARMA, LLC | 42806-555-80 | 42806-555 | ANDA215208 | ANDA | N/A |
| Oseltamivir Phosphate | Powder, For Suspension | Oral | 6mg/mL | 1 Bottle, Glass In 1 Carton (42806-363-13) / 60 Ml In 1 Bottle, Glass | EPIC PHARMA, LLC | 42806-363-13 | 42806-363 | ANDA215538 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 50mg/10mL | 1 Vial, Single-Use In 1 Carton (50742-405-10) / 10 Ml In 1 Vial, Single-Use | Ingenus Pharmaceuticals, LLC | 50742-405-10 | 50742-405 | ANDA207562 | ANDA | N/A |
| Oxaliplatin | Injection, Solution | Intravenous | 100mg/20mL | 1 Vial, Single-Use In 1 Carton (50742-406-20) / 20 Ml In 1 Vial, Single-Use | Ingenus Pharmaceuticals, LLC | 50742-406-20 | 50742-406 | ANDA207562 | ANDA | N/A |
| Oxcarbazepine | Suspension | Oral | 300mg/5mL | 10 Cup, Unit-Dose In 1 Tray (65162-649-48) / 5 Ml In 1 Cup, Unit-Dose (65162-649-43) | Amneal Pharmaceuticals LLC | 65162-649-48 | 65162-649 | ANDA202961 | ANDA | N/A |
| Oxcarbazepine | Suspension | Oral | 300mg/5mL | 1 Bottle In 1 Carton (65162-649-78) / 250 Ml In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-649-78 | 65162-649 | ANDA202961 | ANDA | N/A |
| OXCARBAZEPINE | Suspension | Oral | 60mg/mL | 1 Bottle In 1 Carton (31722-687-25) / 250 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-687-25 | 31722-687 | ANDA216749 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-023-01) | Camber Pharmaceuticals, Inc. | 31722-023-01 | 31722-023 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-023-05) | Camber Pharmaceuticals, Inc. | 31722-023-05 | 31722-023 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-023-10) | Camber Pharmaceuticals, Inc. | 31722-023-10 | 31722-023 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 10 Blister Pack In 1 Carton (31722-023-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-023-31 | 31722-023 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-024-01) | Camber Pharmaceuticals, Inc. | 31722-024-01 | 31722-024 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-024-05) | Camber Pharmaceuticals, Inc. | 31722-024-05 | 31722-024 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-024-10) | Camber Pharmaceuticals, Inc. | 31722-024-10 | 31722-024 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 10 Blister Pack In 1 Carton (31722-024-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-024-31 | 31722-024 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-025-01) | Camber Pharmaceuticals, Inc. | 31722-025-01 | 31722-025 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-025-05) | Camber Pharmaceuticals, Inc. | 31722-025-05 | 31722-025 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-025-10) | Camber Pharmaceuticals, Inc. | 31722-025-10 | 31722-025 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 10 Blister Pack In 1 Carton (31722-025-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-025-31 | 31722-025 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Suspension | Oral | 300mg/5mL | 1 Bottle In 1 Carton (42806-600-22) / 250 Ml In 1 Bottle | EPIC PHARMA, LLC | 42806-600-22 | 42806-600 | ANDA215332 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-283-01) | XLCare Pharmaceuticals Inc. | 72865-283-01 | 72865-283 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 150mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-283-05) | XLCare Pharmaceuticals Inc. | 72865-283-05 | 72865-283 | ANDA215939 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (27808-155-01) | Tris Pharma Inc | 27808-155-01 | 27808-155 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (27808-155-03) | Tris Pharma Inc | 27808-155-03 | 27808-155 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (27808-156-01) | Tris Pharma Inc | 27808-156-01 | 27808-156 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (27808-156-03) | Tris Pharma Inc | 27808-156-03 | 27808-156 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (27808-157-01) | Tris Pharma Inc | 27808-157-01 | 27808-157 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (27808-157-03) | Tris Pharma Inc | 27808-157-03 | 27808-157 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (27808-158-01) | Tris Pharma Inc | 27808-158-01 | 27808-158 | ANDA207408 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (27808-158-03) | Tris Pharma Inc | 27808-158-03 | 27808-158 | ANDA207408 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-284-01) | XLCare Pharmaceuticals Inc. | 72865-284-01 | 72865-284 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-284-05) | XLCare Pharmaceuticals Inc. | 72865-284-05 | 72865-284 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-285-01) | XLCare Pharmaceuticals Inc. | 72865-285-01 | 72865-285 | ANDA215939 | ANDA | N/A |
| Oxcarbazepine | Tablet, Film Coated | Oral | 600mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-285-05) | XLCare Pharmaceuticals Inc. | 72865-285-05 | 72865-285 | ANDA215939 | ANDA | N/A |
| Oxiconazole Nitrate | Lotion | Topical | 10mg/mL | 6 Bottle In 1 Carton (62559-285-06) / 7 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-285-06 | 62559-285 | NDA020209 | NDA | N/A |
| Oxiconazole Nitrate | Lotion | Topical | 10mg/mL | 1 Bottle In 1 Carton (62559-285-30) / 30 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-285-30 | 62559-285 | NDA020209 | NDA | N/A |
| Oxiconazole Nitrate | Lotion | Topical | 10mg/mL | 1 Bottle In 1 Carton (62559-285-60) / 60 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-285-60 | 62559-285 | NDA020209 | NDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-371-03) | Amneal Pharmaceuticals LLC | 65162-371-03 | 65162-371 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-371-09) | Amneal Pharmaceuticals LLC | 65162-371-09 | 65162-371 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-371-10) | Amneal Pharmaceuticals LLC | 65162-371-10 | 65162-371 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-371-50) | Amneal Pharmaceuticals LLC | 65162-371-50 | 65162-371 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-372-03) | Amneal Pharmaceuticals LLC | 65162-372-03 | 65162-372 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-372-09) | Amneal Pharmaceuticals LLC | 65162-372-09 | 65162-372 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-372-10) | Amneal Pharmaceuticals LLC | 65162-372-10 | 65162-372 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-372-50) | Amneal Pharmaceuticals LLC | 65162-372-50 | 65162-372 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-373-03) | Amneal Pharmaceuticals LLC | 65162-373-03 | 65162-373 | ANDA204010 | ANDA | N/A |
| Rubidium Chloride Rb-82 | Injection, Solution | Intravenous | 100mCi/1 | 1 Injection, Solution In 1 Container (65174-021-10) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-021-10 | 65174-021 | NDA202153 | NDA | N/A |
| Rufinamide | Suspension | Oral | 40mg/mL | 1 Bottle In 1 Carton (69452-223-84) / 460 Ml In 1 Bottle | Bionpharma Inc. | 69452-223-84 | 69452-223 | ANDA211388 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 200mg/1 | 120 Tablet, Film Coated In 1 Bottle (0054-0425-23) | Hikma Pharmaceuticals USA Inc. | 0054-0425-23 | 0054-0425 | ANDA204988 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 400mg/1 | 120 Tablet, Film Coated In 1 Bottle (0054-0426-23) | Hikma Pharmaceuticals USA Inc. | 0054-0426-23 | 0054-0426 | ANDA204988 | ANDA | N/A |
| Rufinamide | Suspension | Oral | 40mg/mL | 1 Bottle In 1 Carton (0054-0528-63) / 460 Ml In 1 Bottle | Hikma Pharmaceuticals USA Inc. | 0054-0528-63 | 0054-0528 | ANDA207363 | ANDA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2506-2) | Jubilant HollisterStier LLC | 65044-2506-2 | 65044-2506 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2506-3) | Jubilant HollisterStier LLC | 65044-2506-3 | 65044-2506 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2506-4) | Jubilant HollisterStier LLC | 65044-2506-4 | 65044-2506 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2507-1) | Jubilant HollisterStier LLC | 65044-2507-1 | 65044-2507 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-2508-2) | Jubilant HollisterStier LLC | 65044-2508-2 | 65044-2508 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-2508-3) | Jubilant HollisterStier LLC | 65044-2508-3 | 65044-2508 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-2508-4) | Jubilant HollisterStier LLC | 65044-2508-4 | 65044-2508 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 10 Ml In 1 Vial (65044-1516-2) | Jubilant HollisterStier LLC | 65044-1516-2 | 65044-1516 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 30 Ml In 1 Vial (65044-1516-3) | Jubilant HollisterStier LLC | 65044-1516-3 | 65044-1516 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL, .05 g/mL | 50 Ml In 1 Vial (65044-1516-4) | Jubilant HollisterStier LLC | 65044-1516-4 | 65044-1516 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous | .05g/mL, .05 g/mL | 5 Ml In 1 Vial (65044-1517-1) | Jubilant HollisterStier LLC | 65044-1517-1 | 65044-1517 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-1519-2) | Jubilant HollisterStier LLC | 65044-1519-2 | 65044-1519 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-1519-3) | Jubilant HollisterStier LLC | 65044-1519-3 | 65044-1519 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-1519-4) | Jubilant HollisterStier LLC | 65044-1519-4 | 65044-1519 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 10 Ml In 1 Vial (65044-1520-2) | Jubilant HollisterStier LLC | 65044-1520-2 | 65044-1520 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 30 Ml In 1 Vial (65044-1520-3) | Jubilant HollisterStier LLC | 65044-1520-3 | 65044-1520 | BLA103888 | BLA | N/A |
| Rumex Acetosella Pollen; Rumex Crispus Pollen | Injection, Solution | Percutaneous; Subcutaneous | 20000[PNU]/mL, 20000 [PNU]/mL | 50 Ml In 1 Vial (65044-1520-4) | Jubilant HollisterStier LLC | 65044-1520-4 | 65044-1520 | BLA103888 | BLA | N/A |
| Rye | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3554-2) | Jubilant HollisterStier LLC | 65044-3554-2 | 65044-3554 | BLA103888 | BLA | N/A |
| Saccharum Officinarum Whole | Gel | Topical | 6[hp_X]/58g | 1 Tube In 1 Carton (72715-001-03) / 56 G In 1 Tube | Beautiful Day Organics, LLC | 72715-001-03 | 72715-001 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Salicylic Acid | Cream | Topical | 5mg/g | 1.4 G In 1 Tube (80684-109-00) | Fourstar Group USA, Inc. | 80684-109-00 | 80684-109 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 5mg/g | 1.4 G In 1 Tube (80684-108-00) | Fourstar Group USA, Inc. | 80684-108-00 | 80684-108 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Powder | Topical | 5mg/g | 4.8 G In 1 Container (80684-110-00) | Fourstar Group USA, Inc. | 80684-110-00 | 80684-110 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Powder | Topical | 5mg/g | 4.8 G In 1 Container (80684-111-00) | Fourstar Group USA, Inc. | 80684-111-00 | 80684-111 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Liquid | Topical | 18mg/mL | 1 Tube In 1 Box (83707-426-00) / 60 Ml In 1 Tube | AAVRANI, INC. | 83707-426-00 | 83707-426 | M029 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 10mg/mL | 1 Bottle In 1 Box (15751-3030-2) / 35 Ml In 1 Bottle | Eminence Organic Skin Care Ltd. | 15751-3030-2 | 15751-3030 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 10mg/mL | 3 Ml In 1 Packet (15751-3030-6) | Eminence Organic Skin Care Ltd. | 15751-3030-6 | 15751-3030 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 10mg/mL | 55 Ml In 1 Bottle (15751-3030-9) | Eminence Organic Skin Care Ltd. | 15751-3030-9 | 15751-3030 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 5mg/mL | 1 Tube In 1 Box (15751-3020-2) / 60 Ml In 1 Tube | Eminence Organic Skin Care Ltd. | 15751-3020-2 | 15751-3020 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 5mg/mL | 120 Ml In 1 Tube (15751-3020-4) | Eminence Organic Skin Care Ltd. | 15751-3020-4 | 15751-3020 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 5mg/mL | 3 Ml In 1 Packet (15751-3020-6) | Eminence Organic Skin Care Ltd. | 15751-3020-6 | 15751-3020 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Liquid | Topical | 10mg/mL | 1 Bottle In 1 Box (15751-3010-5) / 150 Ml In 1 Bottle | Eminence Organic Skin Care Ltd. | 15751-3010-5 | 15751-3010 | part333D | OTC MONOGRAPH FINAL | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 40 Patch In 1 Box (78936-405-10) / 17 Mg In 1 Patch (78936-405-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-405-10 | 78936-405 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 150 Patch In 1 Box (78936-409-38) / 17 Mg In 1 Patch (78936-409-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-409-38 | 78936-409 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 40 Patch In 1 Box (78936-411-10) / 17 Mg In 1 Patch (78936-411-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-411-10 | 78936-411 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 150 Patch In 1 Box (78936-413-38) / 17 Mg In 1 Patch (78936-413-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-413-38 | 78936-413 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 140 Patch In 1 Box (78936-417-35) / 17 Mg In 1 Patch (78936-417-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-417-35 | 78936-417 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 40 Patch In 1 Box (78936-401-10) / 17 Mg In 1 Patch (78936-401-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-401-10 | 78936-401 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Percutaneous | 5mg/1000mg | 20 Patch In 1 Box (78936-403-02) / 17 Mg In 1 Patch (78936-403-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-403-02 | 78936-403 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 36 Patch In 1 Box (78936-415-09) / 17 Mg In 1 Patch (78936-415-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-415-09 | 78936-415 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 72 Patch In 1 Box (78936-415-18) / 17 Mg In 1 Patch (78936-415-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-415-18 | 78936-415 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Patch | Transdermal | 5mg/1000mg | 36 Patch In 1 Box (78936-407-09) / 17 Mg In 1 Patch (78936-407-01) | Hangzhou Caring Cleaning Commodity Co., Ltd | 78936-407-09 | 78936-407 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Cream | Topical | 20mg/mL | 30 Ml In 1 Tube (71435-0005-0) | New Milani Group, LLC | 71435-0005-0 | 71435-0005 | M006 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 50mg/mL | 15 Ml In 1 Bottle (82266-238-00) | BALBOA COMPANIES LLC | 82266-238-00 | 82266-238 | M028 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Cream | Topical | 50mg/mL | 15 Ml In 1 Bottle (82266-237-00) | BALBOA COMPANIES LLC | 82266-237-00 | 82266-237 | M028 | OTC MONOGRAPH DRUG | N/A |
| Salicylic Acid | Aerosol, Foam | Topical | 6g/100g | 70 G In 1 Canister (42192-112-70) | Acella Pharmaceuticals, LLC | 42192-112-70 | 42192-112 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Aerosol, Foam | Topical | 6g/100g | 200 G In 1 Canister (42192-130-02) | Acella Pharmaceuticals, LLC | 42192-130-02 | 42192-130 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Gel | Topical | 60mg/g | 1 Tube In 1 Carton (42192-134-40) / 40 G In 1 Tube | Acella Pharmaceuticals, LLC | 42192-134-40 | 42192-134 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salicylic Acid | Liquid | Topical | 275mg/mL | 1 Bottle, With Applicator In 1 Carton (42192-135-10) / 10 Ml In 1 Bottle, With Applicator | Acella Pharmaceuticals, LLC | 42192-135-10 | 42192-135 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2677-2) | Jubilant HollisterStier LLC | 65044-2677-2 | 65044-2677 | BLA103888 | BLA | N/A |
| Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2677-3) | Jubilant HollisterStier LLC | 65044-2677-3 | 65044-2677 | BLA103888 | BLA | N/A |
| Salix Nigra Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2677-4) | Jubilant HollisterStier LLC | 65044-2677-4 | 65044-2677 | BLA103888 | BLA | N/A |
| Salix Nigra Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2678-1) | Jubilant HollisterStier LLC | 65044-2678-1 | 65044-2678 | BLA103888 | BLA | N/A |
| Salmon, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3565-2) | Jubilant HollisterStier LLC | 65044-3565-2 | 65044-3565 | BLA103888 | BLA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-373-09) | Amneal Pharmaceuticals LLC | 65162-373-09 | 65162-373 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 100 Tablet, Extended Release In 1 Bottle (65162-373-10) | Amneal Pharmaceuticals LLC | 65162-373-10 | 65162-373 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 250 Tablet, Extended Release In 1 Bottle (65162-373-25) | Amneal Pharmaceuticals LLC | 65162-373-25 | 65162-373 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 500 Tablet, Extended Release In 1 Bottle (65162-373-50) | Amneal Pharmaceuticals LLC | 65162-373-50 | 65162-373 | ANDA204010 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 100 Tablet, Extended Release In 1 Bottle (64980-209-01) | Rising Pharma Holdings, Inc. | 64980-209-01 | 64980-209 | ANDA206121 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-209-03) | Rising Pharma Holdings, Inc. | 64980-209-03 | 64980-209 | ANDA206121 | ANDA | N/A |
| Salsola Kali Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2362-2) | Jubilant HollisterStier LLC | 65044-2362-2 | 65044-2362 | BLA103888 | BLA | N/A |
| Salsola Kali Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2362-3) | Jubilant HollisterStier LLC | 65044-2362-3 | 65044-2362 | BLA103888 | BLA | N/A |
| Salsola Kali Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2362-4) | Jubilant HollisterStier LLC | 65044-2362-4 | 65044-2362 | BLA103888 | BLA | N/A |
| Salsola Kali Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2363-1) | Jubilant HollisterStier LLC | 65044-2363-1 | 65044-2363 | BLA103888 | BLA | N/A |
| Sarocladium Strictum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-5056-2) | Jubilant HollisterStier LLC | 65044-5056-2 | 65044-5056 | BLA103888 | BLA | N/A |
| Sarocladium Strictum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-5056-3) | Jubilant HollisterStier LLC | 65044-5056-3 | 65044-5056 | BLA103888 | BLA | N/A |
| Sarocladium Strictum | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-5056-4) | Jubilant HollisterStier LLC | 65044-5056-4 | 65044-5056 | BLA103888 | BLA | N/A |
| Sarocladium Strictum | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-5057-1) | Jubilant HollisterStier LLC | 65044-5057-1 | 65044-5057 | BLA103888 | BLA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 5mg/1 | 500 Tablet, Extended Release In 1 Bottle (64980-209-05) | Rising Pharma Holdings, Inc. | 64980-209-05 | 64980-209 | ANDA206121 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 100 Tablet, Extended Release In 1 Bottle (64980-210-01) | Rising Pharma Holdings, Inc. | 64980-210-01 | 64980-210 | ANDA206121 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 10mg/1 | 500 Tablet, Extended Release In 1 Bottle (64980-210-05) | Rising Pharma Holdings, Inc. | 64980-210-05 | 64980-210 | ANDA206121 | ANDA | N/A |
| Schinus Molle Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2107-2) | Jubilant HollisterStier LLC | 65044-2107-2 | 65044-2107 | BLA103888 | BLA | N/A |
| Schinus Molle Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2107-3) | Jubilant HollisterStier LLC | 65044-2107-3 | 65044-2107 | BLA103888 | BLA | N/A |
| Schinus Molle Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2107-4) | Jubilant HollisterStier LLC | 65044-2107-4 | 65044-2107 | BLA103888 | BLA | N/A |
| Schinus Molle Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2108-1) | Jubilant HollisterStier LLC | 65044-2108-1 | 65044-2108 | BLA103888 | BLA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1mg/1 | 1 Patch, Extended Release In 1 Pouch (45802-580-01) | Padagis Israel Pharmaceuticals Ltd | 45802-580-01 | 45802-580 | ANDA078830 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1mg/1 | 10 Pouch In 1 Carton (45802-580-46) / 1 Patch, Extended Release In 1 Pouch | Padagis Israel Pharmaceuticals Ltd | 45802-580-46 | 45802-580 | ANDA078830 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1mg/1 | 24 Pouch In 1 Carton (45802-580-62) / 1 Patch, Extended Release In 1 Pouch | Padagis Israel Pharmaceuticals Ltd | 45802-580-62 | 45802-580 | ANDA078830 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1mg/1 | 4 Pouch In 1 Carton (45802-580-84) / 1 Patch, Extended Release In 1 Pouch | Padagis Israel Pharmaceuticals Ltd | 45802-580-84 | 45802-580 | ANDA078830 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (64980-431-01) | RISING PHARMA HOLDINGS, INC. | 64980-431-01 | 64980-431 | ANDA209025 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (64980-431-10) | RISING PHARMA HOLDINGS, INC. | 64980-431-10 | 64980-431 | ANDA209025 | ANDA | N/A |
| Oxybutynin Chloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (64980-431-50) | RISING PHARMA HOLDINGS, INC. | 64980-431-50 | 64980-431 | ANDA209025 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 60 Capsule In 1 Bottle (70954-504-10) | Novitium Pharma LLC | 70954-504-10 | 70954-504 | ANDA075352 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 1000 Capsule In 1 Bottle (70954-504-20) | Novitium Pharma LLC | 70954-504-20 | 70954-504 | ANDA075352 | ANDA | N/A |
| Selegiline Hydrochloride | Tablet | Oral | 5mg/1 | 60 Tablet In 1 Bottle (60429-176-60) | Golden State Medical Supply, Inc. | 60429-176-60 | 60429-176 | ANDA074871 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 60 Capsule In 1 Bottle (60505-0055-1) | Apotex Corp. | 60505-0055-1 | 60505-0055 | ANDA075321 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 1000 Capsule In 1 Bottle (60505-0055-2) | Apotex Corp. | 60505-0055-2 | 60505-0055 | ANDA075321 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (60505-0055-3) | Apotex Corp. | 60505-0055-3 | 60505-0055 | ANDA075321 | ANDA | N/A |
| Selegiline Hydrochloride | Tablet | Oral | 5mg/1 | 60 Tablet In 1 Bottle (60505-3438-3) | Apotex Corp. | 60505-3438-3 | 60505-3438 | ANDA074871 | ANDA | N/A |
| Selegiline Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (60505-3438-8) | Apotex Corp. | 60505-3438-8 | 60505-3438 | ANDA074871 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 100 Tablet, Extended Release In 1 Bottle (64980-211-01) | Rising Pharma Holdings, Inc. | 64980-211-01 | 64980-211 | ANDA206121 | ANDA | N/A |
| Oxybutynin Chloride | Tablet, Extended Release | Oral | 15mg/1 | 500 Tablet, Extended Release In 1 Bottle (64980-211-05) | Rising Pharma Holdings, Inc. | 64980-211-05 | 64980-211 | ANDA206121 | ANDA | N/A |
| Selenium | Injection, Solution | Intravenous | 6ug/mL | 10 Vial, Single-Dose In 1 Box (0517-6502-10) / 2 Ml In 1 Vial, Single-Dose (0517-6502-01) | American Regent, Inc. | 0517-6502-10 | 0517-6502 | NDA209379 | NDA | N/A |
| Selenium | Injection, Solution | Intravenous | 60ug/mL | 5 Vial, Pharmacy Bulk Package In 1 Box (0517-6560-05) / 10 Ml In 1 Vial, Pharmacy Bulk Package (0517-6560-01) | American Regent, Inc. | 0517-6560-05 | 0517-6560 | NDA209379 | NDA | N/A |
| Selenium Sulfide | Lotion | Topical | 2.5mg/100mL | 118 Ml In 1 Bottle (45802-040-64) | Padagis Israel Pharmaceuticals Ltd | 45802-040-64 | 45802-040 | ANDA089996 | ANDA | N/A |
| Sennosides | Syrup | Oral | 8.8mg/5mL | 237 Ml In 1 Bottle, Plastic (39328-020-08) | Patrin Pharma, Inc. | 39328-020-08 | 39328-020 | M007 | OTC MONOGRAPH DRUG | N/A |
| Sennosides | Syrup | Oral | 26.4mg/15mL | 5 Tray In 1 Case (39328-220-50) / 10 Cup, Unit-Dose In 1 Tray / 15 Ml In 1 Cup, Unit-Dose (39328-220-15) | Patrin Pharma, Inc. | 39328-220-50 | 39328-220 | M007 | OTC MONOGRAPH DRUG | N/A |
| Sennosides | Syrup | Oral | 8.8mg/5mL | 5 Tray In 1 Case (39328-120-50) / 10 Cup, Unit-Dose In 1 Tray / 5 Ml In 1 Cup, Unit-Dose (39328-120-05) | Patrin Pharma, Inc. | 39328-120-50 | 39328-120 | M007 | OTC MONOGRAPH DRUG | N/A |
| Oxybutynin Chloride | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (64980-531-01) | RISING PHARMA HOLDINGS, INC. | 64980-531-01 | 64980-531 | ANDA209025 | ANDA | N/A |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (31722-948-01) | Camber Pharmaceuticals, Inc. | 31722-948-01 | 31722-948 | ANDA207419 | ANDA | CII |
| Sepia Officinalis Juice | Soap | Topical | 12[hp_X]/mL | 177 Ml In 1 Tube (52389-666-06) | Alva-Amco Pharmacal Companies, Inc. | 52389-666-06 | 52389-666 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Sepia Officinalis Juice | Soap | Topical | 12[hp_X]/mL | 177 Ml In 1 Tube (52389-226-06) | Alva-Amco Pharmacal Companies, Inc. | 52389-226-06 | 52389-226 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (31722-948-05) | Camber Pharmaceuticals, Inc. | 31722-948-05 | 31722-948 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (31722-949-01) | Camber Pharmaceuticals, Inc. | 31722-949-01 | 31722-949 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (31722-949-05) | Camber Pharmaceuticals, Inc. | 31722-949-05 | 31722-949 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (31722-950-01) | Camber Pharmaceuticals, Inc. | 31722-950-01 | 31722-950 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (31722-950-05) | Camber Pharmaceuticals, Inc. | 31722-950-05 | 31722-950 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (31722-191-01) | Camber Pharmaceuticals, Inc. | 31722-191-01 | 31722-191 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (31722-191-05) | Camber Pharmaceuticals, Inc. | 31722-191-05 | 31722-191 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (31722-951-01) | Camber Pharmaceuticals, Inc. | 31722-951-01 | 31722-951 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (31722-951-05) | Camber Pharmaceuticals, Inc. | 31722-951-05 | 31722-951 | ANDA207419 | ANDA | CII |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-091-90) | St. Mary's Medical Park Pharmacy | 60760-091-90 | 60760-091 | ANDA077206 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-737-90) | St. Mary's Medical Park Pharmacy | 60760-737-90 | 60760-737 | ANDA202825 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-738-90) | St. Mary's Medical Park Pharmacy | 60760-738-90 | 60760-738 | ANDA202825 | ANDA | N/A |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (31722-192-01) | Camber Pharmaceuticals, Inc. | 31722-192-01 | 31722-192 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (31722-192-05) | Camber Pharmaceuticals, Inc. | 31722-192-05 | 31722-192 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (31722-193-01) | Camber Pharmaceuticals, Inc. | 31722-193-01 | 31722-193 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (31722-193-05) | Camber Pharmaceuticals, Inc. | 31722-193-05 | 31722-193 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (31722-194-01) | Camber Pharmaceuticals, Inc. | 31722-194-01 | 31722-194 | ANDA207419 | ANDA | CII |
| Oxycodone and Acetaminophen | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (31722-194-05) | Camber Pharmaceuticals, Inc. | 31722-194-05 | 31722-194 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 2.5 mg/1 | 100 Tablet In 1 Bottle (72865-113-01) | XLCare Pharmaceuticals, Inc. | 72865-113-01 | 72865-113 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 2.5 mg/1 | 500 Tablet In 1 Bottle (72865-113-05) | XLCare Pharmaceuticals, Inc. | 72865-113-05 | 72865-113 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 5 mg/1 | 100 Tablet In 1 Bottle (72865-114-01) | XLCare Pharmaceuticals, Inc. | 72865-114-01 | 72865-114 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 5 mg/1 | 500 Tablet In 1 Bottle (72865-114-05) | XLCare Pharmaceuticals, Inc. | 72865-114-05 | 72865-114 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 7.5 mg/1 | 100 Tablet In 1 Bottle (72865-115-01) | XLCare Pharmaceuticals, Inc. | 72865-115-01 | 72865-115 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 7.5 mg/1 | 500 Tablet In 1 Bottle (72865-115-05) | XLCare Pharmaceuticals, Inc. | 72865-115-05 | 72865-115 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 10 mg/1 | 100 Tablet In 1 Bottle (72865-116-01) | XLCare Pharmaceuticals, Inc. | 72865-116-01 | 72865-116 | ANDA207419 | ANDA | CII |
| OXYCODONE AND ACETAMINOPHEN | Tablet | Oral | 325mg/1, 10 mg/1 | 500 Tablet In 1 Bottle (72865-116-05) | XLCare Pharmaceuticals, Inc. | 72865-116-05 | 72865-116 | ANDA207419 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (65162-047-03) | Amneal Pharmaceuticals LLC | 65162-047-03 | 65162-047 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (65162-047-10) | Amneal Pharmaceuticals LLC | 65162-047-10 | 65162-047 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 250 Tablet In 1 Bottle (65162-047-25) | Amneal Pharmaceuticals LLC | 65162-047-25 | 65162-047 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-047-50) | Amneal Pharmaceuticals LLC | 65162-047-50 | 65162-047 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (65162-048-03) | Amneal Pharmaceuticals LLC | 65162-048-03 | 65162-048 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (65162-048-10) | Amneal Pharmaceuticals LLC | 65162-048-10 | 65162-048 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 250 Tablet In 1 Bottle (65162-048-25) | Amneal Pharmaceuticals LLC | 65162-048-25 | 65162-048 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (65162-049-03) | Amneal Pharmaceuticals LLC | 65162-049-03 | 65162-049 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (65162-049-10) | Amneal Pharmaceuticals LLC | 65162-049-10 | 65162-049 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 250 Tablet In 1 Bottle (65162-049-25) | Amneal Pharmaceuticals LLC | 65162-049-25 | 65162-049 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (65162-049-50) | Amneal Pharmaceuticals LLC | 65162-049-50 | 65162-049 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (65162-050-03) | Amneal Pharmaceuticals LLC | 65162-050-03 | 65162-050 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (65162-050-10) | Amneal Pharmaceuticals LLC | 65162-050-10 | 65162-050 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 250 Tablet In 1 Bottle (65162-050-25) | Amneal Pharmaceuticals LLC | 65162-050-25 | 65162-050 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (65162-051-03) | Amneal Pharmaceuticals LLC | 65162-051-03 | 65162-051 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (65162-051-10) | Amneal Pharmaceuticals LLC | 65162-051-10 | 65162-051 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 250 Tablet In 1 Bottle (65162-051-25) | Amneal Pharmaceuticals LLC | 65162-051-25 | 65162-051 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (65162-051-50) | Amneal Pharmaceuticals LLC | 65162-051-50 | 65162-051 | ANDA203638 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 1 Bottle In 1 Carton (62559-151-16) / 473 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 62559-151-16 | 62559-151 | ANDA204979 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 40 Cup, Unit-Dose In 1 Case (62559-151-40) / 5 Ml In 1 Cup, Unit-Dose (62559-151-15) | ANI Pharmaceuticals, Inc. | 62559-151-40 | 62559-151 | ANDA204979 | ANDA | CII |
| Sevelamer Carbonate | Powder, For Suspension | Oral | 800mg/1 | 90 Packet In 1 Carton (69452-126-19) / 1 Powder, For Suspension In 1 Packet (69452-126-60) | Bionpharma Inc. | 69452-126-19 | 69452-126 | ANDA209374 | ANDA | N/A |
| Sevelamer Carbonate | Powder, For Suspension | Oral | 2400mg/1 | 90 Packet In 1 Carton (69452-127-19) / 1 Powder, For Suspension In 1 Packet (69452-127-60) | Bionpharma Inc. | 69452-127-19 | 69452-127 | ANDA209374 | ANDA | N/A |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 50 Cup, Unit-Dose In 1 Case (62559-151-50) / 5 Ml In 1 Cup, Unit-Dose (62559-151-15) | ANI Pharmaceuticals, Inc. | 62559-151-50 | 62559-151 | ANDA204979 | ANDA | CII |
| Oxycodone Hydrochloride | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (62559-167-01) | ANI Pharmaceuticals, Inc. | 62559-167-01 | 62559-167 | ANDA205177 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 30 Ml In 1 Bottle (43602-190-31) | Ascent Pharmaceuticals Inc | 43602-190-31 | 43602-190 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (43602-190-50) | Ascent Pharmaceuticals Inc | 43602-190-50 | 43602-190 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 30 Ml In 1 Bottle (43602-198-31) | Ascent Pharmaceuticals Inc | 43602-198-31 | 43602-198 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 500 Ml In 1 Bottle (43602-198-50) | Ascent Pharmaceuticals Inc | 43602-198-50 | 43602-198 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 30 Ml In 1 Bottle (43602-190-31) | Ascent Pharmaceuticals Inc | 43602-190-31 | 43602-190 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 5mg/5mL | 500 Ml In 1 Bottle (43602-190-50) | Ascent Pharmaceuticals Inc | 43602-190-50 | 43602-190 | ANDA209021 | ANDA | CII |
| Shrimp, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3584-2) | Jubilant HollisterStier LLC | 65044-3584-2 | 65044-3584 | BLA103888 | BLA | N/A |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 30 Ml In 1 Bottle (43602-198-31) | Ascent Pharmaceuticals Inc | 43602-198-31 | 43602-198 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Solution | Oral | 100mg/5mL | 500 Ml In 1 Bottle (43602-198-50) | Ascent Pharmaceuticals Inc | 43602-198-50 | 43602-198 | ANDA209021 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (31722-917-01) | Camber Pharmaceuticals Inc | 31722-917-01 | 31722-917 | ANDA207418 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (31722-917-05) | Camber Pharmaceuticals Inc | 31722-917-05 | 31722-917 | ANDA207418 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (31722-918-01) | Camber Pharmaceuticals Inc | 31722-918-01 | 31722-918 | ANDA207418 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (31722-918-05) | Camber Pharmaceuticals Inc | 31722-918-05 | 31722-918 | ANDA207418 | ANDA | CII |
| Sildenafil Citrate | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (75834-272-00) | NIVAGEN PHARMACEUTICALS, INC. | 75834-272-00 | 75834-272 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (75834-272-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-272-30 | 75834-272 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (75834-272-90) | NIVAGEN PHARMACEUTICALS, INC. | 75834-272-90 | 75834-272 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (75834-240-00) | NIVAGEN PHARMACEUTICALS, INC. | 75834-240-00 | 75834-240 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (75834-240-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-240-01 | 75834-240 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (75834-240-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-240-05 | 75834-240 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (75834-240-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-240-30 | 75834-240 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (75834-241-00) | NIVAGEN PHARMACEUTICALS, INC. | 75834-241-00 | 75834-241 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (75834-241-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-241-01 | 75834-241 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (75834-241-05) | NIVAGEN PHARMACEUTICALS, INC. | 75834-241-05 | 75834-241 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (75834-241-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-241-30 | 75834-241 | ANDA209302 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-251-10) | AustarPharma LLC | 35561-251-10 | 35561-251 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-251-14) | AustarPharma LLC | 35561-251-14 | 35561-251 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-252-10) | AustarPharma LLC | 35561-252-10 | 35561-252 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-252-14) | AustarPharma LLC | 35561-252-14 | 35561-252 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-253-10) | AustarPharma LLC | 35561-253-10 | 35561-253 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-253-14) | AustarPharma LLC | 35561-253-14 | 35561-253 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Powder, For Suspension | Oral | 10mg/mL | 1 Bottle In 1 Carton (51672-4231-8) / 112 Ml In 1 Bottle | Taro Pharmaceuticals U.S.A. Inc. | 51672-4231-8 | 51672-4231 | ANDA215522 | ANDA | N/A |
| Sildenafil Citrate | Powder, For Suspension | Oral | 10mg/mL | 1 Bottle In 1 Carton (27808-163-01) / 112 Ml In 1 Bottle | Tris Pharma Inc | 27808-163-01 | 27808-163 | ANDA212312 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (42806-007-01) | Epic Pharma, LLC | 42806-007-01 | 42806-007 | ANDA202662 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (42806-008-01) | Epic Pharma, LLC | 42806-008-01 | 42806-008 | ANDA202662 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (42806-009-01) | Epic Pharma, LLC | 42806-009-01 | 42806-009 | ANDA202662 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-005-01) | Epic Pharma, LLC | 42806-005-01 | 42806-005 | ANDA202662 | ANDA | CII |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-251-10) | AustarPharma LLC | 35561-251-10 | 35561-251 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-251-14) | AustarPharma LLC | 35561-251-14 | 35561-251 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-252-10) | AustarPharma LLC | 35561-252-10 | 35561-252 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-252-14) | AustarPharma LLC | 35561-252-14 | 35561-252 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-253-10) | AustarPharma LLC | 35561-253-10 | 35561-253 | ANDA208494 | ANDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (35561-253-14) | AustarPharma LLC | 35561-253-14 | 35561-253 | ANDA208494 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-006-01) | Epic Pharma, LLC | 42806-006-01 | 42806-006 | ANDA202662 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (72865-128-01) | XLCare Pharmaceuticals, Inc | 72865-128-01 | 72865-128 | ANDA207418 | ANDA | CII |
| Sildenafil Citrate | Powder, For Suspension | Oral | 10mg/mL | 1 Bottle In 1 Carton (0069-0336-21) / 112 Ml In 1 Bottle | PFIZER LABORATORIES DIV PFIZER INC | 0069-0336-21 | 0069-0336 | NDA203109 | NDA | N/A |
| Sildenafil Citrate | Injection, Solution | Intravenous | .8mg/mL | 1 Vial In 1 Carton (0069-0338-01) / 12.5 Ml In 1 Vial | PFIZER LABORATORIES DIV PFIZER INC | 0069-0338-01 | 0069-0338 | NDA022473 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (0069-4190-68) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4190-68 | 0069-4190 | NDA021845 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-4200-30) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4200-30 | 0069-4200 | NDA020895 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-4210-30) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4210-30 | 0069-4210 | NDA020895 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (0069-4210-66) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4210-66 | 0069-4210 | NDA020895 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (0069-4220-30) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4220-30 | 0069-4220 | NDA020895 | NDA | N/A |
| Sildenafil Citrate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (0069-4220-66) | PFIZER LABORATORIES DIV PFIZER INC | 0069-4220-66 | 0069-4220 | NDA020895 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (61570-131-20) / 20 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 61570-131-20 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (61570-131-25) / 25 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 61570-131-25 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 400 G In 1 Jar (61570-131-40) | Pfizer Laboratories Div Pfizer Inc | 61570-131-40 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 50 G In 1 Jar (61570-131-50) | Pfizer Laboratories Div Pfizer Inc | 61570-131-50 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (61570-131-55) / 50 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 61570-131-55 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 1 Tube In 1 Carton (61570-131-85) / 85 G In 1 Tube | Pfizer Laboratories Div Pfizer Inc | 61570-131-85 | 61570-131 | NDA017381 | NDA | N/A |
| Silver Sulfadiazine | Cream | Topical | 10mg/g | 1000 G In 1 Jar (61570-131-98) | Pfizer Laboratories Div Pfizer Inc | 61570-131-98 | 61570-131 | NDA017381 | NDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-005-30) | St Marys Medical Park Pharmacy | 60760-005-30 | 60760-005 | ANDA078155 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (60760-005-90) | St Marys Medical Park Pharmacy | 60760-005-90 | 60760-005 | ANDA078155 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-006-30) | St Marys Medical Park Pharmacy | 60760-006-30 | 60760-006 | ANDA078155 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 80mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-019-30) | St Marys Medical Park Pharmacy | 60760-019-30 | 60760-019 | ANDA078155 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (60760-585-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-585-30 | 60760-585 | ANDA078103 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (72865-128-05) | XLCare Pharmaceuticals, Inc | 72865-128-05 | 72865-128 | ANDA207418 | ANDA | CII |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (72865-129-01) | XLCare Pharmaceuticals, Inc | 72865-129-01 | 72865-129 | ANDA207418 | ANDA | CII |
| Sirolimus | Solution | Oral | 1mg/mL | 1 Carton In 1 Kit (66689-347-02) / 1 Bottle In 1 Carton / 60 Ml In 1 Bottle | VistaPharm, LLC | 66689-347-02 | 66689-347 | ANDA211040 | ANDA | N/A |
| Sirolimus | Solution | Oral | 1mg/mL | 1 Bottle, Glass In 1 Carton (60505-6197-2) / 60 Ml In 1 Bottle, Glass | Apotex Corp | 60505-6197-2 | 60505-6197 | ANDA211406 | ANDA | N/A |
| Sirolimus | Solution | Oral | 1mg/mL | 1 Carton In 1 Kit (0008-1030-06) / 1 Bottle, Glass In 1 Carton (0008-1030-04) / 60 Ml In 1 Bottle, Glass | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1030-06 | 0008-1030 | NDA021083 | NDA | N/A |
| Sirolimus | Tablet, Sugar Coated | Oral | .5mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (0008-1040-05) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1040-05 | 0008-1040 | NDA021110 | NDA | N/A |
| Sirolimus | Tablet, Sugar Coated | Oral | .5mg/1 | 100 Blister Pack In 1 Carton (0008-1040-10) / 1 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1040-10 | 0008-1040 | NDA021110 | NDA | N/A |
| Sirolimus | Tablet, Sugar Coated | Oral | 1mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (0008-1041-05) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1041-05 | 0008-1041 | NDA021110 | NDA | N/A |
| Sirolimus | Tablet, Sugar Coated | Oral | 1mg/1 | 100 Blister Pack In 1 Carton (0008-1041-10) / 1 Tablet, Sugar Coated In 1 Blister Pack | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1041-10 | 0008-1041 | NDA021110 | NDA | N/A |
| Sirolimus | Tablet, Sugar Coated | Oral | 2mg/1 | 100 Tablet, Sugar Coated In 1 Bottle (0008-1042-05) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1042-05 | 0008-1042 | NDA021110 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection | Intravenous | 164mg/mL | 1 Vial In 1 Carton (0641-6261-01) / 20 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0641-6261-01 | 0641-6261 | ANDA216920 | ANDA | N/A |
| Sodium Acetate Anhydrous | Injection | Intravenous | 164mg/mL | 1 Vial In 1 Carton (0641-6262-01) / 50 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0641-6262-01 | 0641-6262 | ANDA216920 | ANDA | N/A |
| Sodium Acetate Anhydrous | Injection | Intravenous | 164mg/mL | 10 Vial In 1 Carton (0641-6263-10) / 100 Ml In 1 Vial (0641-6263-01) | Hikma Pharmaceuticals USA Inc. | 0641-6263-10 | 0641-6263 | ANDA216920 | ANDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 164mg/mL | 25 Vial In 1 Case (0409-3299-25) / 100 Ml In 1 Vial (0409-3299-45) | Hospira, Inc. | 0409-3299-25 | 0409-3299 | NDA018893 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 164mg/mL | 25 Vial In 1 Tray (0409-3299-26) / 50 Ml In 1 Vial (0409-3299-46) | Hospira, Inc. | 0409-3299-26 | 0409-3299 | NDA018893 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 164mg/mL | 25 Vial In 1 Tray (0409-3299-05) / 50 Ml In 1 Vial (0409-3299-15) | Hospira, Inc. | 0409-3299-05 | 0409-3299 | NDA018893 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 164mg/mL | 25 Vial In 1 Case (0409-3299-06) / 100 Ml In 1 Vial (0409-3299-16) | Hospira, Inc. | 0409-3299-06 | 0409-3299 | NDA018893 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 3.28g/20mL | 25 Vial, Single-Dose In 1 Tray (0409-7299-25) / 20 Ml In 1 Vial, Single-Dose (0409-7299-45) | Hospira, Inc. | 0409-7299-25 | 0409-7299 | NDA018893 | NDA | N/A |
| Sodium Acetate Anhydrous | Injection, Solution, Concentrate | Intravenous | 3.28g/20mL | 25 Vial, Single-Dose In 1 Tray (0409-7299-73) / 20 Ml In 1 Vial, Single-Dose (0409-7299-83) | Hospira, Inc. | 0409-7299-73 | 0409-7299 | NDA018893 | NDA | N/A |
| Sodium Benzoate; Sodium Phenylacetate | Injection, Solution, Concentrate | Intravenous | 100mg/mL, 100 mg/mL | 1 Vial In 1 Carton (68475-001-50) / 50 Ml In 1 Vial | Navinta LLC | 68475-001-50 | 68475-001 | ANDA205880 | ANDA | N/A |
| Sodium Bicarbonate | Solution | Intravenous | 84mg/mL | 20 Vial In 1 Carton (75834-286-20) / 50 Ml In 1 Vial (75834-286-01) | Nivagen Pharmaceuticals, Inc. | 75834-286-20 | 75834-286 | ANDA216042 | ANDA | N/A |
| Oxycodone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (72865-129-05) | XLCare Pharmaceuticals, Inc | 72865-129-05 | 72865-129 | ANDA207418 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-695-01) | Amneal Pharmaceuticals LLC | 64896-695-01 | 64896-695 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-695-03) | Amneal Pharmaceuticals LLC | 64896-695-03 | 64896-695 | ANDA079087 | ANDA | CII |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 84mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6625-14) / 50 Ml In 1 Vial, Single-Dose (0409-6625-22) | Hospira, Inc. | 0409-6625-14 | 0409-6625 | ANDA202432 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 84mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-6625-35) / 50 Ml In 1 Vial, Single-Dose (0409-6625-30) | Hospira, Inc. | 0409-6625-35 | 0409-6625 | ANDA202432 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 84mg/mL | 10 Carton In 1 Package (0409-6637-14) / 1 Syringe In 1 Carton / 50 Ml In 1 Syringe (0409-6637-24) | Hospira, Inc. | 0409-6637-14 | 0409-6637 | ANDA202494 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 42mg/mL | 10 Carton In 1 Package (0409-5534-14) / 1 Syringe In 1 Carton / 10 Ml In 1 Syringe (0409-5534-24) | Hospira, Inc. | 0409-5534-14 | 0409-5534 | ANDA202679 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 42mg/mL | 25 Vial, Single-Use In 1 Tray (0409-5555-02) / 5 Ml In 1 Vial, Single-Use (0409-5555-12) | Hospira, Inc. | 0409-5555-02 | 0409-5555 | ANDA202981 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 42mg/mL | 25 Vial, Single-Use In 1 Tray (0409-5555-01) / 5 Ml In 1 Vial, Single-Use (0409-5555-11) | Hospira, Inc. | 0409-5555-01 | 0409-5555 | ANDA202981 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 84mg/mL | 10 Carton In 1 Package (0409-4900-14) / 1 Syringe In 1 Carton / 10 Ml In 1 Syringe (0409-4900-24) | Hospira, Inc. | 0409-4900-14 | 0409-4900 | ANDA202495 | ANDA | N/A |
| Sodium Bicarbonate | Injection, Solution | Intravenous | 75mg/mL | 10 Carton In 1 Package (0409-4916-14) / 1 Syringe In 1 Carton / 50 Ml In 1 Syringe (0409-4916-24) | Hospira, Inc. | 0409-4916-14 | 0409-4916 | ANDA202494 | ANDA | N/A |
| Sodium Bicarbonate; Sodium Chloride | Powder, For Solution | Nasal | 22.2mg/100mg, 77.8 mg/100mg | 100 Packet In 1 Carton (42829-408-00) / 3000 Mg In 1 Packet | ASCENT CONSUMER PRODUCTS, INC. | 42829-408-00 | 42829-408 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Bicarbonate; Sodium Chloride | Powder, For Solution | Nasal | 22.2mg/100mg, 77.8 mg/100mg | 60 Packet In 1 Carton (42829-408-60) / 3000 Mg In 1 Packet | ASCENT CONSUMER PRODUCTS, INC. | 42829-408-60 | 42829-408 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Bicarbonate; Sodium Chloride | Powder, For Solution | Nasal | 700mg/3000mg, 2300 mg/3000mg | 3000 Mg In 1 Packet (42829-401-01) | ASCENT CONSUMER PRODUCTS, INC. | 42829-401-01 | 42829-401 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-695-08) | Amneal Pharmaceuticals LLC | 64896-695-08 | 64896-695 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 5mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-695-13) | Amneal Pharmaceuticals LLC | 64896-695-13 | 64896-695 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-696-01) | Amneal Pharmaceuticals LLC | 64896-696-01 | 64896-696 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-696-03) | Amneal Pharmaceuticals LLC | 64896-696-03 | 64896-696 | ANDA079087 | ANDA | CII |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Glass In 1 Carton (14789-133-05) / 10 Ml In 1 Vial, Glass (14789-133-07) | Nexus Pharmaceuticals LLC | 14789-133-05 | 14789-133 | ANDA217535 | ANDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Glass In 1 Carton (14789-134-05) / 20 Ml In 1 Vial, Glass (14789-134-07) | Nexus Pharmaceuticals LLC | 14789-134-05 | 14789-134 | ANDA217535 | ANDA | N/A |
| Sodium Chloride | Gel | Nasal | .9mg/100mL | 30 Ml In 1 Bottle, Spray (42829-407-10) | ASCENT CONSUMER PRODUCTS, INC | 42829-407-10 | 42829-407 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | 3g/100g | 129 G In 1 Bottle, Spray (42829-505-60) | ASCENT CONSUMER PRODUCTS, INC | 42829-505-60 | 42829-505 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | 3g/100g | 213 G In 1 Bottle, Spray (42829-505-75) | ASCENT CONSUMER PRODUCTS, INC | 42829-505-75 | 42829-505 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | .9g/100g | 127 G In 1 Bottle, Spray (42829-504-45) | ASCENT CONSUMER PRODUCTS, INC | 42829-504-45 | 42829-504 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | .9g/100g | 213 G In 1 Bottle, Spray (42829-504-75) | ASCENT CONSUMER PRODUCTS, INC | 42829-504-75 | 42829-504 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | .9g/100g | 127 G In 1 Bottle, Spray (42829-001-12) | ASCENT CONSUMER PRODUCTS, INC. | 42829-001-12 | 42829-001 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Spray | Nasal | .9g/100g | 127 G In 1 Bottle, Spray (42829-003-12) | ASCENT CONSUMER PRODUCTS, INC. | 42829-003-12 | 42829-003 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Chloride | Injection | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 100 Ampule In 1 Carton (0641-1512-36) / 10 Ml In 1 Ampule (0641-1512-10) | Hikma Pharmaceuticals USA Inc. | 0641-1512-36 | 0641-1512 | ANDA201850 | ANDA | N/A |
| Sodium Chloride | Injection | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial In 1 Carton (0641-6144-25) / 10 Ml In 1 Vial (0641-6144-01) | Hikma Pharmaceuticals USA Inc. | 0641-6144-25 | 0641-6144 | ANDA201833 | ANDA | N/A |
| Sodium Chloride | Injection | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial In 1 Carton (0641-0497-25) / 2 Ml In 1 Vial (0641-0497-17) | Hikma Pharmaceuticals USA Inc. | 0641-0497-25 | 0641-0497 | ANDA201833 | ANDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-1966-05) / 20 Ml In 1 Vial, Multi-Dose (0409-1966-01) | Hospira, Inc. | 0409-1966-05 | 0409-1966 | NDA018800 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-1966-07) / 30 Ml In 1 Vial, Multi-Dose (0409-1966-02) | Hospira, Inc. | 0409-1966-07 | 0409-1966 | NDA018800 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-1966-12) / 10 Ml In 1 Vial, Multi-Dose (0409-1966-06) | Hospira, Inc. | 0409-1966-12 | 0409-1966 | NDA018800 | NDA | N/A |
| Sodium Chloride | Injection, Solution, Concentrate | Intravenous | 5.84g/40mL | 25 Vial In 1 Tray (0409-6660-75) / 40 Ml In 1 Vial (0409-6660-01) | Hospira, Inc. | 0409-6660-75 | 0409-6660 | NDA018897 | NDA | N/A |
| Sodium Chloride | Injection, Solution, Concentrate | Intravenous | 234mg/mL | 25 Vial, Pharmacy Bulk Package In 1 Case (0409-1141-02) / 100 Ml In 1 Vial, Pharmacy Bulk Package (0409-1141-12) | Hospira, Inc. | 0409-1141-02 | 0409-1141 | NDA018897 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intravenous | 900mg/100mL | 24 Pouch In 1 Case (0409-7101-02) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag (0409-7101-04) | Hospira, Inc. | 0409-7101-02 | 0409-7101 | NDA019465 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intravenous | 900mg/100mL | 10 Pouch In 1 Case (0409-7101-66) / 5 Bag In 1 Pouch / 50 Ml In 1 Bag (0409-7101-68) | Hospira, Inc. | 0409-7101-66 | 0409-7101 | NDA019465 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intravenous | 900mg/100mL | 10 Pouch In 1 Case (0409-7101-67) / 5 Bag In 1 Pouch / 100 Ml In 1 Bag (0409-7101-69) | Hospira, Inc. | 0409-7101-67 | 0409-7101 | NDA019465 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4888-10) / 10 Ml In 1 Vial, Single-Dose (0409-4888-02) | Hospira, Inc. | 0409-4888-10 | 0409-4888 | NDA018803 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4888-12) / 10 Ml In 1 Vial, Single-Dose (0409-4888-01) | Hospira, Inc. | 0409-4888-12 | 0409-4888 | NDA018803 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4888-20) / 20 Ml In 1 Vial, Single-Dose (0409-4888-03) | Hospira, Inc. | 0409-4888-20 | 0409-4888 | NDA018803 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-4888-50) / 50 Ml In 1 Vial, Single-Dose (0409-4888-06) | Hospira, Inc. | 0409-4888-50 | 0409-4888 | NDA018803 | NDA | N/A |
| Sodium Chloride | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 9mg/mL | 10 Vial, Single-Dose In 1 Tray (0409-4888-90) / 10 Ml In 1 Vial, Single-Dose (0409-4888-02) | Hospira, Inc. | 0409-4888-90 | 0409-4888 | NDA018803 | NDA | N/A |
| Sodium Ferric Gluconate Complex | Injection | Intravenous | 12.5mg/mL | 10 Vial, Single-Dose In 1 Carton (0143-9298-10) / 5 Ml In 1 Vial, Single-Dose (0143-9298-01) | Hikma Pharmaceuticals USA Inc. | 0143-9298-10 | 0143-9298 | ANDA078215 | ANDA | N/A |
| Sodium Ferric Gluconate Complex | Injection | Intravenous | 12.5mg/mL | 10 Vial In 1 Carton (0143-9570-10) / 5 Ml In 1 Vial (0143-9570-01) | Hikma Pharmaceuticals USA Inc. | 0143-9570-10 | 0143-9570 | ANDA078215 | ANDA | N/A |
| Sodium Fluoride | Rinse | Dental | .5mg/mL | 237 Ml In 1 Bottle (66923-003-34) | Ranir LLC | 66923-003-34 | 66923-003 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .5mg/mL | 473 Ml In 1 Bottle (66923-003-43) | Ranir LLC | 66923-003-43 | 66923-003 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .5mg/mL | 473 Ml In 1 Bottle (66923-004-16) | Ranir LLC | 66923-004-16 | 66923-004 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .5mg/mL | 473 Ml In 1 Bottle (66923-007-00) | Ranir LLC | 66923-007-00 | 66923-007 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .5mg/mL | 473 Ml In 1 Bottle (66923-111-43) | Ranir LLC | 66923-111-43 | 66923-111 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Paste, Dentifrice | Dental | 2.2mg/g | 119 G In 1 Tube (66923-006-00) | Ranir LLC | 66923-006-00 | 66923-006 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Paste, Dentifrice | Dental | 2.4mg/g | 119 G In 1 Tube (66923-005-00) | Ranir LLC | 66923-005-00 | 66923-005 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .1mg/mL | 400 Ml In 1 Bottle (66923-300-08) | Ranir LLC | 66923-300-08 | 66923-300 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Rinse | Dental | .1mg/mL | 1000 Ml In 1 Bottle (66923-300-64) | Ranir LLC | 66923-300-64 | 66923-300 | part355 | OTC MONOGRAPH FINAL | N/A |
| Sodium Fluoride | Paste, Dentifrice | Oral | 24.3mg/g | 1 Tube In 1 Carton (66923-373-02) / 99.2 G In 1 Tube (66923-373-01) | Ranir LLC | 66923-373-02 | 66923-373 | part355 | OTC MONOGRAPH FINAL | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-696-08) | Amneal Pharmaceuticals LLC | 64896-696-08 | 64896-696 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 7.5mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-696-13) | Amneal Pharmaceuticals LLC | 64896-696-13 | 64896-696 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-697-01) | Amneal Pharmaceuticals LLC | 64896-697-01 | 64896-697 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-697-03) | Amneal Pharmaceuticals LLC | 64896-697-03 | 64896-697 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-697-08) | Amneal Pharmaceuticals LLC | 64896-697-08 | 64896-697 | ANDA079087 | ANDA | CII |
| Sodium Iodide I-131 | Solution | Oral | 1000mCi/mL | 1 Vial In 1 Kit (65174-880-00) / 1 Ml In 1 Vial | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-880-00 | 65174-880 | NDA021305 | NDA | N/A |
| Sodium Iodide I-131 | Solution | Oral | 1000mCi/mL | 1 Vial In 1 Kit (65174-880-25) / .25 Ml In 1 Vial | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-880-25 | 65174-880 | NDA021305 | NDA | N/A |
| Sodium Iodide I-131 | Solution | Oral | 1000mCi/mL | 1 Vial In 1 Kit (65174-880-50) / .5 Ml In 1 Vial | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-880-50 | 65174-880 | NDA021305 | NDA | N/A |
| Sodium Iodide I-131 | Capsule | Oral | 100mCi/1 | 5 Capsule In 1 Vial (65174-461-05) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-461-05 | 65174-461 | NDA021305 | NDA | N/A |
| Sodium Monofluorophosphate | Paste, Dentifrice | Oral | 88.4mg/g | 1 Tube In 1 Carton (66923-258-02) / 99.2 G In 1 Tube (66923-258-01) | Ranir LLC | 66923-258-02 | 66923-258 | M021 | OTC MONOGRAPH DRUG | N/A |
| Sodium Nitroprusside | Injection, Solution | Intravenous | 50mg/2mL | 1 Vial, Single-Dose In 1 Carton (71288-202-02) / 2 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-202-02 | 71288-202 | ANDA211016 | ANDA | N/A |
| Sodium Nitroprusside | Injection | Intravenous | 25mg/mL | 1 Vial, Glass In 1 Carton (14789-012-02) / 2 Ml In 1 Vial, Glass | Nexus Pharmaceuticals Inc | 14789-012-02 | 14789-012 | ANDA207499 | ANDA | N/A |
| Sodium Nitroprusside | Injection, Solution, Concentrate | Intravenous | 25mg/mL | 1 Vial In 1 Carton (70069-261-01) / 2 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-261-01 | 70069-261 | ANDA210882 | ANDA | N/A |
| Sodium Oxybate | Solution | Oral | .5g/mL | 180 Ml In 1 Bottle, Plastic (0054-9628-57) | Hikma Pharmaceuticals USA Inc. | 0054-9628-57 | 0054-9628 | NDA021196 | NDA AUTHORIZED GENERIC | CIII |
| Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Injection, Solution | Intravenous | 142mg/mL, 276 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-7305-25) / 5 Ml In 1 Vial, Single-Dose (0517-7305-01) | American Regent, Inc. | 0517-7305-25 | 0517-7305 | ANDA218314 | ANDA | N/A |
| Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Injection, Solution | Intravenous | 142mg/mL, 276 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-7315-25) / 15 Ml In 1 Vial, Single-Dose (0517-7315-01) | American Regent, Inc. | 0517-7315-25 | 0517-7315 | ANDA218314 | ANDA | N/A |
| Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Injection, Solution | Intravenous | 142mg/mL, 276 mg/mL | 25 Vial, Single-Dose In 1 Tray (0517-7350-25) / 50 Ml In 1 Vial, Single-Dose (0517-7350-01) | American Regent, Inc. | 0517-7350-25 | 0517-7350 | ANDA218314 | ANDA | N/A |
| Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Injection, Solution | Intravenous | 142mg/mL, 276 mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-7391-72) / 15 Ml In 1 Vial, Single-Dose (0409-7391-82) | Hospira, Inc. | 0409-7391-72 | 0409-7391 | NDA018892 | NDA | N/A |
| Sodium Polystyrene Sulfonate | Powder | Oral; Rectal | 1g/g | 15 G In 1 Bottle (10702-036-15) | KVK-Tech, Inc. | 10702-036-15 | 10702-036 | ANDA040905 | ANDA | N/A |
| Sodium Polystyrene Sulfonate | Powder | Oral; Rectal | 1g/g | 454 G In 1 Jar (10702-036-45) | KVK-Tech, Inc. | 10702-036-45 | 10702-036 | ANDA040905 | ANDA | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 10mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-697-13) | Amneal Pharmaceuticals LLC | 64896-697-13 | 64896-697 | ANDA079087 | ANDA | CII |
| Sodium Polystyrene Sulfonate | Powder, For Suspension | Oral; Rectal | 4.1meq/g | 454 G In 1 Bottle (62250-660-23) | Belcher Pharmaceuticals, LLC | 62250-660-23 | 62250-660 | ANDA205727 | ANDA | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-698-01) | Amneal Pharmaceuticals LLC | 64896-698-01 | 64896-698 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-698-03) | Amneal Pharmaceuticals LLC | 64896-698-03 | 64896-698 | ANDA079087 | ANDA | CII |
| Sodium Tetradecyl Sulfate | Injection, Solution | Intravenous | 30mg/mL | 5 Vial, Glass In 1 Carton (24201-201-05) / 2 Ml In 1 Vial, Glass (24201-201-01) | Hikma Pharmaceuticals USA Inc. | 24201-201-05 | 24201-201 | ANDA209937 | ANDA | N/A |
| Sofpironium Bromide | Gel | Topical | 87mg/.67mL | 1 Bottle In 1 Carton (83723-010-50) / 50 Ml In 1 Bottle | Botanix SB Inc. | 83723-010-50 | 83723-010 | NDA217347 | NDA | N/A |
| Solenopsis Invicta | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-6513-1) | Jubilant HollisterStier LLC | 65044-6513-1 | 65044-6513 | BLA103888 | BLA | N/A |
| Solenopsis Invicta | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-6513-2) | Jubilant HollisterStier LLC | 65044-6513-2 | 65044-6513 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-6515-1) | Jubilant HollisterStier LLC | 65044-6515-1 | 65044-6515 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-6517-2) | Jubilant HollisterStier LLC | 65044-6517-2 | 65044-6517 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-6517-3) | Jubilant HollisterStier LLC | 65044-6517-3 | 65044-6517 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-6517-4) | Jubilant HollisterStier LLC | 65044-6517-4 | 65044-6517 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-6518-2) | Jubilant HollisterStier LLC | 65044-6518-2 | 65044-6518 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-6518-3) | Jubilant HollisterStier LLC | 65044-6518-3 | 65044-6518 | BLA103888 | BLA | N/A |
| Solenopsis Invicta; Solenopsis Richteri | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-6518-4) | Jubilant HollisterStier LLC | 65044-6518-4 | 65044-6518 | BLA103888 | BLA | N/A |
| Solidago Canadensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1630-2) | Jubilant HollisterStier LLC | 65044-1630-2 | 65044-1630 | BLA103888 | BLA | N/A |
| Solidago Canadensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1630-3) | Jubilant HollisterStier LLC | 65044-1630-3 | 65044-1630 | BLA103888 | BLA | N/A |
| Solidago Canadensis Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1630-4) | Jubilant HollisterStier LLC | 65044-1630-4 | 65044-1630 | BLA103888 | BLA | N/A |
| Solidago Canadensis Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1631-1) | Jubilant HollisterStier LLC | 65044-1631-1 | 65044-1631 | BLA103888 | BLA | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-698-08) | Amneal Pharmaceuticals LLC | 64896-698-08 | 64896-698 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 15mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-698-13) | Amneal Pharmaceuticals LLC | 64896-698-13 | 64896-698 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 20mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-699-01) | Amneal Pharmaceuticals LLC | 64896-699-01 | 64896-699 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 20mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-699-03) | Amneal Pharmaceuticals LLC | 64896-699-03 | 64896-699 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 20mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-699-08) | Amneal Pharmaceuticals LLC | 64896-699-08 | 64896-699 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 20mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-699-13) | Amneal Pharmaceuticals LLC | 64896-699-13 | 64896-699 | ANDA079087 | ANDA | CII |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-285-10) | AustarPharma LLC | 35561-285-10 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (35561-285-11) | AustarPharma LLC | 35561-285-11 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (35561-285-13) | AustarPharma LLC | 35561-285-13 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-286-10) | AustarPharma LLC | 35561-286-10 | 35561-286 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (35561-286-11) | AustarPharma LLC | 35561-286-11 | 35561-286 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (35561-286-13) | AustarPharma LLC | 35561-286-13 | 35561-286 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-471-30) | Golden State Medical Supply, Inc. | 51407-471-30 | 51407-471 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-471-90) | Golden State Medical Supply, Inc. | 51407-471-90 | 51407-471 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-472-30) | Golden State Medical Supply, Inc. | 51407-472-30 | 51407-472 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-472-90) | Golden State Medical Supply, Inc. | 51407-472-90 | 51407-472 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4702-3) | Apotex Corp. | 60505-4702-3 | 60505-4702 | ANDA209333 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4703-3) | Apotex Corp. | 60505-4703-3 | 60505-4703 | ANDA209333 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-285-10) | AustarPharma LLC | 35561-285-10 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (35561-285-11) | AustarPharma LLC | 35561-285-11 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (35561-285-13) | AustarPharma LLC | 35561-285-13 | 35561-285 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (35561-286-10) | AustarPharma LLC | 35561-286-10 | 35561-286 | ANDA210281 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (35561-286-11) | AustarPharma LLC | 35561-286-11 | 35561-286 | ANDA210281 | ANDA | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-700-01) | Amneal Pharmaceuticals LLC | 64896-700-01 | 64896-700 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-700-03) | Amneal Pharmaceuticals LLC | 64896-700-03 | 64896-700 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-700-08) | Amneal Pharmaceuticals LLC | 64896-700-08 | 64896-700 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 30mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-700-13) | Amneal Pharmaceuticals LLC | 64896-700-13 | 64896-700 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 40mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (64896-701-01) | Amneal Pharmaceuticals LLC | 64896-701-01 | 64896-701 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 40mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (64896-701-03) | Amneal Pharmaceuticals LLC | 64896-701-03 | 64896-701 | ANDA079087 | ANDA | CII |
| Somatrogon | Injection, Solution | Subcutaneous | 60mg/1.2mL | 1 Cartridge In 1 Carton (0069-0520-02) / 1.2 Ml In 1 Cartridge (0069-0520-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0520-02 | 0069-0520 | BLA761184 | BLA | N/A |
| Somatrogon | Injection, Solution | Subcutaneous | 24mg/1.2mL | 1 Cartridge In 1 Carton (0069-0505-02) / 1.2 Ml In 1 Cartridge (0069-0505-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0505-02 | 0069-0505 | BLA761184 | BLA | N/A |
| Sorafenib | Tablet, Film Coated | Oral | 200mg/1 | 120 Tablet, Film Coated In 1 Bottle (51407-760-12) | Golden State Medical Supply, Inc. | 51407-760-12 | 51407-760 | ANDA209050 | ANDA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1744-2) | Jubilant HollisterStier LLC | 65044-1744-2 | 65044-1744 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1744-3) | Jubilant HollisterStier LLC | 65044-1744-3 | 65044-1744 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1744-4) | Jubilant HollisterStier LLC | 65044-1744-4 | 65044-1744 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1745-1) | Jubilant HollisterStier LLC | 65044-1745-1 | 65044-1745 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1747-2) | Jubilant HollisterStier LLC | 65044-1747-2 | 65044-1747 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1747-3) | Jubilant HollisterStier LLC | 65044-1747-3 | 65044-1747 | BLA103888 | BLA | N/A |
| Sorghum Halepense Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1747-4) | Jubilant HollisterStier LLC | 65044-1747-4 | 65044-1747 | BLA103888 | BLA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle, Plastic (60505-0222-1) | Apotex Corp. | 60505-0222-1 | 60505-0222 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle, Plastic (60505-0222-2) | Apotex Corp. | 60505-0222-2 | 60505-0222 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle, Plastic (60505-0223-1) | Apotex Corp. | 60505-0223-1 | 60505-0223 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 1000 Tablet In 1 Bottle, Plastic (60505-0223-2) | Apotex Corp. | 60505-0223-2 | 60505-0223 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 100 Tablet In 1 Bottle, Plastic (60505-0224-1) | Apotex Corp. | 60505-0224-1 | 60505-0224 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle, Plastic (60505-0224-2) | Apotex Corp. | 60505-0224-2 | 60505-0224 | ANDA076214 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle (60505-0080-0) | Apotex Corp. | 60505-0080-0 | 60505-0080 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (60505-0080-1) | Apotex Corp. | 60505-0080-1 | 60505-0080 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 100 Tablet In 1 Bottle (60505-0081-0) | Apotex Corp. | 60505-0081-0 | 60505-0081 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle (60505-0081-1) | Apotex Corp. | 60505-0081-1 | 60505-0081 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 240mg/1 | 100 Tablet In 1 Bottle (60505-0082-0) | Apotex Corp. | 60505-0082-0 | 60505-0082 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 240mg/1 | 1000 Tablet In 1 Bottle (60505-0082-1) | Apotex Corp. | 60505-0082-1 | 60505-0082 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (60505-0159-0) | Apotex Corp. | 60505-0159-0 | 60505-0159 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 1000 Tablet In 1 Bottle (60505-0159-1) | Apotex Corp. | 60505-0159-1 | 60505-0159 | ANDA076140 | ANDA | N/A |
| Sotalol Hydrochloride | Solution | Oral | 5mg/mL | 250 Ml In 1 Bottle (24338-530-25) | Azurity Pharmaceuticals, Inc. | 24338-530-25 | 24338-530 | NDA205108 | NDA | N/A |
| Sotalol Hydrochloride | Solution | Oral | 5mg/mL | 480 Ml In 1 Bottle (24338-530-48) | Azurity Pharmaceuticals, Inc. | 24338-530-48 | 24338-530 | NDA205108 | NDA | N/A |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 40mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (64896-701-08) | Amneal Pharmaceuticals LLC | 64896-701-08 | 64896-701 | ANDA079087 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet, Film Coated, Extended Release | Oral | 40mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (64896-701-13) | Amneal Pharmaceuticals LLC | 64896-701-13 | 64896-701 | ANDA079087 | ANDA | CII |
| OXYMORPHONE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-929-01) | Camber Pharmaceuticals, Inc | 31722-929-01 | 31722-929 | ANDA210175 | ANDA | CII |
| OXYMORPHONE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-930-01) | Camber Pharmaceuticals, Inc | 31722-930-01 | 31722-930 | ANDA210175 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (42806-330-01) | Epic Pharma, LLC | 42806-330-01 | 42806-330 | ANDA201187 | ANDA | CII |
| Oxymorphone Hydrochloride | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (42806-331-01) | Epic Pharma, LLC | 42806-331-01 | 42806-331 | ANDA201187 | ANDA | CII |
| Soybean | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3596-2) | Jubilant HollisterStier LLC | 65044-3596-2 | 65044-3596 | BLA103888 | BLA | N/A |
| Spironolactone | Suspension | Oral | 25mg/5mL | 118 Ml In 1 Bottle (0574-1133-04) | Padagis US LLC | 0574-1133-04 | 0574-1133 | NDA209478 | NDA AUTHORIZED GENERIC | N/A |
| Spironolactone | Suspension | Oral | 25mg/5mL | 10 Cup, Unit-Dose In 1 Carton (0574-1133-10) / 5 Ml In 1 Cup, Unit-Dose (0574-1133-05) | Padagis US LLC | 0574-1133-10 | 0574-1133 | NDA209478 | NDA AUTHORIZED GENERIC | N/A |
| Spironolactone | Suspension | Oral | 25mg/5mL | 473 Ml In 1 Bottle (0574-1133-16) | Padagis US LLC | 0574-1133-16 | 0574-1133 | NDA209478 | NDA AUTHORIZED GENERIC | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-216-01) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-01 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-216-05) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-05 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-216-10) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-10 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-216-06) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-06 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-216-09) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-09 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (59746-216-15) | Jubilant Cadista Pharmacuticals Inc. | 59746-216-15 | 59746-216 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-217-01) | Jubilant Cadista Pharmacuticals Inc. | 59746-217-01 | 59746-217 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-217-05) | Jubilant Cadista Pharmacuticals Inc. | 59746-217-05 | 59746-217 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-217-06) | Jubilant Cadista Pharmacuticals Inc. | 59746-217-06 | 59746-217 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-217-09) | Jubilant Cadista Pharmacuticals Inc. | 59746-217-09 | 59746-217 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-218-01) | Jubilant Cadista Pharmacuticals Inc. | 59746-218-01 | 59746-218 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-218-05) | Jubilant Cadista Pharmacuticals Inc. | 59746-218-05 | 59746-218 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-218-06) | Jubilant Cadista Pharmacuticals Inc. | 59746-218-06 | 59746-218 | ANDA203253 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (59746-218-09) | Jubilant Cadista Pharmacuticals Inc. | 59746-218-09 | 59746-218 | ANDA203253 | ANDA | N/A |
| OXYMORPHONE HYDROCHLORIDE | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (72865-130-01) | XLCare Pharmaceuticals, Inc. | 72865-130-01 | 72865-130 | ANDA210175 | ANDA | CII |
| OXYMORPHONE HYDROCHLORIDE | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (72865-131-01) | XLCare Pharmaceuticals, Inc. | 72865-131-01 | 72865-131 | ANDA210175 | ANDA | CII |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-280-03) | Amneal Pharmaceuticals LLC | 65162-280-03 | 65162-280 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-280-09) | Amneal Pharmaceuticals LLC | 65162-280-09 | 65162-280 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-281-03) | Amneal Pharmaceuticals LLC | 65162-281-03 | 65162-281 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-281-09) | Amneal Pharmaceuticals LLC | 65162-281-09 | 65162-281 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-282-03) | Amneal Pharmaceuticals LLC | 65162-282-03 | 65162-282 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-282-09) | Amneal Pharmaceuticals LLC | 65162-282-09 | 65162-282 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (65162-283-03) | Amneal Pharmaceuticals LLC | 65162-283-03 | 65162-283 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 90 Tablet, Extended Release In 1 Bottle (65162-283-09) | Amneal Pharmaceuticals LLC | 65162-283-09 | 65162-283 | ANDA204707 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (43975-349-03) | ANI Pharmaceuticals, Inc. | 43975-349-03 | 43975-349 | ANDA204452 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (43975-350-03) | ANI Pharmaceuticals, Inc. | 43975-350-03 | 43975-350 | ANDA204452 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (43975-351-03) | ANI Pharmaceuticals, Inc. | 43975-351-03 | 43975-351 | ANDA204452 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (43975-352-03) | ANI Pharmaceuticals, Inc. | 43975-352-03 | 43975-352 | ANDA204452 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-294-05) | Ascent Pharmaceuticals, Inc. | 43602-294-05 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-294-07) | Ascent Pharmaceuticals, Inc. | 43602-294-07 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-294-30) | Ascent Pharmaceuticals, Inc. | 43602-294-30 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-295-05) | Ascent Pharmaceuticals, Inc. | 43602-295-05 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-295-07) | Ascent Pharmaceuticals, Inc. | 43602-295-07 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-295-30) | Ascent Pharmaceuticals, Inc. | 43602-295-30 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-296-05) | Ascent Pharmaceuticals, Inc. | 43602-296-05 | 43602-296 | ANDA216174 | ANDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (0025-1001-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1001-31 | 0025-1001 | NDA012151 | NDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (0025-1031-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1031-31 | 0025-1031 | NDA012151 | NDA | N/A |
| Spironolactone | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (0025-1041-31) | Pfizer Laboratories Div Pfizer Inc | 0025-1041-31 | 0025-1041 | NDA012151 | NDA | N/A |
| Strawberry | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-3626-2) | Jubilant HollisterStier LLC | 65044-3626-2 | 65044-3626 | BLA103888 | BLA | N/A |
| String Bean | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3074-2) | Jubilant HollisterStier LLC | 65044-3074-2 | 65044-3074 | BLA103888 | BLA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Multi-Dose In 1 Carton (71288-719-11) / 10 Ml In 1 Vial, Multi-Dose (71288-719-10) | Meitheal Pharmaceuticals Inc. | 71288-719-11 | 71288-719 | ANDA214514 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Multi-Dose In 1 Tray (75834-151-25) / 10 Ml In 1 Vial, Multi-Dose (75834-151-02) | Nivagen Pharmaceuticals, Inc. | 75834-151-25 | 75834-151 | ANDA211625 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial In 1 Carton (25021-677-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-677-10 | 25021-677 | ANDA215022 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 10 Vial In 1 Carton (70069-783-10) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-783-10 | 70069-783 | ANDA211589 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial In 1 Carton (70069-783-25) / 10 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-783-25 | 70069-783 | ANDA211589 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 10 Vial In 1 Carton (70069-301-10) / 10 Ml In 1 Vial (70069-301-01) | Somerset Therapeutics, LLC | 70069-301-10 | 70069-301 | ANDA211589 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial In 1 Carton (70069-301-25) / 10 Ml In 1 Vial (70069-301-01) | Somerset Therapeutics, LLC | 70069-301-25 | 70069-301 | ANDA211589 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-296-07) | Ascent Pharmaceuticals, Inc. | 43602-296-07 | 43602-296 | ANDA216174 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-6629-02) / 10 Ml In 1 Vial, Multi-Dose (0409-6629-12) | Hospira, Inc. | 0409-6629-02 | 0409-6629 | NDA008845 | NDA | N/A |
| Succinylcholine Chloride Dihydrate | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 10 Syringe, Plastic In 1 Carton (0641-6234-10) / 5 Ml In 1 Syringe, Plastic | Hikma Pharmaceuticals USA Inc. | 0641-6234-10 | 0641-6234 | NDA215143 | NDA | N/A |
| Succinylcholine Chloride Dihydrate | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial In 1 Carton (0143-9338-25) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9338-25 | 0143-9338 | ANDA213229 | ANDA | N/A |
| Sucralfate | Tablet | Oral | 1g/1 | 100 Tablet In 1 Bottle, Plastic (29033-003-01) | Nostrum Laboratories, Inc. | 29033-003-01 | 29033-003 | ANDA074415 | ANDA | N/A |
| Sucralfate | Tablet | Oral | 1g/1 | 500 Tablet In 1 Bottle, Plastic (29033-003-05) | Nostrum Laboratories, Inc. | 29033-003-05 | 29033-003 | ANDA074415 | ANDA | N/A |
| Sucralfate | Tablet | Oral | 1g/1 | 90 Tablet In 1 Bottle, Plastic (51407-881-90) | Golden State Medical Supply, Inc. | 51407-881-90 | 51407-881 | ANDA074415 | ANDA | N/A |
| Sucralfate | Suspension | Oral | 1g/10mL | 1 Bottle, Plastic In 1 Carton (66689-305-16) / 414 Ml In 1 Bottle, Plastic | VistaPharm, LLC | 66689-305-16 | 66689-305 | ANDA211884 | ANDA | N/A |
| Sufentanil Citrate | Injection | Epidural; Intravenous | .05mg/mL | 10 Ampule In 1 Carton (0641-6110-10) / 1 Ml In 1 Ampule (0641-6110-01) | Hikma Pharmaceuticals USA Inc. | 0641-6110-10 | 0641-6110 | ANDA074413 | ANDA | CII |
| Sufentanil Citrate | Injection | Epidural; Intravenous | .05mg/mL | 10 Ampule In 1 Carton (0641-6111-10) / 2 Ml In 1 Ampule (0641-6111-01) | Hikma Pharmaceuticals USA Inc. | 0641-6111-10 | 0641-6111 | ANDA074413 | ANDA | CII |
| Sufentanil Citrate | Injection | Epidural; Intravenous | .05mg/mL | 10 Ampule In 1 Carton (0641-6112-10) / 5 Ml In 1 Ampule (0641-6112-01) | Hikma Pharmaceuticals USA Inc. | 0641-6112-10 | 0641-6112 | ANDA074413 | ANDA | CII |
| Sufentanil Citrate | Injection, Solution | Epidural; Intravenous | 50ug/mL | 10 Vial, Single-Dose In 1 Carton (0409-3382-21) / 1 Ml In 1 Vial, Single-Dose (0409-3382-11) | Hospira, Inc. | 0409-3382-21 | 0409-3382 | ANDA074534 | ANDA | CII |
| Sulfacetamide Sodium | Lotion | Topical | 100mg/mL | 118 Ml In 1 Bottle, Plastic (45802-896-26) | Padagis Israel Pharmaceuticals Ltd | 45802-896-26 | 45802-896 | ANDA078649 | ANDA | N/A |
| Sulfacetamide Sodium | Ointment | Ophthalmic | 100mg/g | 1 Tube In 1 Carton (0574-4190-35) / 3.5 G In 1 Tube | Padagis US LLC | 0574-4190-35 | 0574-4190 | ANDA080029 | ANDA | N/A |
| Sulfacetamide Sodium | Liquid | Topical | 100mg/mL | 480 Ml In 1 Bottle (42192-129-16) | Acella Pharmaceuticals, LLC | 42192-129-16 | 42192-129 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium | Gel | Topical | 100mg/mL | 355 Ml In 1 Bottle (42192-146-12) | Acella Pharmaceuticals, LLC | 42192-146-12 | 42192-146 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Solution | Topical | 100mg/g, 20 mg/g | 227 G In 1 Bottle (42192-147-08) | Acella Pharmaceuticals, LLC | 42192-147-08 | 42192-147 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Cream | Topical | 100mg/g, 20 mg/g | 57 G In 1 Tube (42192-150-02) | Acella Pharmaceuticals, LLC | 42192-150-02 | 42192-150 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Rinse | Topical | 10mg/g, 5 mg/g | 170.3 G In 1 Bottle (42192-136-06) | Acella Pharmaceuticals, LLC | 42192-136-06 | 42192-136 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Rinse | Topical | 10mg/g, 5 mg/g | 227 G In 1 Bottle (42192-136-08) | Acella Pharmaceuticals, LLC | 42192-136-08 | 42192-136 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Rinse | Topical | 10mg/g, 5 mg/g | 340.2 G In 1 Bottle (42192-136-12) | Acella Pharmaceuticals, LLC | 42192-136-12 | 42192-136 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Aerosol, Foam | Topical | 10mg/g, 5 mg/g | 100 G In 1 Can (42192-143-01) | Acella Pharmaceuticals, LLC | 42192-143-01 | 42192-143 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Aerosol, Foam | Topical | 10mg/g, 5 mg/g | 60 G In 1 Can (42192-143-60) | Acella Pharmaceuticals, LLC | 42192-143-60 | 42192-143 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Rinse | Topical | 9mg/g, 4.5 mg/g | 1 Bottle In 1 Carton (42192-144-16) / 454 G In 1 Bottle | Acella Pharmaceuticals, LLC | 42192-144-16 | 42192-144 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Liquid | Topical | 98mg/g, 48 mg/g | 285 G In 1 Bottle, Plastic (42192-156-10) | Acella Pharmaceuticals, LLC | 42192-156-10 | 42192-156 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Liquid | Topical | 100mg/g, 10 mg/g | 1 Tube In 1 Carton (42192-104-06) / 170.1 G In 1 Tube | Acella Pharmaceuticals, LLC | 42192-104-06 | 42192-104 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Solution | Topical | 80mg/mL, 40 mg/mL | 473 Ml In 1 Bottle (42192-133-16) | Acella Pharmaceuticals, LLC | 42192-133-16 | 42192-133 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Cream | Topical | 100mg/g, 50 mg/g | 28 G In 1 Tube (42192-139-01) | Acella Pharmaceuticals, LLC | 42192-139-01 | 42192-139 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide Sodium; Sulfur | Cream | Topical | 100mg/g, 50 mg/g | 57 G In 1 Tube (42192-149-02) | Acella Pharmaceuticals, LLC | 42192-149-02 | 42192-149 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sulfacetamide; Sulfur | Liquid | Topical | 90mg/473.2mL, 40 mg/473.2mL | 473.2 Ml In 1 Bottle (42192-121-16) | ACELLA PHARMACEUTICALS | 42192-121-16 | 42192-121 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-296-30) | Ascent Pharmaceuticals, Inc. | 43602-296-30 | 43602-296 | ANDA216174 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Suspension | Oral | 200mg/5mL, 40 mg/5mL | 473 Ml In 1 Bottle, Plastic (66993-727-57) | Prasco Laboratories | 66993-727-57 | 66993-727 | ANDA077612 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 6 Tablet In 1 Bottle, Plastic (60760-541-06) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-541-06 | 60760-541 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 14 Tablet In 1 Bottle, Plastic (60760-541-14) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-541-14 | 60760-541 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-541-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-541-20 | 60760-541 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Injection, Solution, Concentrate | Intravenous | 80mg/mL, 16 mg/mL | 1 Vial In 1 Carton (70069-363-01) / 30 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-363-01 | 70069-363 | ANDA212231 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Injection, Solution, Concentrate | Intravenous | 80mg/mL, 16 mg/mL | 10 Vial In 1 Carton (70069-361-10) / 5 Ml In 1 Vial (70069-361-01) | Somerset Therapeutics, LLC | 70069-361-10 | 70069-361 | ANDA212231 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Injection, Solution, Concentrate | Intravenous | 80mg/mL, 16 mg/mL | 10 Vial In 1 Carton (70069-362-10) / 10 Ml In 1 Vial (70069-362-01) | Somerset Therapeutics, LLC | 70069-362-10 | 70069-362 | ANDA212231 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 100 Tablet In 1 Bottle, Plastic (60429-259-01) | Golden State Medical Supply, Inc. | 60429-259-01 | 60429-259 | ANDA071017 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 100 Tablet In 1 Bottle (61971-115-01) | Vista Pharmaceuticals, Inc. | 61971-115-01 | 61971-115 | ANDA076817 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 500 Tablet In 1 Bottle (61971-115-05) | Vista Pharmaceuticals, Inc. | 61971-115-05 | 61971-115 | ANDA076817 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 100 Tablet In 1 Bottle (61971-120-01) | Vista Pharmaceuticals, Inc. | 61971-120-01 | 61971-120 | ANDA076817 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 500 Tablet In 1 Bottle (61971-120-05) | Vista Pharmaceuticals, Inc. | 61971-120-05 | 61971-120 | ANDA076817 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-297-05) | Ascent Pharmaceuticals, Inc. | 43602-297-05 | 43602-297 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-297-07) | Ascent Pharmaceuticals, Inc. | 43602-297-07 | 43602-297 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-297-30) | Ascent Pharmaceuticals, Inc. | 43602-297-30 | 43602-297 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-294-05) | Ascent Pharmaceuticals, Inc. | 43602-294-05 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-294-07) | Ascent Pharmaceuticals, Inc. | 43602-294-07 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-294-30) | Ascent Pharmaceuticals, Inc. | 43602-294-30 | 43602-294 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-295-05) | Ascent Pharmaceuticals, Inc. | 43602-295-05 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-295-07) | Ascent Pharmaceuticals, Inc. | 43602-295-07 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-295-30) | Ascent Pharmaceuticals, Inc. | 43602-295-30 | 43602-295 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-296-05) | Ascent Pharmaceuticals, Inc. | 43602-296-05 | 43602-296 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-296-07) | Ascent Pharmaceuticals, Inc. | 43602-296-07 | 43602-296 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-296-30) | Ascent Pharmaceuticals, Inc. | 43602-296-30 | 43602-296 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-297-05) | Ascent Pharmaceuticals, Inc. | 43602-297-05 | 43602-297 | ANDA216174 | ANDA | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 7 Tablet, Extended Release In 1 Bottle (43602-297-07) | Ascent Pharmaceuticals, Inc. | 43602-297-07 | 43602-297 | ANDA216174 | ANDA | N/A |
| Sulfasalazine | Tablet | Oral | 500mg/1 | 1 Bottle In 1 Carton (0013-0101-10) / 100 Tablet In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0013-0101-10 | 0013-0101 | NDA007073 | NDA | N/A |
| Sulfasalazine | Tablet | Oral | 500mg/1 | 1 Bottle In 1 Carton (0013-0101-30) / 300 Tablet In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0013-0101-30 | 0013-0101 | NDA007073 | NDA | N/A |
| Sulfasalazine | Tablet, Delayed Release | Oral | 500mg/1 | 1 Bottle In 1 Carton (0013-0102-50) / 100 Tablet, Delayed Release In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0013-0102-50 | 0013-0102 | NDA007073 | NDA | N/A |
| Sulfasalazine | Tablet, Delayed Release | Oral | 500mg/1 | 1 Bottle In 1 Carton (0013-0102-60) / 300 Tablet, Delayed Release In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0013-0102-60 | 0013-0102 | NDA007073 | NDA | N/A |
| Sulfur | Gel | Topical | 1[hp_X]/g | 1 Tube In 1 Carton (52389-173-21) / 21 G In 1 Tube (52389-173-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-173-21 | 52389-173 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Sulfur | Gel | Topical | 1[hp_X]/g | 2 Tube In 1 Carton (52389-173-42) / 21 G In 1 Tube (52389-173-01) | Alva-Amco Pharmacal Companies, Inc. | 52389-173-42 | 52389-173 | N/A | UNAPPROVED HOMEOPATHIC | N/A |
| Paliperidone | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-297-30) | Ascent Pharmaceuticals, Inc. | 43602-297-30 | 43602-297 | ANDA216174 | ANDA | N/A |
| PALIPERIDONE | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-317-30) | Camber Pharmaceuticals, Inc | 31722-317-30 | 31722-317 | ANDA216174 | ANDA | N/A |
| PALIPERIDONE | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-318-30) | Camber Pharmaceuticals, Inc | 31722-318-30 | 31722-318 | ANDA216174 | ANDA | N/A |
| PALIPERIDONE | Tablet, Extended Release | Oral | 6mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-319-30) | Camber Pharmaceuticals, Inc | 31722-319-30 | 31722-319 | ANDA216174 | ANDA | N/A |
| PALIPERIDONE | Tablet, Extended Release | Oral | 9mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-320-30) | Camber Pharmaceuticals, Inc | 31722-320-30 | 31722-320 | ANDA216174 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 30 Tablet, Delayed Release In 1 Bottle (65162-636-03) | Amneal Pharmaceuticals LLC | 65162-636-03 | 65162-636 | ANDA205119 | ANDA | N/A |
| Sumatriptan | Spray | Nasal | 20mg/1 | 6 Container In 1 Carton (45802-598-06) / 1 Spray In 1 Container (45802-598-00) | Padagis Israel Pharmaceuticals Ltd | 45802-598-06 | 45802-598 | ANDA213465 | ANDA | N/A |
| Sumatriptan | Spray | Nasal | 5mg/1 | 6 Container In 1 Carton (45802-619-06) / 1 Spray In 1 Container (45802-619-00) | Padagis Israel Pharmaceuticals Ltd | 45802-619-06 | 45802-619 | ANDA213465 | ANDA | N/A |
| Sumatriptan | Spray | Nasal | 5mg/100uL | 6 Container In 1 Box (66993-081-69) / 100 Ul In 1 Container | Prasco Laboratories | 66993-081-69 | 66993-081 | NDA020626 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan | Spray | Nasal | 20mg/100uL | 6 Container In 1 Box (66993-082-69) / 100 Ul In 1 Container | Prasco Laboratories | 66993-082-69 | 66993-082 | NDA020626 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 6mg/.5mL | 2 Syringe In 1 Carton (66993-084-79) / .5 Ml In 1 Syringe | Prasco Laboratories | 66993-084-79 | 66993-084 | NDA020080 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 6mg/.5mL | 1 Package In 1 Carton (66993-084-98) / 2 Syringe In 1 Package / .5 Ml In 1 Syringe | Prasco Laboratories | 66993-084-98 | 66993-084 | NDA020080 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 4mg/.5mL | 2 Syringe In 1 Carton (66993-083-79) / .5 Ml In 1 Syringe | Prasco Laboratories | 66993-083-79 | 66993-083 | NDA020080 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 4mg/.5mL | 1 Package In 1 Carton (66993-083-98) / 2 Syringe In 1 Package / .5 Ml In 1 Syringe | Prasco Laboratories | 66993-083-98 | 66993-083 | NDA020080 | NDA AUTHORIZED GENERIC | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 6mg/.5mL | 1 Vial In 1 Carton (70069-804-01) / .5 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-804-01 | 70069-804 | ANDA213998 | ANDA | N/A |
| Sumatriptan Succinate | Injection, Solution | Subcutaneous | 6mg/.5mL | 5 Vial In 1 Carton (70069-804-05) / .5 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-804-05 | 70069-804 | ANDA213998 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 25mg/1 | 9 Tablet, Film Coated In 1 Bottle, Plastic (51407-011-09) | Golden State Medical Supply, Inc. | 51407-011-09 | 51407-011 | ANDA077744 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 50mg/1 | 9 Tablet, Film Coated In 1 Bottle, Plastic (51407-012-09) | Golden State Medical Supply, Inc. | 51407-012-09 | 51407-012 | ANDA077744 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 100mg/1 | 9 Tablet, Film Coated In 1 Bottle, Plastic (51407-013-09) | Golden State Medical Supply, Inc. | 51407-013-09 | 51407-013 | ANDA077744 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 25mg/1 | 1 Blister Pack In 1 Carton (69452-344-72) / 9 Tablet, Film Coated In 1 Blister Pack (69452-344-60) | Bionpharma Inc. | 69452-344-72 | 69452-344 | ANDA078284 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 50mg/1 | 1 Blister Pack In 1 Carton (69452-345-72) / 9 Tablet, Film Coated In 1 Blister Pack (69452-345-60) | Bionpharma Inc. | 69452-345-72 | 69452-345 | ANDA078284 | ANDA | N/A |
| Sumatriptan Succinate | Tablet, Film Coated | Oral | 100mg/1 | 1 Blister Pack In 1 Carton (69452-346-72) / 9 Tablet, Film Coated In 1 Blister Pack (69452-346-60) | Bionpharma Inc. | 69452-346-72 | 69452-346 | ANDA078284 | ANDA | N/A |
| Sumatriptan Succinate | Injection | Subcutaneous | 6mg/.5mL | 5 Vial In 1 Carton (0143-9638-05) / .5 Ml In 1 Vial (0143-9638-01) | Hikma Pharmaceuticals USA Inc. | 0143-9638-05 | 0143-9638 | ANDA200183 | ANDA | N/A |
| Sumatriptan Succinate | Injection | Subcutaneous | 6mg/.5mL | 25 Vial In 1 Carton (0143-9638-25) / .5 Ml In 1 Vial (0143-9638-01) | Hikma Pharmaceuticals USA Inc. | 0143-9638-25 | 0143-9638 | ANDA200183 | ANDA | N/A |
| Sunitinib Malate | Capsule | Oral | 12.5mg/1 | 28 Capsule In 1 Bottle (0069-0550-38) | Pfizer Laboratories Div Pfizer Inc | 0069-0550-38 | 0069-0550 | NDA021938 | NDA | N/A |
| Sunitinib Malate | Capsule | Oral | 25mg/1 | 28 Capsule In 1 Bottle (0069-0770-38) | Pfizer Laboratories Div Pfizer Inc | 0069-0770-38 | 0069-0770 | NDA021938 | NDA | N/A |
| Sunitinib Malate | Capsule | Oral | 37.5mg/1 | 28 Capsule In 1 Bottle (0069-0830-38) | Pfizer Laboratories Div Pfizer Inc | 0069-0830-38 | 0069-0830 | NDA021938 | NDA | N/A |
| Sunitinib Malate | Capsule | Oral | 50mg/1 | 28 Capsule In 1 Bottle (0069-0980-38) | Pfizer Laboratories Div Pfizer Inc | 0069-0980-38 | 0069-0980 | NDA021938 | NDA | N/A |
| Syagrus Romanzoffiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-2074-2) | Jubilant HollisterStier LLC | 65044-2074-2 | 65044-2074 | BLA103888 | BLA | N/A |
| Syagrus Romanzoffiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-2074-3) | Jubilant HollisterStier LLC | 65044-2074-3 | 65044-2074 | BLA103888 | BLA | N/A |
| Syagrus Romanzoffiana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-2074-4) | Jubilant HollisterStier LLC | 65044-2074-4 | 65044-2074 | BLA103888 | BLA | N/A |
| Syagrus Romanzoffiana Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-2075-1) | Jubilant HollisterStier LLC | 65044-2075-1 | 65044-2075 | BLA103888 | BLA | N/A |
| Tacrolimus | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-700-00) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-700-00 | 45802-700 | NDA050777 | NDA | N/A |
| Tacrolimus | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-700-01) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-700-01 | 45802-700 | NDA050777 | NDA | N/A |
| Tacrolimus | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-700-02) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-700-02 | 45802-700 | NDA050777 | NDA | N/A |
| Tacrolimus | Ointment | Topical | .3mg/g | 1 Tube In 1 Carton (45802-390-00) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-390-00 | 45802-390 | NDA050777 | NDA | N/A |
| Tacrolimus | Ointment | Topical | .3mg/g | 1 Tube In 1 Carton (45802-390-01) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-390-01 | 45802-390 | NDA050777 | NDA | N/A |
| Tacrolimus | Ointment | Topical | .3mg/g | 1 Tube In 1 Carton (45802-390-02) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-390-02 | 45802-390 | NDA050777 | NDA | N/A |
| Tacrolimus | Capsule | Oral | .5mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-377-01) | Golden State Medical Supply, Inc. | 60429-377-01 | 60429-377 | ANDA090596 | ANDA | N/A |
| Tacrolimus | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-378-01) | Golden State Medical Supply, Inc. | 60429-378-01 | 60429-378 | ANDA090596 | ANDA | N/A |
| Tacrolimus | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle, Plastic (60429-379-01) | Golden State Medical Supply, Inc. | 60429-379-01 | 60429-379 | ANDA090596 | ANDA | N/A |
| Tacrolimus | Capsule | Oral | .5mg/1 | 100 Capsule In 1 Bottle (62250-665-02) | Belcher Pharmaceuticals,LLC | 62250-665-02 | 62250-665 | ANDA206651 | ANDA | N/A |
| Tacrolimus | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (62250-666-02) | Belcher Pharmaceuticals,LLC | 62250-666-02 | 62250-666 | ANDA206651 | ANDA | N/A |
| Tacrolimus | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (62250-667-02) | Belcher Pharmaceuticals,LLC | 62250-667-02 | 62250-667 | ANDA206651 | ANDA | N/A |
| Tacrolimus | Capsule, Gelatin Coated | Oral | .5mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (69452-153-20) | BionPharma Inc., | 69452-153-20 | 69452-153 | ANDA090802 | ANDA | N/A |
| Tacrolimus | Capsule, Gelatin Coated | Oral | 1mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (69452-154-20) | BionPharma Inc., | 69452-154-20 | 69452-154 | ANDA090802 | ANDA | N/A |
| Tacrolimus | Capsule, Gelatin Coated | Oral | 5mg/1 | 100 Capsule, Gelatin Coated In 1 Bottle (69452-155-20) | BionPharma Inc., | 69452-155-20 | 69452-155 | ANDA090802 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 2.5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (75834-247-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-247-01 | 75834-247 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Blister Pack (75834-247-15) | NIVAGEN PHARMACEUTICALS, INC. | 75834-247-15 | 75834-247 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-247-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-247-30 | 75834-247 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (75834-248-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-248-01 | 75834-248 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Blister Pack (75834-248-15) | NIVAGEN PHARMACEUTICALS, INC. | 75834-248-15 | 75834-248 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-248-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-248-30 | 75834-248 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (75834-249-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-249-01 | 75834-249 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Blister Pack (75834-249-10) | NIVAGEN PHARMACEUTICALS, INC. | 75834-249-10 | 75834-249 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-249-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-249-30 | 75834-249 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (75834-250-01) | NIVAGEN PHARMACEUTICALS, INC. | 75834-250-01 | 75834-250 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Blister Pack (75834-250-10) | NIVAGEN PHARMACEUTICALS, INC. | 75834-250-10 | 75834-250 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (75834-250-30) | NIVAGEN PHARMACEUTICALS, INC. | 75834-250-30 | 75834-250 | ANDA211298 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle (66302-467-60) | United Therapeutics Corporation | 66302-467-60 | 66302-467 | NDA022332 | NDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (65162-636-09) | Amneal Pharmaceuticals LLC | 65162-636-09 | 65162-636 | ANDA205119 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 30 Tablet, Delayed Release In 1 Bottle (65162-637-03) | Amneal Pharmaceuticals LLC | 65162-637-03 | 65162-637 | ANDA205119 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (65162-637-09) | Amneal Pharmaceuticals LLC | 65162-637-09 | 65162-637 | ANDA205119 | ANDA | N/A |
| Tafamidis | Capsule, Liquid Filled | Oral | 61mg/1 | 30 Blister Pack In 1 Carton (0069-8730-30) / 1 Capsule, Liquid Filled In 1 Blister Pack (0069-8730-01) | Pfizer Laboratories Div Pfizer Inc | 0069-8730-30 | 0069-8730 | NDA212161 | NDA | N/A |
| Tafamidis Meglumine | Capsule, Liquid Filled | Oral | 20mg/1 | 4 Carton In 1 Carton (0069-1975-40) / 30 Blister Pack In 1 Carton / 1 Capsule, Liquid Filled In 1 Blister Pack (0069-1975-12) | Pfizer Laboratories Div Pfizer Inc | 0069-1975-40 | 0069-1975 | NDA211996 | NDA | N/A |
| Tafluprost | Solution/ Drops | Ophthalmic | .0045mg/.3mL | 3 Pouch In 1 Carton (66993-429-30) / 10 Vial, Single-Use In 1 Pouch (66993-429-81) / .3 Ml In 1 Vial, Single-Use | Prasco Laboratories | 66993-429-30 | 66993-429 | NDA202514 | NDA AUTHORIZED GENERIC | N/A |
| Talazoparib Tosylate | Capsule | Oral | .25mg/1 | 1 Bottle In 1 Carton (0069-0296-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-0296-30 | 0069-0296 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | .5mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0546-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0546-30 | 0069-0546 | NDA217439 | NDA | N/A |
| Talazoparib Tosylate | Capsule | Oral | .5mg/1 | 1 Bottle In 1 Carton (0069-1501-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-1501-30 | 0069-1501 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | .75mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0655-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0655-30 | 0069-0655 | NDA217439 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | 1mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0757-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0757-30 | 0069-0757 | NDA217439 | NDA | N/A |
| Talazoparib Tosylate | Capsule | Oral | .75mg/1 | 1 Bottle In 1 Carton (0069-1751-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-1751-30 | 0069-1751 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | .25mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0353-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0353-30 | 0069-0353 | NDA217439 | NDA | N/A |
| Talazoparib Tosylate | Capsule | Oral | .1mg/1 | 1 Bottle In 1 Carton (0069-1031-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-1031-30 | 0069-1031 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule | Oral | 1mg/1 | 1 Bottle In 1 Carton (0069-1195-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-1195-30 | 0069-1195 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | .35mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0454-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0454-30 | 0069-0454 | NDA217439 | NDA | N/A |
| Talazoparib Tosylate | Capsule | Oral | .35mg/1 | 1 Bottle In 1 Carton (0069-1235-30) / 30 Capsule In 1 Bottle | Pfizer Laboratories Div Pfizer Inc | 0069-1235-30 | 0069-1235 | NDA211651 | NDA | N/A |
| Talazoparib Tosylate | Capsule, Liquid Filled | Oral | .1mg/1 | 30 Capsule, Liquid Filled In 1 Bottle (0069-0252-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0252-30 | 0069-0252 | NDA217439 | NDA | N/A |
| Taliglucerase Alfa | Injection, Powder, Lyophilized, For Solution | Intravenous | 200U/5mL | 1 Vial, Glass In 1 Carton (0069-0106-01) / 5 Ml In 1 Vial, Glass | Pfizer Laboratories Div Pfizer Inc | 0069-0106-01 | 0069-0106 | BLA022458 | BLA | N/A |
| Tamoxifen Citrate | Tablet, Film Coated | Oral | 10mg/1 | 60 Tablet, Film Coated In 1 Bottle (51407-439-60) | Golden State Medical Supply, Inc. | 51407-439-60 | 51407-439 | ANDA075797 | ANDA | N/A |
| Tamoxifen Citrate | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-440-30) | Golden State Medical Supply, Inc. | 51407-440-30 | 51407-440 | ANDA075797 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (65162-637-11) | Amneal Pharmaceuticals LLC | 65162-637-11 | 65162-637 | ANDA205119 | ANDA | N/A |
| Tamsulosin Hydrochloride | Capsule | Oral | .4mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-450-90) | St. Mary's Medical Park Pharmacy | 60760-450-90 | 60760-450 | ANDA204645 | ANDA | N/A |
| Tamsulosin Hydrochloride | Capsule | Oral | .4mg/1 | 90 Capsule In 1 Bottle (51407-879-90) | Golden State Medical Supply, Inc. | 51407-879-90 | 51407-879 | ANDA207405 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 500 Tablet, Delayed Release In 1 Bottle (65162-637-50) | Amneal Pharmaceuticals LLC | 65162-637-50 | 65162-637 | ANDA205119 | ANDA | N/A |
| pantoprazole sodium | Injection, Powder, For Solution | Intravenous | 40mg/1 | 10 Vial, Single-Dose In 1 Carton (31722-204-10) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (31722-204-31) | Camber Pharmaceuticals, Inc. | 31722-204-10 | 31722-204 | ANDA213778 | ANDA | N/A |
| Tasimelteon | Capsule | Oral | 20mg/1 | 30 Capsule In 1 Bottle (60505-4665-3) | Apotex Corp. | 60505-4665-3 | 60505-4665 | ANDA211607 | ANDA | N/A |
| Tasimelteon | Capsule | Oral | 20mg/1 | 90 Capsule In 1 Bottle (60505-4665-9) | Apotex Corp. | 60505-4665-9 | 60505-4665 | ANDA211607 | ANDA | N/A |
| Tavaborole | Solution | Topical | 43.5mg/mL | 1 Bottle, Glass In 1 Carton (0574-0157-10) / 10 Ml In 1 Bottle, Glass | Padagis US LLC | 0574-0157-10 | 0574-0157 | ANDA211848 | ANDA | N/A |
| Tavaborole | Solution | Topical | 43.5mg/mL | 1 Bottle, With Applicator In 1 Carton (51672-1397-9) / 10 Ml In 1 Bottle, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-1397-9 | 51672-1397 | ANDA212215 | ANDA | N/A |
| Taxodium Distichum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .02g/mL | 10 Ml In 1 Vial (65044-1453-2) | Jubilant HollisterStier LLC | 65044-1453-2 | 65044-1453 | BLA103888 | BLA | N/A |
| Taxodium Distichum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .02g/mL | 30 Ml In 1 Vial (65044-1453-3) | Jubilant HollisterStier LLC | 65044-1453-3 | 65044-1453 | BLA103888 | BLA | N/A |
| Taxodium Distichum Pollen | Injection, Solution | Percutaneous; Subcutaneous | .02g/mL | 50 Ml In 1 Vial (65044-1453-4) | Jubilant HollisterStier LLC | 65044-1453-4 | 65044-1453 | BLA103888 | BLA | N/A |
| Taxodium Distichum Pollen | Injection, Solution | Percutaneous | .02g/mL | 5 Ml In 1 Vial (65044-1454-1) | Jubilant HollisterStier LLC | 65044-1454-1 | 65044-1454 | BLA103888 | BLA | N/A |
| Tazarotene | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (45802-436-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-436-01 | 45802-436 | ANDA213079 | ANDA | N/A |
| Tazarotene | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (45802-436-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-436-94 | 45802-436 | ANDA213079 | ANDA | N/A |
| Tazarotene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (45802-442-01) / 100 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-442-01 | 45802-442 | ANDA213079 | ANDA | N/A |
| Tazarotene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (45802-442-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-442-94 | 45802-442 | ANDA213079 | ANDA | N/A |
| Tazarotene | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-706-94) / 30 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-706-94 | 45802-706 | ANDA217075 | ANDA | N/A |
| Tazarotene | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (45802-706-96) / 60 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-706-96 | 45802-706 | ANDA217075 | ANDA | N/A |
| Tazarotene | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1373-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1373-2 | 51672-1373 | ANDA208258 | ANDA | N/A |
| Tazarotene | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1373-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1373-3 | 51672-1373 | ANDA208258 | ANDA | N/A |
| Tazarotene | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1374-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1374-2 | 51672-1374 | ANDA208258 | ANDA | N/A |
| Tazarotene | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0670-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0670-31 | 0713-0670 | ANDA208662 | ANDA | N/A |
| Tazarotene | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0670-60) / 60 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0670-60 | 0713-0670 | ANDA208662 | ANDA | N/A |
| Tazarotene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0804-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0804-31 | 0713-0804 | ANDA214136 | ANDA | N/A |
| Tazarotene | Gel | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0804-99) / 100 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0804-99 | 0713-0804 | ANDA214136 | ANDA | N/A |
| Tazarotene | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0805-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0805-31 | 0713-0805 | ANDA215433 | ANDA | N/A |
| Tazarotene | Gel | Topical | .5mg/g | 1 Tube In 1 Carton (0713-0805-99) / 100 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0805-99 | 0713-0805 | ANDA215433 | ANDA | N/A |
| Technetium Tc-99M Exametazime | Injection, Powder, Lyophilized, For Solution | Intravenous | .5mg/1 | 5 Vial In 1 Carton (65174-200-05) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (65174-200-01) | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-200-05 | 65174-200 | NDA208870 | NDA | N/A |
| Technetium Tc-99M Sestamibi | Injection, Powder, For Solution | Intravenous | 1mg/mL | 5 Vial In 1 Kit (45548-141-05) / 10 Ml In 1 Vial | Jubilant Draximage (USA) Inc. | 45548-141-05 | 45548-141 | ANDA078806 | ANDA | N/A |
| Technetium Tc-99M Sestamibi | Injection, Powder, For Solution | Intravenous | 1mg/mL | 10 Vial In 1 Kit (45548-141-10) / 10 Ml In 1 Vial | Jubilant Draximage (USA) Inc. | 45548-141-10 | 45548-141 | ANDA078806 | ANDA | N/A |
| Technetium Tc-99M Sestamibi | Injection, Powder, For Solution | Intravenous | 1mg/mL | 30 Vial In 1 Kit (45548-141-30) / 10 Ml In 1 Vial | Jubilant Draximage (USA) Inc. | 45548-141-30 | 45548-141 | ANDA078806 | ANDA | N/A |
| pantoprazole sodium | Injection, Powder, For Solution | Intravenous | 40mg/1 | 25 Vial, Single-Dose In 1 Carton (31722-204-32) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose (31722-204-31) | Camber Pharmaceuticals, Inc. | 31722-204-32 | 31722-204 | ANDA213778 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 20mg/1 | 10 Tablet, Delayed Release In 1 Blister Pack (31722-712-31) | Camber Pharmaceuticals, Inc. | 31722-712-31 | 31722-712 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 20mg/1 | 10 Tablet, Delayed Release In 1 Carton (31722-712-32) | Camber Pharmaceuticals, Inc. | 31722-712-32 | 31722-712 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (31722-712-90) | Camber Pharmaceuticals, Inc. | 31722-712-90 | 31722-712 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (31722-713-10) | Camber Pharmaceuticals, Inc. | 31722-713-10 | 31722-713 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 10 Tablet, Delayed Release In 1 Blister Pack (31722-713-31) | Camber Pharmaceuticals, Inc. | 31722-713-31 | 31722-713 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 10 Tablet, Delayed Release In 1 Carton (31722-713-32) | Camber Pharmaceuticals, Inc. | 31722-713-32 | 31722-713 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (31722-713-90) | Camber Pharmaceuticals, Inc. | 31722-713-90 | 31722-713 | ANDA202882 | ANDA | N/A |
| Pantoprazole Sodium | Granule, Delayed Release | Oral | 40mg/1 | 30 Packet In 1 Carton (31722-032-32) / 1 Granule, Delayed Release In 1 Packet | Camber Pharmaceuticals, Inc. | 31722-032-32 | 31722-032 | ANDA216139 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (50742-151-10) | Ingenus Pharmaceuticals, LLC | 50742-151-10 | 50742-151 | ANDA211368 | ANDA | N/A |
| Pantoprazole Sodium | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (50742-151-90) | Ingenus Pharmaceuticals, LLC | 50742-151-90 | 50742-151 | ANDA211368 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (72865-229-90) | XLCare Pharmaceuticals Inc. | 72865-229-90 | 72865-229 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (72865-230-10) | XLCare Pharmaceuticals Inc. | 72865-230-10 | 72865-230 | ANDA202882 | ANDA | N/A |
| PANTOPRAZOLE SODIUM | Tablet, Delayed Release | Oral | 40mg/1 | 90 Tablet, Delayed Release In 1 Bottle (72865-230-90) | XLCare Pharmaceuticals Inc. | 72865-230-90 | 72865-230 | ANDA202882 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 1ug/1 | 30 Capsule In 1 Bottle (65162-822-03) | Amneal Pharmaceuticals LLC | 65162-822-03 | 65162-822 | ANDA204327 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 1ug/1 | 90 Capsule In 1 Bottle (65162-822-09) | Amneal Pharmaceuticals LLC | 65162-822-09 | 65162-822 | ANDA204327 | ANDA | N/A |
| Temazepam | Capsule | Oral | 15mg/1 | 500 Capsule In 1 Bottle (51407-507-05) | Golden State Medical Supply, Inc. | 51407-507-05 | 51407-507 | ANDA211542 | ANDA | CIV |
| Temazepam | Capsule | Oral | 30mg/1 | 500 Capsule In 1 Bottle (51407-508-05) | Golden State Medical Supply, Inc. | 51407-508-05 | 51407-508 | ANDA211542 | ANDA | CIV |
| Paricalcitol | Capsule | Oral | 2ug/1 | 30 Capsule In 1 Bottle (65162-823-03) | Amneal Pharmaceuticals LLC | 65162-823-03 | 65162-823 | ANDA204327 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 2ug/1 | 90 Capsule In 1 Bottle (65162-823-09) | Amneal Pharmaceuticals LLC | 65162-823-09 | 65162-823 | ANDA204327 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 4ug/1 | 30 Capsule In 1 Bottle (65162-824-03) | Amneal Pharmaceuticals LLC | 65162-824-03 | 65162-824 | ANDA204327 | ANDA | N/A |
| Paricalcitol | Capsule | Oral | 4ug/1 | 90 Capsule In 1 Bottle (65162-824-09) | Amneal Pharmaceuticals LLC | 65162-824-09 | 65162-824 | ANDA204327 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 5ug/mL | 25 Vial, Single-Dose In 1 Carton (70121-1034-5) / 1 Ml In 1 Vial, Single-Dose (70121-1034-1) | Amneal Pharmaceuticals LLC | 70121-1034-5 | 70121-1034 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 5ug/mL | 10 Vial, Single-Dose In 1 Carton (70121-1034-7) / 1 Ml In 1 Vial, Single-Dose (70121-1034-1) | Amneal Pharmaceuticals LLC | 70121-1034-7 | 70121-1034 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 10ug/2mL | 25 Vial, Single-Dose In 1 Carton (70121-1035-5) / 2 Ml In 1 Vial, Single-Dose (70121-1035-1) | Amneal Pharmaceuticals LLC | 70121-1035-5 | 70121-1035 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 10ug/2mL | 10 Vial, Single-Dose In 1 Carton (70121-1035-7) / 2 Ml In 1 Vial, Single-Dose (70121-1035-1) | Amneal Pharmaceuticals LLC | 70121-1035-7 | 70121-1035 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 2ug/mL | 25 Vial, Single-Dose In 1 Carton (70121-1033-5) / 1 Ml In 1 Vial, Single-Dose (70121-1033-1) | Amneal Pharmaceuticals LLC | 70121-1033-5 | 70121-1033 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 2ug/mL | 10 Vial, Single-Dose In 1 Carton (70121-1033-7) / 1 Ml In 1 Vial, Single-Dose (70121-1033-1) | Amneal Pharmaceuticals LLC | 70121-1033-7 | 70121-1033 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 10ug/2mL | 25 Vial, Multi-Dose In 1 Carton (70121-1036-5) / 2 Ml In 1 Vial, Multi-Dose (70121-1036-1) | Amneal Pharmaceuticals LLC | 70121-1036-5 | 70121-1036 | ANDA206699 | ANDA | N/A |
| Paricalcitol | Injection | Intravenous | 10ug/2mL | 10 Vial, Multi-Dose In 1 Carton (70121-1036-7) / 2 Ml In 1 Vial, Multi-Dose (70121-1036-1) | Amneal Pharmaceuticals LLC | 70121-1036-7 | 70121-1036 | ANDA206699 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 1 Bottle In 1 Carton (75834-132-05) / 5 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-132-05 | 75834-132 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 1 Carton In 1 Carton (75834-132-14) / 1 Capsule In 1 Carton | Nivagen Pharmaceuticals, Inc. | 75834-132-14 | 75834-132 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 1 Bottle In 1 Carton (75834-142-05) / 5 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-142-05 | 75834-142 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 1 Bottle In 1 Carton (75834-142-14) / 14 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-142-14 | 75834-142 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 100mg/1 | 1 Bottle In 1 Carton (75834-143-05) / 5 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-143-05 | 75834-143 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 100mg/1 | 1 Carton In 1 Carton (75834-143-14) / 14 Capsule In 1 Carton | Nivagen Pharmaceuticals, Inc. | 75834-143-14 | 75834-143 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 140mg/1 | 1 Bottle In 1 Carton (75834-144-05) / 5 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-144-05 | 75834-144 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 140mg/1 | 1 Bottle In 1 Carton (75834-144-14) / 14 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-144-14 | 75834-144 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 180mg/1 | 1 Carton In 1 Carton (75834-145-05) / 5 Capsule In 1 Carton | Nivagen Pharmaceuticals, Inc. | 75834-145-05 | 75834-145 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 180mg/1 | 1 Carton In 1 Carton (75834-145-14) / 14 Capsule In 1 Carton | Nivagen Pharmaceuticals, Inc. | 75834-145-14 | 75834-145 | ANDA213328 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 250mg/1 | 1 Bottle In 1 Carton (75834-146-05) / 5 Capsule In 1 Bottle | Nivagen Pharmaceuticals, Inc. | 75834-146-05 | 75834-146 | ANDA213328 | ANDA | N/A |
| Paroxetine Hydrochloride Hemihydrate | Suspension | Oral | 10mg/5mL | 250 Ml In 1 Bottle (70954-319-10) | ANI Pharmaceuticals, Inc. | 70954-319-10 | 70954-319 | ANDA215003 | ANDA | N/A |
| Pegfilgrastim | Injection | Subcutaneous | 6mg/.6mL | 1 Syringe In 1 Carton (70121-1627-1) / .6 Ml In 1 Syringe | Amneal Pharmaceuticals LLC | 70121-1627-1 | 70121-1627 | BLA761084 | BLA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/10mL | 1 Vial, Single-Dose In 1 Carton (70121-1232-1) / 10 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1232-1 | 70121-1232 | ANDA210047 | ANDA | N/A |
| Pemetrexed Disodium | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 1 Vial, Single-Dose In 1 Carton (70121-1233-1) / 20 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1233-1 | 70121-1233 | ANDA210047 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection | Intravenous | 500mg/50mL | 1 Vial In 1 Carton (70121-2461-1) / 50 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-2461-1 | 70121-2461 | NDA215179 | NDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection | Intravenous | 1000mg/100mL | 1 Vial In 1 Carton (70121-2462-1) / 100 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-2462-1 | 70121-2462 | NDA215179 | NDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 100mg/4mL | 1 Vial In 1 Carton (50742-340-01) / 4 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-340-01 | 50742-340 | ANDA204890 | ANDA | N/A |
| Pemetrexed Disodium Hemipentahydrate | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/20mL | 1 Vial In 1 Carton (50742-341-01) / 20 Ml In 1 Vial | Ingenus Pharmaceuticals, LLC | 50742-341-01 | 50742-341 | ANDA204890 | ANDA | N/A |
| Penicillamine | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (62559-970-01) | ANI Pharmaceuticals, Inc. | 62559-970-01 | 62559-970 | ANDA209921 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 250mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-040-01) | Rising Health, LLC | 57237-040-01 | 57237-040 | ANDA065435 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 250mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-040-99) | Rising Health, LLC | 57237-040-99 | 57237-040 | ANDA065435 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (57237-041-01) | Rising Health, LLC | 57237-041-01 | 57237-041 | ANDA065435 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-041-05) | Rising Health, LLC | 57237-041-05 | 57237-041 | ANDA065435 | ANDA | N/A |
| Penicillin V Potassium | Tablet, Film Coated | Oral | 500mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-041-99) | Rising Health, LLC | 57237-041-99 | 57237-041 | ANDA065435 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (70954-668-10) | ANI Pharmaceuticals, Inc. | 70954-668-10 | 70954-668 | ANDA074878 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 500 Tablet, Extended Release In 1 Bottle (70954-668-20) | ANI Pharmaceuticals, Inc. | 70954-668-20 | 70954-668 | ANDA074878 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-856-01) | Rising Pharma Holdings, Inc. | 16571-856-01 | 16571-856 | ANDA074425 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 500 Tablet, Extended Release In 1 Bottle (16571-856-50) | Rising Pharma Holdings, Inc. | 16571-856-50 | 16571-856 | ANDA074425 | ANDA | N/A |
| Pentoxifylline | Tablet, Extended Release | Oral | 400mg/1 | 1 Blister Pack In 1 Carton (16571-856-90) / 10 Tablet, Extended Release In 1 Blister Pack | Rising Pharma Holdings, Inc. | 16571-856-90 | 16571-856 | ANDA074425 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-290-01) | Rising Pharma Holdings, Inc. | 64980-290-01 | 64980-290 | ANDA205056 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 4mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-291-01) | Rising Pharma Holdings, Inc. | 64980-291-01 | 64980-291 | ANDA205056 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 8mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-292-01) | Rising Pharma Holdings, Inc. | 64980-292-01 | 64980-292 | ANDA205056 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 90 Capsule In 1 Bottle, Plastic (60760-816-90) | St Mary's Medical Park Pharmacy | 60760-816-90 | 60760-816 | ANDA075614 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 1000 Capsule In 1 Bottle (51407-732-10) | Golden State Medical Supply, Inc. | 51407-732-10 | 51407-732 | ANDA074823 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 1000 Capsule In 1 Bottle (51407-733-10) | Golden State Medical Supply, Inc. | 51407-733-10 | 51407-733 | ANDA074823 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 1000 Capsule In 1 Bottle (51407-734-10) | Golden State Medical Supply, Inc. | 51407-734-10 | 51407-734 | ANDA074823 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (51407-735-10) | Golden State Medical Supply, Inc. | 51407-735-10 | 51407-735 | ANDA074823 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (69452-331-20) | Bionpharma Inc. | 69452-331-20 | 69452-331 | ANDA075667 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (69452-332-20) | Bionpharma Inc. | 69452-332-20 | 69452-332 | ANDA075667 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (69452-333-20) | Bionpharma Inc. | 69452-333-20 | 69452-333 | ANDA075667 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (69452-330-20) | Bionpharma Inc. | 69452-330-20 | 69452-330 | ANDA075667 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (59746-383-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-383-06 | 59746-383 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 500 Capsule In 1 Bottle (59746-383-09) | Jubilant Cadista Pharmaceuticals Inc. | 59746-383-09 | 59746-383 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 1000 Capsule In 1 Bottle (59746-383-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-383-10 | 59746-383 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 1mg/1 | 90 Capsule In 1 Bottle (59746-383-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-383-90 | 59746-383 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (59746-384-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-384-06 | 59746-384 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 500 Capsule In 1 Bottle (59746-384-09) | Jubilant Cadista Pharmaceuticals Inc. | 59746-384-09 | 59746-384 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 1000 Capsule In 1 Bottle (59746-384-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-384-10 | 59746-384 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 2mg/1 | 90 Capsule In 1 Bottle (59746-384-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-384-90 | 59746-384 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (59746-385-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-385-06 | 59746-385 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (59746-385-09) | Jubilant Cadista Pharmaceuticals Inc. | 59746-385-09 | 59746-385 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 1000 Capsule In 1 Bottle (59746-385-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-385-10 | 59746-385 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 5mg/1 | 90 Capsule In 1 Bottle (59746-385-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-385-90 | 59746-385 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (59746-386-06) | Jubilant Cadista Pharmaceuticals Inc. | 59746-386-06 | 59746-386 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (59746-386-09) | Jubilant Cadista Pharmaceuticals Inc. | 59746-386-09 | 59746-386 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (59746-386-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-386-10 | 59746-386 | ANDA075317 | ANDA | N/A |
| Terazosin Hydrochloride | Capsule | Oral | 10mg/1 | 90 Capsule In 1 Bottle (59746-386-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-386-90 | 59746-386 | ANDA075317 | ANDA | N/A |
| Terbinafine Hydrochloride | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle (60429-222-30) | Golden State Medical Supply, Inc. | 60429-222-30 | 60429-222 | ANDA077714 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-1 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-2 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-3) / 60 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-3 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-4) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-4 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-6) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-6 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-8) / 12 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-8 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2080-9) / 24 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2080-9 | 51672-2080 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2140-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2140-1 | 51672-2140 | ANDA077511 | ANDA | N/A |
| Terbinafine Hydrochloride | Tablet | Oral | 250mg/1 | 30 Tablet In 1 Bottle, Plastic (69452-351-13) | Bionpharma Inc. | 69452-351-13 | 69452-351 | ANDA078163 | ANDA | N/A |
| Terbinafine Hydrochloride | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle, Plastic (69452-351-20) | Bionpharma Inc. | 69452-351-20 | 69452-351 | ANDA078163 | ANDA | N/A |
| Perphenazine | Tablet, Film Coated | Oral | 16mg/1 | 100 Tablet, Film Coated In 1 Bottle (64980-293-01) | Rising Pharma Holdings, Inc. | 64980-293-01 | 64980-293 | ANDA205056 | ANDA | N/A |
| Phenazopyridine Hydrochloride | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (65162-682-10) | Amneal Pharmaceuticals LLC | 65162-682-10 | 65162-682 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Terbutaline Sulfate | Injection | Subcutaneous | 1mg/mL | 10 Vial In 1 Carton (0143-9375-10) / 1 Ml In 1 Vial (0143-9375-01) | Hikma Pharmaceuticals USA Inc. | 0143-9375-10 | 0143-9375 | ANDA078630 | ANDA | N/A |
| Terbutaline Sulfate | Injection | Subcutaneous | 1mg/mL | 10 Vial In 1 Carton (0143-9746-10) / 1 Ml In 1 Vial (0143-9746-01) | Hikma Pharmaceuticals USA Inc. | 0143-9746-10 | 0143-9746 | ANDA078630 | ANDA | N/A |
| Terconazole | Suppository | Vaginal | 80mg/1 | 3 Blister Pack In 1 Carton (45802-717-08) / 1 Suppository In 1 Blister Pack (45802-717-00) | Padagis Israel Pharmaceuticals Ltd | 45802-717-08 | 45802-717 | ANDA077149 | ANDA | N/A |
| Terconazole | Cream | Vaginal | 8mg/g | 1 Tube, With Applicator In 1 Carton (51672-1302-0) / 20 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-1302-0 | 51672-1302 | ANDA075953 | ANDA | N/A |
| Terconazole | Cream | Vaginal | 4mg/g | 1 Tube, With Applicator In 1 Carton (51672-1304-6) / 45 G In 1 Tube, With Applicator | Taro Pharmaceuticals U.S.A., Inc. | 51672-1304-6 | 51672-1304 | ANDA076043 | ANDA | N/A |
| Terconazole | Suppository | Vaginal | 80mg/1 | 1 Dose Pack In 1 Carton (51672-1330-3) / 3 Suppository In 1 Dose Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-1330-3 | 51672-1330 | ANDA077553 | ANDA | N/A |
| Terconazole | Suppository | Vaginal | 80mg/1 | 3 Blister Pack In 1 Carton (0713-0552-73) / 1 Suppository In 1 Blister Pack | Cosette Pharmaceuticals, Inc. | 0713-0552-73 | 0713-0552 | ANDA077553 | ANDA | N/A |
| Teriflunomide | Tablet, Film Coated | Oral | 7mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4477-3) | Apotex Corp | 60505-4477-3 | 60505-4477 | ANDA209601 | ANDA | N/A |
| Teriflunomide | Tablet, Film Coated | Oral | 14mg/1 | 30 Tablet, Film Coated In 1 Bottle (60505-4478-3) | Apotex Corp | 60505-4478-3 | 60505-4478 | ANDA209601 | ANDA | N/A |
| Teriparatide | Injection, Solution | Subcutaneous | 250ug/mL | 1 Syringe In 1 Carton (66993-495-28) / 2.24 Ml In 1 Syringe | Prasco Laboratories | 66993-495-28 | 66993-495 | NDA021318 | NDA AUTHORIZED GENERIC | N/A |
| Teriparatide | Injection, Solution | Subcutaneous | 250ug/mL | 1 Syringe In 1 Carton (60505-6188-0) / 2.4 Ml In 1 Syringe | Apotex Corp. | 60505-6188-0 | 60505-6188 | ANDA211097 | ANDA | N/A |
| Teriparatide | Injection, Solution | Subcutaneous | 250ug/mL | 1 Syringe In 1 Carton (47781-652-89) / 2.48 Ml In 1 Syringe | Alvogen, Inc. | 47781-652-89 | 47781-652 | NDA211939 | NDA | N/A |
| Testosterone | Solution | Topical | 30mg/1.5mL | 1 Bottle, Pump In 1 Carton (45802-610-01) / 110 Ml In 1 Bottle, Pump | Padagis Israel Pharmaceuticals Ltd | 45802-610-01 | 45802-610 | ANDA204255 | ANDA | CIII |
| Testosterone | Gel | Topical | 20.25mg/1.25g | 30 Packet In 1 Carton (45802-281-39) / 1.25 G In 1 Packet (45802-281-03) | Padagis Israel Pharmaceuticals Ltd | 45802-281-39 | 45802-281 | ANDA205781 | ANDA | CIII |
| Testosterone | Gel | Topical | 16.2mg/g | 1 Bottle, Pump In 1 Carton (45802-754-01) / 88 G In 1 Bottle, Pump | Padagis Israel Pharmaceuticals Ltd | 45802-754-01 | 45802-754 | ANDA204268 | ANDA | CIII |
| Testosterone | Gel | Topical | 40.5mg/2.5g | 30 Packet In 1 Carton (45802-366-65) / 2.5 G In 1 Packet (45802-366-02) | Padagis Israel Pharmaceuticals Ltd | 45802-366-65 | 45802-366 | ANDA205781 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial, Glass In 1 Carton (0574-0820-01) / 1 Ml In 1 Vial, Glass | Padagis US LLC | 0574-0820-01 | 0574-0820 | ANDA040530 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial, Glass In 1 Carton (0574-0820-10) / 10 Ml In 1 Vial, Glass | Padagis US LLC | 0574-0820-10 | 0574-0820 | ANDA040530 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial, Glass In 1 Carton (0574-0827-01) / 1 Ml In 1 Vial, Glass | Padagis US LLC | 0574-0827-01 | 0574-0827 | ANDA091244 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial, Glass In 1 Carton (0574-0827-10) / 10 Ml In 1 Vial, Glass | Padagis US LLC | 0574-0827-10 | 0574-0827 | ANDA091244 | ANDA | CIII |
| Testosterone Cypionate | Injection | Intramuscular | 200mg/mL | 1 Vial, Single-Dose In 1 Carton (52536-625-01) / 1 Ml In 1 Vial, Single-Dose | Wilshire Pharmaceuticals | 52536-625-01 | 52536-625 | ANDA206368 | ANDA | CIII |
| Testosterone Cypionate | Injection | Intramuscular | 200mg/mL | 1 Vial, Multi-Dose In 1 Carton (52536-625-10) / 10 Ml In 1 Vial, Multi-Dose | Wilshire Pharmaceuticals | 52536-625-10 | 52536-625 | ANDA206368 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 10 Vial, Multi-Dose In 1 Carton (47781-910-91) / 10 Ml In 1 Vial, Multi-Dose (47781-910-22) | Alvogen Inc. | 47781-910-91 | 47781-910 | ANDA207742 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial, Single-Dose In 1 Carton (47781-911-93) / 1 Ml In 1 Vial, Single-Dose | Alvogen Inc. | 47781-911-93 | 47781-911 | ANDA207742 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial In 1 Box (0517-1830-01) / 1 Ml In 1 Vial | American Regent, Inc. | 0517-1830-01 | 0517-1830 | ANDA207742 | ANDA | CIII |
| Testosterone Cypionate | Injection | Intramuscular | 200mg/mL | 1 Vial In 1 Carton (0143-9005-01) / 10 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9005-01 | 0143-9005 | ANDA091244 | ANDA | CIII |
| Testosterone Cypionate | Injection | Intramuscular | 200mg/mL | 10 Ml In 1 Vial (0143-9726-01) | Hikma Pharmaceuticals USA Inc. | 0143-9726-01 | 0143-9726 | ANDA091244 | ANDA | CIII |
| Testosterone Cypionate | Injection | Intramuscular | 200mg/mL | 1 Ml In 1 Vial (0143-9659-01) | Hikma Pharmaceuticals USA Inc. | 0143-9659-01 | 0143-9659 | ANDA091244 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 100mg/mL | 1 Vial In 1 Carton (0409-6557-01) / 10 Ml In 1 Vial | Hospira, Inc. | 0409-6557-01 | 0409-6557 | ANDA085635 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial In 1 Carton (0409-6562-01) / 1 Ml In 1 Vial | Hospira, Inc. | 0409-6562-01 | 0409-6562 | ANDA085635 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial In 1 Carton (0409-6562-20) / 10 Ml In 1 Vial | Hospira, Inc. | 0409-6562-20 | 0409-6562 | ANDA085635 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial In 1 Carton (0409-6562-02) / 1 Ml In 1 Vial | Hospira, Inc. | 0409-6562-02 | 0409-6562 | ANDA085635 | ANDA | CIII |
| Testosterone Cypionate | Injection, Solution | Intramuscular | 200mg/mL | 1 Vial In 1 Carton (0409-6562-22) / 10 Ml In 1 Vial | Hospira, Inc. | 0409-6562-22 | 0409-6562 | ANDA085635 | ANDA | CIII |
| Testosterone Enanthate | Injection, Solution | Intramuscular | 200mg/mL | 5 Ml In 1 Vial, Multi-Dose (0143-9750-01) | Hikma Pharmaceuticals USA Inc. | 0143-9750-01 | 0143-9750 | ANDA091120 | ANDA | CIII |
| Testosterone Undecanoate | Capsule, Liquid Filled | Oral | 158mg/1 | 12 Bottle, Plastic In 1 Box (69087-158-12) / 120 Capsule, Liquid Filled In 1 Bottle, Plastic | TOLMAR Inc. | 69087-158-12 | 69087-158 | NDA206089 | NDA | CIII |
| Testosterone Undecanoate | Capsule, Liquid Filled | Oral | 198mg/1 | 12 Bottle, Plastic In 1 Box (69087-198-12) / 120 Capsule, Liquid Filled In 1 Bottle, Plastic | TOLMAR Inc. | 69087-198-12 | 69087-198 | NDA206089 | NDA | CIII |
| Testosterone Undecanoate | Capsule, Liquid Filled | Oral | 237mg/1 | 12 Bottle, Plastic In 1 Box (69087-237-12) / 120 Capsule, Liquid Filled In 1 Bottle, Plastic | TOLMAR Inc. | 69087-237-12 | 69087-237 | NDA206089 | NDA | CIII |
| Tetrabenazine | Tablet | Oral | 12.5mg/1 | 112 Tablet In 1 Bottle (51407-480-12) | Golden State Medical Supply, Inc. | 51407-480-12 | 51407-480 | ANDA206093 | ANDA | N/A |
| Tetrabenazine | Tablet | Oral | 25mg/1 | 112 Tablet In 1 Bottle (51407-481-12) | Golden State Medical Supply, Inc. | 51407-481-12 | 51407-481 | ANDA206093 | ANDA | N/A |
| Tetrabenazine | Tablet | Oral | 12.5mg/1 | 112 Tablet In 1 Bottle (60505-3882-7) | Apotex Corp. | 60505-3882-7 | 60505-3882 | ANDA206093 | ANDA | N/A |
| Tetrabenazine | Tablet | Oral | 25mg/1 | 112 Tablet In 1 Bottle (60505-3883-7) | Apotex Corp. | 60505-3883-7 | 60505-3883 | ANDA206093 | ANDA | N/A |
| Tetrabenazine | Tablet | Oral | 12.5mg/1 | 112 Tablet In 1 Bottle (69452-117-21) | Bionpharma Inc. | 69452-117-21 | 69452-117 | ANDA208826 | ANDA | N/A |
| Tetrabenazine | Tablet | Oral | 25mg/1 | 112 Tablet In 1 Bottle (69452-118-21) | Bionpharma Inc. | 69452-118-21 | 69452-118 | ANDA208826 | ANDA | N/A |
| Theophylline | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (69315-226-01) | Leading Pharma, LLC | 69315-226-01 | 69315-226 | ANDA214950 | ANDA | N/A |
| Theophylline | Tablet, Extended Release | Oral | 450mg/1 | 100 Tablet, Extended Release In 1 Bottle (69315-227-01) | Leading Pharma, LLC | 69315-227-01 | 69315-227 | ANDA214950 | ANDA | N/A |
| Theophylline Anhydrous | Liquid | Oral | 80mg/15mL | 473 Ml In 1 Bottle (70408-644-34) | Nostrum Laboratories, Inc. | 70408-644-34 | 70408-644 | ANDA085186 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 100mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-057-01) | Nostrum Laboratories, Inc. | 29033-057-01 | 29033-057 | ANDA087400 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 200mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-058-01) | Nostrum Laboratories, Inc. | 29033-058-01 | 29033-058 | ANDA087400 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-059-01) | Nostrum Laboratories, Inc. | 29033-059-01 | 29033-059 | ANDA087400 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 450mg/1 | 100 Tablet, Extended Release In 1 Bottle (29033-060-01) | Nostrum Laboratories, Inc. | 29033-060-01 | 29033-060 | ANDA087400 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 400mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (29033-001-01) | Nostrum Laboratories, Inc. | 29033-001-01 | 29033-001 | ANDA040560 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 600mg/1 | 100 Tablet, Extended Release In 1 Bottle, Plastic (29033-002-01) | Nostrum Laboratories, Inc. | 29033-002-01 | 29033-002 | ANDA040560 | ANDA | N/A |
| Theophylline Anhydrous | Solution | Oral | 80mg/15mL | 473 Ml In 1 Bottle (27808-033-01) | Tris Pharma Inc | 27808-033-01 | 27808-033 | ANDA091586 | ANDA | N/A |
| Theophylline Anhydrous | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (69452-267-20) | Bionpharma Inc., | 69452-267-20 | 69452-267 | ANDA216300 | ANDA | N/A |
| Thiamine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (25021-500-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-500-02 | 25021-500 | ANDA206106 | ANDA | N/A |
| Thiamine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | 100mg/mL | 25 Vial In 1 Carton (0641-6228-25) / 2 Ml In 1 Vial (0641-6228-01) | Hikma Pharmaceuticals USA Inc. | 0641-6228-25 | 0641-6228 | ANDA080575 | ANDA | N/A |
| Thioguanine | Tablet | Oral | 40mg/1 | 1 Bottle In 1 Carton (80725-630-25) / 25 Tablet In 1 Bottle | Waylis Therapeutics LLC | 80725-630-25 | 80725-630 | NDA012429 | NDA | N/A |
| Thiotepa | Injection, Powder, For Solution | Intracavitary; Intravenous; Intravesical | 15mg/1 | 1 Vial, Single-Dose In 1 Carton (71288-156-05) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-156-05 | 71288-156 | ANDA216037 | ANDA | N/A |
| Thiotepa | Injection, Powder, For Solution | Intracavitary; Intravenous; Intravesical | 100mg/1 | 1 Vial, Single-Dose In 1 Carton (71288-157-10) / 1 Injection, Powder, For Solution In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc | 71288-157-10 | 71288-157 | ANDA216037 | ANDA | N/A |
| Thiotepa | Injection, Powder, Lyophilized, For Solution | Intracavitary; Intravenous; Intravesical | 15mg/1.5mL | 1 Vial In 1 Carton (25021-246-02) / 1.5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-246-02 | 25021-246 | ANDA209150 | ANDA | N/A |
| Phenazopyridine Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (60846-501-01) | Amneal Pharmaceuticals LLC | 60846-501-01 | 60846-501 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (60846-502-01) | Amneal Pharmaceuticals LLC | 60846-502-01 | 60846-502 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thiotepa | Injection, Powder, Lyophilized, For Solution | Intracavitary; Intravenous; Intravesical | 15mg/1.5mL | 1 Vial In 1 Box, Unit-Dose (0143-9309-01) / 1.5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9309-01 | 0143-9309 | ANDA075547 | ANDA | N/A |
| Thiotepa | Injection, Powder, Lyophilized, For Solution | Intracavitary; Intravenous; Intravesical | 15mg/1.5mL | 1 Vial In 1 Box, Unit-Dose (0143-9565-01) / 1.5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9565-01 | 0143-9565 | ANDA075547 | ANDA | N/A |
| Thiotepa | Injection, Powder, Lyophilized, For Solution | Intracavitary; Intravenous; Intravesical | 100mg/1 | 1 Vial In 1 Box, Unit-Dose (0143-9292-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9292-01 | 0143-9292 | ANDA211755 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (70954-014-10) | Novitium Pharma LLC | 70954-014-10 | 70954-014 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 1mg/1 | 1000 Capsule In 1 Bottle (70954-014-20) | Novitium Pharma LLC | 70954-014-20 | 70954-014 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (70954-015-10) | Novitium Pharma LLC | 70954-015-10 | 70954-015 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 2mg/1 | 1000 Capsule In 1 Bottle (70954-015-20) | Novitium Pharma LLC | 70954-015-20 | 70954-015 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 2mg/1 | 100 Blister Pack In 1 Carton (70954-015-40) / 1 Capsule In 1 Blister Pack (70954-015-30) | Novitium Pharma LLC | 70954-015-40 | 70954-015 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (70954-016-10) | Novitium Pharma LLC | 70954-016-10 | 70954-016 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 5mg/1 | 1000 Capsule In 1 Bottle (70954-016-20) | Novitium Pharma LLC | 70954-016-20 | 70954-016 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 5mg/1 | 100 Blister Pack In 1 Carton (70954-016-40) / 1 Capsule In 1 Blister Pack (70954-016-30) | Novitium Pharma LLC | 70954-016-40 | 70954-016 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (70954-017-10) | Novitium Pharma LLC | 70954-017-10 | 70954-017 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 10mg/1 | 1000 Capsule In 1 Bottle (70954-017-20) | Novitium Pharma LLC | 70954-017-20 | 70954-017 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 10mg/1 | 100 Blister Pack In 1 Carton (70954-017-40) / 1 Capsule In 1 Blister Pack (70954-017-30) | Novitium Pharma LLC | 70954-017-40 | 70954-017 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 1mg/1 | 100 Capsule In 1 Bottle (51407-275-01) | Golden State Medical Supply, Inc. | 51407-275-01 | 51407-275 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 2mg/1 | 100 Capsule In 1 Bottle (51407-276-01) | Golden State Medical Supply, Inc. | 51407-276-01 | 51407-276 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (51407-277-01) | Golden State Medical Supply, Inc. | 51407-277-01 | 51407-277 | ANDA211642 | ANDA | N/A |
| Thiothixene | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (51407-278-01) | Golden State Medical Supply, Inc. | 51407-278-01 | 51407-278 | ANDA211642 | ANDA | N/A |
| Thyroid | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (75834-310-01) | Nivagen Pharmaceuticals, Inc. | 75834-310-01 | 75834-310 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (75834-311-01) | Nivagen Pharmaceuticals, Inc. | 75834-311-01 | 75834-311 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (75834-312-01) | Nivagen Pharmaceuticals, Inc. | 75834-312-01 | 75834-312 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 90mg/1 | 100 Tablet In 1 Bottle (75834-313-01) | Nivagen Pharmaceuticals, Inc. | 75834-313-01 | 75834-313 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (75834-314-01) | Nivagen Pharmaceuticals, Inc. | 75834-314-01 | 75834-314 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 180mg/1 | 100 Tablet In 1 Bottle (75834-315-01) | Nivagen Pharmaceuticals, Inc. | 75834-315-01 | 75834-315 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 240mg/1 | 100 Tablet In 1 Bottle (75834-316-01) | Nivagen Pharmaceuticals, Inc. | 75834-316-01 | 75834-316 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (75834-317-01) | Nivagen Pharmaceuticals, Inc. | 75834-317-01 | 75834-317 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet | Oral | 99.5mg/1 | 1 Blister Pack In 1 Carton (57237-330-21) / 12 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-330-21 | 57237-330 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet | Oral | 99.5mg/1 | 1 Blister Pack In 1 Carton (57237-330-42) / 24 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-330-42 | 57237-330 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenazopyridine Hydrochloride | Tablet | Oral | 95mg/1 | 1 Blister Pack In 1 Carton (57237-331-03) / 30 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-331-03 | 57237-331 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Phenobarbital | Tablet | Oral | 64.8mg/1 | 100 Tablet In 1 Bottle (16571-667-01) | Rising Pharma Holdings, Inc. | 16571-667-01 | 16571-667 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 64.8mg/1 | 1000 Tablet In 1 Bottle (16571-667-10) | Rising Pharma Holdings, Inc. | 16571-667-10 | 16571-667 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tick-Borne Encephalitis Purified Antigen (Formaldehyde Inactivated) | Injection | Intramuscular | 1.2ug/.25mL | 1 Syringe In 1 Carton (0069-0297-02) / .25 Ml In 1 Syringe (0069-0297-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0297-02 | 0069-0297 | BLA125740 | BLA | N/A |
| Tick-Borne Encephalitis Purified Antigen (Formaldehyde Inactivated) | Injection | Intramuscular | 1.2ug/.25mL | 10 Syringe In 1 Carton (0069-0297-10) / .25 Ml In 1 Syringe (0069-0297-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0297-10 | 0069-0297 | BLA125740 | BLA | N/A |
| Tick-Borne Encephalitis Purified Antigen (Formaldehyde Inactivated) | Injection | Intramuscular | 2.4ug/.5mL | 1 Syringe In 1 Carton (0069-0411-02) / .5 Ml In 1 Syringe (0069-0411-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0411-02 | 0069-0411 | BLA125740 | BLA | N/A |
| Tick-Borne Encephalitis Purified Antigen (Formaldehyde Inactivated) | Injection | Intramuscular | 2.4ug/.5mL | 10 Syringe In 1 Carton (0069-0411-10) / .5 Ml In 1 Syringe (0069-0411-01) | Pfizer Laboratories Div Pfizer Inc | 0069-0411-10 | 0069-0411 | BLA125740 | BLA | N/A |
| Tigecycline | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial, Single-Dose In 1 Carton (71288-019-11) / 5 Ml In 1 Vial, Single-Dose (71288-019-10) | Meitheal Pharmaceuticals Inc. | 71288-019-11 | 71288-019 | ANDA214020 | ANDA | N/A |
| Tigecycline | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial, Single-Use In 1 Carton (60505-6098-1) / 5 Ml In 1 Vial, Single-Use | Apotex Corp | 60505-6098-1 | 60505-6098 | ANDA204439 | ANDA | N/A |
| Phenobarbital | Tablet | Oral | 64.8mg/1 | 500 Tablet In 1 Bottle (16571-667-50) | Rising Pharma Holdings, Inc. | 16571-667-50 | 16571-667 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tigecycline | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial, Single-Use In 1 Carton (0008-4990-20) / 50 Ml In 1 Vial, Single-Use (0008-4990-19) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4990-20 | 0008-4990 | NDA021821 | NDA | N/A |
| Tigecycline | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial, Single-Use In 1 Carton (0008-4994-20) / 50 Ml In 1 Vial, Single-Use (0008-4994-19) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4994-20 | 0008-4994 | NDA021821 | NDA | N/A |
| Tilia Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1801-2) | Jubilant HollisterStier LLC | 65044-1801-2 | 65044-1801 | BLA103888 | BLA | N/A |
| Tilia Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1801-3) | Jubilant HollisterStier LLC | 65044-1801-3 | 65044-1801 | BLA103888 | BLA | N/A |
| Tilia Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1801-4) | Jubilant HollisterStier LLC | 65044-1801-4 | 65044-1801 | BLA103888 | BLA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (70069-516-01) / 2.5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-516-01 | 70069-516 | ANDA216653 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (70069-517-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-517-01 | 70069-517 | ANDA216653 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (70069-701-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-701-01 | 70069-701 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (70069-702-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-702-01 | 70069-702 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (70069-703-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-703-01 | 70069-703 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (70069-706-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-706-01 | 70069-706 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (70069-707-01) / 10 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-707-01 | 70069-707 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (70069-708-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-708-01 | 70069-708 | ANDA217764 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 6.8mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1005-1) / 5 Ml In 1 Bottle, Dropper | Apotex Corp | 60505-1005-1 | 60505-1005 | ANDA204936 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 6.8mg/mL | 1 Bottle, Dropper In 1 Carton (60505-1005-4) / 2.5 Ml In 1 Bottle, Dropper | Apotex Corp | 60505-1005-4 | 60505-1005 | ANDA204936 | ANDA | N/A |
| Phenobarbital | Tablet | Oral | 97.2mg/1 | 100 Tablet In 1 Bottle (16571-668-01) | Rising Pharma Holdings, Inc. | 16571-668-01 | 16571-668 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 97.2mg/1 | 1000 Tablet In 1 Bottle (16571-668-10) | Rising Pharma Holdings, Inc. | 16571-668-10 | 16571-668 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 97.2mg/1 | 500 Tablet In 1 Bottle (16571-668-50) | Rising Pharma Holdings, Inc. | 16571-668-50 | 16571-668 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (16571-669-01) | Rising Pharma Holdings, Inc. | 16571-669-01 | 16571-669 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (16571-669-10) | Rising Pharma Holdings, Inc. | 16571-669-10 | 16571-669 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (16571-669-50) | Rising Pharma Holdings, Inc. | 16571-669-50 | 16571-669 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (16571-670-01) | Rising Pharma Holdings, Inc. | 16571-670-01 | 16571-670 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 1000 Tablet In 1 Bottle (16571-670-10) | Rising Pharma Holdings, Inc. | 16571-670-10 | 16571-670 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (16571-670-50) | Rising Pharma Holdings, Inc. | 16571-670-50 | 16571-670 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 16.2mg/1 | 100 Tablet In 1 Bottle (16571-671-01) | Rising Pharma Holdings, Inc. | 16571-671-01 | 16571-671 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tirofiban Hydrochloride | Injection | Intravenous | 50ug/mL | 1 Bag In 1 Carton (14789-101-01) / 100 Ml In 1 Bag | Nexus Pharmaceuticals LLC | 14789-101-01 | 14789-101 | ANDA213947 | ANDA | N/A |
| Tirofiban Hydrochloride | Injection | Intravenous | 50ug/mL | 1 Bag In 1 Carton (14789-102-02) / 250 Ml In 1 Bag | Nexus Pharmaceuticals LLC | 14789-102-02 | 14789-102 | ANDA213947 | ANDA | N/A |
| Tirofiban Hydrochloride | Injection | Intravenous | 50ug/mL | 2 Bag In 1 Carton (14789-102-10) / 250 Ml In 1 Bag | Nexus Pharmaceuticals LLC | 14789-102-10 | 14789-102 | ANDA213947 | ANDA | N/A |
| Titanium Dioxide | Lotion | Topical | 120mg/g | 82 G In 1 Tube (52915-068-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-068-29 | 52915-068 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion | Topical | 120mg/g | 82 G In 1 Tube (52915-067-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-067-29 | 52915-067 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 82 G In 1 Tube (52915-030-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-030-29 | 52915-030 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Stick | Topical | 170mg/g | 14 G In 1 Container (52915-060-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-060-05 | 52915-060 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 82 G In 1 Tube (52915-040-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-040-29 | 52915-040 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 14 G In 1 Tube (52915-050-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-050-05 | 52915-050 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 170 G In 1 Tube (52915-050-06) | ORGANIC & SUSTAINABLE BEAUTY | 52915-050-06 | 52915-050 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 51 G In 1 Tube (52915-050-18) | ORGANIC & SUSTAINABLE BEAUTY | 52915-050-18 | 52915-050 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 562 G In 1 Tube (52915-050-19) | ORGANIC & SUSTAINABLE BEAUTY | 52915-050-19 | 52915-050 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Lotion/Shampoo | Topical | 120mg/g | 82 G In 1 Tube (52915-050-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-050-29 | 52915-050 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide | Stick | Topical | 170mg/g | 14 G In 1 Container (52915-070-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-070-05 | 52915-070 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-301-01) / 10 G In 1 Case | BEL STAR S A | 14141-301-01 | 14141-301 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-304-01) / 10 G In 1 Case | BEL STAR S A | 14141-304-01 | 14141-304 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-302-01) / 10 G In 1 Case | BEL STAR S A | 14141-302-01 | 14141-302 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-305-01) / 10 G In 1 Case | BEL STAR S A | 14141-305-01 | 14141-305 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-300-01) / 10 G In 1 Case | BEL STAR S A | 14141-300-01 | 14141-300 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Powder | Topical | 57.5mg/g, 49 mg/g | 1 Case In 1 Box (14141-303-01) / 10 G In 1 Case | BEL STAR S A | 14141-303-01 | 14141-303 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Cream | Topical | 7.75g/100mL, 10 g/100mL | 50 Ml In 1 Bottle, Pump (82917-0650-2) | Antonio Aguilar Physician Assistant Professional Corp. | 82917-0650-2 | 82917-0650 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 59mg/mL, 33 mg/mL | 1 Tube In 1 Box (79265-8708-1) / 50 Ml In 1 Tube | Babo Botanicals, Inc. | 79265-8708-1 | 79265-8708 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 19mg/mL, 157 mg/mL | 1 Tube In 1 Carton (79265-8078-1) / 50 Ml In 1 Tube | Babo Botanicals, Inc. | 79265-8078-1 | 79265-8078 | M020 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 3000mg/100mL, 3000 mg/100mL | 1 Tube In 1 Box (79265-8072-0) / 50 Ml In 1 Tube (79265-8072-1) | Babo Botanicals, Inc. | 79265-8072-0 | 79265-8072 | part352 | OTC MONOGRAPH FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Aerosol, Spray | Topical | 43mg/mL, 147 mg/mL | 177 Ml In 1 Can (79265-7978-1) | Babo Botanicals, Inc. | 79265-7978-1 | 79265-7978 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 30mg/mL, 30 mg/mL | 118 Ml In 1 Tube (59062-1227-1) | KAS Direct LLC dba BabyGanics | 59062-1227-1 | 59062-1227 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Stick | Topical | 79mg/g, 67 mg/g | 45.5 G In 1 Applicator (59062-2200-4) | KAS Direct LLC dba BabyGanics | 59062-2200-4 | 59062-2200 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Spray | Topical | 3.5g/100g, 7.25 g/100g | 2 Can In 1 Blister Pack (59062-2400-2) / 170 G In 1 Can (59062-2400-6) | KAS Direct LLC dba BabyGanics | 59062-2400-2 | 59062-2400 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Spray | Topical | 3.5g/100g, 7.25 g/100g | 170 G In 1 Can (59062-2400-6) | KAS Direct LLC dba BabyGanics | 59062-2400-6 | 59062-2400 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Spray | Topical | 3.5g/100mL, 7.25 g/100mL | 88 Ml In 1 Bottle, Plastic (59062-2300-3) | KAS Direct LLC dba BabyGanics | 59062-2300-3 | 59062-2300 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 45mg/mL, 70 mg/mL | 1 Bottle In 1 Box (15751-2323-2) / 35 Ml In 1 Bottle | Eminence Organic Skin Care Ltd. | 15751-2323-2 | 15751-2323 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 45mg/mL, 70 mg/mL | 1 Bottle In 1 Box (15751-2323-9) / 55 Ml In 1 Bottle | Eminence Organic Skin Care Ltd. | 15751-2323-9 | 15751-2323 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Cream | Topical | 78mg/mL, 40 mg/mL | 1 Jar In 1 Box (15751-3333-2) / 60 Ml In 1 Jar | Eminence Organic Skin Care Ltd. | 15751-3333-2 | 15751-3333 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Cream | Topical | 78mg/mL, 40 mg/mL | 1 Jar In 1 Box (15751-3333-4) / 125 Ml In 1 Jar | Eminence Organic Skin Care Ltd. | 15751-3333-4 | 15751-3333 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 31.6mg/mL, 120 mg/mL | 59 Ml In 1 Tube (59062-1001-2) | KAS Direct LLC dba BabyGanics | 59062-1001-2 | 59062-1001 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 31.6mg/mL, 120 mg/mL | 177 Ml In 1 Tube (59062-1001-6) | KAS Direct LLC dba BabyGanics | 59062-1001-6 | 59062-1001 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 31.6mg/mL, 120 mg/mL | 226 Ml In 1 Tube (59062-1001-8) | KAS Direct LLC dba BabyGanics | 59062-1001-8 | 59062-1001 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 31.6mg/mL, 120 mg/mL | 59 Ml In 1 Tube (59062-1101-2) | KAS Direct LLC dba BabyGanics | 59062-1101-2 | 59062-1101 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 31.6mg/mL, 120 mg/mL | 177 Ml In 1 Tube (59062-1101-6) | KAS Direct LLC dba BabyGanics | 59062-1101-6 | 59062-1101 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Stick | Topical | 79mg/g, 67 mg/g | 1 Applicator In 1 Blister Pack (59062-1200-1) / 13 G In 1 Applicator | KAS Direct LLC dba BabyGanics | 59062-1200-1 | 59062-1200 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Stick | Topical | 79mg/g, 67 mg/g | 2 Applicator In 1 Blister Pack (59062-1200-2) / 13 G In 1 Applicator | KAS Direct LLC dba BabyGanics | 59062-1200-2 | 59062-1200 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Spray | Topical | 3.5g/100mL, 7.25 g/100mL | 170 Ml In 1 Bottle, Pump (59062-2210-6) | KAS Direct LLC dba BabyGanics | 59062-2210-6 | 59062-2210 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Spray | Topical | 3.5g/100mL, 7.25 g/100mL | 236 Ml In 1 Bottle, Pump (59062-2210-8) | KAS Direct LLC dba BabyGanics | 59062-2210-8 | 59062-2210 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 2.45g/100mL, 4.2 g/100mL | 1 Bottle, Pump In 1 Carton (42627-101-01) / 30 Ml In 1 Bottle, Pump | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-101-01 | 42627-101 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 2.45g/100mL, 4.2 g/100mL | 1 Tube In 1 Carton (42627-101-02) / 60 Ml In 1 Tube | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-101-02 | 42627-101 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Lotion | Topical | 2.45g/100mL, 4.2 g/100mL | 1 Bottle, Pump In 1 Carton (42627-101-03) / 8.9 Ml In 1 Bottle, Pump | Kingdom Animalia, LLC DBA Hourglass Cosmetics | 42627-101-03 | 42627-101 | M020 | OTC MONOGRAPH DRUG | N/A |
| Titanium Dioxide; Zinc Oxide | Cream | Topical | 23mg/mL, 60 mg/mL | 1 Tube In 1 Package (76187-850-03) / 100 Ml In 1 Tube | Isagenix International, LLC | 76187-850-03 | 76187-850 | M020 | OTC MONOGRAPH DRUG | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 2mg/1 | 150 Capsule In 1 Bottle (75834-207-15) | Nivagen Pharmaceuticals, Inc. | 75834-207-15 | 75834-207 | ANDA210021 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 4mg/1 | 150 Capsule In 1 Bottle (75834-208-15) | Nivagen Pharmaceuticals, Inc. | 75834-208-15 | 75834-208 | ANDA210021 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 6mg/1 | 150 Capsule In 1 Bottle (75834-209-15) | Nivagen Pharmaceuticals, Inc. | 75834-209-15 | 75834-209 | ANDA210021 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-694-90) | St Mary's Medical Park Pharmacy | 60760-694-90 | 60760-694 | ANDA076286 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 4 Tablet In 1 Bottle, Plastic (60760-719-04) | St. Mary's Medical Park Pharmacy | 60760-719-04 | 60760-719 | ANDA076416 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 15 Tablet In 1 Bottle, Plastic (60760-719-15) | St. Mary's Medical Park Pharmacy | 60760-719-15 | 60760-719 | ANDA076416 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 4 Tablet In 1 Bottle, Plastic (60760-263-04) | St. Mary's Medical Park Pharmacy | 60760-263-04 | 60760-263 | ANDA091283 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 15 Tablet In 1 Bottle, Plastic (60760-263-15) | St. Mary's Medical Park Pharmacy | 60760-263-15 | 60760-263 | ANDA091283 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-263-30) | St. Mary's Medical Park Pharmacy | 60760-263-30 | 60760-263 | ANDA091283 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-263-60) | St. Mary's Medical Park Pharmacy | 60760-263-60 | 60760-263 | ANDA091283 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-263-90) | St. Mary's Medical Park Pharmacy | 60760-263-90 | 60760-263 | ANDA091283 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (60505-0251-1) | Apotex Corp. | 60505-0251-1 | 60505-0251 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (60505-0251-2) | Apotex Corp. | 60505-0251-2 | 60505-0251 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 2mg/1 | 150 Tablet In 1 Bottle (60505-0251-3) | Apotex Corp. | 60505-0251-3 | 60505-0251 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (60505-0252-1) | Apotex Corp. | 60505-0252-1 | 60505-0252 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (60505-0252-2) | Apotex Corp. | 60505-0252-2 | 60505-0252 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Tablet | Oral | 4mg/1 | 150 Tablet In 1 Bottle (60505-0252-3) | Apotex Corp. | 60505-0252-3 | 60505-0252 | ANDA076533 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 2mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (60505-2648-3) | Apotex Corp. | 60505-2648-3 | 60505-2648 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 2mg/1 | 150 Capsule, Gelatin Coated In 1 Bottle (60505-2648-7) | Apotex Corp. | 60505-2648-7 | 60505-2648 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 2mg/1 | 1000 Capsule, Gelatin Coated In 1 Bottle (60505-2648-8) | Apotex Corp. | 60505-2648-8 | 60505-2648 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 4mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (60505-2649-3) | Apotex Corp. | 60505-2649-3 | 60505-2649 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 4mg/1 | 150 Capsule, Gelatin Coated In 1 Bottle (60505-2649-7) | Apotex Corp. | 60505-2649-7 | 60505-2649 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 4mg/1 | 1000 Capsule, Gelatin Coated In 1 Bottle (60505-2649-8) | Apotex Corp. | 60505-2649-8 | 60505-2649 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 6mg/1 | 30 Capsule, Gelatin Coated In 1 Bottle (60505-2650-3) | Apotex Corp. | 60505-2650-3 | 60505-2650 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 6mg/1 | 150 Capsule, Gelatin Coated In 1 Bottle (60505-2650-7) | Apotex Corp. | 60505-2650-7 | 60505-2650 | ANDA078868 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule, Gelatin Coated | Oral | 6mg/1 | 1000 Capsule, Gelatin Coated In 1 Bottle (60505-2650-8) | Apotex Corp. | 60505-2650-8 | 60505-2650 | ANDA078868 | ANDA | N/A |
| Phenobarbital | Tablet | Oral | 16.2mg/1 | 1000 Tablet In 1 Bottle (16571-671-10) | Rising Pharma Holdings, Inc. | 16571-671-10 | 16571-671 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 16.2mg/1 | 500 Tablet In 1 Bottle (16571-671-50) | Rising Pharma Holdings, Inc. | 16571-671-50 | 16571-671 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (16571-672-01) | Rising Pharma Holdings, Inc. | 16571-672-01 | 16571-672 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tobramycin | Solution | Respiratory (Inhalation) | 300mg/4mL | 14 Pouch In 1 Carton (66993-195-94) / 4 Ampule In 1 Pouch / 4 Ml In 1 Ampule | Prasco, LLC | 66993-195-94 | 66993-195 | NDA201820 | NDA AUTHORIZED GENERIC | N/A |
| Tobramycin | Solution/ Drops | Ophthalmic | 3mg/mL | 1 Bottle In 1 Carton (70069-131-01) / 5 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-131-01 | 70069-131 | ANDA207444 | ANDA | N/A |
| Phenobarbital | Tablet | Oral | 30mg/1 | 1000 Tablet In 1 Bottle (16571-672-10) | Rising Pharma Holdings, Inc. | 16571-672-10 | 16571-672 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tobramycin Sulfate | Injection, Solution | Intramuscular; Intravenous | 40mg/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3578-01) / 2 Ml In 1 Vial, Multi-Dose (0409-3578-11) | Hospira, Inc. | 0409-3578-01 | 0409-3578 | ANDA063111 | ANDA | N/A |
| Tofacitinib Citrate | Tablet, Film Coated | Oral | 5mg/1 | 60 Tablet, Film Coated In 1 Bottle (0069-1001-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1001-01 | 0069-1001 | NDA203214 | NDA | N/A |
| Tofacitinib Citrate | Tablet, Film Coated | Oral | 10mg/1 | 60 Tablet, Film Coated In 1 Bottle (0069-1002-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1002-01 | 0069-1002 | NDA203214 | NDA | N/A |
| Tofacitinib Citrate | Solution | Oral | 1mg/mL | 1 Bottle In 1 Carton (0069-1029-02) / 240 Ml In 1 Bottle (0069-1029-01) | Pfizer Laboratories Div Pfizer Inc | 0069-1029-02 | 0069-1029 | NDA213082 | NDA | N/A |
| Tofacitinib Citrate | Tablet, Film Coated, Extended Release | Oral | 11mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0069-0501-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0501-30 | 0069-0501 | NDA208246 | NDA | N/A |
| Tofacitinib Citrate | Tablet, Film Coated, Extended Release | Oral | 22mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (0069-0502-30) | Pfizer Laboratories Div Pfizer Inc | 0069-0502-30 | 0069-0502 | NDA208246 | NDA | N/A |
| Phenobarbital | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (16571-672-50) | Rising Pharma Holdings, Inc. | 16571-672-50 | 16571-672 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 32.4mg/1 | 100 Tablet In 1 Bottle (16571-673-01) | Rising Pharma Holdings, Inc. | 16571-673-01 | 16571-673 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 32.4mg/1 | 1000 Tablet In 1 Bottle (16571-673-10) | Rising Pharma Holdings, Inc. | 16571-673-10 | 16571-673 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Tolnaftate | Cream | Topical | 10mg/g | 1 Tube In 1 Box (80684-040-01) / 14 G In 1 Tube | FOURSTAR GROUP USA, INC. | 80684-040-01 | 80684-040 | M005 | OTC MONOGRAPH DRUG | N/A |
| Tolnaftate | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2020-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2020-1 | 51672-2020 | part333C | OTC MONOGRAPH FINAL | N/A |
| Tolnaftate | Cream | Topical | 1g/100g | 1 Tube In 1 Carton (51672-2020-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-2020-2 | 51672-2020 | part333C | OTC MONOGRAPH FINAL | N/A |
| Tolnaftate | Liquid | Topical | 8.65mg/mL | 1 Bottle, With Applicator In 1 Box (52389-298-30) / 30 Ml In 1 Bottle, With Applicator | Alva-Amco Pharmacal Companies, Inc. | 52389-298-30 | 52389-298 | M005 | OTC MONOGRAPH DRUG | N/A |
| Tolnaftate | Liquid | Topical | 8.65mg/mL | 1 Bottle, With Applicator In 1 Box (52389-298-40) / 40 Ml In 1 Bottle, With Applicator | Alva-Amco Pharmacal Companies, Inc. | 52389-298-40 | 52389-298 | M005 | OTC MONOGRAPH DRUG | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 500 Capsule, Extended Release In 1 Bottle (51407-739-05) | Golden State Medical Supply, Inc. | 51407-739-05 | 51407-739 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 30 Capsule, Extended Release In 1 Bottle (51407-739-30) | Golden State Medical Supply, Inc. | 51407-739-30 | 51407-739 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-739-90) | Golden State Medical Supply, Inc. | 51407-739-90 | 51407-739 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 500 Capsule, Extended Release In 1 Bottle (51407-740-05) | Golden State Medical Supply, Inc. | 51407-740-05 | 51407-740 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 30 Capsule, Extended Release In 1 Bottle (51407-740-30) | Golden State Medical Supply, Inc. | 51407-740-30 | 51407-740 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 90 Capsule, Extended Release In 1 Bottle (51407-740-90) | Golden State Medical Supply, Inc. | 51407-740-90 | 51407-740 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 60 Tablet, Film Coated In 1 Bottle (58151-098-91) | Viatris Specialty LLC | 58151-098-91 | 58151-098 | NDA020771 | NDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 2mg/1 | 60 Tablet, Film Coated In 1 Bottle (58151-099-91) | Viatris Specialty LLC | 58151-099-91 | 58151-099 | NDA020771 | NDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 90 Capsule, Extended Release In 1 Bottle (58151-103-77) | Viatris Specialty LLC | 58151-103-77 | 58151-103 | NDA021228 | NDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 30 Capsule, Extended Release In 1 Bottle (58151-103-93) | Viatris Specialty LLC | 58151-103-93 | 58151-103 | NDA021228 | NDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 90 Capsule, Extended Release In 1 Bottle (58151-104-77) | Viatris Specialty LLC | 58151-104-77 | 58151-104 | NDA021228 | NDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 30 Capsule, Extended Release In 1 Bottle (58151-104-93) | Viatris Specialty LLC | 58151-104-93 | 58151-104 | NDA021228 | NDA | N/A |
| Phenobarbital | Tablet | Oral | 32.4mg/1 | 500 Tablet In 1 Bottle (16571-673-50) | Rising Pharma Holdings, Inc. | 16571-673-50 | 16571-673 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (16571-674-01) | Rising Pharma Holdings, Inc. | 16571-674-01 | 16571-674 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 1000 Tablet In 1 Bottle (16571-674-10) | Rising Pharma Holdings, Inc. | 16571-674-10 | 16571-674 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Tablet | Oral | 60mg/1 | 500 Tablet In 1 Bottle (16571-674-50) | Rising Pharma Holdings, Inc. | 16571-674-50 | 16571-674 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phenobarbital | Liquid | Oral | 20mg/5mL | 473 Ml In 1 Bottle (16571-675-16) | Rising Pharma Holdings, Inc. | 16571-675-16 | 16571-675 | N/A | UNAPPROVED DRUG OTHER | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 37.5mg/1 | 100 Tablet In 1 Bottle (42806-810-01) | Epic Pharma, LLC | 42806-810-01 | 42806-810 | ANDA040190 | ANDA | CIV |
| Phentermine Hydrochloride | Tablet | Oral | 37.5mg/1 | 1000 Tablet In 1 Bottle (42806-810-10) | Epic Pharma, LLC | 42806-810-10 | 42806-810 | ANDA040190 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 37.5mg/1 | 100 Capsule In 1 Bottle (42806-524-01) | Epic Pharma, LLC | 42806-524-01 | 42806-524 | ANDA040228 | ANDA | CIV |
| Phentermine Hydrochloride | Capsule | Oral | 37.5mg/1 | 1000 Capsule In 1 Bottle (42806-524-10) | Epic Pharma, LLC | 42806-524-10 | 42806-524 | ANDA040228 | ANDA | CIV |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 25 Vial, Single-Dose In 1 Carton (70121-1577-5) / 1 Ml In 1 Vial, Single-Dose (70121-1577-1) | Amneal Pharmaceuticals LLC | 70121-1577-5 | 70121-1577 | ANDA211079 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 10 Vial, Pharmacy Bulk Package In 1 Carton (70121-1578-7) / 5 Ml In 1 Vial, Pharmacy Bulk Package (70121-1578-1) | Amneal Pharmaceuticals LLC | 70121-1578-7 | 70121-1578 | ANDA211078 | ANDA | N/A |
| Phenylephrine Hydrochloride | Injection | Intravenous | 10mg/mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (70121-1579-1) / 10 Ml In 1 Vial, Pharmacy Bulk Package | Amneal Pharmaceuticals LLC | 70121-1579-1 | 70121-1579 | ANDA211078 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 1 Blister Pack In 1 Carton (60505-4317-0) / 10 Tablet In 1 Blister Pack | Apotex Corp. | 60505-4317-0 | 60505-4317 | ANDA207605 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (60505-4317-3) | Apotex Corp. | 60505-4317-3 | 60505-4317 | ANDA207605 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 30mg/1 | 1 Blister Pack In 1 Carton (60505-4318-0) / 10 Tablet In 1 Blister Pack | Apotex Corp. | 60505-4318-0 | 60505-4318 | ANDA207605 | ANDA | N/A |
| Tomato | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3656-2) | Jubilant HollisterStier LLC | 65044-3656-2 | 65044-3656 | BLA103888 | BLA | N/A |
| Phenytoin | Tablet, Chewable | Oral | 50mg/1 | 100 Tablet, Chewable In 1 Bottle (64980-573-01) | Rising Pharma Holdings, Inc. | 64980-573-01 | 64980-573 | ANDA200691 | ANDA | N/A |
| Phytonadione | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (50228-333-01) / 100 Tablet In 1 Bottle | ScieGen Pharmaceuticals Inc | 50228-333-01 | 50228-333 | ANDA213329 | ANDA | N/A |
| Phytonadione | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (50228-333-30) / 30 Tablet In 1 Bottle | ScieGen Pharmaceuticals Inc | 50228-333-30 | 50228-333 | ANDA213329 | ANDA | N/A |
| Phytonadione | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (50228-333-01) / 100 Tablet In 1 Bottle | ScieGen Pharmaceuticals Inc | 50228-333-01 | 50228-333 | ANDA213329 | ANDA | N/A |
| Phytonadione | Tablet | Oral | 5mg/1 | 1 Bottle In 1 Carton (50228-333-30) / 30 Tablet In 1 Bottle | ScieGen Pharmaceuticals Inc | 50228-333-30 | 50228-333 | ANDA213329 | ANDA | N/A |
| Pindolol | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (62559-560-01) | ANI Pharmaceuticals, Inc. | 62559-560-01 | 62559-560 | ANDA073609 | ANDA | N/A |
| Pindolol | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (62559-561-01) | ANI Pharmaceuticals, Inc. | 62559-561-01 | 62559-561 | ANDA073609 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 15mg/1 | 500 Tablet In 1 Bottle (57237-219-05) | Rising Pharma Holdings, Inc. | 57237-219-05 | 57237-219 | ANDA200268 | ANDA | N/A |
| Topiramate | Solution | Oral | 25mg/mL | 473 Ml In 1 Bottle (52652-9001-1) | Azurity Pharmaceuticals, Inc. | 52652-9001-1 | 52652-9001 | NDA214679 | NDA | N/A |
| Topiramate | Solution | Oral | 25mg/mL | 1 Bottle In 1 Carton (52652-9001-2) / 240 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc. | 52652-9001-2 | 52652-9001 | NDA214679 | NDA | N/A |
| Topiramate | Solution | Oral | 25mg/mL | 1 Bottle In 1 Carton (52652-9001-3) / 120 Ml In 1 Bottle | Azurity Pharmaceuticals, Inc. | 52652-9001-3 | 52652-9001 | NDA214679 | NDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 15mg/1 | 30 Tablet In 1 Bottle (57237-219-30) | Rising Pharma Holdings, Inc. | 57237-219-30 | 57237-219 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 15mg/1 | 90 Tablet In 1 Bottle (57237-219-90) | Rising Pharma Holdings, Inc. | 57237-219-90 | 57237-219 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 30mg/1 | 500 Tablet In 1 Bottle (57237-220-05) | Rising Pharma Holdings, Inc. | 57237-220-05 | 57237-220 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 30mg/1 | 30 Tablet In 1 Bottle (57237-220-30) | Rising Pharma Holdings, Inc. | 57237-220-30 | 57237-220 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 30mg/1 | 90 Tablet In 1 Bottle (57237-220-90) | Rising Pharma Holdings, Inc. | 57237-220-90 | 57237-220 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 45mg/1 | 500 Tablet In 1 Bottle (57237-221-05) | Rising Pharma Holdings, Inc. | 57237-221-05 | 57237-221 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 45mg/1 | 30 Tablet In 1 Bottle (57237-221-30) | Rising Pharma Holdings, Inc. | 57237-221-30 | 57237-221 | ANDA200268 | ANDA | N/A |
| Pioglitazone Hydrochloride | Tablet | Oral | 45mg/1 | 90 Tablet In 1 Bottle (57237-221-90) | Rising Pharma Holdings, Inc. | 57237-221-90 | 57237-221 | ANDA200268 | ANDA | N/A |
| Pirfenidone | Tablet, Film Coated | Oral | 267mg/1 | 3 Bottle In 1 Carton (70954-869-10) / 90 Tablet, Film Coated In 1 Bottle | ANI Pharmaceuticals, Inc. | 70954-869-10 | 70954-869 | ANDA212722 | ANDA | N/A |
| Pirfenidone | Tablet, Film Coated | Oral | 267mg/1 | 270 Tablet, Film Coated In 1 Bottle (70954-869-30) | ANI Pharmaceuticals, Inc. | 70954-869-30 | 70954-869 | ANDA212722 | ANDA | N/A |
| Pirfenidone | Tablet, Film Coated | Oral | 801mg/1 | 90 Tablet, Film Coated In 1 Bottle (70954-870-10) | ANI Pharmaceuticals, Inc. | 70954-870-10 | 70954-870 | ANDA212722 | ANDA | N/A |
| Pirfenidone | Tablet, Film Coated | Oral | 267mg/1 | 3 Bottle In 1 Carton (31722-872-27) / 90 Tablet, Film Coated In 1 Bottle (31722-872-90) | Camber Pharmaceuticals, Inc. | 31722-872-27 | 31722-872 | ANDA212674 | ANDA | N/A |
| Pirfenidone | Tablet, Film Coated | Oral | 801mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-873-90) | Camber Pharmaceuticals, Inc. | 31722-873-90 | 31722-873 | ANDA212674 | ANDA | N/A |
| Pirfenidone | Capsule | Oral | 267mg/1 | 500 Capsule In 1 Bottle (50228-441-05) | ScieGen Pharmaceuticals, Inc. | 50228-441-05 | 50228-441 | ANDA212077 | ANDA | N/A |
| Pirfenidone | Capsule | Oral | 267mg/1 | 30 Capsule In 1 Bottle (50228-441-30) | ScieGen Pharmaceuticals, Inc. | 50228-441-30 | 50228-441 | ANDA212077 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 267mg/1 | 1000 Tablet In 1 Bottle (50228-442-10) | ScieGen Pharmaceuticals, Inc. | 50228-442-10 | 50228-442 | ANDA212078 | ANDA | N/A |
| Topotecan Hydrochloride | Injection, Solution, Concentrate | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (0409-0302-01) / 4 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 0409-0302-01 | 0409-0302 | NDA200582 | NDA | N/A |
| Pirfenidone | Tablet | Oral | 267mg/1 | 30 Tablet In 1 Bottle (50228-442-30) | ScieGen Pharmaceuticals, Inc. | 50228-442-30 | 50228-442 | ANDA212078 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle, Plastic (51407-362-90) | Golden State Medical Supply, Inc. | 51407-362-90 | 51407-362 | ANDA076943 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 500 Tablet In 1 Bottle (50228-443-05) | ScieGen Pharmaceuticals, Inc. | 50228-443-05 | 50228-443 | ANDA212078 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 30 Tablet In 1 Bottle (50228-443-30) | ScieGen Pharmaceuticals, Inc. | 50228-443-30 | 50228-443 | ANDA212078 | ANDA | N/A |
| Pirfenidone | Capsule | Oral | 267mg/1 | 500 Capsule In 1 Bottle (50228-441-05) | ScieGen Pharmaceuticals, Inc. | 50228-441-05 | 50228-441 | ANDA212077 | ANDA | N/A |
| Pirfenidone | Capsule | Oral | 267mg/1 | 30 Capsule In 1 Bottle (50228-441-30) | ScieGen Pharmaceuticals, Inc. | 50228-441-30 | 50228-441 | ANDA212077 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle, Plastic (0054-0077-25) | Hikma Pharmaceuticals USA Inc. | 0054-0077-25 | 0054-0077 | ANDA076943 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle, Plastic (0054-0077-29) | Hikma Pharmaceuticals USA Inc. | 0054-0077-29 | 0054-0077 | ANDA076943 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 267mg/1 | 1000 Tablet In 1 Bottle (50228-442-10) | ScieGen Pharmaceuticals, Inc. | 50228-442-10 | 50228-442 | ANDA212078 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 267mg/1 | 30 Tablet In 1 Bottle (50228-442-30) | ScieGen Pharmaceuticals, Inc. | 50228-442-30 | 50228-442 | ANDA212078 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 500 Tablet In 1 Bottle (50228-443-05) | ScieGen Pharmaceuticals, Inc. | 50228-443-05 | 50228-443 | ANDA212078 | ANDA | N/A |
| Pirfenidone | Tablet | Oral | 801mg/1 | 30 Tablet In 1 Bottle (50228-443-30) | ScieGen Pharmaceuticals, Inc. | 50228-443-30 | 50228-443 | ANDA212078 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 1mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-029-03) | Amneal Pharmaceuticals LLC | 65162-029-03 | 65162-029 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 1mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-029-09) | Amneal Pharmaceuticals LLC | 65162-029-09 | 65162-029 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 1mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-029-50) | Amneal Pharmaceuticals LLC | 65162-029-50 | 65162-029 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 2mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-030-03) | Amneal Pharmaceuticals LLC | 65162-030-03 | 65162-030 | ANDA205961 | ANDA | N/A |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-588-20) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-588-20 | 60760-588 | ANDA202075 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-588-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-588-30 | 60760-588 | ANDA202075 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 50 Tablet In 1 Bottle, Plastic (60760-588-50) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-588-50 | 60760-588 | ANDA202075 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-588-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-588-60 | 60760-588 | ANDA202075 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-588-90) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-588-90 | 60760-588 | ANDA202075 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 9 Tablet In 1 Bottle, Plastic (60760-377-09) | St. Mary's Medical Park Pharmacy | 60760-377-09 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 20 Tablet In 1 Bottle, Plastic (60760-377-20) | St. Mary's Medical Park Pharmacy | 60760-377-20 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-377-30) | St. Mary's Medical Park Pharmacy | 60760-377-30 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 50 Tablet In 1 Bottle, Plastic (60760-377-50) | St. Mary's Medical Park Pharmacy | 60760-377-50 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-377-60) | St. Mary's Medical Park Pharmacy | 60760-377-60 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle, Plastic (60760-377-90) | St. Mary's Medical Park Pharmacy | 60760-377-90 | 60760-377 | ANDA075964 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (60429-588-01) | Golden State Medical Supply, Inc. | 60429-588-01 | 60429-588 | ANDA075977 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (60429-588-05) | Golden State Medical Supply, Inc. | 60429-588-05 | 60429-588 | ANDA075977 | ANDA | CIV |
| Tramadol Hydrochloride | Capsule, Extended Release | Oral | 100mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (68025-071-30) | Vertical Pharmaceuticals, LLC | 68025-071-30 | 68025-071 | NDA022370 | NDA | CIV |
| Tramadol Hydrochloride | Capsule, Extended Release | Oral | 200mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (68025-072-30) | Vertical Pharmaceuticals, LLC | 68025-072-30 | 68025-072 | NDA022370 | NDA | CIV |
| Tramadol Hydrochloride | Capsule, Extended Release | Oral | 300mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (68025-073-30) | Vertical Pharmaceuticals, LLC | 68025-073-30 | 68025-073 | NDA022370 | NDA | CIV |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 2mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-030-09) | Amneal Pharmaceuticals LLC | 65162-030-09 | 65162-030 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 2mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-030-50) | Amneal Pharmaceuticals LLC | 65162-030-50 | 65162-030 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 4mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-031-03) | Amneal Pharmaceuticals LLC | 65162-031-03 | 65162-031 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 4mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-031-09) | Amneal Pharmaceuticals LLC | 65162-031-09 | 65162-031 | ANDA205961 | ANDA | N/A |
| Pitavastatin Calcium | Tablet, Film Coated | Oral | 4mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-031-50) | Amneal Pharmaceuticals LLC | 65162-031-50 | 65162-031 | ANDA205961 | ANDA | N/A |
| Plerixafor | Injection, Solution | Subcutaneous | 24mg/1.2mL | 1 Vial, Single-Dose In 1 Carton (70121-1694-2) / 1.2 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1694-2 | 70121-1694 | ANDA215334 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 100 Packet In 1 Carton (62559-157-10) / 17 G In 1 Packet (62559-157-17) | ANI Pharmaceuticals, Inc. | 62559-157-10 | 62559-157 | ANDA202850 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 30 Packet In 1 Carton (62559-157-30) / 17 G In 1 Packet (62559-157-17) | ANI Pharmaceuticals, Inc. | 62559-157-30 | 62559-157 | ANDA202850 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 7 Packet In 1 Carton (69230-324-32) / 17 G In 1 Packet | Camber Consumer Care Inc | 69230-324-32 | 69230-324 | ANDA214990 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 10 Packet In 1 Carton (69230-324-33) / 17 G In 1 Packet | Camber Consumer Care Inc | 69230-324-33 | 69230-324 | ANDA214990 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 119 G In 1 Bottle (69230-324-34) | Camber Consumer Care Inc | 69230-324-34 | 69230-324 | ANDA214990 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 238 G In 1 Bottle (69230-324-35) | Camber Consumer Care Inc | 69230-324-35 | 69230-324 | ANDA214990 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 510 G In 1 Bottle (69230-324-36) | Camber Consumer Care Inc | 69230-324-36 | 69230-324 | ANDA214990 | ANDA | N/A |
| Polyethylene Glycol 3350 | Powder, For Solution | Oral | 17g/17g | 14 Packet In 1 Carton (69230-324-37) / 17 G In 1 Packet | Camber Consumer Care Inc | 69230-324-37 | 69230-324 | ANDA214990 | ANDA | N/A |
| Potassium Chloride | For Solution | Oral | 1.5g/1.56g | 30 Pouch In 1 Carton (70954-197-20) / 1.56 G In 1 Pouch (70954-197-10) | ANI Pharmaceuticals, Inc. | 70954-197-20 | 70954-197 | ANDA212816 | ANDA | N/A |
| Potassium Chloride | For Solution | Oral | 1.5g/1.56g | 100 Pouch In 1 Carton (70954-197-30) / 1.56 G In 1 Pouch (70954-197-10) | ANI Pharmaceuticals, Inc. | 70954-197-30 | 70954-197 | ANDA212816 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-283-05) | Ascent Pharmaceuticals, Inc. | 43602-283-05 | 43602-283 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-283-30) | Ascent Pharmaceuticals, Inc. | 43602-283-30 | 43602-283 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1125mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-284-05) | Ascent Pharmaceuticals, Inc. | 43602-284-05 | 43602-284 | ANDA214422 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 10 Vial In 1 Carton (25021-415-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-415-10 | 25021-415 | ANDA207239 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1125mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-284-30) | Ascent Pharmaceuticals, Inc. | 43602-284-30 | 43602-284 | ANDA214422 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 10 Vial In 1 Carton (60505-6169-1) / 10 Ml In 1 Vial | Apotex Corp. | 60505-6169-1 | 60505-6169 | ANDA209860 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1500mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-285-05) | Ascent Pharmaceuticals, Inc. | 43602-285-05 | 43602-285 | ANDA214422 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 1 Vial, Glass In 1 Carton (0517-0960-01) / 10 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-0960-01 | 0517-0960 | ANDA201885 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 10 Vial, Glass In 1 Carton (0517-0960-10) / 10 Ml In 1 Vial, Glass | American Regent, Inc. | 0517-0960-10 | 0517-0960 | ANDA201885 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 1 Ampule In 1 Carton (0013-1114-15) / 10 Ml In 1 Ampule (0013-1114-01) | Pfizer Laboratories Div Pfizer Inc | 0013-1114-15 | 0013-1114 | NDA019281 | NDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 10 Vial In 1 Box (0013-1114-21) / 10 Ml In 1 Vial (0013-1114-20) | Pfizer Laboratories Div Pfizer Inc | 0013-1114-21 | 0013-1114 | NDA019281 | NDA | N/A |
| Tranylcypromine Sulfate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (70954-538-10) | Novitium Pharma LLC | 70954-538-10 | 70954-538 | ANDA206856 | ANDA | N/A |
| Trastuzumab | Injection, Powder, Lyophilized, For Solution | Intravenous | 150mg/7.15mL | 1 Vial In 1 Carton (0069-0308-01) / 7.15 Ml In 1 Vial | Pfizer Laboratories Div Pfizer Inc | 0069-0308-01 | 0069-0308 | BLA761081 | BLA | N/A |
| Travoprost | Solution | Ophthalmic | .04mg/mL | 1 Bottle In 1 Carton (51407-731-05) / 5 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 51407-731-05 | 51407-731 | ANDA203431 | ANDA | N/A |
| Travoprost | Solution | Ophthalmic | .04mg/mL | 1 Bottle In 1 Carton (51407-731-25) / 2.5 Ml In 1 Bottle | Golden State Medical Supply, Inc. | 51407-731-25 | 51407-731 | ANDA203431 | ANDA | N/A |
| Travoprost | Solution | Ophthalmic | .04mg/mL | 1 Bottle In 1 Carton (60505-0593-1) / 5 Ml In 1 Bottle | Apotex Corp. | 60505-0593-1 | 60505-0593 | ANDA203431 | ANDA | N/A |
| Travoprost | Solution | Ophthalmic | .04mg/mL | 1 Bottle In 1 Carton (60505-0593-4) / 2.5 Ml In 1 Bottle | Apotex Corp. | 60505-0593-4 | 60505-0593 | ANDA203431 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-806-60) | St. Mary's Medical Park Pharmacy | 60760-806-60 | 60760-806 | ANDA205253 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (60505-2653-0) / 10 Tablet In 1 Blister Pack | Apotex Corp | 60505-2653-0 | 60505-2653 | ANDA071258 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (60505-2653-1) | Apotex Corp | 60505-2653-1 | 60505-2653 | ANDA071258 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (60505-2654-0) / 10 Tablet In 1 Blister Pack | Apotex Corp | 60505-2654-0 | 60505-2654 | ANDA071196 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (60505-2654-1) | Apotex Corp | 60505-2654-1 | 60505-2654 | ANDA071196 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (60505-2655-1) | Apotex Corp | 60505-2655-1 | 60505-2655 | ANDA071196 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (60505-2659-1) | Apotex Corp | 60505-2659-1 | 60505-2659 | ANDA071196 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 300mg/1 | 500 Tablet In 1 Bottle (60505-2659-5) | Apotex Corp | 60505-2659-5 | 60505-2659 | ANDA071196 | ANDA | N/A |
| Trazodone Hydrochloride | Tablet | Oral | 300mg/1 | 1400 Tablet In 1 Bottle (60505-2659-7) | Apotex Corp | 60505-2659-7 | 60505-2659 | ANDA071196 | ANDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .125mg/1 | 100 Tablet, Extended Release In 1 Bottle (66302-300-01) | United Therapeutics Corporation | 66302-300-01 | 66302-300 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .125mg/1 | 1 Blister Pack In 1 Carton (66302-300-02) / 10 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-300-02 | 66302-300 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .125mg/1 | 10 Tablet, Extended Release In 1 Bottle (66302-300-10) | United Therapeutics Corporation | 66302-300-10 | 66302-300 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .25mg/1 | 100 Tablet, Extended Release In 1 Bottle (66302-302-01) | United Therapeutics Corporation | 66302-302-01 | 66302-302 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .25mg/1 | 1 Blister Pack In 1 Carton (66302-302-02) / 10 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-302-02 | 66302-302 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | .25mg/1 | 10 Tablet, Extended Release In 1 Bottle (66302-302-10) | United Therapeutics Corporation | 66302-302-10 | 66302-302 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 1mg/1 | 100 Tablet, Extended Release In 1 Bottle (66302-310-01) | United Therapeutics Corporation | 66302-310-01 | 66302-310 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 1mg/1 | 1 Blister Pack In 1 Carton (66302-310-02) / 10 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-310-02 | 66302-310 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 1mg/1 | 10 Tablet, Extended Release In 1 Bottle (66302-310-10) | United Therapeutics Corporation | 66302-310-10 | 66302-310 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 2.5mg/1 | 100 Tablet, Extended Release In 1 Bottle (66302-325-01) | United Therapeutics Corporation | 66302-325-01 | 66302-325 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 2.5mg/1 | 1 Blister Pack In 1 Carton (66302-325-02) / 10 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-325-02 | 66302-325 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 2.5mg/1 | 10 Tablet, Extended Release In 1 Bottle (66302-325-10) | United Therapeutics Corporation | 66302-325-10 | 66302-325 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 5mg/1 | 100 Tablet, Extended Release In 1 Bottle (66302-350-01) | United Therapeutics Corporation | 66302-350-01 | 66302-350 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 5mg/1 | 1 Blister Pack In 1 Carton (66302-350-02) / 10 Tablet, Extended Release In 1 Blister Pack | United Therapeutics Corporation | 66302-350-02 | 66302-350 | NDA203496 | NDA | N/A |
| Treprostinil | Tablet, Extended Release | Oral | 5mg/1 | 10 Tablet, Extended Release In 1 Bottle (66302-350-10) | United Therapeutics Corporation | 66302-350-10 | 66302-350 | NDA203496 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 200mg/20mL | 1 Vial In 1 Box (66302-110-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-110-01 | 66302-110 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 2mg/20mL | 1 Vial In 1 Box (66302-111-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-111-01 | 66302-111 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 4mg/20mL | 1 Vial In 1 Box (66302-112-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-112-01 | 66302-112 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 8mg/20mL | 1 Vial In 1 Box (66302-114-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-114-01 | 66302-114 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 400mg/20mL | 1 Vial In 1 Box (66302-120-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-120-01 | 66302-120 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 20mg/20mL | 1 Vial In 1 Box (66302-101-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-101-01 | 66302-101 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 50mg/20mL | 1 Vial In 1 Box (66302-102-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-102-01 | 66302-102 | NDA021272 | NDA | N/A |
| Treprostinil | Injection, Solution | Intravenous; Subcutaneous | 100mg/20mL | 1 Vial In 1 Box (66302-105-01) / 20 Ml In 1 Vial | United Therapeutics Corporation | 66302-105-01 | 66302-105 | NDA021272 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 1.74mg/2.9mL | 1 Box In 1 Kit (66302-206-01) / 28 Ampule In 1 Box / 2.9 Ml In 1 Ampule | United Therapeutics Corporation | 66302-206-01 | 66302-206 | NDA022387 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 1.74mg/2.9mL | 1 Box In 1 Kit (66302-206-02) / 28 Ampule In 1 Box / 2.9 Ml In 1 Ampule | United Therapeutics Corporation | 66302-206-02 | 66302-206 | NDA022387 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 1.74mg/2.9mL | 4 Ampule In 1 Box (66302-206-03) / 2.9 Ml In 1 Ampule | United Therapeutics Corporation | 66302-206-03 | 66302-206 | NDA022387 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 1.74mg/2.9mL | 1 Box In 1 Kit (66302-206-04) / 4 Ampule In 1 Box / 2.9 Ml In 1 Ampule | United Therapeutics Corporation | 66302-206-04 | 66302-206 | NDA022387 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 16ug/1 | 4 Blister Pack In 1 Kit (66302-616-03) / 7 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-616-03 | 66302-616 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 32ug/1 | 4 Blister Pack In 1 Kit (66302-632-03) / 7 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-632-03 | 66302-632 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 48ug/1 | 4 Blister Pack In 1 Kit (66302-648-03) / 7 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-648-03 | 66302-648 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 64ug/1 | 4 Blister Pack In 1 Kit (66302-664-03) / 7 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-664-03 | 66302-664 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 16ug/1 | 1 Blister Pack In 1 Kit (66302-716-04) / 4 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-716-04 | 66302-716 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 32ug/1 | 1 Blister Pack In 1 Kit (66302-732-04) / 4 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-732-04 | 66302-732 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 48ug/1 | 1 Blister Pack In 1 Kit (66302-748-04) / 4 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-748-04 | 66302-748 | NDA214324 | NDA | N/A |
| Treprostinil | Inhalant | Oral | 64ug/1 | 1 Blister Pack In 1 Kit (66302-764-04) / 4 Blister Pack In 1 Blister Pack / 4 Inhalant In 1 Blister Pack | United Therapeutics Corporation | 66302-764-04 | 66302-764 | NDA214324 | NDA | N/A |
| Tretinoin | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0574-2201-20) / 20 G In 1 Tube | Padagis US LLC | 0574-2201-20 | 0574-2201 | ANDA075213 | ANDA | N/A |
| Tretinoin | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0574-2201-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2201-45 | 0574-2201 | ANDA075213 | ANDA | N/A |
| Tretinoin | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0574-2205-20) / 20 G In 1 Tube | Padagis US LLC | 0574-2205-20 | 0574-2205 | ANDA075265 | ANDA | N/A |
| Tretinoin | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (0574-2205-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2205-45 | 0574-2205 | ANDA075265 | ANDA | N/A |
| Tretinoin | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0574-2225-20) / 20 G In 1 Tube | Padagis US LLC | 0574-2225-20 | 0574-2225 | ANDA075264 | ANDA | N/A |
| Tretinoin | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0574-2225-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2225-45 | 0574-2225 | ANDA075264 | ANDA | N/A |
| Tretinoin | Gel | Topical | .1mg/g | 1 Tube In 1 Carton (0574-2301-15) / 15 G In 1 Tube | Padagis US LLC | 0574-2301-15 | 0574-2301 | ANDA075589 | ANDA | N/A |
| Tretinoin | Gel | Topical | .1mg/g | 1 Tube In 1 Carton (0574-2301-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2301-45 | 0574-2301 | ANDA075589 | ANDA | N/A |
| Tretinoin | Gel | Topical | .25mg/g | 1 Tube In 1 Carton (0574-2325-15) / 15 G In 1 Tube | Padagis US LLC | 0574-2325-15 | 0574-2325 | ANDA075529 | ANDA | N/A |
| Tretinoin | Gel | Topical | .25mg/g | 1 Tube In 1 Carton (0574-2325-45) / 45 G In 1 Tube | Padagis US LLC | 0574-2325-45 | 0574-2325 | ANDA075529 | ANDA | N/A |
| Tretinoin | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1394-0) / 20 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1394-0 | 51672-1394 | ANDA211644 | ANDA | N/A |
| Tretinoin | Cream | Topical | .5mg/g | 1 Tube In 1 Carton (51672-1394-9) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1394-9 | 51672-1394 | ANDA211644 | ANDA | N/A |
| Tretinoin | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1395-0) / 20 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1395-0 | 51672-1395 | ANDA211645 | ANDA | N/A |
| Tretinoin | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1395-9) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1395-9 | 51672-1395 | ANDA211645 | ANDA | N/A |
| Tretinoin | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (51672-1407-0) / 20 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1407-0 | 51672-1407 | ANDA215713 | ANDA | N/A |
| Tretinoin | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (51672-1407-9) / 45 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1407-9 | 51672-1407 | ANDA215713 | ANDA | N/A |
| Triamcinolone Acetonide | Suspension | Intra-Arterial; Intramuscular | 40mg/mL | 25 Vial, Single-Use In 1 Carton (81298-5781-5) / 1 Ml In 1 Vial, Single-Use (81298-5781-1) | Long Grove Pharmaceuticals, LLC | 81298-5781-5 | 81298-5781 | ANDA213543 | ANDA | N/A |
| Triamcinolone Acetonide | Suspension | Intra-Arterial; Intramuscular | 40mg/mL | 1 Vial, Multi-Dose In 1 Carton (81298-5783-3) / 10 Ml In 1 Vial, Multi-Dose | Long Grove Pharmaceuticals, LLC | 81298-5783-3 | 81298-5783 | ANDA213543 | ANDA | N/A |
| Triamcinolone Acetonide | Suspension | Intra-Arterial; Intramuscular | 40mg/mL | 1 Vial, Multi-Dose In 1 Carton (81298-5785-3) / 5 Ml In 1 Vial, Multi-Dose | Long Grove Pharmaceuticals, LLC | 81298-5785-3 | 81298-5785 | ANDA213543 | ANDA | N/A |
| Triamcinolone Acetonide | Aerosol, Spray | Topical | .147mg/g | 63 G In 1 Can (45802-045-01) | Padagis Israel Pharmaceuticals Ltd | 45802-045-01 | 45802-045 | ANDA205782 | ANDA | N/A |
| Triamcinolone Acetonide | Aerosol, Spray | Topical | .147mg/g | 100 G In 1 Can (45802-045-02) | Padagis Israel Pharmaceuticals Ltd | 45802-045-02 | 45802-045 | ANDA205782 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 5mg/g | 1 Tube In 1 Carton (45802-049-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-049-35 | 45802-049 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .25mg/g | 454 G In 1 Jar (45802-054-05) | Padagis Israel Pharmaceuticals Ltd | 45802-054-05 | 45802-054 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (45802-054-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-054-35 | 45802-054 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (45802-054-36) / 80 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-054-36 | 45802-054 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 454 G In 1 Jar (45802-055-05) | Padagis Israel Pharmaceuticals Ltd | 45802-055-05 | 45802-055 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-055-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-055-35 | 45802-055 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (45802-055-36) / 80 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-055-36 | 45802-055 | ANDA087385 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | .25mg/g | 454 G In 1 Jar (45802-063-05) | Padagis Israel Pharmaceuticals Ltd | 45802-063-05 | 45802-063 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (45802-063-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-063-35 | 45802-063 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (45802-063-36) / 80 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-063-36 | 45802-063 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 454 G In 1 Jar (45802-064-05) | Padagis Israel Pharmaceuticals Ltd | 45802-064-05 | 45802-064 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-064-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-064-35 | 45802-064 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (45802-064-36) / 80 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-064-36 | 45802-064 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 5mg/g | 1 Tube In 1 Carton (45802-065-35) / 15 G In 1 Tube | Padagis Israel Pharmaceuticals Ltd | 45802-065-35 | 45802-065 | ANDA086413 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .5mg/g | 430 G In 1 Jar (45802-817-01) | Padagis Israel Pharmaceuticals Ltd | 45802-817-01 | 45802-817 | ANDA212460 | ANDA | N/A |
| Triamcinolone Acetonide | Spray, Metered | Nasal | 55ug/1 | 1 Bottle In 1 Carton (45802-109-01) / 120 Spray, Metered In 1 Bottle | Padagis Israel Pharmaceuticals Ltd | 45802-109-01 | 45802-109 | ANDA078104 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Dental | 1mg/g | 1 Tube In 1 Carton (51672-1335-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1335-5 | 51672-1335 | ANDA070730 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Dental | 1mg/g | 1 Tube In 1 Carton (51672-1335-8) / 7.5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1335-8 | 51672-1335 | ANDA070730 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Dental | 1mg/g | 1 Tube In 1 Carton (51672-1267-5) / 5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1267-5 | 51672-1267 | ANDA070730 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Dental | 1mg/g | 1 Tube In 1 Carton (51672-1267-8) / 7.5 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1267-8 | 51672-1267 | ANDA070730 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1282-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1282-1 | 51672-1282 | ANDA040039 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1282-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1282-2 | 51672-1282 | ANDA040039 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1282-8) / 80 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1282-8 | 51672-1282 | ANDA040039 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1284-1) / 15 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1284-1 | 51672-1284 | ANDA040037 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1284-2) / 30 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1284-2 | 51672-1284 | ANDA040037 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (51672-1284-8) / 80 G In 1 Tube | Taro Pharmaceuticals U.S.A., Inc. | 51672-1284-8 | 51672-1284 | ANDA040037 | ANDA | N/A |
| Triamcinolone Acetonide | Spray, Metered | Nasal | 55ug/1 | 1 Bottle, Spray In 1 Carton (60505-6275-7) / 120 Spray, Metered In 1 Bottle, Spray | Apotex Corp. | 60505-6275-7 | 60505-6275 | ANDA214615 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0225-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0225-15 | 0713-0225 | ANDA089798 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0225-31) / 30 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0225-31 | 0713-0225 | ANDA089798 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0225-80) / 80 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0225-80 | 0713-0225 | ANDA089798 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0226-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0226-15 | 0713-0226 | ANDA089797 | ANDA | N/A |
| Triamcinolone Acetonide | Cream | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0226-80) / 80 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0226-80 | 0713-0226 | ANDA089797 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Dental | 1mg/g | 1 Tube In 1 Carton (0713-0655-40) / 5 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0655-40 | 0713-0655 | ANDA205592 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0228-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0228-15 | 0713-0228 | ANDA089796 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | 1mg/g | 1 Tube In 1 Carton (0713-0228-80) / 80 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0228-80 | 0713-0228 | ANDA089796 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0229-15) / 15 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0229-15 | 0713-0229 | ANDA089795 | ANDA | N/A |
| Triamcinolone Acetonide | Ointment | Topical | .25mg/g | 1 Tube In 1 Carton (0713-0229-80) / 80 G In 1 Tube | Cosette Pharmaceuticals, Inc. | 0713-0229-80 | 0713-0229 | ANDA089795 | ANDA | N/A |
| Triamcinolone Acetonide | Lotion | Topical | 1mg/mL | 1 Bottle In 1 Carton (0713-0676-53) / 60 Ml In 1 Bottle | Cosette Pharmaceuticals, Inc. | 0713-0676-53 | 0713-0676 | ANDA089129 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1500mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-285-30) | Ascent Pharmaceuticals, Inc. | 43602-285-30 | 43602-285 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-283-05) | Ascent Pharmaceuticals, Inc. | 43602-283-05 | 43602-283 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-283-30) | Ascent Pharmaceuticals, Inc. | 43602-283-30 | 43602-283 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1125mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-284-05) | Ascent Pharmaceuticals, Inc. | 43602-284-05 | 43602-284 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1125mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-284-30) | Ascent Pharmaceuticals, Inc. | 43602-284-30 | 43602-284 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1500mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-285-05) | Ascent Pharmaceuticals, Inc. | 43602-285-05 | 43602-285 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 1500mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-285-30) | Ascent Pharmaceuticals, Inc. | 43602-285-30 | 43602-285 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-133-01) | Camber Pharmaceuticals, Inc. | 31722-133-01 | 31722-133 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (31722-133-05) | Camber Pharmaceuticals, Inc. | 31722-133-05 | 31722-133 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1125mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-134-01) | Camber Pharmaceuticals, Inc. | 31722-134-01 | 31722-134 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1500mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-135-01) | Camber Pharmaceuticals, Inc. | 31722-135-01 | 31722-135 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1500mg/1 | 500 Tablet, Extended Release In 1 Bottle (31722-135-05) | Camber Pharmaceuticals, Inc. | 31722-135-05 | 31722-135 | ANDA214422 | ANDA | N/A |
| Potassium Chloride | Powder, For Solution | Oral | 1.5g/1.77g | 100 Packet In 1 Carton (42806-094-01) / 1.77 G In 1 Packet (42806-094-99) | Epic Pharma, LLC | 42806-094-01 | 42806-094 | ANDA210200 | ANDA | N/A |
| Triamterene | Capsule | Oral | 50mg/1 | 100 Capsule In 1 Bottle (66993-831-02) | Prasco Laboratories | 66993-831-02 | 66993-831 | NDA013174 | NDA AUTHORIZED GENERIC | N/A |
| Triazolam | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle (0054-4858-25) | Hikma Pharmaceuticals USA Inc. | 0054-4858-25 | 0054-4858 | ANDA074224 | ANDA | CIV |
| Triazolam | Tablet | Oral | .25mg/1 | 100 Tablet In 1 Bottle (0054-4859-25) | Hikma Pharmaceuticals USA Inc. | 0054-4859-25 | 0054-4859 | ANDA074224 | ANDA | CIV |
| Triazolam | Tablet | Oral | .25mg/1 | 500 Tablet In 1 Bottle (0054-4859-29) | Hikma Pharmaceuticals USA Inc. | 0054-4859-29 | 0054-4859 | ANDA074224 | ANDA | CIV |
| Potassium Chloride | Powder, For Solution | Oral | 1.5g/1.77g | 30 Packet In 1 Carton (42806-094-30) / 1.77 G In 1 Packet (42806-094-99) | Epic Pharma, LLC | 42806-094-30 | 42806-094 | ANDA210200 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 600mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (42806-422-01) | Epic Pharma, LLC | 42806-422-01 | 42806-422 | ANDA209314 | ANDA | N/A |
| Trichophyton Mentagrophytes; Trichophyton Rubrum; Trichophyton Tonsurans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 10 Ml In 1 Vial (65044-5284-2) | Jubilant HollisterStier LLC | 65044-5284-2 | 65044-5284 | BLA103888 | BLA | N/A |
| Trichophyton Mentagrophytes; Trichophyton Rubrum; Trichophyton Tonsurans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 30 Ml In 1 Vial (65044-5284-3) | Jubilant HollisterStier LLC | 65044-5284-3 | 65044-5284 | BLA103888 | BLA | N/A |
| Trichophyton Mentagrophytes; Trichophyton Rubrum; Trichophyton Tonsurans | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL, .1 g/mL, .1 g/mL | 50 Ml In 1 Vial (65044-5284-4) | Jubilant HollisterStier LLC | 65044-5284-4 | 65044-5284 | BLA103888 | BLA | N/A |
| Trichophyton Mentagrophytes; Trichophyton Rubrum; Trichophyton Tonsurans | Injection, Solution | Percutaneous | .1g/mL, .1 g/mL, .1 g/mL | 5 Ml In 1 Vial (65044-5285-1) | Jubilant HollisterStier LLC | 65044-5285-1 | 65044-5285 | BLA103888 | BLA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 600mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (42806-422-05) | Epic Pharma, LLC | 42806-422-05 | 42806-422 | ANDA209314 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 600mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (42806-422-10) | Epic Pharma, LLC | 42806-422-10 | 42806-422 | ANDA209314 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 100 Tablet, Film Coated, Extended Release In 1 Bottle (42806-423-01) | Epic Pharma, LLC | 42806-423-01 | 42806-423 | ANDA209314 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (70954-212-10) | Novitium Pharma LLC | 70954-212-10 | 70954-212 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (70954-212-20) | Novitium Pharma LLC | 70954-212-20 | 70954-212 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-211-10) | Novitium Pharma LLC | 70954-211-10 | 70954-211 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (70954-211-20) | Novitium Pharma LLC | 70954-211-20 | 70954-211 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51407-265-01) | Golden State Medical Supply Inc. | 51407-265-01 | 51407-265 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-266-01) | Golden State Medical Supply Inc. | 51407-266-01 | 51407-266 | ANDA040254 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (69452-241-20) | Bionpharma Inc. | 69452-241-20 | 69452-241 | ANDA091630 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (69452-241-32) | Bionpharma Inc. | 69452-241-32 | 69452-241 | ANDA091630 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (69452-242-20) | Bionpharma Inc. | 69452-242-20 | 69452-242 | ANDA091630 | ANDA | N/A |
| Trihexyphenidyl Hydrochloride | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (69452-242-32) | Bionpharma Inc. | 69452-242-32 | 69452-242 | ANDA091630 | ANDA | N/A |
| Trimethoprim | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle, Plastic (51407-738-01) | Golden State Medical Supply, Inc. | 51407-738-01 | 51407-738 | ANDA216393 | ANDA | N/A |
| Trisodium Citrate Dihydrate | Tablet, Chewable | Oral | 230mg/1 | 1 Blister Pack In 1 Carton (52389-242-10) / 10 Tablet, Chewable In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-242-10 | 52389-242 | M001 | OTC MONOGRAPH DRUG | N/A |
| Trisodium Citrate Dihydrate | Tablet, Chewable | Oral | 230mg/1 | 4 Blister Pack In 1 Carton (52389-242-40) / 10 Tablet, Chewable In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-242-40 | 52389-242 | M001 | OTC MONOGRAPH DRUG | N/A |
| Trisodium Citrate Dihydrate | Tablet, Chewable | Oral | 230mg/1 | 3 Blister Pack In 1 Carton (52389-242-42) / 14 Tablet, Chewable In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-242-42 | 52389-242 | M001 | OTC MONOGRAPH DRUG | N/A |
| Trisodium Citrate Dihydrate | Tablet, Chewable | Oral | 230mg/1 | 5 Blister Pack In 1 Carton (52389-242-50) / 10 Tablet, Chewable In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-242-50 | 52389-242 | M001 | OTC MONOGRAPH DRUG | N/A |
| Trisodium Citrate Dihydrate | Tablet, Chewable | Oral | 230mg/1 | 4 Blister Pack In 1 Carton (52389-242-56) / 14 Tablet, Chewable In 1 Blister Pack | Alva-Amco Pharmacal Companies, Inc. | 52389-242-56 | 52389-242 | M001 | OTC MONOGRAPH DRUG | N/A |
| Tromethamine | Injection, Solution | Intravenous | 3.6g/100mL | 6 Bottle, Glass In 1 Case (0409-1593-04) / 500 Ml In 1 Bottle, Glass (0409-1593-14) | Hospira, Inc. | 0409-1593-04 | 0409-1593 | NDA013025 | NDA | N/A |
| Tropicamide | Solution/ Drops | Ophthalmic | 10mg/mL | 1 Bottle In 1 Carton (70069-121-01) / 15 Ml In 1 Bottle | Somerset Therapeutics, LLC | 70069-121-01 | 70069-121 | ANDA207524 | ANDA | N/A |
| Trospium Chloride | Tablet, Film Coated | Oral | 20mg/1 | 60 Tablet, Film Coated In 1 Bottle (0574-0145-60) | Padagis US LLC | 0574-0145-60 | 0574-0145 | ANDA091573 | ANDA | N/A |
| Trospium Chloride | Capsule, Extended Release | Oral | 60mg/1 | 30 Capsule, Extended Release In 1 Bottle (0574-0118-30) | Padagis US LLC | 0574-0118-30 | 0574-0118 | ANDA201291 | ANDA | N/A |
| Trospium Chloride | Capsule, Extended Release | Oral | 60mg/1 | 30 Capsule, Extended Release In 1 Bottle, Plastic (60429-098-30) | Golden State Medical Supply, Inc. | 60429-098-30 | 60429-098 | ANDA091289 | ANDA | N/A |
| Tuna, Unspecified | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3674-2) | Jubilant HollisterStier LLC | 65044-3674-2 | 65044-3674 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1540-2) | Jubilant HollisterStier LLC | 65044-1540-2 | 65044-1540 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1540-3) | Jubilant HollisterStier LLC | 65044-1540-3 | 65044-1540 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1540-4) | Jubilant HollisterStier LLC | 65044-1540-4 | 65044-1540 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1541-1) | Jubilant HollisterStier LLC | 65044-1541-1 | 65044-1541 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1543-2) | Jubilant HollisterStier LLC | 65044-1543-2 | 65044-1543 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1543-3) | Jubilant HollisterStier LLC | 65044-1543-3 | 65044-1543 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1543-4) | Jubilant HollisterStier LLC | 65044-1543-4 | 65044-1543 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 10 Ml In 1 Vial (65044-1544-2) | Jubilant HollisterStier LLC | 65044-1544-2 | 65044-1544 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 30 Ml In 1 Vial (65044-1544-3) | Jubilant HollisterStier LLC | 65044-1544-3 | 65044-1544 | BLA103888 | BLA | N/A |
| Ulmus Americana Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 50 Ml In 1 Vial (65044-1544-4) | Jubilant HollisterStier LLC | 65044-1544-4 | 65044-1544 | BLA103888 | BLA | N/A |
| Ulmus Parvifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1546-2) | Jubilant HollisterStier LLC | 65044-1546-2 | 65044-1546 | BLA103888 | BLA | N/A |
| Ulmus Parvifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1546-3) | Jubilant HollisterStier LLC | 65044-1546-3 | 65044-1546 | BLA103888 | BLA | N/A |
| Ulmus Parvifolia Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1546-4) | Jubilant HollisterStier LLC | 65044-1546-4 | 65044-1546 | BLA103888 | BLA | N/A |
| Ulmus Parvifolia Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1547-1) | Jubilant HollisterStier LLC | 65044-1547-1 | 65044-1547 | BLA103888 | BLA | N/A |
| Undecylenic Acid | Spray | Topical | 100mg/mL | 1 Bottle In 1 Package (54312-325-05) / 35 Ml In 1 Bottle | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-325-05 | 54312-325 | M005 | OTC MONOGRAPH DRUG | N/A |
| Undecylenic Acid; Zinc Undecylenate | Cream | Topical | 5g/100g, 18 g/100g | 1 Tube In 1 Carton (54312-125-01) / 25 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-125-01 | 54312-125 | M005 | OTC MONOGRAPH DRUG | N/A |
| Undecylenic Acid; Zinc Undecylenate | Cream | Topical | 5g/100g, 18 g/100g | 1 Tube In 1 Carton (54312-125-02) / 50 G In 1 Tube | Compania Internacional de Comercio, S.A.P.I de C.V. | 54312-125-02 | 54312-125 | M005 | OTC MONOGRAPH DRUG | N/A |
| Undecylenic Acid; Zinc Undecylenate | Powder | Topical | 2g/100g, 20 g/100g | 1 Bottle In 1 Package (54312-925-01) / 80 G In 1 Bottle | Compania Internacional de Comercio, S.A.P.I. de C.V. | 54312-925-01 | 54312-925 | M005 | OTC MONOGRAPH DRUG | N/A |
| Ursodiol | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (79739-7143-1) | LGM PHARMA SOLUTIONS, LLC | 79739-7143-1 | 79739-7143 | ANDA205789 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (42806-423-05) | Epic Pharma, LLC | 42806-423-05 | 42806-423 | ANDA209314 | ANDA | N/A |
| Potassium Chloride | Tablet, Film Coated, Extended Release | Oral | 750mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (42806-423-10) | Epic Pharma, LLC | 42806-423-10 | 42806-423 | ANDA209314 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 600mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-842-01) | Rising Pharma Holdings, Inc. | 16571-842-01 | 16571-842 | ANDA217412 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 600mg/1 | 500 Tablet, Extended Release In 1 Bottle (16571-842-50) | Rising Pharma Holdings, Inc. | 16571-842-50 | 16571-842 | ANDA217412 | ANDA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1945-2) | Jubilant HollisterStier LLC | 65044-1945-2 | 65044-1945 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1945-3) | Jubilant HollisterStier LLC | 65044-1945-3 | 65044-1945 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1945-4) | Jubilant HollisterStier LLC | 65044-1945-4 | 65044-1945 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1946-1) | Jubilant HollisterStier LLC | 65044-1946-1 | 65044-1946 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1947-2) | Jubilant HollisterStier LLC | 65044-1947-2 | 65044-1947 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1947-3) | Jubilant HollisterStier LLC | 65044-1947-3 | 65044-1947 | BLA103888 | BLA | N/A |
| Urtica Dioica Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1947-4) | Jubilant HollisterStier LLC | 65044-1947-4 | 65044-1947 | BLA103888 | BLA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 42 Tablet, Film Coated In 1 Bottle, Plastic (60760-469-42) | St. Mary's Medical Park Pharmacy | 60760-469-42 | 60760-469 | ANDA203047 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-107-30) | Golden State Medical Supply, Inc. | 51407-107-30 | 51407-107 | ANDA076588 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 90 Tablet, Film Coated In 1 Bottle (51407-107-90) | Golden State Medical Supply, Inc. | 51407-107-90 | 51407-107 | ANDA076588 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 30 Tablet, Film Coated In 1 Bottle (51407-108-30) | Golden State Medical Supply, Inc. | 51407-108-30 | 51407-108 | ANDA076588 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 90 Tablet, Film Coated In 1 Bottle (51407-108-90) | Golden State Medical Supply, Inc. | 51407-108-90 | 51407-108 | ANDA076588 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (59746-324-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-01 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 10 Tablet, Film Coated In 1 Bottle (59746-324-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-10 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (59746-324-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-30 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 250 Tablet, Film Coated In 1 Bottle (59746-324-37) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-37 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 300 Tablet, Film Coated In 1 Bottle (59746-324-47) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-47 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 90 Tablet, Film Coated In 1 Bottle (59746-324-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-324-90 | 59746-324 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 100 Tablet, Film Coated In 1 Bottle (59746-325-01) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-01 | 59746-325 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 10 Tablet, Film Coated In 1 Bottle (59746-325-10) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-10 | 59746-325 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 30 Tablet, Film Coated In 1 Bottle (59746-325-30) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-30 | 59746-325 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 250 Tablet, Film Coated In 1 Bottle (59746-325-37) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-37 | 59746-325 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 300 Tablet, Film Coated In 1 Bottle (59746-325-47) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-47 | 59746-325 | ANDA201506 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 90 Tablet, Film Coated In 1 Bottle (59746-325-90) | Jubilant Cadista Pharmaceuticals Inc. | 59746-325-90 | 59746-325 | ANDA201506 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (16571-843-01) | Rising Pharma Holdings, Inc. | 16571-843-01 | 16571-843 | ANDA217412 | ANDA | N/A |
| Potassium Chloride | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (16571-843-50) | Rising Pharma Holdings, Inc. | 16571-843-50 | 16571-843 | ANDA217412 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 1.5g/15mL | 10 TRAY in 1 CASE (71656-021-01) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15) | Saptalis Pharmaceuticals, LLC | 71656-021-01 | 71656-021 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 1.5g/15mL | 10 TRAY in 1 CASE (71656-021-02) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30) | Saptalis Pharmaceuticals, LLC | 71656-021-02 | 71656-021 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 1.5g/15mL | 473 mL in 1 BOTTLE (71656-021-16) | Saptalis Pharmaceuticals, LLC | 71656-021-16 | 71656-021 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 1.5g/15mL | 5 TRAY in 1 CASE (71656-021-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15) | Saptalis Pharmaceuticals, LLC | 71656-021-50 | 71656-021 | ANDA211648 | ANDA | N/A |
| Valganciclovir | For Solution | Oral | 50mg/mL | 100 Ml In 1 Bottle (70069-810-01) | Somerset Therapeutics, LLC | 70069-810-01 | 70069-810 | ANDA213306 | ANDA | N/A |
| Valganciclovir Hydrochloride | Tablet, Film Coated | Oral | 450mg/1 | 60 Tablet, Film Coated In 1 Bottle (60429-846-60) | Golden State Medical Supply, Inc. | 60429-846-60 | 60429-846 | ANDA203511 | ANDA | N/A |
| Valproate Sodium | Injection | Intravenous | 100mg/mL | 10 Vial, Single-Dose In 1 Tray (0143-9637-10) / 5 Ml In 1 Vial, Single-Dose (0143-9637-01) | Hikma Pharmaceuticals USA Inc. | 0143-9637-10 | 0143-9637 | ANDA078523 | ANDA | N/A |
| Valproate Sodium | Injection | Intravenous | 500mg/5mL | 10 Vial, Single-Dose In 1 Carton (0143-9785-10) / 5 Ml In 1 Vial, Single-Dose (0143-9785-01) | Hikma Pharmaceuticals USA Inc. | 0143-9785-10 | 0143-9785 | ANDA078523 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 1.5g/15mL | 5 TRAY in 1 CASE (71656-021-51) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30) | Saptalis Pharmaceuticals, LLC | 71656-021-51 | 71656-021 | ANDA211648 | ANDA | N/A |
| Valproic Acid | Capsule, Liquid Filled | Oral | 250mg/1 | 100 Capsule, Liquid Filled In 1 Bottle, Plastic (69452-150-20) | Bionpharma Inc. | 69452-150-20 | 69452-150 | ANDA073484 | ANDA | N/A |
| Valrubicin | Solution, Concentrate | Intravesical | 40mg/mL | 4 Vial In 1 Carton (24201-101-04) / 5 Ml In 1 Vial | Hikma Pharmaceuticals USA Inc. | 24201-101-04 | 24201-101 | ANDA206430 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 3g/15mL | 10 TRAY in 1 CASE (71656-022-01) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-022-15) | Saptalis Pharmaceuticals, LLC | 71656-022-01 | 71656-022 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 3g/15mL | 473 mL in 1 BOTTLE (71656-022-16) | Saptalis Pharmaceuticals, LLC | 71656-022-16 | 71656-022 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | SOLUTION | ORAL | 3g/15mL | 5 TRAY in 1 CASE (71656-022-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-022-15) | Saptalis Pharmaceuticals, LLC. | 71656-022-50 | 71656-022 | ANDA211648 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 750mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-194-01) | XLCare Pharmaceuticals, Inc. | 72865-194-01 | 72865-194 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 750mg/1 | 500 Tablet, Extended Release In 1 Bottle (72865-194-05) | XLCare Pharmaceuticals, Inc. | 72865-194-05 | 72865-194 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1125mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-195-01) | XLCare Pharmaceuticals, Inc. | 72865-195-01 | 72865-195 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1125mg/1 | 500 Tablet, Extended Release In 1 Bottle (72865-195-05) | XLCare Pharmaceuticals, Inc. | 72865-195-05 | 72865-195 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1500mg/1 | 100 Tablet, Extended Release In 1 Bottle (72865-196-01) | XLCare Pharmaceuticals, Inc. | 72865-196-01 | 72865-196 | ANDA214422 | ANDA | N/A |
| POTASSIUM CHLORIDE | Tablet, Extended Release | Oral | 1500mg/1 | 500 Tablet, Extended Release In 1 Bottle (72865-196-05) | XLCare Pharmaceuticals, Inc. | 72865-196-05 | 72865-196 | ANDA214422 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (59746-360-58) | Jubilant Cadista Pharmaceuticals Inc. | 59746-360-58 | 59746-360 | ANDA203536 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (59746-360-62) | Jubilant Cadista Pharmaceuticals Inc. | 59746-360-62 | 59746-360 | ANDA203536 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (59746-361-62) | Jubilant Cadista Pharmaceuticals Inc. | 59746-361-62 | 59746-361 | ANDA203536 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 90 Tablet In 1 Bottle (59746-362-62) | Jubilant Cadista Pharmaceuticals Inc. | 59746-362-62 | 59746-362 | ANDA203536 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 90 Tablet In 1 Bottle (59746-363-62) | Jubilant Cadista Pharmaceuticals Inc. | 59746-363-62 | 59746-363 | ANDA203536 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 100 Tablet, Extended Release In 1 Bottle (62559-291-01) | ANI Pharmaceuticals, Inc. | 62559-291-01 | 62559-291 | ANDA212779 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 100 Tablet, Extended Release In 1 Bottle (62559-292-01) | ANI Pharmaceuticals, Inc. | 62559-292-01 | 62559-292 | ANDA212779 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 5meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-399-05) | Ascent Pharmaceuticals Inc | 43602-399-05 | 43602-399 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 5meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-399-30) | Ascent Pharmaceuticals Inc | 43602-399-30 | 43602-399 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-400-05) | Ascent Pharmaceuticals Inc | 43602-400-05 | 43602-400 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-400-30) | Ascent Pharmaceuticals Inc | 43602-400-30 | 43602-400 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-401-05) | Ascent Pharmaceuticals Inc | 43602-401-05 | 43602-401 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-401-30) | Ascent Pharmaceuticals Inc | 43602-401-30 | 43602-401 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 5meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-399-05) | Ascent Pharmaceuticals Inc | 43602-399-05 | 43602-399 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 5meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-399-30) | Ascent Pharmaceuticals Inc | 43602-399-30 | 43602-399 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-400-05) | Ascent Pharmaceuticals Inc | 43602-400-05 | 43602-400 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 10meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-400-30) | Ascent Pharmaceuticals Inc | 43602-400-30 | 43602-400 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 500 Tablet, Extended Release In 1 Bottle (43602-401-05) | Ascent Pharmaceuticals Inc | 43602-401-05 | 43602-401 | ANDA214420 | ANDA | N/A |
| Potassium Citrate | Tablet, Extended Release | Oral | 15meq/1 | 30 Tablet, Extended Release In 1 Bottle (43602-401-30) | Ascent Pharmaceuticals Inc | 43602-401-30 | 43602-401 | ANDA214420 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 5meq/1 | 100 Tablet, Extended Release In 1 Bottle (31722-129-01) | Camber Pharmaceuticals, Inc | 31722-129-01 | 31722-129 | ANDA214420 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 10meq/1 | 100 Tablet, Extended Release In 1 Bottle (31722-130-01) | Camber Pharmaceuticals, Inc | 31722-130-01 | 31722-130 | ANDA214420 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 15meq/1 | 100 Tablet, Extended Release In 1 Bottle (31722-132-01) | Camber Pharmaceuticals, Inc | 31722-132-01 | 31722-132 | ANDA214420 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 5meq/1 | 100 Tablet, Extended Release In 1 Bottle (72865-191-01) | XLCare Pharmaceuticals, Inc. | 72865-191-01 | 72865-191 | ANDA214420 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 10meq/1 | 100 Tablet, Extended Release In 1 Bottle (72865-192-01) | XLCare Pharmaceuticals, Inc. | 72865-192-01 | 72865-192 | ANDA214420 | ANDA | N/A |
| Vancomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/1 | 10 Vial In 1 Carton (0143-9355-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9355-01) | Hikma Pharmaceuticals USA Inc. | 0143-9355-10 | 0143-9355 | ANDA206616 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 10 Vial, Single-Dose In 1 Carton (71288-022-11) / 10 Ml In 1 Vial, Single-Dose (71288-022-10) | Meitheal Pharmaceuticals Inc. | 71288-022-11 | 71288-022 | ANDA215197 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/20mL | 10 Vial, Single-Dose In 1 Carton (71288-023-21) / 20 Ml In 1 Vial, Single-Dose (71288-023-20) | Meitheal Pharmaceuticals Inc. | 71288-023-21 | 71288-023 | ANDA215197 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/15mL | 10 Vial, Single-Dose In 1 Carton (71288-024-21) / 15 Ml In 1 Vial, Single-Dose (71288-024-20) | Meitheal Pharmaceuticals Inc. | 71288-024-21 | 71288-024 | ANDA215195 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 5g/100mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (71288-025-75) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Meitheal Pharmaceuticals Inc. | 71288-025-75 | 71288-025 | ANDA215196 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 10g/95mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (71288-026-75) / 95 Ml In 1 Vial, Pharmacy Bulk Package | Meitheal Pharmaceuticals Inc. | 71288-026-75 | 71288-026 | ANDA215196 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 5g/100mL | 1 Bottle In 1 Carton (25021-157-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-157-99 | 25021-157 | ANDA200837 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 10g/100mL | 1 Bottle In 1 Carton (25021-158-99) / 100 Ml In 1 Bottle | Sagent Pharmaceuticals | 25021-158-99 | 25021-158 | ANDA200837 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 10 Vial In 1 Carton (25021-150-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-150-10 | 25021-150 | ANDA205694 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/20mL | 10 Vial In 1 Carton (25021-151-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-151-20 | 25021-151 | ANDA205694 | ANDA | N/A |
| POTASSIUM CITRATE | Tablet, Extended Release | Oral | 15meq/1 | 100 Tablet, Extended Release In 1 Bottle (72865-193-01) | XLCare Pharmaceuticals, Inc. | 72865-193-01 | 72865-193 | ANDA214420 | ANDA | N/A |
| Potassium Nitrate; Sodium Fluoride | Gel, Dentifrice | Dental | 57.5mg/mL, 5.8 mg/mL | 100 Ml In 1 Tube (16571-823-10) | Rising Pharma Holdings, Inc. | 16571-823-10 | 16571-823 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | Injection | Intravenous | 4.72mg/mL, 4.48 mg/mL | 24 Pouch In 1 Carton (70121-1722-9) / 1 Bag In 1 Pouch / 250 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1722-9 | 70121-1722 | NDA218343 | NDA | N/A |
| Potassium Phosphate, Monobasic; Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Tablet | Oral | 155mg/1, 852 mg/1, 130 mg/1 | 100 Tablet In 1 Bottle (64980-104-01) | Rising Pharma Holdings, Inc. | 64980-104-01 | 64980-104 | N/A | UNAPPROVED DRUG OTHER | N/A |
| PRAMIPEXOLE | Tablet | Oral | .125mg/1 | 500 Tablet In 1 Bottle (31722-906-05) | Camber Pharmaceuticals, Inc. | 31722-906-05 | 31722-906 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (31722-906-10) | Camber Pharmaceuticals, Inc. | 31722-906-10 | 31722-906 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (31722-906-90) | Camber Pharmaceuticals, Inc. | 31722-906-90 | 31722-906 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .25mg/1 | 500 Tablet In 1 Bottle (31722-907-05) | Camber Pharmaceuticals, Inc. | 31722-907-05 | 31722-907 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (31722-907-10) | Camber Pharmaceuticals, Inc. | 31722-907-10 | 31722-907 | ANDA203855 | ANDA | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 125mg/1 | 2 Blister Pack In 1 Carton (47781-729-02) / 10 Capsule In 1 Blister Pack | Alvogen Inc. | 47781-729-02 | 47781-729 | ANDA065490 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous; Oral | 513mg/mg | 25 Vial In 1 Package (0143-9161-25) / 513 Mg In 1 Vial (0143-9161-01) | HIKMA PHARMACEUTICALS USA INC. | 0143-9161-25 | 0143-9161 | NDA210274 | NDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous; Oral | 1025mg/mg | 10 Vial In 1 Package (0143-9162-10) / 1025 Mg In 1 Vial (0143-9162-01) | HIKMA PHARMACEUTICALS USA INC. | 0143-9162-10 | 0143-9162 | NDA210274 | NDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous; Oral | 5.13g/g | 1 Vial, Pharmacy Bulk Package In 1 Carton (0143-9163-01) / 5.13 G In 1 Vial, Pharmacy Bulk Package | HIKMA PHARMACEUTICALS USA INC. | 0143-9163-01 | 0143-9163 | NDA210274 | NDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous; Oral | 10.25g/g | 1 Vial, Pharmacy Bulk Package In 1 Carton (0143-9164-01) / 10.25 G In 1 Vial, Pharmacy Bulk Package | HIKMA PHARMACEUTICALS USA INC. | 0143-9164-01 | 0143-9164 | NDA210274 | NDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1.25g/1 | 10 Vial In 1 Carton (0143-9152-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9152-10 | 0143-9152 | ANDA217489 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 25 Vial In 1 Carton (0143-9356-25) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9356-01) | Hikma Pharmaceuticals USA Inc. | 0143-9356-25 | 0143-9356 | ANDA203300 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1.5g/1 | 10 Vial In 1 Carton (0143-9153-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial | Hikma Pharmaceuticals USA Inc. | 0143-9153-10 | 0143-9153 | ANDA217489 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 10 Vial In 1 Carton (0143-9357-10) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0143-9357-01) | Hikma Pharmaceuticals USA Inc. | 0143-9357-10 | 0143-9357 | ANDA203300 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous | 5g/1 | 1 Injection, Powder, For Solution In 1 Carton (0143-9358-01) | Hikma Pharmaceuticals USA Inc. | 0143-9358-01 | 0143-9358 | ANDA204360 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, For Solution | Intravenous | 10g/1 | 1 Injection, Powder, For Solution In 1 Bottle (0143-9359-01) | Hikma Pharmaceuticals USA Inc. | 0143-9359-01 | 0143-9359 | ANDA204360 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 10 Vial In 1 Tray (0409-4332-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0409-4332-11) | Hospira, Inc. | 0409-4332-01 | 0409-4332 | ANDA062911 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1.5g/1 | 10 Vial In 1 Tray (0409-3515-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0409-3515-11) | Hospira, Inc. | 0409-3515-01 | 0409-3515 | ANDA062912 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/5mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-1319-01) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc. | 0409-1319-01 | 0409-1319 | ANDA063076 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-6509-49) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc. | 0409-6509-49 | 0409-6509 | ANDA063076 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-6509-01) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc. | 0409-6509-01 | 0409-6509 | ANDA063076 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/1 | 10 Vial, Single-Dose In 1 Tray (0409-6531-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-6531-11) | Hospira, Inc. | 0409-6531-01 | 0409-6531 | ANDA062933 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 750mg/1 | 10 Vial In 1 Tray (0409-6531-02) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0409-6531-12) | Hospira, Inc. | 0409-6531-02 | 0409-6531 | ANDA062912 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 10 Vial In 1 Carton (0409-6533-21) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0409-6533-11) | Hospira, Inc. | 0409-6533-21 | 0409-6533 | ANDA062912 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 10 Vial In 1 Carton (0409-6533-31) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial (0409-6533-59) | Hospira, Inc. | 0409-6533-31 | 0409-6533 | ANDA062912 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/1 | 10 Vial, Single-Dose In 1 Tray (0409-6534-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-6534-11) | Hospira, Inc. | 0409-6534-01 | 0409-6534 | ANDA062931 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/1 | 10 Vial, Single-Dose In 1 Tray (0409-6535-01) / 1 Injection, Powder, Lyophilized, For Solution In 1 Vial, Single-Dose (0409-6535-11) | Hospira, Inc. | 0409-6535-01 | 0409-6535 | ANDA062933 | ANDA | N/A |
| Vancomycin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/5mL | 1 Vial, Pharmacy Bulk Package In 1 Carton (0409-5017-01) / 100 Ml In 1 Vial, Pharmacy Bulk Package | Hospira, Inc. | 0409-5017-01 | 0409-5017 | ANDA063076 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | .5mg/1 | 56 Tablet, Film Coated In 1 Bottle (51407-755-56) | Golden State Medical Supply, Inc. | 51407-755-56 | 51407-755 | ANDA201962 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 56 Tablet, Film Coated In 1 Bottle (51407-756-56) | Golden State Medical Supply, Inc. | 51407-756-56 | 51407-756 | ANDA201962 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | .5mg/561 | 56 Tablet, Film Coated In 1 Bottle (69315-402-56) | Leading Pharma, LLC | 69315-402-56 | 69315-402 | ANDA217151 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | 1mg/561 | 56 Tablet, Film Coated In 1 Bottle (69315-403-56) | Leading Pharma, LLC | 69315-403-56 | 69315-403 | ANDA217151 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | .5mg/1 | 56 Tablet, Film Coated In 1 Bottle (60505-4765-5) | Apotex Corp | 60505-4765-5 | 60505-4765 | N/A | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | .5mg/1 | 56 Tablet, Film Coated In 1 Bottle (60505-3613-5) | Apotex Corp | 60505-3613-5 | 60505-3613 | ANDA201962 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 56 Tablet, Film Coated In 1 Bottle (60505-3614-5) | Apotex Corp | 60505-3614-5 | 60505-3614 | ANDA201962 | ANDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | .5mg/1 | 56 Tablet, Film Coated In 1 Bottle (0069-0468-56) | Pfizer Laboratories Div Pfizer Inc | 0069-0468-56 | 0069-0468 | NDA021928 | NDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 1 Blister Pack In 1 Carton (0069-0469-03) / 56 Tablet, Film Coated In 1 Blister Pack | Pfizer Laboratories Div Pfizer Inc | 0069-0469-03 | 0069-0469 | NDA021928 | NDA | N/A |
| Varenicline Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 56 Tablet, Film Coated In 1 Bottle (0069-0469-56) | Pfizer Laboratories Div Pfizer Inc | 0069-0469-56 | 0069-0469 | NDA021928 | NDA | N/A |
| Vasopressin | Solution | Intravenous | 1[USP'U]/mL | 10 Vial, Single-Dose In 1 Carton (81298-8550-3) / 50 Ml In 1 Vial, Single-Dose (81298-8550-1) | Long Grove Pharmaceuticals, LLC | 81298-8550-3 | 81298-8550 | NDA217766 | NDA | N/A |
| Vasopressin | Solution | Intravenous | .2[USP'U]/mL | 10 Vial, Single-Dose In 1 Carton (81298-8552-3) / 100 Ml In 1 Vial, Single-Dose (81298-8552-1) | Long Grove Pharmaceuticals, LLC | 81298-8552-3 | 81298-8552 | NDA217766 | NDA | N/A |
| Vasopressin | Injection | Intravenous | 20[USP'U]/mL | 1 Vial In 1 Carton (0548-9701-00) / 1 Ml In 1 Vial | Amphastar Pharmaceuticals, Inc. | 0548-9701-00 | 0548-9701 | ANDA211857 | ANDA | N/A |
| Vasopressin | Injection, Solution | Intravenous | 20[USP'U]/mL | 25 Vial, Single-Dose In 1 Carton (0517-1020-25) / 1 Ml In 1 Vial, Single-Dose (0517-1020-01) | American Regent, Inc. | 0517-1020-25 | 0517-1020 | NDA212593 | NDA | N/A |
| Vasopressin | Injection, Solution | Intravenous | 20[USP'U]/mL | 1 Vial, Multi-Dose In 1 Carton (0517-1030-01) / 10 Ml In 1 Vial, Multi-Dose | American Regent, Inc. | 0517-1030-01 | 0517-1030 | NDA212593 | NDA | N/A |
| Vecuronium Bromide | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-685-10) / 10 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-685-10 | 25021-685 | ANDA205390 | ANDA | N/A |
| Vecuronium Bromide | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (25021-686-20) / 20 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-686-20 | 25021-686 | ANDA205390 | ANDA | N/A |
| Vecuronium Bromide | Injection, Powder, For Solution | Intravenous | 20mg/1 | 10 Vial In 1 Carton (0143-9232-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9232-01) | Hikma Pharmaceuticals USA Inc. | 0143-9232-10 | 0143-9232 | ANDA203725 | ANDA | N/A |
| Vecuronium Bromide | Injection, Powder, For Solution | Intravenous | 10mg/1 | 10 Vial In 1 Carton (0143-9234-10) / 1 Injection, Powder, For Solution In 1 Vial (0143-9234-01) | Hikma Pharmaceuticals USA Inc. | 0143-9234-10 | 0143-9234 | ANDA203725 | ANDA | N/A |
| Vecuronium Bromide | Injection, Powder, Lyophilized, For Solution | Intravenous | 1mg/mL | 10 Vial In 1 Carton (0409-1632-01) / 10 Ml In 1 Vial (0409-1632-21) | Hospira, Inc. | 0409-1632-01 | 0409-1632 | ANDA075164 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-217-00) | Nivagen Pharmaceuticals, Inc. | 75834-217-00 | 75834-217 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (75834-217-30) | Nivagen Pharmaceuticals, Inc. | 75834-217-30 | 75834-217 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 90 Tablet, Extended Release In 1 Bottle (75834-217-90) | Nivagen Pharmaceuticals, Inc. | 75834-217-90 | 75834-217 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-218-00) | Nivagen Pharmaceuticals, Inc. | 75834-218-00 | 75834-218 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (75834-218-30) | Nivagen Pharmaceuticals, Inc. | 75834-218-30 | 75834-218 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (75834-218-90) | Nivagen Pharmaceuticals, Inc. | 75834-218-90 | 75834-218 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 1000 Tablet, Extended Release In 1 Bottle (75834-219-00) | Nivagen Pharmaceuticals, Inc. | 75834-219-00 | 75834-219 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 30 Tablet, Extended Release In 1 Bottle (75834-219-30) | Nivagen Pharmaceuticals, Inc. | 75834-219-30 | 75834-219 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 90 Tablet, Extended Release In 1 Bottle (75834-219-90) | Nivagen Pharmaceuticals, Inc. | 75834-219-90 | 75834-219 | ANDA211323 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (29033-045-30) | Nostrum Laboratories, Inc. | 29033-045-30 | 29033-045 | ANDA205468 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (29033-045-90) | Nostrum Laboratories, Inc. | 29033-045-90 | 29033-045 | ANDA205468 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 30 Tablet, Extended Release In 1 Bottle (29033-046-30) | Nostrum Laboratories, Inc. | 29033-046-30 | 29033-046 | ANDA205468 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 37.5mg/1 | 60 Tablet In 1 Bottle, Plastic (60760-728-60) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-728-60 | 60760-728 | ANDA077653 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (51407-453-90) | Golden State Medical Supply, Inc. | 51407-453-90 | 51407-453 | ANDA078627 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 37.5mg/1 | 90 Tablet In 1 Bottle (51407-454-90) | Golden State Medical Supply, Inc. | 51407-454-90 | 51407-454 | ANDA078627 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (51407-455-90) | Golden State Medical Supply, Inc. | 51407-455-90 | 51407-455 | ANDA078627 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (51407-456-90) | Golden State Medical Supply, Inc. | 51407-456-90 | 51407-456 | ANDA078627 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (51407-457-90) | Golden State Medical Supply, Inc. | 51407-457-90 | 51407-457 | ANDA078627 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 90 Tablet, Extended Release In 1 Bottle (60429-867-90) | Golden State Medical Supply | 60429-867-90 | 60429-867 | ANDA205468 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 90 Capsule, Extended Release In 1 Bottle (58151-125-77) | Viatris Specialty LLC | 58151-125-77 | 58151-125 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 30 Capsule, Extended Release In 1 Bottle (58151-125-93) | Viatris Specialty LLC | 58151-125-93 | 58151-125 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 90 Capsule, Extended Release In 1 Bottle (58151-127-77) | Viatris Specialty LLC | 58151-127-77 | 58151-127 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-079-30) | Vertical Pharmaceuticals, LLC | 68025-079-30 | 68025-079 | NDA022104 | NDA AUTHORIZED GENERIC | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-080-30) | Vertical Pharmaceuticals, LLC | 68025-080-30 | 68025-080 | NDA022104 | NDA AUTHORIZED GENERIC | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (68025-081-30) | Vertical Pharmaceuticals, LLC | 68025-081-30 | 68025-081 | NDA022104 | NDA AUTHORIZED GENERIC | N/A |
| PRAMIPEXOLE | Tablet | Oral | .25mg/1 | 90 Tablet In 1 Bottle (31722-907-90) | Camber Pharmaceuticals, Inc. | 31722-907-90 | 31722-907 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (31722-908-05) | Camber Pharmaceuticals, Inc. | 31722-908-05 | 31722-908 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (31722-908-10) | Camber Pharmaceuticals, Inc. | 31722-908-10 | 31722-908 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (31722-908-90) | Camber Pharmaceuticals, Inc. | 31722-908-90 | 31722-908 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .75mg/1 | 500 Tablet In 1 Bottle (31722-909-05) | Camber Pharmaceuticals, Inc. | 31722-909-05 | 31722-909 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .75mg/1 | 1000 Tablet In 1 Bottle (31722-909-10) | Camber Pharmaceuticals, Inc. | 31722-909-10 | 31722-909 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | .75mg/1 | 90 Tablet In 1 Bottle (31722-909-90) | Camber Pharmaceuticals, Inc. | 31722-909-90 | 31722-909 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (31722-910-05) | Camber Pharmaceuticals, Inc. | 31722-910-05 | 31722-910 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (31722-910-10) | Camber Pharmaceuticals, Inc. | 31722-910-10 | 31722-910 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (31722-910-90) | Camber Pharmaceuticals, Inc. | 31722-910-90 | 31722-910 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1.5mg/1 | 500 Tablet In 1 Bottle (31722-911-05) | Camber Pharmaceuticals, Inc. | 31722-911-05 | 31722-911 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1.5mg/1 | 1000 Tablet In 1 Bottle (31722-911-10) | Camber Pharmaceuticals, Inc. | 31722-911-10 | 31722-911 | ANDA203855 | ANDA | N/A |
| PRAMIPEXOLE | Tablet | Oral | 1.5mg/1 | 90 Tablet In 1 Bottle (31722-911-90) | Camber Pharmaceuticals, Inc. | 31722-911-90 | 31722-911 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | .375mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-331-30) | Ingenus Pharmaceuticals, LLC | 50742-331-30 | 50742-331 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | .75mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-332-30) | Ingenus Pharmaceuticals, LLC | 50742-332-30 | 50742-332 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | 1.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-333-30) | Ingenus Pharmaceuticals, LLC | 50742-333-30 | 50742-333 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | 2.25mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-334-30) | Ingenus Pharmaceuticals, LLC | 50742-334-30 | 50742-334 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | 3mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-335-30) | Ingenus Pharmaceuticals, LLC | 50742-335-30 | 50742-335 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | 3.75mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-336-30) | Ingenus Pharmaceuticals, LLC | 50742-336-30 | 50742-336 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet, Extended Release | Oral | 4.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-337-30) | Ingenus Pharmaceuticals, LLC | 50742-337-30 | 50742-337 | ANDA213444 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (57237-180-90) | Rising Pharma Holdings, Inc. | 57237-180-90 | 57237-180 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (57237-180-99) | Rising Pharma Holdings, Inc. | 57237-180-99 | 57237-180 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 90 Tablet In 1 Bottle (57237-181-90) | Rising Pharma Holdings, Inc. | 57237-181-90 | 57237-181 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (57237-181-99) | Rising Pharma Holdings, Inc. | 57237-181-99 | 57237-181 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (57237-182-90) | Rising Pharma Holdings, Inc. | 57237-182-90 | 57237-182 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (57237-182-99) | Rising Pharma Holdings, Inc. | 57237-182-99 | 57237-182 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 90 Tablet In 1 Bottle (57237-183-90) | Rising Pharma Holdings, Inc. | 57237-183-90 | 57237-183 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 1000 Tablet In 1 Bottle (57237-183-99) | Rising Pharma Holdings, Inc. | 57237-183-99 | 57237-183 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (57237-184-90) | Rising Pharma Holdings, Inc. | 57237-184-90 | 57237-184 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (57237-184-99) | Rising Pharma Holdings, Inc. | 57237-184-99 | 57237-184 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 90 Tablet In 1 Bottle (57237-185-90) | Rising Pharma Holdings, Inc. | 57237-185-90 | 57237-185 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 1000 Tablet In 1 Bottle (57237-185-99) | Rising Pharma Holdings, Inc. | 57237-185-99 | 57237-185 | ANDA202633 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (50228-126-10) | ScieGen Pharmaceuticals Inc | 50228-126-10 | 50228-126 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (50228-126-90) | ScieGen Pharmaceuticals Inc | 50228-126-90 | 50228-126 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (50228-127-10) | ScieGen Pharmaceuticals Inc | 50228-127-10 | 50228-127 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 90 Tablet In 1 Bottle (50228-127-90) | ScieGen Pharmaceuticals Inc | 50228-127-90 | 50228-127 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (50228-128-10) | ScieGen Pharmaceuticals Inc | 50228-128-10 | 50228-128 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (50228-128-90) | ScieGen Pharmaceuticals Inc | 50228-128-90 | 50228-128 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 1000 Tablet In 1 Bottle (50228-129-10) | ScieGen Pharmaceuticals Inc | 50228-129-10 | 50228-129 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 90 Tablet In 1 Bottle (50228-129-90) | ScieGen Pharmaceuticals Inc | 50228-129-90 | 50228-129 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (50228-130-10) | ScieGen Pharmaceuticals Inc | 50228-130-10 | 50228-130 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (50228-130-90) | ScieGen Pharmaceuticals Inc | 50228-130-90 | 50228-130 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 1000 Tablet In 1 Bottle (50228-131-10) | ScieGen Pharmaceuticals Inc | 50228-131-10 | 50228-131 | ANDA203855 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 75mg/1 | 30 Capsule, Extended Release In 1 Bottle (0008-0833-21) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0833-21 | 0008-0833 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 75mg/1 | 90 Capsule, Extended Release In 1 Bottle (0008-0833-22) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0833-22 | 0008-0833 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 30 Capsule, Extended Release In 1 Bottle (0008-0836-21) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0836-21 | 0008-0836 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 90 Capsule, Extended Release In 1 Bottle (0008-0836-22) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0836-22 | 0008-0836 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 30 Capsule, Extended Release In 1 Bottle (0008-0837-21) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0837-21 | 0008-0837 | NDA020699 | NDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 90 Capsule, Extended Release In 1 Bottle (0008-0837-22) | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0837-22 | 0008-0837 | NDA020699 | NDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 90 Tablet In 1 Bottle (50228-131-90) | ScieGen Pharmaceuticals Inc | 50228-131-90 | 50228-131 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 1000 Tablet In 1 Bottle (50228-126-10) | ScieGen Pharmaceuticals Inc | 50228-126-10 | 50228-126 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .125mg/1 | 90 Tablet In 1 Bottle (50228-126-90) | ScieGen Pharmaceuticals Inc | 50228-126-90 | 50228-126 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 1000 Tablet In 1 Bottle (50228-127-10) | ScieGen Pharmaceuticals Inc | 50228-127-10 | 50228-127 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .25mg/1 | 90 Tablet In 1 Bottle (50228-127-90) | ScieGen Pharmaceuticals Inc | 50228-127-90 | 50228-127 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 1000 Tablet In 1 Bottle (50228-128-10) | ScieGen Pharmaceuticals Inc | 50228-128-10 | 50228-128 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .5mg/1 | 90 Tablet In 1 Bottle (50228-128-90) | ScieGen Pharmaceuticals Inc | 50228-128-90 | 50228-128 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 1000 Tablet In 1 Bottle (50228-129-10) | ScieGen Pharmaceuticals Inc | 50228-129-10 | 50228-129 | ANDA203855 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (75834-320-01) | Nivagen Pharmaceuticals, Inc. | 75834-320-01 | 75834-320 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 120mg/1 | 500 Tablet In 1 Bottle (75834-320-05) | Nivagen Pharmaceuticals, Inc. | 75834-320-05 | 75834-320 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 180mg/1 | 100 Tablet In 1 Bottle (75834-158-01) | Nivagen Pharmaceuticals, Inc. | 75834-158-01 | 75834-158 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 180mg/1 | 500 Tablet In 1 Bottle (75834-158-05) | Nivagen Pharmaceuticals, Inc. | 75834-158-05 | 75834-158 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 240mg/1 | 100 Tablet In 1 Bottle (75834-159-01) | Nivagen Pharmaceuticals, Inc. | 75834-159-01 | 75834-159 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Tablet | Oral | 240mg/1 | 500 Tablet In 1 Bottle (75834-159-05) | Nivagen Pharmaceuticals, Inc. | 75834-159-05 | 75834-159 | ANDA206173 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (25021-312-02) / 2 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-312-02 | 25021-312 | ANDA214361 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Vial In 1 Carton (25021-312-04) / 4 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-312-04 | 25021-312 | ANDA214361 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Vial In 1 Carton (70069-271-05) / 2 Ml In 1 Vial (70069-271-01) | Somerset Therapeutics, LLC | 70069-271-05 | 70069-271 | ANDA211015 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (70069-271-25) / 2 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-271-25 | 70069-271 | ANDA211015 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Vial In 1 Carton (70069-272-05) / 4 Ml In 1 Vial | Somerset Therapeutics, LLC | 70069-272-05 | 70069-272 | ANDA211015 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (70069-272-25) / 4 Ml In 1 Vial (70069-272-01) | Somerset Therapeutics, LLC | 70069-272-25 | 70069-272 | ANDA211015 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Ampule In 1 Tray (70069-273-05) / 2 Ml In 1 Ampule (70069-273-01) | Somerset Therapeutics, LLC | 70069-273-05 | 70069-273 | ANDA211035 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | .75mg/1 | 90 Tablet In 1 Bottle (50228-129-90) | ScieGen Pharmaceuticals Inc | 50228-129-90 | 50228-129 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (50228-130-10) | ScieGen Pharmaceuticals Inc | 50228-130-10 | 50228-130 | ANDA203855 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 10 Carton In 1 Container (0409-9633-05) / 1 Syringe, Plastic In 1 Carton / 4 Ml In 1 Syringe, Plastic (0409-9633-65) | Hospira, Inc. | 0409-9633-05 | 0409-9633 | ANDA075136 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Vial In 1 Carton (0409-1144-02) / 4 Ml In 1 Vial (0409-1144-62) | Hospira, Inc. | 0409-1144-02 | 0409-1144 | ANDA070737 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (0409-1144-05) / 2 Ml In 1 Vial (0409-1144-65) | Hospira, Inc. | 0409-1144-05 | 0409-1144 | ANDA070737 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial, Single-Dose In 1 Tray (0409-1144-10) / 2 Ml In 1 Vial, Single-Dose (0409-1144-11) | Hospira, Inc. | 0409-1144-10 | 0409-1144 | ANDA070737 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Ampule In 1 Container (0409-4011-01) / 2 Ml In 1 Ampule (0409-4011-61) | Hospira, Inc. | 0409-4011-01 | 0409-4011 | ANDA070738 | ANDA | N/A |
| Vespula Germanica Venom Protein; Vespula Maculifrons Venom Protein; Vespula Pensylvanica Venom Protein; Vespula Squamosa Venom Protein; Vespula Vulgaris Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 20ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL | 13 Ml In 1 Vial (65044-9954-6) | Jubilant HollisterStier LLC | 65044-9954-6 | 65044-9954 | BLA103887 | BLA | N/A |
| Vespula Germanica Venom Protein; Vespula Maculifrons Venom Protein; Vespula Pensylvanica Venom Protein; Vespula Squamosa Venom Protein; Vespula Vulgaris Venom Protein | Injection, Powder, Lyophilized, For Solution | Percutaneous; Subcutaneous | 20ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL, 20 ug/mL | 5.5 Ml In 1 Vial (65044-9944-5) | Jubilant HollisterStier LLC | 65044-9944-5 | 65044-9944 | BLA103887 | BLA | N/A |
| Vigabatrin | Solution | Oral | 100mg/mL | 1 Bottle In 1 Carton (80789-003-15) / 150 Ml In 1 Bottle | Pyros Pharmaceuticals, Inc. | 80789-003-15 | 80789-003 | NDA217684 | NDA | N/A |
| Vigabatrin | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (0054-0652-25) | Hikma Pharmaceuticals USA Inc | 0054-0652-25 | 0054-0652 | ANDA213104 | ANDA | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (60505-4774-3) | Apotex Corp | 60505-4774-3 | 60505-4774 | NDA022567 | NDA AUTHORIZED GENERIC | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (60505-4772-3) | Apotex Corp | 60505-4772-3 | 60505-4772 | NDA022567 | NDA AUTHORIZED GENERIC | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (60505-4773-3) | Apotex Corp | 60505-4773-3 | 60505-4773 | NDA022567 | NDA AUTHORIZED GENERIC | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (60505-4372-3) | Apotex Corp. | 60505-4372-3 | 60505-4372 | ANDA208228 | ANDA | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (60505-4373-3) | Apotex Corp. | 60505-4373-3 | 60505-4373 | ANDA208228 | ANDA | N/A |
| Vilazodone Hydrochloride | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (60505-4374-3) | Apotex Corp. | 60505-4374-3 | 60505-4374 | ANDA208228 | ANDA | N/A |
| Vincristine Sulfate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-309-25) / 2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-309-25 | 61703-309 | ANDA071484 | ANDA | N/A |
| Vincristine Sulfate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-309-26) / 1 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-309-26 | 61703-309 | ANDA071484 | ANDA | N/A |
| Vincristine Sulfate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-309-06) / 1 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-309-06 | 61703-309 | ANDA071484 | ANDA | N/A |
| Vincristine Sulfate | Injection, Solution | Intravenous | 1mg/mL | 1 Vial, Single-Dose In 1 Carton (61703-309-16) / 2 Ml In 1 Vial, Single-Dose | Hospira, Inc. | 61703-309-16 | 61703-309 | ANDA071484 | ANDA | N/A |
| Vinorelbine Tartrate | Injection, Solution | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-204-01) / 1 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-204-01 | 25021-204 | ANDA091106 | ANDA | N/A |
| Vinorelbine Tartrate | Injection, Solution | Intravenous | 10mg/mL | 1 Vial In 1 Carton (25021-204-05) / 5 Ml In 1 Vial | Sagent Pharmaceuticals | 25021-204-05 | 25021-204 | ANDA091106 | ANDA | N/A |
| Voriconazole | Injection, Powder, Lyophilized, For Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (71288-027-30) / 20 Ml In 1 Vial, Single-Dose | Meitheal Pharmaceuticals Inc. | 71288-027-30 | 71288-027 | ANDA214516 | ANDA | N/A |
| Voriconazole | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (51407-133-30) | Golden State Medical Supply, Inc. | 51407-133-30 | 51407-133 | ANDA203503 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (50228-130-90) | ScieGen Pharmaceuticals Inc | 50228-130-90 | 50228-130 | ANDA203855 | ANDA | N/A |
| Voxelotor | Tablet, Film Coated | Oral | 500mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (72786-101-01) | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-101-01 | 72786-101 | NDA213137 | NDA | N/A |
| Voxelotor | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle, Plastic (72786-102-02) | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-102-02 | 72786-102 | NDA213137 | NDA | N/A |
| Voxelotor | Tablet, Film Coated | Oral | 300mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (72786-102-03) | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-102-03 | 72786-102 | NDA213137 | NDA | N/A |
| Voxelotor | Tablet, For Suspension | Oral | 300mg/1 | 60 Tablet, For Suspension In 1 Bottle, Plastic (72786-111-02) | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-111-02 | 72786-111 | NDA216157 | NDA | N/A |
| Voxelotor | Tablet, For Suspension | Oral | 300mg/1 | 90 Tablet, For Suspension In 1 Bottle, Plastic (72786-111-03) | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-111-03 | 72786-111 | NDA216157 | NDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (51407-342-10) | Golden State Medical Supply, Inc. | 51407-342-10 | 51407-342 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (51407-343-10) | Golden State Medical Supply, Inc. | 51407-343-10 | 51407-343 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 100 Tablet In 1 Bottle (51407-344-01) | Golden State Medical Supply, Inc. | 51407-344-01 | 51407-344 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (51407-345-01) | Golden State Medical Supply, Inc. | 51407-345-01 | 51407-345 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (51407-345-10) | Golden State Medical Supply, Inc. | 51407-345-10 | 51407-345 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (51407-346-10) | Golden State Medical Supply, Inc. | 51407-346-10 | 51407-346 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (51407-347-01) | Golden State Medical Supply, Inc. | 51407-347-01 | 51407-347 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 1000 Tablet In 1 Bottle (51407-347-10) | Golden State Medical Supply, Inc. | 51407-347-10 | 51407-347 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (51407-784-01) | Golden State Medical Supply, Inc. | 51407-784-01 | 51407-784 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (51407-784-10) | Golden State Medical Supply, Inc. | 51407-784-10 | 51407-784 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51407-785-01) | Golden State Medical Supply, Inc. | 51407-785-01 | 51407-785 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (51407-785-10) | Golden State Medical Supply, Inc. | 51407-785-10 | 51407-785 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (51407-786-01) | Golden State Medical Supply, Inc. | 51407-786-01 | 51407-786 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (51407-786-10) | Golden State Medical Supply, Inc. | 51407-786-10 | 51407-786 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 100 Tablet In 1 Bottle (51407-787-01) | Golden State Medical Supply, Inc. | 51407-787-01 | 51407-787 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 1000 Tablet In 1 Bottle (51407-787-10) | Golden State Medical Supply, Inc. | 51407-787-10 | 51407-787 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (51407-788-01) | Golden State Medical Supply, Inc. | 51407-788-01 | 51407-788 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (51407-788-10) | Golden State Medical Supply, Inc. | 51407-788-10 | 51407-788 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-789-01) | Golden State Medical Supply, Inc. | 51407-789-01 | 51407-789 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (51407-789-10) | Golden State Medical Supply, Inc. | 51407-789-10 | 51407-789 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (51407-790-01) | Golden State Medical Supply, Inc. | 51407-790-01 | 51407-790 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 1000 Tablet In 1 Bottle (51407-790-10) | Golden State Medical Supply, Inc. | 51407-790-10 | 51407-790 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (51407-791-01) | Golden State Medical Supply, Inc. | 51407-791-01 | 51407-791 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 10 Blister Pack In 1 Carton (51672-4027-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4027-0 | 51672-4027 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (51672-4027-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4027-1 | 51672-4027 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (51672-4027-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4027-3 | 51672-4027 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 5000 Tablet In 1 Bottle (51672-4027-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4027-7 | 51672-4027 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 10 Blister Pack In 1 Carton (51672-4028-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4028-0 | 51672-4028 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (51672-4028-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4028-1 | 51672-4028 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (51672-4028-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4028-3 | 51672-4028 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 5000 Tablet In 1 Bottle (51672-4028-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4028-7 | 51672-4028 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 10 Blister Pack In 1 Carton (51672-4029-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4029-0 | 51672-4029 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (51672-4029-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4029-1 | 51672-4029 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (51672-4029-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4029-3 | 51672-4029 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 5000 Tablet In 1 Bottle (51672-4029-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4029-7 | 51672-4029 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 10 Blister Pack In 1 Carton (51672-4030-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4030-0 | 51672-4030 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 100 Tablet In 1 Bottle (51672-4030-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4030-1 | 51672-4030 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 1000 Tablet In 1 Bottle (51672-4030-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4030-3 | 51672-4030 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 5000 Tablet In 1 Bottle (51672-4030-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4030-7 | 51672-4030 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 10 Blister Pack In 1 Carton (51672-4031-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4031-0 | 51672-4031 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (51672-4031-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4031-1 | 51672-4031 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (51672-4031-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4031-3 | 51672-4031 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 5000 Tablet In 1 Bottle (51672-4031-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4031-7 | 51672-4031 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (51672-4032-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4032-0 | 51672-4032 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51672-4032-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4032-1 | 51672-4032 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (51672-4032-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4032-3 | 51672-4032 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 5000 Tablet In 1 Bottle (51672-4032-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4032-7 | 51672-4032 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 10 Blister Pack In 1 Carton (51672-4033-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4033-0 | 51672-4033 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (51672-4033-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4033-1 | 51672-4033 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 1000 Tablet In 1 Bottle (51672-4033-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4033-3 | 51672-4033 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 5000 Tablet In 1 Bottle (51672-4033-7) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4033-7 | 51672-4033 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 10 Blister Pack In 1 Carton (51672-4034-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4034-0 | 51672-4034 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (51672-4034-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4034-1 | 51672-4034 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (51672-4034-3) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4034-3 | 51672-4034 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (51672-4035-0) / 10 Tablet In 1 Blister Pack | Taro Pharmaceuticals U.S.A., Inc. | 51672-4035-0 | 51672-4035 | ANDA040301 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51672-4035-1) | Taro Pharmaceuticals U.S.A., Inc. | 51672-4035-1 | 51672-4035 | ANDA040301 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 1000 Tablet In 1 Bottle (50228-131-10) | ScieGen Pharmaceuticals Inc | 50228-131-10 | 50228-131 | ANDA203855 | ANDA | N/A |
| Pramipexole Dihydrochloride | Tablet | Oral | 1.5mg/1 | 90 Tablet In 1 Bottle (50228-131-90) | ScieGen Pharmaceuticals Inc | 50228-131-90 | 50228-131 | ANDA203855 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-001-03) | Amneal Pharmaceuticals LLC | 65162-001-03 | 65162-001 | ANDA205913 | ANDA | N/A |
| Prasugrel Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-002-03) | Amneal Pharmaceuticals LLC | 65162-002-03 | 65162-002 | ANDA205913 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (70954-056-10) | ANI Pharmaceuticals, Inc. | 70954-056-10 | 70954-056 | ANDA215246 | ANDA | N/A |
| Prednisone | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (70954-056-20) | ANI Pharmaceuticals, Inc. | 70954-056-20 | 70954-056 | ANDA215246 | ANDA | N/A |
| Prednisone | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (70954-057-10) | ANI Pharmaceuticals, Inc. | 70954-057-10 | 70954-057 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-058-10) | ANI Pharmaceuticals, Inc. | 70954-058-10 | 70954-058 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (70954-058-20) | ANI Pharmaceuticals, Inc. | 70954-058-20 | 70954-058 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1 Blister Pack In 1 Box (70954-058-30) / 21 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 70954-058-30 | 70954-058 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 5mg/1 | 1 Blister Pack In 1 Box (70954-058-40) / 48 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 70954-058-40 | 70954-058 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (70954-059-10) | ANI Pharmaceuticals, Inc. | 70954-059-10 | 70954-059 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (70954-059-20) | ANI Pharmaceuticals, Inc. | 70954-059-20 | 70954-059 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 1 Blister Pack In 1 Box (70954-059-30) / 21 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 70954-059-30 | 70954-059 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 10mg/1 | 1 Blister Pack In 1 Box (70954-059-40) / 48 Tablet In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 70954-059-40 | 70954-059 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (70954-060-10) | ANI Pharmaceuticals, Inc. | 70954-060-10 | 70954-060 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (70954-060-20) | ANI Pharmaceuticals, Inc. | 70954-060-20 | 70954-060 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (70954-060-30) | ANI Pharmaceuticals, Inc. | 70954-060-30 | 70954-060 | ANDA211575 | ANDA | N/A |
| Prednisone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (70954-061-10) | ANI Pharmaceuticals, Inc. | 70954-061-10 | 70954-061 | ANDA211575 | ANDA | N/A |
| Pregabalin | Capsule | Oral | 25mg/1 | 500 Capsule In 1 Bottle (31722-610-05) | Camber Pharmaceuticals, Inc. | 31722-610-05 | 31722-610 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 10 Blister Pack In 1 Carton (31722-610-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-610-31 | 31722-610 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 10 Blister Pack In 1 Carton (31722-610-32) / 7 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-610-32 | 31722-610 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 60 Capsule In 1 Bottle (31722-610-60) | Camber Pharmaceuticals, Inc. | 31722-610-60 | 31722-610 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (31722-610-90) | Camber Pharmaceuticals, Inc. | 31722-610-90 | 31722-610 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 500 Capsule In 1 Bottle (31722-611-05) | Camber Pharmaceuticals, Inc. | 31722-611-05 | 31722-611 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (31722-611-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-611-31 | 31722-611 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (31722-611-32) / 7 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-611-32 | 31722-611 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 60 Capsule In 1 Bottle (31722-611-60) | Camber Pharmaceuticals, Inc. | 31722-611-60 | 31722-611 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (31722-611-90) | Camber Pharmaceuticals, Inc. | 31722-611-90 | 31722-611 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 500 Capsule In 1 Bottle (31722-612-05) | Camber Pharmaceuticals, Inc. | 31722-612-05 | 31722-612 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 10 Blister Pack In 1 Carton (31722-612-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-612-31 | 31722-612 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 60 Capsule In 1 Bottle (31722-612-60) | Camber Pharmaceuticals, Inc. | 31722-612-60 | 31722-612 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (31722-612-90) | Camber Pharmaceuticals, Inc. | 31722-612-90 | 31722-612 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (31722-613-05) | Camber Pharmaceuticals, Inc. | 31722-613-05 | 31722-613 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (31722-613-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-613-31 | 31722-613 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 60 Capsule In 1 Bottle (31722-613-60) | Camber Pharmaceuticals, Inc. | 31722-613-60 | 31722-613 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (31722-613-90) | Camber Pharmaceuticals, Inc. | 31722-613-90 | 31722-613 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 500 Capsule In 1 Bottle (31722-614-05) | Camber Pharmaceuticals, Inc. | 31722-614-05 | 31722-614 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 10 Blister Pack In 1 Carton (31722-614-31) / 10 Capsule In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-614-31 | 31722-614 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 60 Capsule In 1 Bottle (31722-614-60) | Camber Pharmaceuticals, Inc. | 31722-614-60 | 31722-614 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (31722-614-90) | Camber Pharmaceuticals, Inc. | 31722-614-90 | 31722-614 | ANDA206912 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 10 Blister Pack In 1 Carton (64980-410-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-410-01 | 64980-410 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (64980-410-09) | Rising Pharma Holdings, Inc. | 64980-410-09 | 64980-410 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (64980-410-10) | Rising Pharma Holdings, Inc. | 64980-410-10 | 64980-410 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 10 Blister Pack In 1 Carton (64980-411-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-411-01 | 64980-411 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (64980-411-09) | Rising Pharma Holdings, Inc. | 64980-411-09 | 64980-411 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (64980-411-10) | Rising Pharma Holdings, Inc. | 64980-411-10 | 64980-411 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 10 Blister Pack In 1 Carton (64980-412-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-412-01 | 64980-412 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (64980-412-09) | Rising Pharma Holdings, Inc. | 64980-412-09 | 64980-412 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Bottle (64980-412-10) | Rising Pharma Holdings, Inc. | 64980-412-10 | 64980-412 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 10 Blister Pack In 1 Carton (64980-413-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-413-01 | 64980-413 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Carton (64980-413-09) | Rising Pharma Holdings, Inc. | 64980-413-09 | 64980-413 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Carton (64980-413-10) | Rising Pharma Holdings, Inc. | 64980-413-10 | 64980-413 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 10 Blister Pack In 1 Carton (64980-414-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-414-01 | 64980-414 | ANDA210432 | ANDA | CV |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 10mL/10mL | 25 Vial, Glass In 1 Carton (14789-131-05) / 10 Ml In 1 Vial, Glass (14789-131-07) | Nexus Pharmaceuticals Inc | 14789-131-05 | 14789-131 | ANDA217536 | ANDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 20mL/20mL | 25 Vial, Glass In 1 Carton (14789-132-05) / 20 Ml In 1 Vial, Glass (14789-132-07) | Nexus Pharmaceuticals Inc | 14789-132-05 | 14789-132 | ANDA217536 | ANDA | N/A |
| Water | Injection, Solution | Intravenous | 1mL/mL | 1 Vial In 1 Box (66302-150-50) / 50 Ml In 1 Vial | United Therapeutics Corporation | 66302-150-50 | 66302-150 | NDA021272 | NDA | N/A |
| Water | Injection, Solution | Intravenous | 1mL/mL | 25 Vial, Single-Dose In 1 Tray (0517-3010-25) / 10 Ml In 1 Vial, Single-Dose (0517-3010-01) | American Regent, Inc. | 0517-3010-25 | 0517-3010 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Water | Injection, Solution | Intravenous | 1mL/mL | 25 Vial, Single-Dose In 1 Tray (0517-3020-25) / 20 Ml In 1 Vial, Single-Dose (0517-3020-01) | American Regent, Inc. | 0517-3020-25 | 0517-3020 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Water | Injection, Solution | Intravenous | 1mL/mL | 12 Bag In 1 Case (0143-9339-12) / 1000 Ml In 1 Bag | Hikma Pharmaceuticals USA Inc. | 0143-9339-12 | 0143-9339 | ANDA212735 | ANDA | N/A |
| Water | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 10 Vial In 1 Carton (0641-6147-10) / 10 Ml In 1 Vial (0641-6147-01) | Hikma Pharmaceuticals USA Inc. | 0641-6147-10 | 0641-6147 | ANDA206369 | ANDA | N/A |
| Water | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial In 1 Carton (0641-6147-25) / 10 Ml In 1 Vial (0641-6147-01) | Hikma Pharmaceuticals USA Inc. | 0641-6147-25 | 0641-6147 | ANDA206369 | ANDA | N/A |
| Water | Injection, Solution | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial, Multi-Dose In 1 Tray (0409-3977-03) / 30 Ml In 1 Vial, Multi-Dose (0409-3977-01) | Hospira, Inc. | 0409-3977-03 | 0409-3977 | NDA018802 | NDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial, Plastic In 1 Tray (0409-4887-10) / 10 Ml In 1 Vial, Plastic (0409-4887-17) | Hospira, Inc. | 0409-4887-10 | 0409-4887 | NDA018801 | NDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial, Plastic In 1 Tray (0409-4887-20) / 20 Ml In 1 Vial, Plastic (0409-4887-23) | Hospira, Inc. | 0409-4887-20 | 0409-4887 | NDA018801 | NDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 30 Vial, Plastic In 1 Tray (0409-4887-34) / 10 Ml In 1 Vial, Plastic (0409-4887-32) | Hospira, Inc. | 0409-4887-34 | 0409-4887 | NDA018801 | NDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial, Plastic In 1 Tray (0409-4887-50) / 50 Ml In 1 Vial, Plastic (0409-4887-24) | Hospira, Inc. | 0409-4887-50 | 0409-4887 | NDA018801 | NDA | N/A |
| Water | Injection | Intramuscular; Intravenous; Subcutaneous | 1mL/mL | 25 Vial, Glass In 1 Case (0409-4887-99) / 100 Ml In 1 Vial, Glass (0409-4887-25) | Hospira, Inc. | 0409-4887-99 | 0409-4887 | NDA018801 | NDA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1405-2) | Jubilant HollisterStier LLC | 65044-1405-2 | 65044-1405 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1405-3) | Jubilant HollisterStier LLC | 65044-1405-3 | 65044-1405 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1405-4) | Jubilant HollisterStier LLC | 65044-1405-4 | 65044-1405 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1406-1) | Jubilant HollisterStier LLC | 65044-1406-1 | 65044-1406 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-1408-2) | Jubilant HollisterStier LLC | 65044-1408-2 | 65044-1408 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 30 Ml In 1 Vial (65044-1408-3) | Jubilant HollisterStier LLC | 65044-1408-3 | 65044-1408 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 50 Ml In 1 Vial (65044-1408-4) | Jubilant HollisterStier LLC | 65044-1408-4 | 65044-1408 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 10 Ml In 1 Vial (65044-1409-2) | Jubilant HollisterStier LLC | 65044-1409-2 | 65044-1409 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 30 Ml In 1 Vial (65044-1409-3) | Jubilant HollisterStier LLC | 65044-1409-3 | 65044-1409 | BLA103888 | BLA | N/A |
| Xanthium Strumarium Pollen | Injection, Solution | Percutaneous; Subcutaneous | 40000[PNU]/mL | 50 Ml In 1 Vial (65044-1409-4) | Jubilant HollisterStier LLC | 65044-1409-4 | 65044-1409 | BLA103888 | BLA | N/A |
| Yeast | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3713-2) | Jubilant HollisterStier LLC | 65044-3713-2 | 65044-3713 | BLA103888 | BLA | N/A |
| Yeast | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3714-1) | Jubilant HollisterStier LLC | 65044-3714-1 | 65044-3714 | BLA103888 | BLA | N/A |
| Yeast | Injection, Solution | Percutaneous; Subcutaneous | .1g/mL | 10 Ml In 1 Vial (65044-3716-2) | Jubilant HollisterStier LLC | 65044-3716-2 | 65044-3716 | BLA103888 | BLA | N/A |
| Yeast | Injection, Solution | Percutaneous | .1g/mL | 5 Ml In 1 Vial (65044-3717-1) | Jubilant HollisterStier LLC | 65044-3717-1 | 65044-3717 | BLA103888 | BLA | N/A |
| Zaleplon | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (69452-364-20) | Bionpharma Inc. | 69452-364-20 | 69452-364 | ANDA090374 | ANDA | CIV |
| Zaleplon | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (69452-365-20) | Bionpharma Inc. | 69452-365-20 | 69452-365 | ANDA090374 | ANDA | CIV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (64980-414-09) | Rising Pharma Holdings, Inc. | 64980-414-09 | 64980-414 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 1000 Capsule In 1 Bottle (64980-414-10) | Rising Pharma Holdings, Inc. | 64980-414-10 | 64980-414 | ANDA210432 | ANDA | CV |
| Zaleplon | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (0054-0084-25) | Hikma Pharmaceuticals USA Inc. | 0054-0084-25 | 0054-0084 | ANDA077237 | ANDA | CIV |
| Zaleplon | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (0054-0085-25) | Hikma Pharmaceuticals USA Inc. | 0054-0085-25 | 0054-0085 | ANDA077237 | ANDA | CIV |
| Zavegepant Hydrochloride | Spray | Nasal | 10mg/.1mL | 6 Blister Pack In 1 Carton (0069-3500-02) / 1 Vial, Single-Dose In 1 Blister Pack (0069-3500-01) / .1 Ml In 1 Vial, Single-Dose | Pfizer Laboratories Div Pfizer Inc | 0069-3500-02 | 0069-3500 | NDA216386 | NDA | N/A |
| Zea Mays Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 10 Ml In 1 Vial (65044-1414-2) | Jubilant HollisterStier LLC | 65044-1414-2 | 65044-1414 | BLA103888 | BLA | N/A |
| Zea Mays Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 30 Ml In 1 Vial (65044-1414-3) | Jubilant HollisterStier LLC | 65044-1414-3 | 65044-1414 | BLA103888 | BLA | N/A |
| Zea Mays Pollen | Injection, Solution | Percutaneous; Subcutaneous | .05g/mL | 50 Ml In 1 Vial (65044-1414-4) | Jubilant HollisterStier LLC | 65044-1414-4 | 65044-1414 | BLA103888 | BLA | N/A |
| Zea Mays Pollen | Injection, Solution | Percutaneous | .05g/mL | 5 Ml In 1 Vial (65044-1415-1) | Jubilant HollisterStier LLC | 65044-1415-1 | 65044-1415 | BLA103888 | BLA | N/A |
| Zileuton | Tablet, Multilayer, Extended Release | Oral | 600mg/1 | 120 Tablet, Multilayer, Extended Release In 1 Bottle (51407-741-12) | Golden State Medical Supply, Inc. | 51407-741-12 | 51407-741 | ANDA212670 | ANDA | N/A |
| Pregabalin | Capsule | Oral | 200mg/1 | 10 Blister Pack In 1 Carton (64980-415-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-415-01 | 64980-415 | ANDA210432 | ANDA | CV |
| Zinc Oxide | Ointment | Topical | 200mg/g | 28.4 G In 1 Tube (75834-170-01) | Nivagen Pharmaceuticals, Inc. | 75834-170-01 | 75834-170 | part347 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Ointment | Topical | 200mg/g | 56.7 G In 1 Tube (75834-170-02) | Nivagen Pharmaceuticals, Inc. | 75834-170-02 | 75834-170 | part347 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Ointment | Topical | 200mg/g | 425 G In 1 Jar (75834-170-15) | Nivagen Pharmaceuticals, Inc. | 75834-170-15 | 75834-170 | part347 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Lotion | Topical | 200mg/mL | 120 Ml In 1 Tube (83722-002-00) | Dermastart Inc | 83722-002-00 | 83722-002 | OKM020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 120 Ml In 1 Tube (83722-000-00) | Dermastart Inc. | 83722-000-00 | 83722-000 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Spray | Topical | 100mg/mL | 1 Bottle, Spray In 1 Carton (51672-5318-3) / 50 Ml In 1 Bottle, Spray | TARO PHARMACEUTICALS U.S.A., INC. | 51672-5318-3 | 51672-5318 | M016 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Spray | Topical | 100mg/mL | 1 Bottle, Spray In 1 Carton (51672-5318-7) / 100 Ml In 1 Bottle, Spray | TARO PHARMACEUTICALS U.S.A., INC. | 51672-5318-7 | 51672-5318 | M016 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Stick | Topical | 20.267g/100g | 1 Tube In 1 Carton (79265-8065-1) / 17 G In 1 Tube | Babo Botanicals, Inc. | 79265-8065-1 | 79265-8065 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Spray | Topical | 14.5g/100mL | 177 Ml In 1 Bottle, Spray (79265-8579-6) | Babo Botanicals, Inc. | 79265-8579-6 | 79265-8579 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Lotion | Topical | 206mg/mL | 1 Bottle, Plastic In 1 Box (79265-8061-1) / 50 Ml In 1 Bottle, Plastic | Babo Botanicals, Inc. | 79265-8061-1 | 79265-8061 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 206mg/mL | 1 Bottle, Plastic In 1 Box (79265-8063-1) / 50 Ml In 1 Bottle, Plastic | Babo Botanicals, Inc. | 79265-8063-1 | 79265-8063 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 250mg/g | 170 G In 1 Jar (79265-8580-1) | Babo Botanicals, Inc. | 79265-8580-1 | 79265-8580 | M016 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Spray | Topical | 206mg/mL | 89 Ml In 1 Bottle, Spray (79265-8576-1) | Babo Botanicals, Inc. | 79265-8576-1 | 79265-8576 | M016 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Spray | Topical | 145mg/mL | 177 Ml In 1 Bottle, Spray (79265-9758-1) | Babo Botanicals, Inc. | 79265-9758-1 | 79265-9758 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 200mg/mL | 89 Ml In 1 Tube (79265-8758-1) | Babo Botanicals, Inc. | 79265-8758-1 | 79265-8758 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Stick | Topical | 197mg/g | 1 Tube In 1 Carton (79265-5608-1) / 17 G In 1 Tube | Babo Botanicals, Inc. | 79265-5608-1 | 79265-5608 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 160mg/mL | 89 Ml In 1 Tube (79265-7708-1) | Babo Botanicals, Inc. | 79265-7708-1 | 79265-7708 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Spray | Topical | 120mg/mL | 177 Ml In 1 Can (79265-7908-1) | Babo Botanicals, Inc. | 79265-7908-1 | 79265-7908 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 200mg/mL | 89 Ml In 1 Tube (79265-7778-1) | Babo Botanicals, Inc | 79265-7778-1 | 79265-7778 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Stick | Topical | 197mg/g | 1 Cylinder In 1 Box (79265-8908-1) / 17 G In 1 Cylinder | Babo Botanicals, Inc. | 79265-8908-1 | 79265-8908 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Salve | Topical | 245mg/g | 1 Can In 1 Carton (79265-8776-1) / 56 G In 1 Can | Babo Botanicals, Inc. | 79265-8776-1 | 79265-8776 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Spray | Topical | 145mg/mL | 177 Ml In 1 Bottle, Spray (79265-8775-1) | Babo Botanicals, Inc. | 79265-8775-1 | 79265-8775 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 25g/100g | 85 G In 1 Tube (79265-8566-3) | Babo Botanicals, Inc. | 79265-8566-3 | 79265-8566 | M016 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 16g/100mL | 89 Ml In 1 Tube (79265-8077-3) | Babo Botanicals, Inc. | 79265-8077-3 | 79265-8077 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Stick | Topical | 15.326g/100g | 1 Tube, With Applicator In 1 Box (79265-8075-0) / 17 G In 1 Tube, With Applicator (79265-8075-1) | Babo Botanicals, Inc. | 79265-8075-0 | 79265-8075 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Spray | Topical | 12.222g/100mL | 177 Ml In 1 Can (79265-8097-6) | Babo Botanicals, Inc. | 79265-8097-6 | 79265-8097 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 89 Ml In 1 Tube (79265-8777-3) | Babo Botanicals, Inc | 79265-8777-3 | 79265-8777 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 89 Ml In 1 Tube (79265-8578-3) | Babo Botanicals, Inc. | 79265-8578-3 | 79265-8578 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 150mg/g | 1 Tube In 1 Carton (59062-1219-1) / 113 G In 1 Tube | KAS Direct LLC dba BabyGanics | 59062-1219-1 | 59062-1219 | part347 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 89 Ml In 1 Tube (59062-2203-3) | KAS Direct LLC dba BabyGanics | 59062-2203-3 | 59062-2203 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 50 Ml In 1 Tube (59062-2202-1) | KAS Direct LLC dba BabyGanics | 59062-2202-1 | 59062-2202 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 89 Ml In 1 Tube (59062-2202-3) | KAS Direct LLC dba BabyGanics | 59062-2202-3 | 59062-2202 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 20g/100mL | 236 Ml In 1 Tube (59062-2202-8) | KAS Direct LLC dba BabyGanics | 59062-2202-8 | 59062-2202 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 120mg/g | 14 G In 1 Tube (52915-069-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-069-05 | 52915-069 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 120mg/g | 82 G In 1 Tube (52915-069-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-069-29 | 52915-069 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3503-1) / 60 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3503-1 | 15751-3503 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3503-2) / 250 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3503-2 | 15751-3503 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 3 Ml In 1 Packet (15751-3503-3) | Eminence Organic Skin Care | 15751-3503-3 | 15751-3503 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Liquid | Topical | 115mg/mL | 1 Bottle In 1 Box (15751-3508-1) / 50 Ml In 1 Bottle | Eminence Organic Skin Care | 15751-3508-1 | 15751-3508 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3501-1) / 60 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3501-1 | 15751-3501 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3501-2) / 125 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3501-2 | 15751-3501 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 3 Ml In 1 Packet (15751-3501-3) | Eminence Organic Skin Care | 15751-3501-3 | 15751-3501 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Liquid | Topical | 150mg/mL | 1 Bottle In 1 Box (15751-3506-1) / 50 Ml In 1 Bottle | Eminence Organic Skin Care | 15751-3506-1 | 15751-3506 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3502-1) / 60 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3502-1 | 15751-3502 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3502-2) / 125 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3502-2 | 15751-3502 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3500-1) / 60 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3500-1 | 15751-3500 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Jar In 1 Box (15751-3500-2) / 125 Ml In 1 Jar | Eminence Organic Skin Care | 15751-3500-2 | 15751-3500 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 3 Ml In 1 Packet (15751-3500-3) | Eminence Organic Skin Care | 15751-3500-3 | 15751-3500 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 17g/100g | 3000 G In 1 Bottle, Pump (73964-032-01) | Happy Farm Botanicals, Inc. | 73964-032-01 | 73964-032 | part346 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 1 Tube In 1 Box (15751-3040-5) / 147 Ml In 1 Tube | Eminence Organic Skin Care Ltd. | 15751-3040-5 | 15751-3040 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 200mg/mL | 3 Ml In 1 Packet (15751-3040-6) | Eminence Organic Skin Care Ltd. | 15751-3040-6 | 15751-3040 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Cream | Topical | 140mg/mL | 1 Tube In 1 Package (84124-000-00) / 50 Ml In 1 Tube | Lucin Organics, LLC | 84124-000-00 | 84124-000 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-004-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-004-01 | 83249-004 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-005-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-005-01 | 83249-005 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-006-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-006-01 | 83249-006 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-007-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-007-01 | 83249-007 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-008-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-008-01 | 83249-008 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-009-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-009-01 | 83249-009 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-010-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-010-01 | 83249-010 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-011-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-011-01 | 83249-011 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-012-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-012-01 | 83249-012 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-013-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-013-01 | 83249-013 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-014-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-014-01 | 83249-014 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-015-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-015-01 | 83249-015 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Lotion | Topical | 120mg/mL | 1 Bottle, Glass In 1 Carton (83249-016-01) / 30 Ml In 1 Bottle, Glass | Rms organics LLC | 83249-016-01 | 83249-016 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Emulsion | Topical | 200mg/mL | 1 Bottle, Plastic In 1 Carton (83249-001-01) / 30 Ml In 1 Bottle, Plastic | Rms organics LLC | 83249-001-01 | 83249-001 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Emulsion | Topical | 200mg/mL | 1 Bottle, Plastic In 1 Carton (83249-002-01) / 30 Ml In 1 Bottle, Plastic | Rms organics LLC | 83249-002-01 | 83249-002 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Emulsion | Topical | 200mg/mL | 1 Bottle, Plastic In 1 Carton (83249-003-01) / 30 Ml In 1 Bottle, Plastic | Rms organics LLC | 83249-003-01 | 83249-003 | M020 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Stick | Topical | 35mg/g | 1 Tube In 1 Box (15751-1321-1) / 4 G In 1 Tube | Eminence Organic Skin Care | 15751-1321-1 | 15751-1321 | M020 | OTC MONOGRAPH DRUG | N/A |
| Zinc Oxide | Stick | Topical | 216mg/g | 45 G In 1 Container (59062-2201-4) | KAS Direct LLC dba BabyGanics | 59062-2201-4 | 59062-2201 | part352 | OTC MONOGRAPH NOT FINAL | N/A |
| Zinc Oxide | Stick | Topical | 17.363g/100g | 1 Cylinder In 1 Box (79265-8098-0) / 17 G In 1 Cylinder (79265-8098-1) | Babo Botanicals, Inc. | 79265-8098-0 | 79265-8098 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Stick | Topical | 20.2115g/100g | 1 Cylinder In 1 Box (79265-8068-0) / 17 G In 1 Cylinder (79265-8068-1) | Babo Botanicals, Inc. | 79265-8068-0 | 79265-8068 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 120mg/g | 14 G In 1 Tube (52915-140-05) | ORGANIC & SUSTAINABLE BEAUTY | 52915-140-05 | 52915-140 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Oxide | Cream | Topical | 120mg/g | 82 G In 1 Tube (52915-140-29) | ORGANIC & SUSTAINABLE BEAUTY | 52915-140-29 | 52915-140 | part352 | OTC MONOGRAPH FINAL | N/A |
| Zinc Sulfate | Injection, Solution | Intravenous | 1mg/mL | 25 Vial In 1 Tray (75834-271-25) / 10 Ml In 1 Vial (75834-271-01) | Nivagen Pharmaceuticals, Inc. | 75834-271-25 | 75834-271 | ANDA214597 | ANDA | N/A |
| Zinc Sulfate | Injection, Solution | Intravenous | 3mg/mL | 25 Vial In 1 Tray (75834-225-25) / 10 Ml In 1 Vial (75834-225-01) | Nivagen Pharmaceuticals, Inc. | 75834-225-25 | 75834-225 | ANDA214597 | ANDA | N/A |
| Zinc Sulfate | Solution | Intravenous | 5mg/mL | 25 Vial In 1 Carton (70069-691-25) / 5 Ml In 1 Vial (70069-691-01) | Somerset Therapeutics, LLC | 70069-691-25 | 70069-691 | ANDA216135 | ANDA | N/A |
| Zinc Sulfate | Injection, Solution | Intravenous | 1mg/mL | 25 Vial In 1 Tray (0517-6101-25) / 10 Ml In 1 Vial (0517-6101-01) | American Regent, Inc. | 0517-6101-25 | 0517-6101 | NDA209377 | NDA | N/A |
| Zinc Sulfate | Injection, Solution | Intravenous | 3mg/mL | 25 Vial In 1 Tray (0517-6103-25) / 10 Ml In 1 Vial (0517-6103-01) | American Regent, Inc. | 0517-6103-25 | 0517-6103 | NDA209377 | NDA | N/A |
| Zinc Sulfate, Unspecified Form | Injection | Intravenous | 5mg/mL | 25 Vial In 1 Carton (60505-6260-5) / 5 Ml In 1 Vial (60505-6260-0) | Apotex Corp | 60505-6260-5 | 60505-6260 | ANDA218059 | ANDA | N/A |
| Ziprasidone Hydrochloride | Capsule | Oral | 60mg/1 | 60 Capsule In 1 Bottle (60429-767-60) | Golden State Medical Supply, Inc. | 60429-767-60 | 60429-767 | ANDA077561 | ANDA | N/A |
| Ziprasidone Hydrochloride | Capsule | Oral | 80mg/1 | 60 Capsule In 1 Bottle (60429-768-60) | Golden State Medical Supply, Inc. | 60429-768-60 | 60429-768 | ANDA077561 | ANDA | N/A |
| Ziprasidone Hydrochloride | Capsule | Oral | 20mg/1 | 60 Capsule In 1 Bottle (60505-2528-6) | Apotex Corp. | 60505-2528-6 | 60505-2528 | ANDA077561 | ANDA | N/A |
| Ziprasidone Hydrochloride | Capsule | Oral | 40mg/1 | 60 Capsule In 1 Bottle (60505-2529-6) | Apotex Corp. | 60505-2529-6 | 60505-2529 | ANDA077561 | ANDA | N/A |
| Ziprasidone Hydrochloride | Capsule | Oral | 60mg/1 | 60 Capsule In 1 Bottle (60505-2530-6) | Apotex Corp. | 60505-2530-6 | 60505-2530 | ANDA077561 | ANDA | N/A |
| Zoledronic Acid | Injection, Solution | Intravenous | .04mg/mL | 1 Bag In 1 Carton (25021-826-82) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-826-82 | 25021-826 | NDA203231 | NDA | N/A |
| Zoledronic Acid | Injection, Solution | Intravenous | .04mg/mL | 1 Bag In 1 Carton (25021-826-67) / 100 Ml In 1 Bag | Sagent Pharmaceuticals | 25021-826-67 | 25021-826 | NDA203231 | NDA | N/A |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (64980-415-09) | Rising Pharma Holdings, Inc. | 64980-415-09 | 64980-415 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 1000 Capsule In 1 Bottle (64980-415-10) | Rising Pharma Holdings, Inc. | 64980-415-10 | 64980-415 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 10 Blister Pack In 1 Carton (64980-416-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-416-01 | 64980-416 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (64980-416-09) | Rising Pharma Holdings, Inc. | 64980-416-09 | 64980-416 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 1000 Capsule In 1 Bottle (64980-416-10) | Rising Pharma Holdings, Inc. | 64980-416-10 | 64980-416 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 10 Blister Pack In 1 Carton (64980-417-01) / 10 Capsule In 1 Blister Pack | Rising Pharma Holdings, Inc. | 64980-417-01 | 64980-417 | ANDA210432 | ANDA | CV |
| Zolpidem Tartrate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-515-30) | St Marys Medical Park Pharmacy | 60760-515-30 | 60760-515 | ANDA077903 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle, Plastic (60760-288-30) | St. Mary's Medical Park Pharmacy | 60760-288-30 | 60760-288 | ANDA077903 | ANDA | CIV |
| Zolpidem Tartrate | Tablet, Extended Release | Oral | 12.5mg/1 | 30 Tablet, Extended Release In 1 Bottle, Plastic (60760-819-30) | ST. MARY'S MEDICAL PARK PHARMACY | 60760-819-30 | 60760-819 | ANDA078970 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (51407-877-01) | Golden State Medical Supply, Inc. | 51407-877-01 | 51407-877 | ANDA077214 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (51407-877-10) | Golden State Medical Supply, Inc. | 51407-877-10 | 51407-877 | ANDA077214 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (51407-877-30) | Golden State Medical Supply, Inc. | 51407-877-30 | 51407-877 | ANDA077214 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (51407-878-01) | Golden State Medical Supply, Inc. | 51407-878-01 | 51407-878 | ANDA077214 | ANDA | CIV |
| Zolpidem Tartrate | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (51407-878-10) | Golden State Medical Supply, Inc. | 51407-878-10 | 51407-878 | ANDA077214 | ANDA | CIV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (64980-417-09) | Rising Pharma Holdings, Inc. | 64980-417-09 | 64980-417 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 1000 Capsule In 1 Bottle (64980-417-10) | Rising Pharma Holdings, Inc. | 64980-417-10 | 64980-417 | ANDA210432 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (50228-350-10) | ScieGen Pharmaceuticals, Inc | 50228-350-10 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (50228-350-30) | ScieGen Pharmaceuticals, Inc | 50228-350-30 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (50228-350-90) | ScieGen Pharmaceuticals, Inc | 50228-350-90 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (50228-351-10) | ScieGen Pharmaceuticals, Inc | 50228-351-10 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (50228-351-30) | ScieGen Pharmaceuticals, Inc | 50228-351-30 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (50228-351-90) | ScieGen Pharmaceuticals, Inc | 50228-351-90 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Bottle (50228-352-10) | ScieGen Pharmaceuticals, Inc | 50228-352-10 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (50228-352-30) | ScieGen Pharmaceuticals, Inc | 50228-352-30 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (50228-352-90) | ScieGen Pharmaceuticals, Inc | 50228-352-90 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-353-10) | ScieGen Pharmaceuticals, Inc | 50228-353-10 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-353-30) | ScieGen Pharmaceuticals, Inc | 50228-353-30 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (50228-353-90) | ScieGen Pharmaceuticals, Inc | 50228-353-90 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 1000 Capsule In 1 Bottle (50228-354-10) | ScieGen Pharmaceuticals, Inc | 50228-354-10 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (50228-354-30) | ScieGen Pharmaceuticals, Inc | 50228-354-30 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (50228-354-90) | ScieGen Pharmaceuticals, Inc | 50228-354-90 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (50228-355-05) | ScieGen Pharmaceuticals, Inc | 50228-355-05 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-355-30) | ScieGen Pharmaceuticals, Inc | 50228-355-30 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (50228-355-90) | ScieGen Pharmaceuticals, Inc | 50228-355-90 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 500 Capsule In 1 Bottle (50228-356-05) | ScieGen Pharmaceuticals, Inc | 50228-356-05 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 30 Capsule In 1 Bottle (50228-356-30) | ScieGen Pharmaceuticals, Inc | 50228-356-30 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (50228-356-90) | ScieGen Pharmaceuticals, Inc | 50228-356-90 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (50228-357-05) | ScieGen Pharmaceuticals, Inc | 50228-357-05 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (50228-357-30) | ScieGen Pharmaceuticals, Inc | 50228-357-30 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (50228-357-90) | ScieGen Pharmaceuticals, Inc | 50228-357-90 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 1000 Capsule In 1 Bottle (50228-350-10) | ScieGen Pharmaceuticals, Inc | 50228-350-10 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 30 Capsule In 1 Bottle (50228-350-30) | ScieGen Pharmaceuticals, Inc | 50228-350-30 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 25mg/1 | 90 Capsule In 1 Bottle (50228-350-90) | ScieGen Pharmaceuticals, Inc | 50228-350-90 | 50228-350 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 1000 Capsule In 1 Bottle (50228-351-10) | ScieGen Pharmaceuticals, Inc | 50228-351-10 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 30 Capsule In 1 Bottle (50228-351-30) | ScieGen Pharmaceuticals, Inc | 50228-351-30 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 50mg/1 | 90 Capsule In 1 Bottle (50228-351-90) | ScieGen Pharmaceuticals, Inc | 50228-351-90 | 50228-351 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 1000 Capsule In 1 Bottle (50228-352-10) | ScieGen Pharmaceuticals, Inc | 50228-352-10 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 30 Capsule In 1 Bottle (50228-352-30) | ScieGen Pharmaceuticals, Inc | 50228-352-30 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 75mg/1 | 90 Capsule In 1 Bottle (50228-352-90) | ScieGen Pharmaceuticals, Inc | 50228-352-90 | 50228-352 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 1000 Capsule In 1 Bottle (50228-353-10) | ScieGen Pharmaceuticals, Inc | 50228-353-10 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 30 Capsule In 1 Bottle (50228-353-30) | ScieGen Pharmaceuticals, Inc | 50228-353-30 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 100mg/1 | 90 Capsule In 1 Bottle (50228-353-90) | ScieGen Pharmaceuticals, Inc | 50228-353-90 | 50228-353 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 1000 Capsule In 1 Bottle (50228-354-10) | ScieGen Pharmaceuticals, Inc | 50228-354-10 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (50228-354-30) | ScieGen Pharmaceuticals, Inc | 50228-354-30 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 150mg/1 | 90 Capsule In 1 Bottle (50228-354-90) | ScieGen Pharmaceuticals, Inc | 50228-354-90 | 50228-354 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (50228-355-05) | ScieGen Pharmaceuticals, Inc | 50228-355-05 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 30 Capsule In 1 Bottle (50228-355-30) | ScieGen Pharmaceuticals, Inc | 50228-355-30 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 200mg/1 | 90 Capsule In 1 Bottle (50228-355-90) | ScieGen Pharmaceuticals, Inc | 50228-355-90 | 50228-355 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 500 Capsule In 1 Bottle (50228-356-05) | ScieGen Pharmaceuticals, Inc | 50228-356-05 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 30 Capsule In 1 Bottle (50228-356-30) | ScieGen Pharmaceuticals, Inc | 50228-356-30 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 225mg/1 | 90 Capsule In 1 Bottle (50228-356-90) | ScieGen Pharmaceuticals, Inc | 50228-356-90 | 50228-356 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (50228-357-05) | ScieGen Pharmaceuticals, Inc | 50228-357-05 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (50228-357-30) | ScieGen Pharmaceuticals, Inc | 50228-357-30 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Capsule | Oral | 300mg/1 | 90 Capsule In 1 Bottle (50228-357-90) | ScieGen Pharmaceuticals, Inc | 50228-357-90 | 50228-357 | ANDA208677 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-463-05) | ScieGen Pharmaceuticals, INC. | 50228-463-05 | 50228-463 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-463-30) | ScieGen Pharmaceuticals, INC. | 50228-463-30 | 50228-463 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-464-05) | ScieGen Pharmaceuticals, INC. | 50228-464-05 | 50228-464 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-464-30) | ScieGen Pharmaceuticals, INC. | 50228-464-30 | 50228-464 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-462-05) | ScieGen Pharmaceuticals, INC. | 50228-462-05 | 50228-462 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-462-30) | ScieGen Pharmaceuticals, INC. | 50228-462-30 | 50228-462 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-463-05) | ScieGen Pharmaceuticals, INC. | 50228-463-05 | 50228-463 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 165mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-463-30) | ScieGen Pharmaceuticals, INC. | 50228-463-30 | 50228-463 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-464-05) | ScieGen Pharmaceuticals, INC. | 50228-464-05 | 50228-464 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 330mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-464-30) | ScieGen Pharmaceuticals, INC. | 50228-464-30 | 50228-464 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-462-05) | ScieGen Pharmaceuticals, INC. | 50228-462-05 | 50228-462 | ANDA215675 | ANDA | CV |
| Pregabalin | Tablet, Film Coated, Extended Release | Oral | 82.5mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-462-30) | ScieGen Pharmaceuticals, INC. | 50228-462-30 | 50228-462 | ANDA215675 | ANDA | CV |
| Primaquine Phosphate | Tablet, Film Coated | Oral | 15mg/1 | 100 Tablet, Film Coated In 1 Bottle, Plastic (50742-191-01) | Ingenus Pharmaceuticals, LLC | 50742-191-01 | 50742-191 | ANDA206043 | ANDA | N/A |
| Primaquine Phosphate | Tablet, Film Coated | Oral | 15mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50742-191-05) | Ingenus Pharmaceuticals, LLC | 50742-191-05 | 50742-191 | ANDA206043 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (65162-544-10) | Amneal Pharmaceuticals LLC | 65162-544-10 | 65162-544 | ANDA040866 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (65162-544-11) | Amneal Pharmaceuticals LLC | 65162-544-11 | 65162-544 | ANDA040866 | ANDA | N/A |
| Primidone | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-544-50) | Amneal Pharmaceuticals LLC | 65162-544-50 | 65162-544 | ANDA040866 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 100 Tablet In 1 Bottle (65162-545-10) | Amneal Pharmaceuticals LLC | 65162-545-10 | 65162-545 | ANDA040866 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 1000 Tablet In 1 Bottle (65162-545-11) | Amneal Pharmaceuticals LLC | 65162-545-11 | 65162-545 | ANDA040866 | ANDA | N/A |
| Primidone | Tablet | Oral | 250mg/1 | 500 Tablet In 1 Bottle (65162-545-50) | Amneal Pharmaceuticals LLC | 65162-545-50 | 65162-545 | ANDA040866 | ANDA | N/A |
| Probenecid | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Container (16571-831-01) | Rising Pharma Holdings, Inc. | 16571-831-01 | 16571-831 | ANDA217020 | ANDA | N/A |
| Probenecid | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Container (16571-831-10) | Rising Pharma Holdings, Inc. | 16571-831-10 | 16571-831 | ANDA217020 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 25 Vial In 1 Carton (70121-1580-5) / 2 Ml In 1 Vial (70121-1580-1) | Amneal Pharmaceuticals LLC | 70121-1580-5 | 70121-1580 | ANDA214192 | ANDA | N/A |
| Prochlorperazine Edisylate | Injection | Intramuscular; Intravenous | 5mg/mL | 10 Vial In 1 Carton (70121-1580-7) / 2 Ml In 1 Vial (70121-1580-1) | Amneal Pharmaceuticals LLC | 70121-1580-7 | 70121-1580 | ANDA214192 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (70954-688-10) | ANI Pharmaceuticals, Inc. | 70954-688-10 | 70954-688 | ANDA216202 | ANDA | N/A |
| Prochlorperazine Maleate | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (70954-689-10) | ANI Pharmaceuticals, Inc. | 70954-689-10 | 70954-689 | ANDA216202 | ANDA | N/A |
| Progesterone | Capsule | Oral | 100mg/1 | 100 Capsule In 1 Bottle (65162-807-10) | Amneal Pharmaceuticals LLC | 65162-807-10 | 65162-807 | ANDA207724 | ANDA | N/A |
| Progesterone | Capsule | Oral | 100mg/1 | 500 Capsule In 1 Bottle (65162-807-50) | Amneal Pharmaceuticals LLC | 65162-807-50 | 65162-807 | ANDA207724 | ANDA | N/A |
| Progesterone | Capsule | Oral | 200mg/1 | 100 Capsule In 1 Bottle (65162-808-10) | Amneal Pharmaceuticals LLC | 65162-808-10 | 65162-808 | ANDA207724 | ANDA | N/A |
| Progesterone | Capsule | Oral | 200mg/1 | 500 Capsule In 1 Bottle (65162-808-50) | Amneal Pharmaceuticals LLC | 65162-808-50 | 65162-808 | ANDA207724 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (65162-521-10) | Amneal Pharmaceuticals LLC | 65162-521-10 | 65162-521 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (65162-521-11) | Amneal Pharmaceuticals LLC | 65162-521-11 | 65162-521 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (65162-521-50) | Amneal Pharmaceuticals LLC | 65162-521-50 | 65162-521 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (65162-522-10) | Amneal Pharmaceuticals LLC | 65162-522-10 | 65162-522 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-522-50) | Amneal Pharmaceuticals LLC | 65162-522-50 | 65162-522 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 12.5mg/1 | 100 Tablet In 1 Bottle (65162-745-10) | Amneal Pharmaceuticals LLC | 65162-745-10 | 65162-745 | ANDA091179 | ANDA | N/A |
| Promethazine Hydrochloride | Tablet | Oral | 12.5mg/1 | 500 Tablet In 1 Bottle (65162-745-50) | Amneal Pharmaceuticals LLC | 65162-745-50 | 65162-745 | ANDA091179 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 150mg/1 | 100 Tablet, Coated In 1 Bottle (62559-230-01) | ANI Pharmaceuticals, Inc. | 62559-230-01 | 62559-230 | ANDA076550 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 225mg/1 | 100 Tablet, Coated In 1 Bottle (62559-231-01) | ANI Pharmaceuticals, Inc. | 62559-231-01 | 62559-231 | ANDA076550 | ANDA | N/A |
| Propafenone Hydrochloride | Tablet, Coated | Oral | 300mg/1 | 100 Tablet, Coated In 1 Bottle (62559-232-01) | ANI Pharmaceuticals, Inc. | 62559-232-01 | 62559-232 | ANDA076550 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 225mg/1 | 60 Capsule, Extended Release In 1 Bottle (16571-736-06) | Rising Pharma Holdings, Inc. | 16571-736-06 | 16571-736 | ANDA205956 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 225mg/1 | 500 Capsule, Extended Release In 1 Bottle (16571-736-50) | Rising Pharma Holdings, Inc. | 16571-736-50 | 16571-736 | ANDA205956 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 325mg/1 | 60 Capsule, Extended Release In 1 Bottle (16571-737-06) | Rising Pharma Holdings, Inc. | 16571-737-06 | 16571-737 | ANDA205956 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 325mg/1 | 500 Capsule, Extended Release In 1 Bottle (16571-737-50) | Rising Pharma Holdings, Inc. | 16571-737-50 | 16571-737 | ANDA205956 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 425mg/1 | 60 Capsule, Extended Release In 1 Bottle (16571-738-06) | Rising Pharma Holdings, Inc. | 16571-738-06 | 16571-738 | ANDA205956 | ANDA | N/A |
| Propafenone Hydrochloride | Capsule, Extended Release | Oral | 425mg/1 | 500 Capsule, Extended Release In 1 Bottle (16571-738-50) | Rising Pharma Holdings, Inc. | 16571-738-50 | 16571-738 | ANDA205956 | ANDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 60mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-520-01) | ANI Pharmaceuticals, Inc. | 62559-520-01 | 62559-520 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 60mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-520-30) | ANI Pharmaceuticals, Inc. | 62559-520-30 | 62559-520 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-521-01) | ANI Pharmaceuticals, Inc. | 62559-521-01 | 62559-521 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-521-30) | ANI Pharmaceuticals, Inc. | 62559-521-30 | 62559-521 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-522-01) | ANI Pharmaceuticals, Inc. | 62559-522-01 | 62559-522 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-522-30) | ANI Pharmaceuticals, Inc. | 62559-522-30 | 62559-522 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 160mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-523-01) | ANI Pharmaceuticals, Inc. | 62559-523-01 | 62559-523 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 160mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-523-30) | ANI Pharmaceuticals, Inc. | 62559-523-30 | 62559-523 | NDA018553 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 14 Capsule, Extended Release In 1 Bottle (62559-600-14) | ANI Pharmaceuticals, Inc. | 62559-600-14 | 62559-600 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-600-30) | ANI Pharmaceuticals, Inc. | 62559-600-30 | 62559-600 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 7 Capsule, Extended Release In 1 Bottle (62559-600-77) | ANI Pharmaceuticals, Inc. | 62559-600-77 | 62559-600 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 14 Capsule, Extended Release In 1 Bottle (62559-601-14) | ANI Pharmaceuticals, Inc. | 62559-601-14 | 62559-601 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-601-30) | ANI Pharmaceuticals, Inc. | 62559-601-30 | 62559-601 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 7 Capsule, Extended Release In 1 Bottle (62559-601-77) | ANI Pharmaceuticals, Inc. | 62559-601-77 | 62559-601 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 14 Capsule, Extended Release In 1 Bottle (62559-590-14) | ANI Pharmaceuticals, Inc. | 62559-590-14 | 62559-590 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-590-30) | ANI Pharmaceuticals, Inc. | 62559-590-30 | 62559-590 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 7 Capsule, Extended Release In 1 Bottle (62559-590-77) | ANI Pharmaceuticals, Inc. | 62559-590-77 | 62559-590 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 14 Capsule, Extended Release In 1 Bottle (62559-591-14) | ANI Pharmaceuticals, Inc. | 62559-591-14 | 62559-591 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 30 Capsule, Extended Release In 1 Bottle (62559-591-30) | ANI Pharmaceuticals, Inc. | 62559-591-30 | 62559-591 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 7 Capsule, Extended Release In 1 Bottle (62559-591-77) | ANI Pharmaceuticals, Inc. | 62559-591-77 | 62559-591 | NDA021438 | NDA | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 60mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-530-01) | ANI Pharmaceuticals, Inc. | 62559-530-01 | 62559-530 | NDA018553 | NDA AUTHORIZED GENERIC | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 80mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-531-01) | ANI Pharmaceuticals, Inc. | 62559-531-01 | 62559-531 | NDA018553 | NDA AUTHORIZED GENERIC | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 120mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-532-01) | ANI Pharmaceuticals, Inc. | 62559-532-01 | 62559-532 | NDA018553 | NDA AUTHORIZED GENERIC | N/A |
| Propranolol Hydrochloride | Capsule, Extended Release | Oral | 160mg/1 | 100 Capsule, Extended Release In 1 Bottle (62559-533-01) | ANI Pharmaceuticals, Inc. | 62559-533-01 | 62559-533 | NDA018553 | NDA AUTHORIZED GENERIC | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-096-01) | Epic Pharma, LLC | 42806-096-01 | 42806-096 | ANDA202220 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-096-10) | Epic Pharma, LLC | 42806-096-10 | 42806-096 | ANDA202220 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-096-30) | Epic Pharma, LLC | 42806-096-30 | 42806-096 | ANDA202220 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (42806-097-01) | Epic Pharma, LLC | 42806-097-01 | 42806-097 | ANDA202220 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (42806-097-10) | Epic Pharma, LLC | 42806-097-10 | 42806-097 | ANDA202220 | ANDA | N/A |
| Protriptyline Hydrochloride | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (42806-097-30) | Epic Pharma, LLC | 42806-097-30 | 42806-097 | ANDA202220 | ANDA | N/A |
| Pyridostigmine Bromide | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (62559-470-01) | ANI Pharmaceuticals, Inc. | 62559-470-01 | 62559-470 | ANDA040512 | ANDA | N/A |
| Pyridostigmine Bromide | Solution | Oral | 60mg/5mL | 473 Ml In 1 Bottle, Plastic (16571-833-16) | Rising Pharma Holdings, Inc. | 16571-833-16 | 16571-833 | ANDA208797 | ANDA | N/A |
| Pyridostigmine Bromide | Tablet | Oral | 180mg/1 | 30 Tablet In 1 Bottle (64980-220-03) | Rising Pharmaceuticals, Inc. | 64980-220-03 | 64980-220 | ANDA205464 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-431-06) | Amneal Pharmaceuticals LLC | 65162-431-06 | 65162-431 | ANDA211405 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-764-01) | Camber Pharmaceuticals, Inc. | 31722-764-01 | 31722-764 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-764-05) | Camber Pharmaceuticals, Inc. | 31722-764-05 | 31722-764 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 100 Blister Pack In 1 Carton (31722-764-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-764-31) | Camber Pharmaceuticals, Inc. | 31722-764-32 | 31722-764 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 150 Blister Pack In 1 Carton (31722-764-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-764-33) | Camber Pharmaceuticals, Inc. | 31722-764-34 | 31722-764 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-765-01) | Camber Pharmaceuticals, Inc. | 31722-765-01 | 31722-765 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-765-05) | Camber Pharmaceuticals, Inc. | 31722-765-05 | 31722-765 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 100 Blister Pack In 1 Carton (31722-765-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-765-31) | Camber Pharmaceuticals, Inc. | 31722-765-32 | 31722-765 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 100 Blister Pack In 1 Carton (31722-765-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-765-33) | Camber Pharmaceuticals, Inc. | 31722-765-34 | 31722-765 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-766-01) | Camber Pharmaceuticals, Inc. | 31722-766-01 | 31722-766 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-766-05) | Camber Pharmaceuticals, Inc. | 31722-766-05 | 31722-766 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (31722-766-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-766-31) | Camber Pharmaceuticals, Inc. | 31722-766-32 | 31722-766 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 100 Blister Pack In 1 Carton (31722-766-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-766-33) | Camber Pharmaceuticals, Inc. | 31722-766-34 | 31722-766 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-767-01) | Camber Pharmaceuticals, Inc. | 31722-767-01 | 31722-767 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-767-05) | Camber Pharmaceuticals, Inc. | 31722-767-05 | 31722-767 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 100 Blister Pack In 1 Carton (31722-767-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-767-31) | Camber Pharmaceuticals, Inc. | 31722-767-32 | 31722-767 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 100 Blister Pack In 1 Carton (31722-767-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-767-33) | Camber Pharmaceuticals, Inc. | 31722-767-34 | 31722-767 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-768-01) | Camber Pharmaceuticals, Inc. | 31722-768-01 | 31722-768 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-768-05) | Camber Pharmaceuticals, Inc. | 31722-768-05 | 31722-768 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 100 Blister Pack In 1 Carton (31722-768-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-768-31) | Camber Pharmaceuticals, Inc. | 31722-768-32 | 31722-768 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 100 Blister Pack In 1 Carton (31722-768-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-768-33) | Camber Pharmaceuticals, Inc. | 31722-768-34 | 31722-768 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-769-01) | Camber Pharmaceuticals, Inc. | 31722-769-01 | 31722-769 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-769-05) | Camber Pharmaceuticals, Inc. | 31722-769-05 | 31722-769 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 100 Blister Pack In 1 Carton (31722-769-32) / 10 Tablet, Film Coated In 1 Blister Pack (31722-769-31) | Camber Pharmaceuticals, Inc. | 31722-769-32 | 31722-769 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 100 Blister Pack In 1 Carton (31722-769-34) / 10 Tablet, Film Coated In 1 Blister Pack (31722-769-33) | Camber Pharmaceuticals, Inc. | 31722-769-34 | 31722-769 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 50mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-635-10) | Ingenus Pharmaceuticals, LLC | 50742-635-10 | 50742-635 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 50mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-635-30) | Ingenus Pharmaceuticals, LLC | 50742-635-30 | 50742-635 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 50mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-635-60) | Ingenus Pharmaceuticals, LLC | 50742-635-60 | 50742-635 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 50mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-635-90) | Ingenus Pharmaceuticals, LLC | 50742-635-90 | 50742-635 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 150mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-636-10) | Ingenus Pharmaceuticals, LLC | 50742-636-10 | 50742-636 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-636-30) | Ingenus Pharmaceuticals, LLC | 50742-636-30 | 50742-636 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 150mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-636-60) | Ingenus Pharmaceuticals, LLC | 50742-636-60 | 50742-636 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-636-90) | Ingenus Pharmaceuticals, LLC | 50742-636-90 | 50742-636 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 200mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-637-10) | Ingenus Pharmaceuticals, LLC | 50742-637-10 | 50742-637 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 200mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-637-30) | Ingenus Pharmaceuticals, LLC | 50742-637-30 | 50742-637 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 200mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-637-60) | Ingenus Pharmaceuticals, LLC | 50742-637-60 | 50742-637 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 200mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-637-90) | Ingenus Pharmaceuticals, LLC | 50742-637-90 | 50742-637 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 300mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-638-10) | Ingenus Pharmaceuticals, LLC | 50742-638-10 | 50742-638 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 300mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-638-30) | Ingenus Pharmaceuticals, LLC | 50742-638-30 | 50742-638 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 300mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-638-60) | Ingenus Pharmaceuticals, LLC | 50742-638-60 | 50742-638 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 300mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-638-90) | Ingenus Pharmaceuticals, LLC | 50742-638-90 | 50742-638 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 400mg/1 | 1000 Tablet, Extended Release In 1 Bottle (50742-639-10) | Ingenus Pharmaceuticals, LLC | 50742-639-10 | 50742-639 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 400mg/1 | 30 Tablet, Extended Release In 1 Bottle (50742-639-30) | Ingenus Pharmaceuticals, LLC | 50742-639-30 | 50742-639 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 400mg/1 | 60 Tablet, Extended Release In 1 Bottle (50742-639-60) | Ingenus Pharmaceuticals, LLC | 50742-639-60 | 50742-639 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Extended Release | Oral | 400mg/1 | 90 Tablet, Extended Release In 1 Bottle (50742-639-90) | Ingenus Pharmaceuticals, LLC | 50742-639-90 | 50742-639 | ANDA208947 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 150mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-809-01) | Rising Pharma Holdings, Inc. | 16571-809-01 | 16571-809 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 150mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-809-10) | Rising Pharma Holdings, Inc. | 16571-809-10 | 16571-809 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-717-01) | Rising Pharma Holdings, Inc. | 16571-717-01 | 16571-717 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-717-10) | Rising Pharma Holdings, Inc. | 16571-717-10 | 16571-717 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-718-01) | Rising Pharma Holdings, Inc. | 16571-718-01 | 16571-718 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-718-10) | Rising Pharma Holdings, Inc. | 16571-718-10 | 16571-718 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-719-01) | Rising Pharma Holdings, Inc. | 16571-719-01 | 16571-719 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-719-10) | Rising Pharma Holdings, Inc. | 16571-719-10 | 16571-719 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-720-01) | Rising Pharma Holdings, Inc. | 16571-720-01 | 16571-720 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-720-10) | Rising Pharma Holdings, Inc. | 16571-720-10 | 16571-720 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-721-01) | Rising Pharma Holdings, Inc. | 16571-721-01 | 16571-721 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-721-06) | Rising Pharma Holdings, Inc. | 16571-721-06 | 16571-721 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-721-10) | Rising Pharma Holdings, Inc. | 16571-721-10 | 16571-721 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-722-01) | Rising Pharma Holdings, Inc. | 16571-722-01 | 16571-722 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-722-50) | Rising Pharma Holdings, Inc. | 16571-722-50 | 16571-722 | ANDA091388 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-10) | ScieGen Pharmaceuticals, Inc | 50228-380-10 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-30) | ScieGen Pharmaceuticals, Inc | 50228-380-30 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-60) | ScieGen Pharmaceuticals, Inc | 50228-380-60 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-10) | ScieGen Pharmaceuticals, Inc | 50228-381-10 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-30) | ScieGen Pharmaceuticals, Inc | 50228-381-30 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-60) | ScieGen Pharmaceuticals, Inc | 50228-381-60 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-10) | ScieGen Pharmaceuticals, Inc | 50228-382-10 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-30) | ScieGen Pharmaceuticals, Inc | 50228-382-30 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-60) | ScieGen Pharmaceuticals, Inc | 50228-382-60 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-05) | ScieGen Pharmaceuticals, Inc | 50228-383-05 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-30) | ScieGen Pharmaceuticals, Inc | 50228-383-30 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-60) | ScieGen Pharmaceuticals, Inc | 50228-383-60 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-05) | ScieGen Pharmaceuticals, Inc | 50228-384-05 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-30) | ScieGen Pharmaceuticals, Inc | 50228-384-30 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-60) | ScieGen Pharmaceuticals, Inc | 50228-384-60 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-10) | ScieGen Pharmaceuticals, Inc | 50228-380-10 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-30) | ScieGen Pharmaceuticals, Inc | 50228-380-30 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 50mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-380-60) | ScieGen Pharmaceuticals, Inc | 50228-380-60 | 50228-380 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-10) | ScieGen Pharmaceuticals, Inc | 50228-381-10 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-30) | ScieGen Pharmaceuticals, Inc | 50228-381-30 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 150mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-381-60) | ScieGen Pharmaceuticals, Inc | 50228-381-60 | 50228-381 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 1000 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-10) | ScieGen Pharmaceuticals, Inc | 50228-382-10 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-30) | ScieGen Pharmaceuticals, Inc | 50228-382-30 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 200mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-382-60) | ScieGen Pharmaceuticals, Inc | 50228-382-60 | 50228-382 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-05) | ScieGen Pharmaceuticals, Inc | 50228-383-05 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-30) | ScieGen Pharmaceuticals, Inc | 50228-383-30 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 300mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-383-60) | ScieGen Pharmaceuticals, Inc | 50228-383-60 | 50228-383 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-05) | ScieGen Pharmaceuticals, Inc | 50228-384-05 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-30) | ScieGen Pharmaceuticals, Inc | 50228-384-30 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated, Extended Release | Oral | 400mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (50228-384-60) | ScieGen Pharmaceuticals, Inc | 50228-384-60 | 50228-384 | ANDA209635 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-264-01) | XLCare Pharmaceuticals Inc. | 72865-264-01 | 72865-264 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (72865-264-10) | XLCare Pharmaceuticals Inc. | 72865-264-10 | 72865-264 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-265-01) | XLCare Pharmaceuticals Inc. | 72865-265-01 | 72865-265 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-265-05) | XLCare Pharmaceuticals Inc. | 72865-265-05 | 72865-265 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-266-01) | XLCare Pharmaceuticals Inc. | 72865-266-01 | 72865-266 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-266-05) | XLCare Pharmaceuticals Inc. | 72865-266-05 | 72865-266 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-267-01) | XLCare Pharmaceuticals Inc. | 72865-267-01 | 72865-267 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 200mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-267-05) | XLCare Pharmaceuticals Inc. | 72865-267-05 | 72865-267 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-268-05) | XLCare Pharmaceuticals Inc. | 72865-268-05 | 72865-268 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (72865-268-60) | XLCare Pharmaceuticals Inc. | 72865-268-60 | 72865-268 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-269-01) | XLCare Pharmaceuticals Inc. | 72865-269-01 | 72865-269 | ANDA204316 | ANDA | N/A |
| Quetiapine Fumarate | Tablet, Film Coated | Oral | 400mg/1 | 500 Tablet, Film Coated In 1 Bottle (72865-269-05) | XLCare Pharmaceuticals Inc. | 72865-269-05 | 72865-269 | ANDA204316 | ANDA | N/A |
| Quinidine Sulfate | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (42806-512-01) | EPIC PHARMA, LLC | 42806-512-01 | 42806-512 | ANDA088072 | ANDA | N/A |
| Quinidine Sulfate | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (42806-512-30) | EPIC PHARMA, LLC | 42806-512-30 | 42806-512 | ANDA088072 | ANDA | N/A |
| Quinidine Sulfate | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (42806-513-01) | EPIC PHARMA, LLC | 42806-513-01 | 42806-513 | ANDA088072 | ANDA | N/A |
| Quinidine Sulfate | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (42806-513-30) | EPIC PHARMA, LLC | 42806-513-30 | 42806-513 | ANDA088072 | ANDA | N/A |
| Quinine Sulfate | Capsule | Oral | 324mg/1 | 30 Capsule In 1 Bottle (65162-811-03) | Amneal Pharmaceuticals LLC | 65162-811-03 | 65162-811 | ANDA203729 | ANDA | N/A |
| Quinine Sulfate | Capsule | Oral | 324mg/1 | 90 Capsule In 1 Bottle (65162-811-09) | Amneal Pharmaceuticals LLC | 65162-811-09 | 65162-811 | ANDA203729 | ANDA | N/A |
| Quinine Sulfate | Capsule | Oral | 324mg/1 | 500 Capsule In 1 Bottle (65162-811-50) | Amneal Pharmaceuticals LLC | 65162-811-50 | 65162-811 | ANDA203729 | ANDA | N/A |
| Quinine Sulfate | Capsule | Oral | 324mg/1 | 30 Capsule In 1 Bottle, Plastic (50742-238-30) | Ingenus Pharmaceuticals, LLC | 50742-238-30 | 50742-238 | ANDA204372 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 30 Tablet, Delayed Release In 1 Bottle (65162-724-03) | Amneal Pharmaceuticals LLC | 65162-724-03 | 65162-724 | ANDA204179 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 90 Tablet, Delayed Release In 1 Bottle (65162-724-09) | Amneal Pharmaceuticals LLC | 65162-724-09 | 65162-724 | ANDA204179 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 1000 Tablet, Delayed Release In 1 Bottle (65162-724-11) | Amneal Pharmaceuticals LLC | 65162-724-11 | 65162-724 | ANDA204179 | ANDA | N/A |
| Rabeprazole Sodium | Tablet, Delayed Release | Oral | 20mg/1 | 500 Tablet, Delayed Release In 1 Bottle (65162-724-50) | Amneal Pharmaceuticals LLC | 65162-724-50 | 65162-724 | ANDA204179 | ANDA | N/A |
| Racepinephrine Hydrochloride | Solution | Respiratory (Inhalation) | 11.25mg/.5mL | 30 Pouch In 1 Carton (0487-2784-01) / 1 Vial, Single-Use In 1 Pouch / .5 Ml In 1 Vial, Single-Use | Nephron Pharmaceuticals Corporation | 0487-2784-01 | 0487-2784 | part341 | OTC MONOGRAPH FINAL | N/A |
| Racepinephrine Hydrochloride | Solution | Respiratory (Inhalation) | 11.25mg/.5mL | 30 Pouch In 1 Carton (0487-5901-99) / 1 Vial, Single-Use In 1 Pouch / .5 Ml In 1 Vial, Single-Use | Nephron SC, Inc. | 0487-5901-99 | 0487-5901 | part341 | OTC MONOGRAPH FINAL | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-057-03) | Amneal Pharmaceuticals LLC | 65162-057-03 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-057-09) | Amneal Pharmaceuticals LLC | 65162-057-09 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 100 Tablet, Film Coated In 1 Bottle (65162-057-10) | Amneal Pharmaceuticals LLC | 65162-057-10 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-057-11) | Amneal Pharmaceuticals LLC | 65162-057-11 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 2000 Tablet, Film Coated In 1 Bottle (65162-057-33) | Amneal Pharmaceuticals LLC | 65162-057-33 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-057-50) | Amneal Pharmaceuticals LLC | 65162-057-50 | 65162-057 | ANDA208206 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 2000 Tablet, Film Coated In 1 Bottle (50228-306-20) | ScieGen Pharmaceuticals Inc | 50228-306-20 | 50228-306 | ANDA206384 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-306-30) | ScieGen Pharmaceuticals Inc | 50228-306-30 | 50228-306 | ANDA206384 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 2000 Tablet, Film Coated In 1 Bottle (50228-306-20) | ScieGen Pharmaceuticals Inc | 50228-306-20 | 50228-306 | ANDA206384 | ANDA | N/A |
| Raloxifene Hydrochloride | Tablet, Film Coated | Oral | 60mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-306-30) | ScieGen Pharmaceuticals Inc | 50228-306-30 | 50228-306 | ANDA206384 | ANDA | N/A |
| Ramipril | Capsule | Oral | 1.25mg/1 | 100 Capsule In 1 Bottle (57237-222-01) | Rising Pharma Holdings, Inc. | 57237-222-01 | 57237-222 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 1.25mg/1 | 30 Capsule In 1 Bottle (57237-222-30) | Rising Pharma Holdings, Inc. | 57237-222-30 | 57237-222 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 100 Capsule In 1 Bottle (57237-223-01) | Rising Pharma Holdings, Inc. | 57237-223-01 | 57237-223 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 2.5mg/1 | 500 Capsule In 1 Bottle (57237-223-05) | Rising Pharma Holdings, Inc. | 57237-223-05 | 57237-223 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (57237-224-01) | Rising Pharma Holdings, Inc. | 57237-224-01 | 57237-224 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (57237-224-05) | Rising Pharma Holdings, Inc. | 57237-224-05 | 57237-224 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (57237-225-01) | Rising Pharma Holdings, Inc. | 57237-225-01 | 57237-225 | ANDA091604 | ANDA | N/A |
| Ramipril | Capsule | Oral | 10mg/1 | 500 Capsule In 1 Bottle (57237-225-05) | Rising Pharma Holdings, Inc. | 57237-225-05 | 57237-225 | ANDA091604 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 150mg/1 | 60 Tablet In 1 Bottle (65162-253-06) | Amneal Pharmaceuticals LLC | 65162-253-06 | 65162-253 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (65162-253-10) | Amneal Pharmaceuticals LLC | 65162-253-10 | 65162-253 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (65162-253-11) | Amneal Pharmaceuticals LLC | 65162-253-11 | 65162-253 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 150mg/1 | 180 Tablet In 1 Bottle (65162-253-18) | Amneal Pharmaceuticals LLC | 65162-253-18 | 65162-253 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (65162-253-50) | Amneal Pharmaceuticals LLC | 65162-253-50 | 65162-253 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 300mg/1 | 30 Tablet In 1 Bottle (65162-254-03) | Amneal Pharmaceuticals LLC | 65162-254-03 | 65162-254 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 300mg/1 | 100 Tablet In 1 Bottle (65162-254-10) | Amneal Pharmaceuticals LLC | 65162-254-10 | 65162-254 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 300mg/1 | 1000 Tablet In 1 Bottle (65162-254-11) | Amneal Pharmaceuticals LLC | 65162-254-11 | 65162-254 | ANDA077824 | ANDA | N/A |
| Ranitidine Hydrochloride | Tablet | Oral | 300mg/1 | 250 Tablet In 1 Bottle (65162-254-25) | Amneal Pharmaceuticals LLC | 65162-254-25 | 65162-254 | ANDA077824 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (65162-376-06) | Amneal Pharmaceuticals LLC | 65162-376-06 | 65162-376 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 180 Tablet, Film Coated, Extended Release In 1 Bottle (65162-376-18) | Amneal Pharmaceuticals LLC | 65162-376-18 | 65162-376 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (65162-376-50) | Amneal Pharmaceuticals LLC | 65162-376-50 | 65162-376 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (65162-379-06) | Amneal Pharmaceuticals LLC | 65162-379-06 | 65162-379 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 180 Tablet, Film Coated, Extended Release In 1 Bottle (65162-379-18) | Amneal Pharmaceuticals LLC | 65162-379-18 | 65162-379 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Bottle (65162-379-50) | Amneal Pharmaceuticals LLC | 65162-379-50 | 65162-379 | ANDA207690 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (31722-668-60) | Camber Pharmaceuticals, Inc. | 31722-668-60 | 31722-668 | ANDA212788 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Bottle (31722-669-60) | Camber Pharmaceuticals, Inc. | 31722-669-60 | 31722-669 | ANDA212788 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Package (50228-423-05) | ScieGen Pharmaceuticals, Inc | 50228-423-05 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Package (50228-423-30) | ScieGen Pharmaceuticals, Inc | 50228-423-30 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Package (50228-423-60) | ScieGen Pharmaceuticals, Inc | 50228-423-60 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Package (50228-424-05) | ScieGen Pharmaceuticals, Inc | 50228-424-05 | 50228-424 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Package (50228-424-30) | ScieGen Pharmaceuticals, Inc | 50228-424-30 | 50228-424 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Package (50228-424-60) | ScieGen Pharmaceuticals, Inc | 50228-424-60 | 50228-424 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Package (50228-423-05) | ScieGen Pharmaceuticals, Inc | 50228-423-05 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Package (50228-423-30) | ScieGen Pharmaceuticals, Inc | 50228-423-30 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 500mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Package (50228-423-60) | ScieGen Pharmaceuticals, Inc | 50228-423-60 | 50228-423 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 500 Tablet, Film Coated, Extended Release In 1 Package (50228-424-05) | ScieGen Pharmaceuticals, Inc | 50228-424-05 | 50228-424 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 30 Tablet, Film Coated, Extended Release In 1 Package (50228-424-30) | ScieGen Pharmaceuticals, Inc | 50228-424-30 | 50228-424 | ANDA211829 | ANDA | N/A |
| Ranolazine | Tablet, Film Coated, Extended Release | Oral | 1000mg/1 | 60 Tablet, Film Coated, Extended Release In 1 Package (50228-424-60) | ScieGen Pharmaceuticals, Inc | 50228-424-60 | 50228-424 | ANDA211829 | ANDA | N/A |
| Repaglinide | Tablet | Oral | .5mg/1 | 100 Tablet In 1 Bottle (57237-157-01) | Rising Pharma Holdings, Inc. | 57237-157-01 | 57237-157 | ANDA203820 | ANDA | N/A |
| Repaglinide | Tablet | Oral | .5mg/1 | 500 Tablet In 1 Bottle (57237-157-05) | Rising Pharma Holdings, Inc. | 57237-157-05 | 57237-157 | ANDA203820 | ANDA | N/A |
| Repaglinide | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (57237-158-01) | Rising Pharma Holdings, Inc. | 57237-158-01 | 57237-158 | ANDA203820 | ANDA | N/A |
| Repaglinide | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (57237-158-05) | Rising Pharma Holdings, Inc. | 57237-158-05 | 57237-158 | ANDA203820 | ANDA | N/A |
| Repaglinide | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (57237-159-01) | Rising Pharma Holdings, Inc. | 57237-159-01 | 57237-159 | ANDA203820 | ANDA | N/A |
| Repaglinide | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (57237-159-05) | Rising Pharma Holdings, Inc. | 57237-159-05 | 57237-159 | ANDA203820 | ANDA | N/A |
| Rifampin | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (42806-799-01) | EPIC PHARMA, LLC | 42806-799-01 | 42806-799 | ANDA064150 | ANDA | N/A |
| Rifampin | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (42806-799-05) | EPIC PHARMA, LLC | 42806-799-05 | 42806-799 | ANDA064150 | ANDA | N/A |
| Rifampin | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (42806-799-30) | EPIC PHARMA, LLC | 42806-799-30 | 42806-799 | ANDA064150 | ANDA | N/A |
| Rifampin | Capsule | Oral | 300mg/1 | 60 Capsule In 1 Bottle (42806-799-60) | EPIC PHARMA, LLC | 42806-799-60 | 42806-799 | ANDA064150 | ANDA | N/A |
| Rifampin | Capsule | Oral | 150mg/1 | 100 Capsule In 1 Bottle (42806-801-01) | EPIC PHARMA, LLC | 42806-801-01 | 42806-801 | ANDA064150 | ANDA | N/A |
| Rifampin | Capsule | Oral | 150mg/1 | 30 Capsule In 1 Bottle (42806-801-30) | EPIC PHARMA, LLC | 42806-801-30 | 42806-801 | ANDA064150 | ANDA | N/A |
| Risperidone | Solution | Oral | 1mg/mL | 30 Ml In 1 Bottle (65162-673-84) | Amneal Pharmaceuticals LLC | 65162-673-84 | 65162-673 | ANDA091384 | ANDA | N/A |
| Ritonavir | Tablet | Oral | 100mg/1 | 120 Tablet In 1 Bottle (31722-597-12) | Camber Pharmaceuticals, Inc. | 31722-597-12 | 31722-597 | ANDA204587 | ANDA | N/A |
| Ritonavir | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (31722-597-30) | Camber Pharmaceuticals, Inc. | 31722-597-30 | 31722-597 | ANDA204587 | ANDA | N/A |
| Rivastigmine | Patch | Transdermal | 4.6mg/24h | 30 Patch In 1 Carton (65162-825-34) / 24 H In 1 Patch | Amneal Pharmaceuticals LLC | 65162-825-34 | 65162-825 | ANDA207308 | ANDA | N/A |
| Rivastigmine | Patch | Transdermal | 9.5mg/24h | 30 Patch In 1 Carton (65162-826-34) / 24 H In 1 Patch | Amneal Pharmaceuticals LLC | 65162-826-34 | 65162-826 | ANDA207308 | ANDA | N/A |
| Rivastigmine | Patch | Transdermal | 13.3mg/24h | 30 Patch In 1 Carton (65162-749-34) / 24 H In 1 Patch | Amneal Pharmaceuticals LLC | 65162-749-34 | 65162-749 | ANDA207308 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 5mg/1 | 3 Blister Pack In 1 Carton (57237-085-63) / 6 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-085-63 | 57237-085 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet, Orally Disintegrating | Oral | 10mg/1 | 3 Blister Pack In 1 Carton (57237-086-63) / 6 Tablet, Orally Disintegrating In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-086-63 | 57237-086 | ANDA203062 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 5mg/1 | 4 Blister Pack In 1 Carton (57237-087-34) / 3 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-087-34 | 57237-087 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 5mg/1 | 3 Blister Pack In 1 Carton (57237-087-63) / 6 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-087-63 | 57237-087 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 10mg/1 | 4 Blister Pack In 1 Carton (57237-088-34) / 3 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-088-34 | 57237-088 | ANDA202490 | ANDA | N/A |
| Rizatriptan Benzoate | Tablet | Oral | 10mg/1 | 3 Blister Pack In 1 Carton (57237-088-63) / 6 Tablet In 1 Blister Pack | Rising Pharma Holdings, Inc. | 57237-088-63 | 57237-088 | ANDA202490 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 12 Pouch In 1 Carton (70121-1732-3) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1732-3 | 70121-1732 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 24 Pouch In 1 Carton (70121-1732-9) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1732-9 | 70121-1732 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 12 Pouch In 1 Carton (70121-1733-3) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1733-3 | 70121-1733 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 2mg/mL | 24 Pouch In 1 Carton (70121-1733-9) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1733-9 | 70121-1733 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 12 Pouch In 1 Carton (70121-1734-3) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1734-3 | 70121-1734 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 10 Pouch In 1 Carton (70121-1734-7) / 1 Bag In 1 Pouch / 100 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1734-7 | 70121-1734 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 12 Pouch In 1 Carton (70121-1735-3) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1735-3 | 70121-1735 | ANDA216605 | ANDA | N/A |
| Ropivacaine Hydrochloride | Injection | Epidural; Infiltration; Perineural | 5mg/mL | 10 Pouch In 1 Carton (70121-1735-7) / 1 Bag In 1 Pouch / 200 Ml In 1 Bag | Amneal Pharmaceuticals LLC | 70121-1735-7 | 70121-1735 | ANDA216605 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-116-05) | ScieGen Pharmaceuticals, Inc. | 50228-116-05 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-116-10) | ScieGen Pharmaceuticals, Inc. | 50228-116-10 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-116-30) | ScieGen Pharmaceuticals, Inc. | 50228-116-30 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-116-90) | ScieGen Pharmaceuticals, Inc. | 50228-116-90 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-117-05) | ScieGen Pharmaceuticals, Inc. | 50228-117-05 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-117-10) | ScieGen Pharmaceuticals, Inc. | 50228-117-10 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-117-30) | ScieGen Pharmaceuticals, Inc. | 50228-117-30 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-117-90) | ScieGen Pharmaceuticals, Inc. | 50228-117-90 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-118-05) | ScieGen Pharmaceuticals, Inc. | 50228-118-05 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-118-10) | ScieGen Pharmaceuticals, Inc. | 50228-118-10 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-118-30) | ScieGen Pharmaceuticals, Inc. | 50228-118-30 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-118-90) | ScieGen Pharmaceuticals, Inc. | 50228-118-90 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-119-05) | ScieGen Pharmaceuticals, Inc. | 50228-119-05 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-119-10) | ScieGen Pharmaceuticals, Inc. | 50228-119-10 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-119-30) | ScieGen Pharmaceuticals, Inc. | 50228-119-30 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-119-90) | ScieGen Pharmaceuticals, Inc. | 50228-119-90 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-116-05) | ScieGen Pharmaceuticals, Inc. | 50228-116-05 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-116-10) | ScieGen Pharmaceuticals, Inc. | 50228-116-10 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-116-30) | ScieGen Pharmaceuticals, Inc. | 50228-116-30 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-116-90) | ScieGen Pharmaceuticals, Inc. | 50228-116-90 | 50228-116 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-117-05) | ScieGen Pharmaceuticals, Inc. | 50228-117-05 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-117-10) | ScieGen Pharmaceuticals, Inc. | 50228-117-10 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-117-30) | ScieGen Pharmaceuticals, Inc. | 50228-117-30 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-117-90) | ScieGen Pharmaceuticals, Inc. | 50228-117-90 | 50228-117 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-118-05) | ScieGen Pharmaceuticals, Inc. | 50228-118-05 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-118-10) | ScieGen Pharmaceuticals, Inc. | 50228-118-10 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-118-30) | ScieGen Pharmaceuticals, Inc. | 50228-118-30 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-118-90) | ScieGen Pharmaceuticals, Inc. | 50228-118-90 | 50228-118 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-119-05) | ScieGen Pharmaceuticals, Inc. | 50228-119-05 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (50228-119-10) | ScieGen Pharmaceuticals, Inc. | 50228-119-10 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-119-30) | ScieGen Pharmaceuticals, Inc. | 50228-119-30 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-119-90) | ScieGen Pharmaceuticals, Inc. | 50228-119-90 | 50228-119 | ANDA206381 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-169-05) | Rising Pharma Holdings, Inc. | 57237-169-05 | 57237-169 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-169-30) | Rising Pharma Holdings, Inc. | 57237-169-30 | 57237-169 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-169-90) | Rising Pharma Holdings, Inc. | 57237-169-90 | 57237-169 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-169-99) | Rising Pharma Holdings, Inc. | 57237-169-99 | 57237-169 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-170-05) | Rising Pharma Holdings, Inc. | 57237-170-05 | 57237-170 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-170-30) | Rising Pharma Holdings, Inc. | 57237-170-30 | 57237-170 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-170-90) | Rising Pharma Holdings, Inc. | 57237-170-90 | 57237-170 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 20mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-170-99) | Rising Pharma Holdings, Inc. | 57237-170-99 | 57237-170 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-171-05) | Rising Pharma Holdings, Inc. | 57237-171-05 | 57237-171 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-171-30) | Rising Pharma Holdings, Inc. | 57237-171-30 | 57237-171 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-171-90) | Rising Pharma Holdings, Inc. | 57237-171-90 | 57237-171 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 40mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-171-99) | Rising Pharma Holdings, Inc. | 57237-171-99 | 57237-171 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-168-05) | Rising Pharma Holdings, Inc. | 57237-168-05 | 57237-168 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-168-30) | Rising Pharma Holdings, Inc. | 57237-168-30 | 57237-168 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-168-90) | Rising Pharma Holdings, Inc. | 57237-168-90 | 57237-168 | ANDA079170 | ANDA | N/A |
| Rosuvastatin Calcium | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (57237-168-99) | Rising Pharma Holdings, Inc. | 57237-168-99 | 57237-168 | ANDA079170 | ANDA | N/A |
| Rufinamide | Suspension | Oral | 40mg/mL | 1 Bottle In 1 Carton (31722-688-46) / 460 Ml In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-688-46 | 31722-688 | ANDA216841 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 200mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-598-12) | Camber Pharmaceuticals, Inc. | 31722-598-12 | 31722-598 | ANDA204993 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 200mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-598-30) | Camber Pharmaceuticals, Inc. | 31722-598-30 | 31722-598 | ANDA204993 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 400mg/1 | 120 Tablet, Film Coated In 1 Bottle (31722-599-12) | Camber Pharmaceuticals, Inc. | 31722-599-12 | 31722-599 | ANDA204993 | ANDA | N/A |
| Rufinamide | Tablet, Film Coated | Oral | 400mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-599-30) | Camber Pharmaceuticals, Inc. | 31722-599-30 | 31722-599 | ANDA204993 | ANDA | N/A |
| Salsalate | Tablet | Oral | 500mg/1 | 100 Tablet In 1 Bottle (65162-512-10) | Amneal Pharmaceuticals LLC | 65162-512-10 | 65162-512 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salsalate | Tablet | Oral | 500mg/1 | 1000 Tablet In 1 Bottle (65162-512-11) | Amneal Pharmaceuticals LLC | 65162-512-11 | 65162-512 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salsalate | Tablet | Oral | 500mg/1 | 500 Tablet In 1 Bottle (65162-512-50) | Amneal Pharmaceuticals LLC | 65162-512-50 | 65162-512 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salsalate | Tablet | Oral | 750mg/1 | 100 Tablet In 1 Bottle (65162-513-10) | Amneal Pharmaceuticals LLC | 65162-513-10 | 65162-513 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salsalate | Tablet | Oral | 750mg/1 | 1000 Tablet In 1 Bottle (65162-513-11) | Amneal Pharmaceuticals LLC | 65162-513-11 | 65162-513 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Salsalate | Tablet | Oral | 750mg/1 | 500 Tablet In 1 Bottle (65162-513-50) | Amneal Pharmaceuticals LLC | 65162-513-50 | 65162-513 | N/A | UNAPPROVED DRUG OTHER | N/A |
| sapropterin dihydrochloride | Tablet | Oral | 100mg/1 | 120 Tablet In 1 Bottle (31722-045-12) | Camber Pharmaceuticals, Inc. | 31722-045-12 | 31722-045 | ANDA215534 | ANDA | N/A |
| Sapropterin dihydrochloride | Powder, For Solution | Oral | 100mg/1 | 30 Packet In 1 Carton (31722-047-30) / 1 Powder, For Solution In 1 Packet (31722-047-01) | Camber Pharmaceuticals, Inc. | 31722-047-30 | 31722-047 | ANDA215420 | ANDA | N/A |
| Sapropterin dihydrochloride | Powder, For Solution | Oral | 100mg/1 | 1 Packet In 1 Carton (31722-047-31) / 1 Powder, For Solution In 1 Packet (31722-047-01) | Camber Pharmaceuticals, Inc. | 31722-047-31 | 31722-047 | ANDA215420 | ANDA | N/A |
| Sapropterin dihydrochloride | Powder, For Solution | Oral | 500mg/1 | 30 Packet In 1 Carton (31722-048-30) / 1 Powder, For Solution In 1 Packet (31722-048-01) | Camber Pharmaceuticals, Inc. | 31722-048-30 | 31722-048 | ANDA215420 | ANDA | N/A |
| Sapropterin dihydrochloride | Powder, For Solution | Oral | 500mg/1 | 1 Packet In 1 Carton (31722-048-31) / 1 Powder, For Solution In 1 Packet (31722-048-01) | Camber Pharmaceuticals, Inc. | 31722-048-31 | 31722-048 | ANDA215420 | ANDA | N/A |
| Saxagliptin Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-059-03) | Amneal Pharmaceuticals LLC | 65162-059-03 | 65162-059 | ANDA205941 | ANDA | N/A |
| Saxagliptin Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-059-09) | Amneal Pharmaceuticals LLC | 65162-059-09 | 65162-059 | ANDA205941 | ANDA | N/A |
| Saxagliptin Hydrochloride | Tablet, Film Coated | Oral | 2.5mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-059-50) | Amneal Pharmaceuticals LLC | 65162-059-50 | 65162-059 | ANDA205941 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1.5mg/1 | 4 Pouch In 1 Carton (50742-505-04) / 1 Patch, Extended Release In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-505-04 | 50742-505 | ANDA212342 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1.5mg/1 | 10 Pouch In 1 Carton (50742-505-10) / 1 Patch, Extended Release In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-505-10 | 50742-505 | ANDA212342 | ANDA | N/A |
| Scopolamine | Patch, Extended Release | Transdermal | 1.5mg/1 | 24 Pouch In 1 Carton (50742-505-24) / 1 Patch, Extended Release In 1 Pouch | Ingenus Pharmaceuticals, LLC | 50742-505-24 | 50742-505 | ANDA212342 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 60 Capsule In 1 Bottle (16571-659-06) | Rising Pharma Holdings, Inc. | 16571-659-06 | 16571-659 | ANDA206803 | ANDA | N/A |
| Selegiline Hydrochloride | Capsule | Oral | 5mg/1 | 500 Capsule In 1 Bottle (16571-659-50) | Rising Pharma Holdings, Inc. | 16571-659-50 | 16571-659 | ANDA206803 | ANDA | N/A |
| Sennosides | Liquid | Oral | 8.8mg/5mL | 237 Ml In 1 Bottle (57237-301-24) | Rising Health, LLC | 57237-301-24 | 57237-301 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Sennosides | Liquid | Oral | 8.8mg/5mL | 40 Cup, Unit-Dose In 1 Box (57237-310-54) / 5 Ml In 1 Cup, Unit-Dose (57237-310-05) | Rising Health, LLC | 57237-310-54 | 57237-310 | part334 | OTC MONOGRAPH NOT FINAL | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (43602-979-15) | Ascent Pharmaceuticals, Inc. | 43602-979-15 | 43602-979 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (43602-979-16) | Ascent Pharmaceuticals, Inc. | 43602-979-16 | 43602-979 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (43602-980-15) | Ascent Pharmaceuticals, Inc. | 43602-980-15 | 43602-980 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (43602-980-16) | Ascent Pharmaceuticals, Inc. | 43602-980-16 | 43602-980 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (43602-981-15) | Ascent Pharmaceuticals, Inc. | 43602-981-15 | 43602-981 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (43602-981-16) | Ascent Pharmaceuticals, Inc. | 43602-981-16 | 43602-981 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (43602-979-15) | Ascent Pharmaceuticals, Inc. | 43602-979-15 | 43602-979 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (43602-979-16) | Ascent Pharmaceuticals, Inc. | 43602-979-16 | 43602-979 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (43602-980-15) | Ascent Pharmaceuticals, Inc. | 43602-980-15 | 43602-980 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (43602-980-16) | Ascent Pharmaceuticals, Inc. | 43602-980-16 | 43602-980 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (43602-981-15) | Ascent Pharmaceuticals, Inc. | 43602-981-15 | 43602-981 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (43602-981-16) | Ascent Pharmaceuticals, Inc. | 43602-981-16 | 43602-981 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (31722-145-05) | Camber Pharmaceuticals, Inc. | 31722-145-05 | 31722-145 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (31722-145-30) | Camber Pharmaceuticals, Inc. | 31722-145-30 | 31722-145 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (31722-145-90) | Camber Pharmaceuticals, Inc. | 31722-145-90 | 31722-145 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (31722-146-05) | Camber Pharmaceuticals, Inc. | 31722-146-05 | 31722-146 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (31722-146-30) | Camber Pharmaceuticals, Inc. | 31722-146-30 | 31722-146 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (31722-146-90) | Camber Pharmaceuticals, Inc. | 31722-146-90 | 31722-146 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (31722-147-05) | Camber Pharmaceuticals, Inc. | 31722-147-05 | 31722-147 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (31722-147-30) | Camber Pharmaceuticals, Inc. | 31722-147-30 | 31722-147 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (31722-147-90) | Camber Pharmaceuticals, Inc. | 31722-147-90 | 31722-147 | ANDA214790 | ANDA | N/A |
| Sertraline Hydrochloride | Solution, Concentrate | Oral | 20mg/mL | 1 Bottle, Plastic In 1 Carton (64980-409-06) / 60 Ml In 1 Bottle, Plastic | Rising Pharma Holdings, Inc. | 64980-409-06 | 64980-409 | ANDA078861 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-05) | ScieGen Pharmaceuticals Inc | 50228-467-05 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-30) | ScieGen Pharmaceuticals Inc | 50228-467-30 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-90) | ScieGen Pharmaceuticals Inc | 50228-467-90 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-05) | ScieGen Pharmaceuticals Inc | 50228-468-05 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-30) | ScieGen Pharmaceuticals Inc | 50228-468-30 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-90) | ScieGen Pharmaceuticals Inc | 50228-468-90 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-05) | ScieGen Pharmaceuticals Inc | 50228-469-05 | 50228-469 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-30) | ScieGen Pharmaceuticals Inc | 50228-469-30 | 50228-469 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-90) | ScieGen Pharmaceuticals Inc | 50228-469-90 | 50228-469 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-05) | ScieGen Pharmaceuticals Inc | 50228-467-05 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-30) | ScieGen Pharmaceuticals Inc | 50228-467-30 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 25mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-467-90) | ScieGen Pharmaceuticals Inc | 50228-467-90 | 50228-467 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-05) | ScieGen Pharmaceuticals Inc | 50228-468-05 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-30) | ScieGen Pharmaceuticals Inc | 50228-468-30 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-468-90) | ScieGen Pharmaceuticals Inc | 50228-468-90 | 50228-468 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-05) | ScieGen Pharmaceuticals Inc | 50228-469-05 | 50228-469 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-30) | ScieGen Pharmaceuticals Inc | 50228-469-30 | 50228-469 | ANDA076442 | ANDA | N/A |
| Sertraline Hydrochloride | Tablet, Film Coated | Oral | 100mg/1 | 90 Tablet, Film Coated In 1 Bottle, Plastic (50228-469-90) | ScieGen Pharmaceuticals Inc | 50228-469-90 | 50228-469 | ANDA076442 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (72865-205-05) | XLCare Pharmaceuticals, Inc. | 72865-205-05 | 72865-205 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 180 Tablet In 1 Bottle (72865-205-18) | XLCare Pharmaceuticals, Inc. | 72865-205-18 | 72865-205 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (72865-205-30) | XLCare Pharmaceuticals, Inc. | 72865-205-30 | 72865-205 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (72865-205-90) | XLCare Pharmaceuticals, Inc. | 72865-205-90 | 72865-205 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (72865-206-05) | XLCare Pharmaceuticals, Inc. | 72865-206-05 | 72865-206 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 180 Tablet In 1 Bottle (72865-206-18) | XLCare Pharmaceuticals, Inc. | 72865-206-18 | 72865-206 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (72865-206-30) | XLCare Pharmaceuticals, Inc. | 72865-206-30 | 72865-206 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (72865-206-90) | XLCare Pharmaceuticals, Inc. | 72865-206-90 | 72865-206 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (72865-207-05) | XLCare Pharmaceuticals, Inc. | 72865-207-05 | 72865-207 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 180 Tablet In 1 Bottle (72865-207-18) | XLCare Pharmaceuticals, Inc. | 72865-207-18 | 72865-207 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (72865-207-30) | XLCare Pharmaceuticals, Inc. | 72865-207-30 | 72865-207 | ANDA214790 | ANDA | N/A |
| SERTRALINE HYDROCHLORIDE | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (72865-207-90) | XLCare Pharmaceuticals, Inc. | 72865-207-90 | 72865-207 | ANDA214790 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 30 Tablet, Film Coated In 1 Bottle (65162-058-03) | Amneal Pharmaceuticals LLC | 65162-058-03 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 60 Tablet, Film Coated In 1 Bottle (65162-058-06) | Amneal Pharmaceuticals LLC | 65162-058-06 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 90 Tablet, Film Coated In 1 Bottle (65162-058-09) | Amneal Pharmaceuticals LLC | 65162-058-09 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 1000 Tablet, Film Coated In 1 Bottle (65162-058-11) | Amneal Pharmaceuticals LLC | 65162-058-11 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 270 Tablet, Film Coated In 1 Bottle (65162-058-27) | Amneal Pharmaceuticals LLC | 65162-058-27 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 500 Tablet, Film Coated In 1 Bottle (65162-058-50) | Amneal Pharmaceuticals LLC | 65162-058-50 | 65162-058 | ANDA207288 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 30 Tablet, Film Coated In 1 Bottle (16571-739-03) | Rising Pharmaceuticals, Inc. | 16571-739-03 | 16571-739 | ANDA204451 | ANDA | N/A |
| Sevelamer Carbonate | Tablet, Film Coated | Oral | 800mg/1 | 270 Tablet, Film Coated In 1 Bottle (16571-739-27) | Rising Pharmaceuticals, Inc. | 16571-739-27 | 16571-739 | ANDA204451 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 25mg/1 | 30 TABLET in 1 BOTTLE (55801-338-01) | Appco Pharma LLC | 55801-338-01 | 55801-338 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 25mg/1 | 100 TABLET in 1 BOTTLE (55801-338-02) | Appco Pharma LLC | 55801-338-02 | 55801-338 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 25mg/1 | 500 TABLET in 1 BOTTLE (55801-338-03) | Appco Pharma LLC | 55801-338-03 | 55801-338 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 50mg/1 | 30 TABLET in 1 BOTTLE (55801-339-01) | Appco Pharma LLC | 55801-339-01 | 55801-339 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 50mg/1 | 100 TABLET in 1 BOTTLE (55801-339-02) | Appco Pharma LLC | 55801-339-02 | 55801-339 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 50mg/1 | 500 TABLET in 1 BOTTLE (55801-339-03) | Appco Pharma LLC | 55801-339-03 | 55801-339 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 100mg/1 | 30 TABLET in 1 BOTTLE (55801-340-01) | Appco Pharma LLC | 55801-340-01 | 55801-340 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 100mg/1 | 100 TABLET in 1 BOTTLE (55801-340-02) | Appco Pharma LLC | 55801-340-02 | 55801-340 | ANDA207178 | ANDA | N/A |
| SILDENAFIL | TABLET | ORAL | 100mg/1 | 500 TABLET in 1 BOTTLE (55801-340-03) | Appco Pharma LLC | 55801-340-03 | 55801-340 | ANDA207178 | ANDA | N/A |
| Sildenafil | For Suspension | Oral | 10mg/mL | 1 Bottle, Glass In 1 Carton (31722-136-31) / 112 Ml In 1 Bottle, Glass | Camber Pharmaceuticals, Inc. | 31722-136-31 | 31722-136 | ANDA213014 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 25mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-709-05) | Camber Pharmaceuticals, Inc. | 31722-709-05 | 31722-709 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-709-30) | Camber Pharmaceuticals, Inc. | 31722-709-30 | 31722-709 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-710-01) | Camber Pharmaceuticals, Inc. | 31722-710-01 | 31722-710 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-710-05) | Camber Pharmaceuticals, Inc. | 31722-710-05 | 31722-710 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-710-30) | Camber Pharmaceuticals, Inc. | 31722-710-30 | 31722-710 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-965-30) | Camber Pharmaceuticals, Inc. | 31722-965-30 | 31722-965 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-711-01) | Camber Pharmaceuticals, Inc. | 31722-711-01 | 31722-711 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-711-05) | Camber Pharmaceuticals, Inc. | 31722-711-05 | 31722-711 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-711-30) | Camber Pharmaceuticals, Inc. | 31722-711-30 | 31722-711 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-966-01) | Camber Pharmaceuticals, Inc. | 31722-966-01 | 31722-966 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-966-30) | Camber Pharmaceuticals, Inc. | 31722-966-30 | 31722-966 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-967-01) | Camber Pharmaceuticals, Inc. | 31722-967-01 | 31722-967 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-967-30) | Camber Pharmaceuticals, Inc. | 31722-967-30 | 31722-967 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 25mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-101-30) | XLCARE Pharmaceuticals INC. | 72865-101-30 | 72865-101 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-102-01) | XLCARE Pharmaceuticals INC. | 72865-102-01 | 72865-102 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 50mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-102-30) | XLCARE Pharmaceuticals INC. | 72865-102-30 | 72865-102 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 100 Tablet, Film Coated In 1 Bottle (72865-103-01) | XLCARE Pharmaceuticals INC. | 72865-103-01 | 72865-103 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 100mg/1 | 30 Tablet, Film Coated In 1 Bottle (72865-103-30) | XLCARE Pharmaceuticals INC. | 72865-103-30 | 72865-103 | ANDA202659 | ANDA | N/A |
| Sildenafil | Tablet, Film Coated | Oral | 20mg/1 | 90 Tablet, Film Coated In 1 Bottle (72865-105-90) | XLCare Pharmaceuticals, Inc. | 72865-105-90 | 72865-105 | ANDA203623 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (65162-351-09) | Amneal Pharmaceuticals LLC | 65162-351-09 | 65162-351 | ANDA202025 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 20mg/1 | 1000 Tablet In 1 Bottle (65162-351-11) | Amneal Pharmaceuticals LLC | 65162-351-11 | 65162-351 | ANDA202025 | ANDA | N/A |
| Sildenafil Citrate | For Suspension | Oral | 10mg/mL | 1 Bottle In 1 Carton (70954-168-10) / 112 Ml In 1 Bottle | ANI Pharmaceuticals, Inc. | 70954-168-10 | 70954-168 | ANDA212260 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (70954-407-10) | ANI Pharmaceuticals, Inc. | 70954-407-10 | 70954-407 | ANDA216383 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (70954-408-10) | ANI Pharmaceuticals, Inc. | 70954-408-10 | 70954-408 | ANDA216383 | ANDA | N/A |
| Sildenafil Citrate | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (70954-409-10) | ANI Pharmaceuticals, Inc. | 70954-409-10 | 70954-409 | ANDA216383 | ANDA | N/A |
| Silodosin | Capsule | Oral | 4mg/1 | 30 Capsule In 1 Bottle (31722-635-30) | Camber Pharmaceuticals, Inc. | 31722-635-30 | 31722-635 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 4mg/1 | 30 Capsule In 1 Bottle (31722-635-31) | Camber Pharmaceuticals, Inc. | 31722-635-31 | 31722-635 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 4mg/1 | 90 Capsule In 1 Bottle (31722-635-90) | Camber Pharmaceuticals, Inc. | 31722-635-90 | 31722-635 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 4mg/1 | 90 Capsule In 1 Bottle (31722-635-91) | Camber Pharmaceuticals, Inc. | 31722-635-91 | 31722-635 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 8mg/1 | 30 Capsule In 1 Bottle (31722-636-30) | Camber Pharmaceuticals, Inc. | 31722-636-30 | 31722-636 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 8mg/1 | 30 Capsule In 1 Bottle (31722-636-31) | Camber Pharmaceuticals, Inc. | 31722-636-31 | 31722-636 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 8mg/1 | 90 Capsule In 1 Bottle (31722-636-90) | Camber Pharmaceuticals, Inc. | 31722-636-90 | 31722-636 | ANDA204793 | ANDA | N/A |
| Silodosin | Capsule | Oral | 8mg/1 | 90 Capsule In 1 Bottle (31722-636-91) | Camber Pharmaceuticals, Inc. | 31722-636-91 | 31722-636 | ANDA204793 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 5mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-510-01) | Camber Pharmaceuticals, Inc. | 31722-510-01 | 31722-510 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 5mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-510-10) | Camber Pharmaceuticals, Inc. | 31722-510-10 | 31722-510 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-510-30) | Camber Pharmaceuticals, Inc. | 31722-510-30 | 31722-510 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-510-90) | Camber Pharmaceuticals, Inc. | 31722-510-90 | 31722-510 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 10mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-511-01) | Camber Pharmaceuticals, Inc. | 31722-511-01 | 31722-511 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 10mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-511-10) | Camber Pharmaceuticals, Inc. | 31722-511-10 | 31722-511 | ANDA200895 | ANDA | N/A |
| Simvastatin | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-511-30) | Camber Pharmaceuticals, Inc. | 31722-511-30 | 31722-511 | ANDA200895 | ANDA | N/A |
| Sinecatechins | Ointment | Topical | 150mg/g | 6 Carton In 1 Carton (62559-385-26) / 1 Tube In 1 Carton (62559-385-02) / 2 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-385-26 | 62559-385 | NDA021902 | NDA | N/A |
| Sinecatechins | Ointment | Topical | 150mg/g | 1 Tube In 1 Carton (62559-385-30) / 30 G In 1 Tube | ANI Pharmaceuticals, Inc. | 62559-385-30 | 62559-385 | NDA021902 | NDA | N/A |
| Sodium Bicarbonate | Tablet | Oral | 650mg/1 | 1000 Tablet In 1 Bottle, Plastic (52682-206-04) | Ingenus Pharmaceuticals NJ, LLC | 52682-206-04 | 52682-206 | part331 | OTC MONOGRAPH FINAL | N/A |
| Sodium Bicarbonate | Tablet | Oral | 650mg/1 | 1000 Tablet In 1 Bottle (64980-294-10) | Rising Pharmaceuticals, Inc. | 64980-294-10 | 64980-294 | part331 | OTC MONOGRAPH FINAL | N/A |
| Sodium Bicarbonate | Tablet | Oral | 650mg/1 | 1000 Tablet In 1 Bottle (64980-528-10) | Rising Pharmaceuticals, Inc. | 64980-528-10 | 64980-528 | part331 | OTC MONOGRAPH FINAL | N/A |
| Sodium Chloride | Injection | Intravenous | 9mg/mL | 64 Bag In 1 Case (0487-4301-05) / 50 Ml In 1 Bag | Nephron SC Inc. | 0487-4301-05 | 0487-4301 | ANDA211968 | ANDA | N/A |
| Sodium Chloride | Injection | Intravenous | 9mg/mL | 64 Bag In 1 Case (0487-4301-10) / 100 Ml In 1 Bag | Nephron SC Inc. | 0487-4301-10 | 0487-4301 | ANDA211968 | ANDA | N/A |
| Sodium Chloride | Injection | Intravenous | 9mg/mL | 35 Bag In 1 Case (0487-4301-25) / 250 Ml In 1 Bag | Nephron SC Inc. | 0487-4301-25 | 0487-4301 | ANDA211968 | ANDA | N/A |
| Sodium Chloride | Injection | Intravenous | 9mg/mL | 18 Bag In 1 Case (0487-4301-50) / 500 Ml In 1 Bag | Nephron SC Inc. | 0487-4301-50 | 0487-4301 | ANDA211968 | ANDA | N/A |
| Sodium Fluoride | Cream | Oral | 1.1g/100g | 51 G In 1 Tube (16571-814-50) | Rising Pharma Holdings, Inc. | 16571-814-50 | 16571-814 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Fluoride | Gel | Oral | 1.1g/100g | 56 G In 1 Tube (16571-815-60) | Rising Pharma Holdings, Inc. | 16571-815-60 | 16571-815 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Fluoride | Gel, Dentifrice | Oral | 1.1g/100g | 51 G In 1 Tube (64980-305-50) | Rising Pharmaceuticals, Inc. | 64980-305-50 | 64980-305 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Fluoride | Gel, Dentifrice | Oral | 1.1g/100g | 2 Tube In 1 Carton (64980-306-50) / 51 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-306-50 | 64980-306 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Fluoride | Gel | Oral | 1.1g/100g | 56 G In 1 Tube (64980-307-60) | Rising Pharmaceuticals, Inc. | 64980-307-60 | 64980-307 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Sodium Polystyrene Sulfonate | Suspension | Oral | 15g/60mL | 10 Bottle In 1 Case (62559-356-01) / 60 Ml In 1 Bottle (62559-356-60) | ANI Pharmaceuticals, Inc. | 62559-356-01 | 62559-356 | ANDA040028 | ANDA | N/A |
| Sodium Polystyrene Sulfonate | Powder, For Suspension | Oral | 4.1meq/g | 15 G In 1 Bottle (42806-013-94) | Epic Pharma, LLC | 42806-013-94 | 42806-013 | ANDA202333 | ANDA | N/A |
| Sodium Polystyrene Sulfonate | Powder, For Suspension | Oral | 4.1meq/g | 453.6 G In 1 Jar (42806-013-96) | Epic Pharma, LLC | 42806-013-96 | 42806-013 | ANDA202333 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-027-30) | Camber Pharmaceuticals, Inc. | 31722-027-30 | 31722-027 | ANDA215761 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 5mg/1 | 10 Blister Pack In 1 Carton (31722-027-31) / 10 Tablet, Film Coated In 1 Blister Pack (31722-027-32) | Camber Pharmaceuticals, Inc. | 31722-027-31 | 31722-027 | ANDA215761 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-027-90) | Camber Pharmaceuticals, Inc. | 31722-027-90 | 31722-027 | ANDA215761 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-028-30) | Camber Pharmaceuticals, Inc. | 31722-028-30 | 31722-028 | ANDA215761 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (31722-028-31) / 10 Tablet, Film Coated In 1 Blister Pack (31722-028-32) | Camber Pharmaceuticals, Inc. | 31722-028-31 | 31722-028 | ANDA215761 | ANDA | N/A |
| solifenacin succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-028-90) | Camber Pharmaceuticals, Inc. | 31722-028-90 | 31722-028 | ANDA215761 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-427-05) | ScieGen Pharmaceuticals, Inc. | 50228-427-05 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-427-30) | ScieGen Pharmaceuticals, Inc. | 50228-427-30 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-427-90) | ScieGen Pharmaceuticals, Inc. | 50228-427-90 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-428-05) | ScieGen Pharmaceuticals, Inc. | 50228-428-05 | 50228-428 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-428-30) | ScieGen Pharmaceuticals, Inc. | 50228-428-30 | 50228-428 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-428-90) | ScieGen Pharmaceuticals, Inc. | 50228-428-90 | 50228-428 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-427-05) | ScieGen Pharmaceuticals, Inc. | 50228-427-05 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-427-30) | ScieGen Pharmaceuticals, Inc. | 50228-427-30 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 5mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-427-90) | ScieGen Pharmaceuticals, Inc. | 50228-427-90 | 50228-427 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 500 Tablet, Film Coated In 1 Bottle (50228-428-05) | ScieGen Pharmaceuticals, Inc. | 50228-428-05 | 50228-428 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (50228-428-30) | ScieGen Pharmaceuticals, Inc. | 50228-428-30 | 50228-428 | ANDA211657 | ANDA | N/A |
| Solifenacin Succinate | Tablet, Film Coated | Oral | 10mg/1 | 90 Tablet, Film Coated In 1 Bottle (50228-428-90) | ScieGen Pharmaceuticals, Inc. | 50228-428-90 | 50228-428 | ANDA211657 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 100 Tablet In 1 Bottle (42806-121-01) | Epic Pharma, LLC | 42806-121-01 | 42806-121 | ANDA077070 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (42806-121-10) | Epic Pharma, LLC | 42806-121-10 | 42806-121 | ANDA077070 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (42806-122-01) | Epic Pharma, LLC | 42806-122-01 | 42806-122 | ANDA077070 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 120mg/1 | 1000 Tablet In 1 Bottle (42806-122-10) | Epic Pharma, LLC | 42806-122-10 | 42806-122 | ANDA077070 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 100 Tablet In 1 Bottle (42806-123-01) | Epic Pharma, LLC | 42806-123-01 | 42806-123 | ANDA077070 | ANDA | N/A |
| Sotalol Hydrochloride | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle (42806-123-10) | Epic Pharma, LLC | 42806-123-10 | 42806-123 | ANDA077070 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (65162-511-03) | Amneal Pharmaceuticals LLC | 65162-511-03 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 60 Tablet In 1 Bottle (65162-511-06) | Amneal Pharmaceuticals LLC | 65162-511-06 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (65162-511-09) | Amneal Pharmaceuticals LLC | 65162-511-09 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (65162-511-10) | Amneal Pharmaceuticals LLC | 65162-511-10 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (65162-511-11) | Amneal Pharmaceuticals LLC | 65162-511-11 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 500 Tablet In 1 Bottle (65162-511-50) | Amneal Pharmaceuticals LLC | 65162-511-50 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Blister Pack (65162-511-60) | Amneal Pharmaceuticals LLC | 65162-511-60 | 65162-511 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (65162-514-03) | Amneal Pharmaceuticals LLC | 65162-514-03 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 60 Tablet In 1 Bottle (65162-514-06) | Amneal Pharmaceuticals LLC | 65162-514-06 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (65162-514-09) | Amneal Pharmaceuticals LLC | 65162-514-09 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (65162-514-10) | Amneal Pharmaceuticals LLC | 65162-514-10 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (65162-514-11) | Amneal Pharmaceuticals LLC | 65162-514-11 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (65162-514-50) | Amneal Pharmaceuticals LLC | 65162-514-50 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Blister Pack (65162-514-60) | Amneal Pharmaceuticals LLC | 65162-514-60 | 65162-514 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (65162-515-03) | Amneal Pharmaceuticals LLC | 65162-515-03 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 60 Tablet In 1 Bottle (65162-515-06) | Amneal Pharmaceuticals LLC | 65162-515-06 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (65162-515-09) | Amneal Pharmaceuticals LLC | 65162-515-09 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (65162-515-10) | Amneal Pharmaceuticals LLC | 65162-515-10 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (65162-515-11) | Amneal Pharmaceuticals LLC | 65162-515-11 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (65162-515-50) | Amneal Pharmaceuticals LLC | 65162-515-50 | 65162-515 | ANDA091426 | ANDA | N/A |
| Spironolactone | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Blister Pack (65162-515-60) | Amneal Pharmaceuticals LLC | 65162-515-60 | 65162-515 | ANDA091426 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Multi-Dose In 1 Carton (70121-1581-5) / 10 Ml In 1 Vial, Multi-Dose (70121-1581-1) | Amneal Pharmaceuticals LLC | 70121-1581-5 | 70121-1581 | ANDA211432 | ANDA | N/A |
| Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | 20mg/mL | 25 Vial, Multi-Dose In 1 Carton (31722-981-31) / 10 Ml In 1 Vial, Multi-Dose (31722-981-10) | Camber Pharmaceuticals, Inc. | 31722-981-31 | 31722-981 | ANDA213810 | ANDA | N/A |
| Sulfadiazine | Tablet | Oral | 500mg/1 | 60 Tablet In 1 Bottle (42806-757-60) | EPIC PHARMA, LLC | 42806-757-60 | 42806-757 | ANDA040091 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 50 Tablet In 1 Bottle (65162-271-05) | Amneal Pharmaceuticals LLC | 65162-271-05 | 65162-271 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 100 Tablet In 1 Bottle (65162-271-10) | Amneal Pharmaceuticals LLC | 65162-271-10 | 65162-271 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 1000 Tablet In 1 Bottle (65162-271-11) | Amneal Pharmaceuticals LLC | 65162-271-11 | 65162-271 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 500 Tablet In 1 Bottle (65162-271-50) | Amneal Pharmaceuticals LLC | 65162-271-50 | 65162-271 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 10 Tablet In 1 Bottle (65162-272-01) | Amneal Pharmaceuticals LLC | 65162-272-01 | 65162-272 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 100 Tablet In 1 Bottle (65162-272-10) | Amneal Pharmaceuticals LLC | 65162-272-10 | 65162-272 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 24 Tablet In 1 Bottle (65162-272-24) | Amneal Pharmaceuticals LLC | 65162-272-24 | 65162-272 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 250 Tablet In 1 Bottle (65162-272-25) | Amneal Pharmaceuticals LLC | 65162-272-25 | 65162-272 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 500 Tablet In 1 Bottle (65162-272-50) | Amneal Pharmaceuticals LLC | 65162-272-50 | 65162-272 | ANDA076899 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Suspension | Oral | 200mg/5mL, 40 mg/5mL | 473 Ml In 1 Bottle (70954-258-10) | ANI Pharmaceuticals, Inc. | 70954-258-10 | 70954-258 | ANDA214330 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 100 Tablet In 1 Bottle (57237-232-01) | Rising Pharma Holdings, Inc. | 57237-232-01 | 57237-232 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 400mg/1, 80 mg/1 | 500 Tablet In 1 Bottle (57237-232-05) | Rising Pharma Holdings, Inc. | 57237-232-05 | 57237-232 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 100 Tablet In 1 Bottle (57237-233-01) | Rising Pharma Holdings, Inc. | 57237-233-01 | 57237-233 | ANDA090624 | ANDA | N/A |
| Sulfamethoxazole; Trimethoprim | Tablet | Oral | 800mg/1, 160 mg/1 | 500 Tablet In 1 Bottle (57237-233-05) | Rising Pharma Holdings, Inc. | 57237-233-05 | 57237-233 | ANDA090624 | ANDA | N/A |
| Sulindac | Tablet | Oral | 200mg/1 | 100 Tablet In 1 Bottle (42806-011-01) | Epic Pharma, LLC | 42806-011-01 | 42806-011 | ANDA072711 | ANDA | N/A |
| Sulindac | Tablet | Oral | 200mg/1 | 500 Tablet In 1 Bottle (42806-011-05) | Epic Pharma, LLC | 42806-011-05 | 42806-011 | ANDA072711 | ANDA | N/A |
| Sulindac | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (42806-011-10) | Epic Pharma, LLC | 42806-011-10 | 42806-011 | ANDA072711 | ANDA | N/A |
| Sulindac | Tablet | Oral | 150mg/1 | 100 Tablet In 1 Bottle (42806-018-01) | Epic Pharma, LLC | 42806-018-01 | 42806-018 | ANDA072710 | ANDA | N/A |
| Sulindac | Tablet | Oral | 150mg/1 | 500 Tablet In 1 Bottle (42806-018-05) | Epic Pharma, LLC | 42806-018-05 | 42806-018 | ANDA072710 | ANDA | N/A |
| Sulindac | Tablet | Oral | 150mg/1 | 1000 Tablet In 1 Bottle (42806-018-10) | Epic Pharma, LLC | 42806-018-10 | 42806-018 | ANDA072710 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 5mg/1 | 30 Tablet In 1 Bottle (70954-433-10) | ANI Pharmaceuticals, Inc. | 70954-433-10 | 70954-433 | ANDA215949 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 10mg/1 | 30 Tablet In 1 Bottle (70954-434-10) | ANI Pharmaceuticals, Inc. | 70954-434-10 | 70954-434 | ANDA215949 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (70954-435-10) | ANI Pharmaceuticals, Inc. | 70954-435-10 | 70954-435 | ANDA215949 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 2.5mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-643-30) | Camber Pharmaceuticals, Inc. | 31722-643-30 | 31722-643 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 2.5mg/1 | 3 Blister Pack In 1 Carton (31722-643-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-643-31 | 31722-643 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 5mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-644-30) | Camber Pharmaceuticals, Inc. | 31722-644-30 | 31722-644 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 5mg/1 | 3 Blister Pack In 1 Carton (31722-644-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-644-31 | 31722-644 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 10mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-645-30) | Camber Pharmaceuticals, Inc. | 31722-645-30 | 31722-645 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 10mg/1 | 10 Blister Pack In 1 Carton (31722-645-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-645-31 | 31722-645 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 20mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-646-30) | Camber Pharmaceuticals, Inc. | 31722-646-30 | 31722-646 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet, Film Coated | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (31722-646-31) / 10 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-646-31 | 31722-646 | ANDA209908 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (31722-647-30) | Camber Pharmaceuticals, Inc. | 31722-647-30 | 31722-647 | ANDA209907 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 20mg/1 | 10 Blister Pack In 1 Carton (31722-647-31) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-647-31 | 31722-647 | ANDA209907 | ANDA | N/A |
| Tadalafil | Tablet | Oral | 20mg/1 | 60 Tablet In 1 Bottle (31722-647-60) | Camber Pharmaceuticals, Inc. | 31722-647-60 | 31722-647 | ANDA209907 | ANDA | N/A |
| Tamsulosin Hydrochloride | Capsule | Oral | .4mg/1 | 100 Capsule In 1 Bottle (57237-014-01) | Rising Pharma Holdings, Inc. | 57237-014-01 | 57237-014 | ANDA202433 | ANDA | N/A |
| Tamsulosin Hydrochloride | Capsule | Oral | .4mg/1 | 500 Capsule In 1 Bottle (57237-014-05) | Rising Pharma Holdings, Inc. | 57237-014-05 | 57237-014 | ANDA202433 | ANDA | N/A |
| Tamsulosin hydrochloride | Capsule | Oral | .4mg/1 | 100 Capsule In 1 Bottle (72865-282-01) | XLCare Pharmaceuticals, Inc | 72865-282-01 | 72865-282 | ANDA214730 | ANDA | N/A |
| Telavancin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 15mg/mL | 1 Vial, Single-Dose In 1 Carton (66220-315-11) / 50 Ml In 1 Vial, Single-Dose | Cumberland Pharmaceuticals Inc. | 66220-315-11 | 66220-315 | NDA022110 | NDA | N/A |
| Telavancin Hydrochloride | Injection, Powder, Lyophilized, For Solution | Intravenous | 15mg/mL | 12 Vial, Single-Dose In 1 Carton (66220-315-22) / 50 Ml In 1 Vial, Single-Dose | Cumberland Pharmaceuticals Inc. | 66220-315-22 | 66220-315 | NDA022110 | NDA | N/A |
| Telmisartan | Tablet | Oral | 20mg/1 | 30 Tablet In 1 Bottle (65162-291-03) | Amneal Pharmaceuticals LLC | 65162-291-03 | 65162-291 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (65162-291-09) | Amneal Pharmaceuticals LLC | 65162-291-09 | 65162-291 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (65162-291-50) | Amneal Pharmaceuticals LLC | 65162-291-50 | 65162-291 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 20mg/1 | 3 Blister Pack In 1 Carton (65162-291-63) / 10 Tablet In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-291-63 | 65162-291 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (65162-292-03) | Amneal Pharmaceuticals LLC | 65162-292-03 | 65162-292 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 40mg/1 | 90 Tablet In 1 Bottle (65162-292-09) | Amneal Pharmaceuticals LLC | 65162-292-09 | 65162-292 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (65162-292-11) | Amneal Pharmaceuticals LLC | 65162-292-11 | 65162-292 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (65162-292-50) | Amneal Pharmaceuticals LLC | 65162-292-50 | 65162-292 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 40mg/1 | 3 Blister Pack In 1 Carton (65162-292-63) / 10 Tablet In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-292-63 | 65162-292 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (65162-293-03) | Amneal Pharmaceuticals LLC | 65162-293-03 | 65162-293 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (65162-293-09) | Amneal Pharmaceuticals LLC | 65162-293-09 | 65162-293 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (65162-293-11) | Amneal Pharmaceuticals LLC | 65162-293-11 | 65162-293 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (65162-293-50) | Amneal Pharmaceuticals LLC | 65162-293-50 | 65162-293 | ANDA204415 | ANDA | N/A |
| Telmisartan | Tablet | Oral | 80mg/1 | 3 Blister Pack In 1 Carton (65162-293-63) / 10 Tablet In 1 Blister Pack | Amneal Pharmaceuticals LLC | 65162-293-63 | 65162-293 | ANDA204415 | ANDA | N/A |
| Temazepam | Capsule | Oral | 30mg/1 | 30 Capsule In 1 Bottle (65162-557-03) | Amneal Pharmaceuticals LLC | 65162-557-03 | 65162-557 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 30mg/1 | 100 Capsule In 1 Bottle (65162-557-10) | Amneal Pharmaceuticals LLC | 65162-557-10 | 65162-557 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 30mg/1 | 1000 Capsule In 1 Bottle (65162-557-11) | Amneal Pharmaceuticals LLC | 65162-557-11 | 65162-557 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 30mg/1 | 500 Capsule In 1 Bottle (65162-557-50) | Amneal Pharmaceuticals LLC | 65162-557-50 | 65162-557 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 7.5mg/1 | 30 Capsule In 1 Bottle (65162-583-03) | Amneal Pharmaceuticals LLC | 65162-583-03 | 65162-583 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 7.5mg/1 | 100 Capsule In 1 Bottle (65162-583-10) | Amneal Pharmaceuticals LLC | 65162-583-10 | 65162-583 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 7.5mg/1 | 1000 Capsule In 1 Bottle (65162-583-11) | Amneal Pharmaceuticals LLC | 65162-583-11 | 65162-583 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 7.5mg/1 | 500 Capsule In 1 Bottle (65162-583-50) | Amneal Pharmaceuticals LLC | 65162-583-50 | 65162-583 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 22.5mg/1 | 30 Capsule In 1 Bottle (65162-584-03) | Amneal Pharmaceuticals LLC | 65162-584-03 | 65162-584 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 22.5mg/1 | 100 Capsule In 1 Bottle (65162-584-10) | Amneal Pharmaceuticals LLC | 65162-584-10 | 65162-584 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 22.5mg/1 | 1000 Capsule In 1 Bottle (65162-584-11) | Amneal Pharmaceuticals LLC | 65162-584-11 | 65162-584 | ANDA203482 | ANDA | CIV |
| Temazepam | Capsule | Oral | 22.5mg/1 | 500 Capsule In 1 Bottle (65162-584-50) | Amneal Pharmaceuticals LLC | 65162-584-50 | 65162-584 | ANDA203482 | ANDA | CIV |
| Temozolomide | Capsule | Oral | 250mg/1 | 1 Bottle In 1 Carton (65162-806-51) / 5 Capsule In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-806-51 | 65162-806 | ANDA203691 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 1 Bottle In 1 Carton (65162-801-14) / 14 Capsule In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-801-14 | 65162-801 | ANDA203691 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 1 Bottle In 1 Carton (65162-801-51) / 5 Capsule In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-801-51 | 65162-801 | ANDA203691 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 1 Bottle In 1 Carton (65162-802-14) / 14 Capsule In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-802-14 | 65162-802 | ANDA203691 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 1 Bottle In 1 Carton (65162-802-51) / 5 Capsule In 1 Bottle | Amneal Pharmaceuticals LLC | 65162-802-51 | 65162-802 | ANDA203691 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 20 Capsule In 1 Bottle (16571-816-02) | Rising Pharma Holdings, Inc. | 16571-816-02 | 16571-816 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 14 Capsule In 1 Bottle (16571-816-41) | Rising Pharma Holdings, Inc. | 16571-816-41 | 16571-816 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 5mg/1 | 5 Capsule In 1 Bottle (16571-816-51) | Rising Pharma Holdings, Inc. | 16571-816-51 | 16571-816 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 20 Capsule In 1 Bottle (16571-817-02) | Rising Pharma Holdings, Inc. | 16571-817-02 | 16571-817 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 14 Capsule In 1 Bottle (16571-817-41) | Rising Pharma Holdings, Inc. | 16571-817-41 | 16571-817 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 20mg/1 | 5 Capsule In 1 Bottle (16571-817-51) | Rising Pharma Holdings, Inc. | 16571-817-51 | 16571-817 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 100mg/1 | 20 Capsule In 1 Bottle (16571-818-02) | Rising Pharma Holdings, Inc. | 16571-818-02 | 16571-818 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 100mg/1 | 14 Capsule In 1 Bottle (16571-818-41) | Rising Pharma Holdings, Inc. | 16571-818-41 | 16571-818 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 100mg/1 | 5 Capsule In 1 Bottle (16571-818-51) | Rising Pharma Holdings, Inc. | 16571-818-51 | 16571-818 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 140mg/1 | 20 Capsule In 1 Bottle (16571-819-02) | Rising Pharma Holdings, Inc. | 16571-819-02 | 16571-819 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 140mg/1 | 14 Capsule In 1 Bottle (16571-819-41) | Rising Pharma Holdings, Inc. | 16571-819-41 | 16571-819 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 140mg/1 | 5 Capsule In 1 Bottle (16571-819-51) | Rising Pharma Holdings, Inc. | 16571-819-51 | 16571-819 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 180mg/1 | 20 Capsule In 1 Bottle (16571-820-02) | Rising Pharma Holdings, Inc. | 16571-820-02 | 16571-820 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 180mg/1 | 14 Capsule In 1 Bottle (16571-820-41) | Rising Pharma Holdings, Inc. | 16571-820-41 | 16571-820 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 180mg/1 | 5 Capsule In 1 Bottle (16571-820-51) | Rising Pharma Holdings, Inc. | 16571-820-51 | 16571-820 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 250mg/1 | 20 Capsule In 1 Bottle (16571-821-02) | Rising Pharma Holdings, Inc. | 16571-821-02 | 16571-821 | ANDA206309 | ANDA | N/A |
| Temozolomide | Capsule | Oral | 250mg/1 | 5 Capsule In 1 Bottle (16571-821-51) | Rising Pharma Holdings, Inc. | 16571-821-51 | 16571-821 | ANDA206309 | ANDA | N/A |
| Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-535-01) | Camber Pharmaceuticals, Inc. | 31722-535-01 | 31722-535 | ANDA090636 | ANDA | N/A |
| Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-535-05) | Camber Pharmaceuticals, Inc. | 31722-535-05 | 31722-535 | ANDA090636 | ANDA | N/A |
| Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 1000 Tablet, Film Coated In 1 Bottle (31722-535-10) | Camber Pharmaceuticals, Inc. | 31722-535-10 | 31722-535 | ANDA090636 | ANDA | N/A |
| Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-535-30) | Camber Pharmaceuticals, Inc. | 31722-535-30 | 31722-535 | ANDA090636 | ANDA | N/A |
| Tenofovir Disoproxil Fumarate | Tablet, Film Coated | Oral | 300mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-535-60) | Camber Pharmaceuticals, Inc. | 31722-535-60 | 31722-535 | ANDA090636 | ANDA | N/A |
| Terbutaline Sulfate | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (62559-721-01) | ANI Pharmaceuticals, Inc. | 62559-721-01 | 62559-721 | NDA017849 | NDA AUTHORIZED GENERIC | N/A |
| Terbutaline Sulfate | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (62559-722-01) | ANI Pharmaceuticals, Inc. | 62559-722-01 | 62559-722 | NDA017849 | NDA AUTHORIZED GENERIC | N/A |
| Teriflunomide | Tablet, Film Coated | Oral | 7mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-246-30) | Camber Pharmaceuticals, Inc. | 31722-246-30 | 31722-246 | ANDA209598 | ANDA | N/A |
| Teriflunomide | Tablet, Film Coated | Oral | 14mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-247-30) | Camber Pharmaceuticals, Inc. | 31722-247-30 | 31722-247 | ANDA209598 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 12.5mg/1 | 112 Tablet, Coated In 1 Bottle (31722-821-11) | Camber Pharmaceuticals, Inc. | 31722-821-11 | 31722-821 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 12.5mg/1 | 10 Tablet, Coated In 1 Blister Pack (31722-821-31) | Camber Pharmaceuticals, Inc. | 31722-821-31 | 31722-821 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 12.5mg/1 | 100 Tablet, Coated In 1 Carton (31722-821-32) | Camber Pharmaceuticals, Inc. | 31722-821-32 | 31722-821 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 12.5mg/1 | 56 Tablet, Coated In 1 Bottle (31722-821-56) | Camber Pharmaceuticals, Inc. | 31722-821-56 | 31722-821 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 25mg/1 | 112 Tablet, Coated In 1 Bottle (31722-822-11) | Camber Pharmaceuticals, Inc. | 31722-822-11 | 31722-822 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 25mg/1 | 10 Tablet, Coated In 1 Blister Pack (31722-822-31) | Camber Pharmaceuticals, Inc. | 31722-822-31 | 31722-822 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 25mg/1 | 100 Tablet, Coated In 1 Carton (31722-822-32) | Camber Pharmaceuticals, Inc. | 31722-822-32 | 31722-822 | ANDA204574 | ANDA | N/A |
| Tetrabenazine | Tablet, Coated | Oral | 25mg/1 | 56 Tablet, Coated In 1 Bottle (31722-822-56) | Camber Pharmaceuticals, Inc. | 31722-822-56 | 31722-822 | ANDA204574 | ANDA | N/A |
| Theophylline | Tablet, Extended Release | Oral | 300mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-077-01) | Camber Pharmaceuticals, Inc. | 31722-077-01 | 31722-077 | ANDA217422 | ANDA | N/A |
| Theophylline | Tablet, Extended Release | Oral | 450mg/1 | 100 Tablet, Extended Release In 1 Bottle (31722-078-01) | Camber Pharmaceuticals, Inc. | 31722-078-01 | 31722-078 | ANDA217422 | ANDA | N/A |
| Thiotepa | Injection, Powder, For Solution | Intracavitary; Intravenous; Intravesical | 15mg/1 | 1 Vial, Glass In 1 Box (70121-1630-1) / 1 Injection, Powder, For Solution In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1630-1 | 70121-1630 | NDA208264 | NDA | N/A |
| Thiotepa | Injection, Powder, For Solution | Intracavitary; Intravenous; Intravesical | 100mg/1 | 1 Vial, Glass In 1 Box (70121-1631-1) / 1 Injection, Powder, For Solution In 1 Vial, Glass | Amneal Pharmaceuticals LLC | 70121-1631-1 | 70121-1631 | NDA208264 | NDA | N/A |
| Thyroid | Tablet | Oral | 15mg/1 | 100 Tablet In 1 Bottle (62559-740-01) | ANI Pharmaceuticals, Inc. | 62559-740-01 | 62559-740 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 30mg/1 | 100 Tablet In 1 Bottle (62559-741-01) | ANI Pharmaceuticals, Inc. | 62559-741-01 | 62559-741 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 60mg/1 | 100 Tablet In 1 Bottle (62559-742-01) | ANI Pharmaceuticals, Inc. | 62559-742-01 | 62559-742 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 90mg/1 | 100 Tablet In 1 Bottle (62559-743-01) | ANI Pharmaceuticals, Inc. | 62559-743-01 | 62559-743 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Thyroid | Tablet | Oral | 120mg/1 | 100 Tablet In 1 Bottle (62559-744-01) | ANI Pharmaceuticals, Inc. | 62559-744-01 | 62559-744 | N/A | UNAPPROVED DRUG OTHER | N/A |
| Tigecycline | Injection, Powder, Lyophilized, For Solution | Intravenous | 50mg/5mL | 10 Vial In 1 Carton (70121-1647-7) / 5 Ml In 1 Vial (70121-1647-1) | Amneal Pharmaceuticals LLC | 70121-1647-7 | 70121-1647 | NDA211158 | NDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 3.4mg/mL | 15 Pouch In 1 Carton (50742-287-60) / 4 Container In 1 Pouch (50742-287-04) / .3 Ml In 1 Container | Ingenus Pharmaceuticals, LLC | 50742-287-60 | 50742-287 | ANDA216533 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 6.8mg/mL | 15 Pouch In 1 Carton (50742-288-60) / 4 Container In 1 Pouch (50742-288-04) / .3 Ml In 1 Container | Ingenus Pharmaceuticals, LLC | 50742-288-60 | 50742-288 | ANDA216533 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (64980-513-01) / 10 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-513-01 | 64980-513 | ANDA077259 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (64980-513-05) / 5 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-513-05 | 64980-513 | ANDA077259 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 2.5mg/mL | 1 Bottle In 1 Carton (64980-513-15) / 15 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-513-15 | 64980-513 | ANDA077259 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (64980-514-01) / 10 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-514-01 | 64980-514 | ANDA077259 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (64980-514-05) / 5 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-514-05 | 64980-514 | ANDA077259 | ANDA | N/A |
| Timolol Maleate | Solution/ Drops | Ophthalmic | 5mg/mL | 1 Bottle In 1 Carton (64980-514-15) / 15 Ml In 1 Bottle | Rising Pharma Holdings, Inc. | 64980-514-15 | 64980-514 | ANDA077259 | ANDA | N/A |
| Tinidazole | Tablet, Film Coated | Oral | 500mg/1 | 12 Tablet, Film Coated In 1 Bottle, Plastic (64980-427-12) | Rising Pharma Holdings, Inc. | 64980-427-12 | 64980-427 | ANDA202489 | ANDA | N/A |
| Tinidazole | Tablet, Film Coated | Oral | 250mg/1 | 20 Tablet, Film Coated In 1 Bottle, Plastic (64980-426-02) | Rising Pharma Holdings, Inc. | 64980-426-02 | 64980-426 | ANDA202489 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 2mg/1 | 150 Capsule In 1 Bottle, Plastic (50742-224-15) | Ingenus Pharmaceuticals, LLC | 50742-224-15 | 50742-224 | ANDA210267 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 4mg/1 | 150 Capsule In 1 Bottle, Plastic (50742-225-15) | Ingenus Pharmaceuticals, LLC | 50742-225-15 | 50742-225 | ANDA210267 | ANDA | N/A |
| Tizanidine Hydrochloride | Capsule | Oral | 6mg/1 | 150 Capsule In 1 Bottle, Plastic (50742-226-15) | Ingenus Pharmaceuticals, LLC | 50742-226-15 | 50742-226 | ANDA210267 | ANDA | N/A |
| Tobramycin | Solution | Respiratory (Inhalation) | 300mg/5mL | 56 Ampule In 1 Carton (65162-914-46) / 5 Ml In 1 Ampule | Amneal Pharmaceuticals LLC | 65162-914-46 | 65162-914 | ANDA205501 | ANDA | N/A |
| Tolcapone | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (50742-193-90) | Ingenus Pharmaceuticals, LLC | 50742-193-90 | 50742-193 | ANDA208937 | ANDA | N/A |
| Tolmetin Sodium | Tablet, Film Coated | Oral | 600mg/1 | 90 Tablet, Film Coated In 1 Bottle (16571-825-09) | Rising Pharma Holdings, Inc. | 16571-825-09 | 16571-825 | ANDA074473 | ANDA | N/A |
| Tolmetin Sodium | Capsule | Oral | 400mg/1 | 90 Capsule In 1 Bottle (16571-826-09) | Rising Pharma Holdings, Inc. | 16571-826-09 | 16571-826 | ANDA073393 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 30 Capsule, Extended Release In 1 Bottle (43975-322-03) | ANI Pharmaceuticals, Inc. | 43975-322-03 | 43975-322 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 90 Capsule, Extended Release In 1 Bottle (43975-322-09) | ANI Pharmaceuticals, Inc. | 43975-322-09 | 43975-322 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 500 Capsule, Extended Release In 1 Bottle (43975-322-50) | ANI Pharmaceuticals, Inc. | 43975-322-50 | 43975-322 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 30 Capsule, Extended Release In 1 Bottle (43975-323-03) | ANI Pharmaceuticals, Inc. | 43975-323-03 | 43975-323 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 90 Capsule, Extended Release In 1 Bottle (43975-323-09) | ANI Pharmaceuticals, Inc. | 43975-323-09 | 43975-323 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 500 Capsule, Extended Release In 1 Bottle (43975-323-50) | ANI Pharmaceuticals, Inc. | 43975-323-50 | 43975-323 | ANDA204562 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 500 Capsule, Extended Release In 1 Bottle (31722-607-05) | Camber Pharmaceuticals, Inc. | 31722-607-05 | 31722-607 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 30 Capsule, Extended Release In 1 Bottle (31722-607-30) | Camber Pharmaceuticals, Inc. | 31722-607-30 | 31722-607 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 2mg/1 | 90 Capsule, Extended Release In 1 Bottle (31722-607-90) | Camber Pharmaceuticals, Inc. | 31722-607-90 | 31722-607 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 500 Capsule, Extended Release In 1 Bottle (31722-608-05) | Camber Pharmaceuticals, Inc. | 31722-608-05 | 31722-608 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 30 Capsule, Extended Release In 1 Bottle (31722-608-30) | Camber Pharmaceuticals, Inc. | 31722-608-30 | 31722-608 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Capsule, Extended Release | Oral | 4mg/1 | 90 Capsule, Extended Release In 1 Bottle (31722-608-90) | Camber Pharmaceuticals, Inc. | 31722-608-90 | 31722-608 | ANDA206419 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-126-01) | Rising Pharma Holdings, Inc. | 16571-126-01 | 16571-126 | ANDA204721 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-126-06) | Rising Pharma Holdings, Inc. | 16571-126-06 | 16571-126 | ANDA204721 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 1mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-126-50) | Rising Pharma Holdings, Inc. | 16571-126-50 | 16571-126 | ANDA204721 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 2mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-127-01) | Rising Pharma Holdings, Inc. | 16571-127-01 | 16571-127 | ANDA204721 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 2mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-127-06) | Rising Pharma Holdings, Inc. | 16571-127-06 | 16571-127 | ANDA204721 | ANDA | N/A |
| Tolterodine Tartrate | Tablet, Film Coated | Oral | 2mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-127-50) | Rising Pharma Holdings, Inc. | 16571-127-50 | 16571-127 | ANDA204721 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 10 Blister Pack In 1 Carton (31722-868-01) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-868-01 | 31722-868 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 10 Blister Pack In 1 Carton (31722-868-02) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-868-02 | 31722-868 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 1 Blister Pack In 1 Carton (31722-868-03) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-868-03 | 31722-868 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 15mg/1 | 1 Blister Pack In 1 Carton (31722-868-04) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-868-04 | 31722-868 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 30mg/1 | 10 Blister Pack In 1 Carton (31722-869-01) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-869-01 | 31722-869 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 30mg/1 | 10 Blister Pack In 1 Carton (31722-869-02) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-869-02 | 31722-869 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 30mg/1 | 1 Blister Pack In 1 Carton (31722-869-03) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-869-03 | 31722-869 | ANDA205646 | ANDA | N/A |
| Tolvaptan | Tablet | Oral | 30mg/1 | 1 Blister Pack In 1 Carton (31722-869-04) / 10 Tablet In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-869-04 | 31722-869 | ANDA205646 | ANDA | N/A |
| Topiramate | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (43602-457-10) | Ascent Pharmaceuticals, Inc. | 43602-457-10 | 43602-457 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (43602-457-30) | Ascent Pharmaceuticals, Inc. | 43602-457-30 | 43602-457 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (43602-458-10) | Ascent Pharmaceuticals, Inc. | 43602-458-10 | 43602-458 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (43602-458-30) | Ascent Pharmaceuticals, Inc. | 43602-458-30 | 43602-458 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (43602-459-10) | Ascent Pharmaceuticals, Inc. | 43602-459-10 | 43602-459 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (43602-459-30) | Ascent Pharmaceuticals, Inc. | 43602-459-30 | 43602-459 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (43602-460-10) | Ascent Pharmaceuticals, Inc. | 43602-460-10 | 43602-460 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (43602-460-30) | Ascent Pharmaceuticals, Inc. | 43602-460-30 | 43602-460 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 25mg/1 | 1000 Tablet In 1 Bottle (43602-457-10) | Ascent Pharmaceuticals, Inc. | 43602-457-10 | 43602-457 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 25mg/1 | 30 Tablet In 1 Bottle (43602-457-30) | Ascent Pharmaceuticals, Inc. | 43602-457-30 | 43602-457 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (43602-458-10) | Ascent Pharmaceuticals, Inc. | 43602-458-10 | 43602-458 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 50mg/1 | 30 Tablet In 1 Bottle (43602-458-30) | Ascent Pharmaceuticals, Inc. | 43602-458-30 | 43602-458 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 100mg/1 | 1000 Tablet In 1 Bottle (43602-459-10) | Ascent Pharmaceuticals, Inc. | 43602-459-10 | 43602-459 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 100mg/1 | 30 Tablet In 1 Bottle (43602-459-30) | Ascent Pharmaceuticals, Inc. | 43602-459-30 | 43602-459 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 200mg/1 | 1000 Tablet In 1 Bottle (43602-460-10) | Ascent Pharmaceuticals, Inc. | 43602-460-10 | 43602-460 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet | Oral | 200mg/1 | 30 Tablet In 1 Bottle (43602-460-30) | Ascent Pharmaceuticals, Inc. | 43602-460-30 | 43602-460 | ANDA215414 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 25mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-705-06) | Rising Pharma Holdings, Inc. | 16571-705-06 | 16571-705 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 25mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-705-10) | Rising Pharma Holdings, Inc. | 16571-705-10 | 16571-705 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 50mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-706-06) | Rising Pharma Holdings, Inc. | 16571-706-06 | 16571-706 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-706-10) | Rising Pharma Holdings, Inc. | 16571-706-10 | 16571-706 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 100mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-707-06) | Rising Pharma Holdings, Inc. | 16571-707-06 | 16571-707 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 100mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-707-10) | Rising Pharma Holdings, Inc. | 16571-707-10 | 16571-707 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 200mg/1 | 60 Tablet, Film Coated In 1 Bottle (16571-708-06) | Rising Pharma Holdings, Inc. | 16571-708-06 | 16571-708 | ANDA078462 | ANDA | N/A |
| Topiramate | Tablet, Film Coated | Oral | 200mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-708-10) | Rising Pharma Holdings, Inc. | 16571-708-10 | 16571-708 | ANDA078462 | ANDA | N/A |
| Toremifene Citrate | Tablet | Oral | 60mg/1 | 30 Tablet In 1 Bottle, Plastic (64980-404-03) | Rising Pharmaceuticals, Inc. | 64980-404-03 | 64980-404 | ANDA208813 | ANDA | N/A |
| Torsemide | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (31722-529-01) | Camber Pharmaceuticals, Inc. | 31722-529-01 | 31722-529 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (31722-529-05) | Camber Pharmaceuticals, Inc. | 31722-529-05 | 31722-529 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (31722-530-01) | Camber Pharmaceuticals, Inc. | 31722-530-01 | 31722-530 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (31722-530-05) | Camber Pharmaceuticals, Inc. | 31722-530-05 | 31722-530 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (31722-531-01) | Camber Pharmaceuticals, Inc. | 31722-531-01 | 31722-531 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (31722-531-05) | Camber Pharmaceuticals, Inc. | 31722-531-05 | 31722-531 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (31722-532-01) | Camber Pharmaceuticals, Inc. | 31722-532-01 | 31722-532 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 100mg/1 | 500 Tablet In 1 Bottle (31722-532-05) | Camber Pharmaceuticals, Inc. | 31722-532-05 | 31722-532 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (57237-138-01) | Rising Pharma Holdings, Inc. | 57237-138-01 | 57237-138 | ANDA078249 | ANDA | N/A |
| Torsemide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (57237-139-01) | Rising Pharma Holdings, Inc. | 57237-139-01 | 57237-139 | ANDA078249 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (57237-140-01) | Rising Pharma Holdings, Inc. | 57237-140-01 | 57237-140 | ANDA078249 | ANDA | N/A |
| Torsemide | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (57237-141-01) | Rising Pharma Holdings, Inc. | 57237-141-01 | 57237-141 | ANDA078249 | ANDA | N/A |
| Torsemide | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (72865-258-90) | XLCare Pharmaceuticals Inc. | 72865-258-90 | 72865-258 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (72865-259-01) | XLCare Pharmaceuticals Inc. | 72865-259-01 | 72865-259 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (72865-259-90) | XLCare Pharmaceuticals Inc. | 72865-259-90 | 72865-259 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 100 Tablet In 1 Bottle (72865-260-01) | XLCare Pharmaceuticals Inc. | 72865-260-01 | 72865-260 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 500 Tablet In 1 Bottle (72865-260-05) | XLCare Pharmaceuticals Inc. | 72865-260-05 | 72865-260 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 20mg/1 | 90 Tablet In 1 Bottle (72865-260-90) | XLCare Pharmaceuticals Inc. | 72865-260-90 | 72865-260 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (72865-261-01) | XLCare Pharmaceuticals Inc. | 72865-261-01 | 72865-261 | ANDA079234 | ANDA | N/A |
| Torsemide | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (72865-261-90) | XLCare Pharmaceuticals Inc. | 72865-261-90 | 72865-261 | ANDA079234 | ANDA | N/A |
| Tramadol Hydrochloride | Tablet, Coated | Oral | 50mg/1 | 10 Tablet, Coated In 1 Bottle (65162-627-01) | Amneal Pharmaceuticals LLC | 65162-627-01 | 65162-627 | ANDA076003 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Coated | Oral | 50mg/1 | 100 Tablet, Coated In 1 Bottle (65162-627-10) | Amneal Pharmaceuticals LLC | 65162-627-10 | 65162-627 | ANDA076003 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Coated | Oral | 50mg/1 | 1000 Tablet, Coated In 1 Bottle (65162-627-11) | Amneal Pharmaceuticals LLC | 65162-627-11 | 65162-627 | ANDA076003 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Coated | Oral | 50mg/1 | 500 Tablet, Coated In 1 Bottle (65162-627-50) | Amneal Pharmaceuticals LLC | 65162-627-50 | 65162-627 | ANDA076003 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 100 Tablet, Film Coated In 1 Bottle (16571-716-01) | Rising Pharma Holdings, Inc. | 16571-716-01 | 16571-716 | ANDA203494 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 1000 Tablet, Film Coated In 1 Bottle (16571-716-10) | Rising Pharma Holdings, Inc. | 16571-716-10 | 16571-716 | ANDA203494 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet, Film Coated | Oral | 50mg/1 | 500 Tablet, Film Coated In 1 Bottle (16571-716-50) | Rising Pharma Holdings, Inc. | 16571-716-50 | 16571-716 | ANDA203494 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (64980-614-01) | Rising Pharma Holdings, Inc. | 64980-614-01 | 64980-614 | ANDA075968 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 1000 Tablet In 1 Bottle (64980-614-10) | Rising Pharma Holdings, Inc. | 64980-614-10 | 64980-614 | ANDA075968 | ANDA | CIV |
| Tramadol Hydrochloride | Tablet | Oral | 50mg/1 | 500 Tablet In 1 Bottle (64980-614-50) | Rising Pharma Holdings, Inc. | 64980-614-50 | 64980-614 | ANDA075968 | ANDA | CIV |
| Trandolapril | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (42806-052-01) | Epic Pharma, LLC | 42806-052-01 | 42806-052 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (42806-052-10) | Epic Pharma, LLC | 42806-052-10 | 42806-052 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (42806-053-01) | Epic Pharma, LLC | 42806-053-01 | 42806-053 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (42806-053-10) | Epic Pharma, LLC | 42806-053-10 | 42806-053 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (42806-054-01) | Epic Pharma, LLC | 42806-054-01 | 42806-054 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (42806-054-10) | Epic Pharma, LLC | 42806-054-10 | 42806-054 | ANDA078508 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (57237-089-01) | Rising Pharma Holdings, Inc. | 57237-089-01 | 57237-089 | ANDA078438 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (57237-090-01) | Rising Pharma Holdings, Inc. | 57237-090-01 | 57237-090 | ANDA078438 | ANDA | N/A |
| Trandolapril | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (57237-091-01) | Rising Pharma Holdings, Inc. | 57237-091-01 | 57237-091 | ANDA078438 | ANDA | N/A |
| Tranexamic Acid | Injection, Solution | Intravenous | 100mg/mL | 1 Vial, Single-Dose In 1 Carton (70121-1398-1) / 10 Ml In 1 Vial, Single-Dose | Amneal Pharmaceuticals LLC | 70121-1398-1 | 70121-1398 | ANDA208840 | ANDA | N/A |
| Tranexamic Acid | Tablet | Oral | 650mg/1 | 30 Tablet In 1 Bottle (62559-265-30) | ANI Pharmaceuticals, Inc. | 62559-265-30 | 62559-265 | ANDA203256 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 1 Vial In 1 Carton (70121-1651-1) / 1 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1651-1 | 70121-1651 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 25 Vial In 1 Carton (70121-1651-5) / 1 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1651-5 | 70121-1651 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 200mg/5mL | 1 Vial, Multi-Dose In 1 Carton (70121-1652-1) / 5 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1652-1 | 70121-1652 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 400mg/10mL | 1 Vial, Multi-Dose In 1 Carton (70121-1653-1) / 10 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1653-1 | 70121-1653 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 200mg/5mL | 1 Vial, Multi-Dose In 1 Carton (70121-1654-1) / 5 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1654-1 | 70121-1654 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 400mg/10mL | 1 Vial, Multi-Dose In 1 Carton (70121-1655-1) / 10 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1655-1 | 70121-1655 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 1 Vial In 1 Carton (70121-1657-1) / 1 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1657-1 | 70121-1657 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 25 Vial In 1 Carton (70121-1657-5) / 1 Ml In 1 Vial | Amneal Pharmaceuticals LLC | 70121-1657-5 | 70121-1657 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 1 Vial In 1 Carton (70121-1049-2) / 1 Ml In 1 Vial (70121-1049-1) | Amneal Pharmaceuticals LLC | 70121-1049-2 | 70121-1049 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 40mg/mL | 25 Vial In 1 Carton (70121-1049-5) / 1 Ml In 1 Vial (70121-1049-1) | Amneal Pharmaceuticals LLC | 70121-1049-5 | 70121-1049 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 200mg/5mL | 1 Vial, Multi-Dose In 1 Carton (70121-1168-1) / 5 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1168-1 | 70121-1168 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Injection, Suspension | Intra-Articular; Intramuscular | 400mg/10mL | 1 Vial, Multi-Dose In 1 Carton (70121-1169-1) / 10 Ml In 1 Vial, Multi-Dose | Amneal Pharmaceuticals LLC | 70121-1169-1 | 70121-1169 | ANDA207550 | ANDA | N/A |
| Triamcinolone Acetonide | Paste | Topical | 1mg/g | 48 Carton In 1 Box (64980-320-05) / 1 Tube In 1 Carton / 5 G In 1 Tube | Rising Pharmaceuticals, Inc. | 64980-320-05 | 64980-320 | ANDA040771 | ANDA | N/A |
| Triamcinolone Acetonide | CREAM | TOPICAL | 1mg/g | 1 TUBE in 1 CARTON (71656-042-15) / 15 g in 1 TUBE | Saptalis Pharmaceuticals, LLC. | 71656-042-15 | 71656-042 | ANDA040671 | ANDA | N/A |
| Triamcinolone Acetonide | CREAM | TOPICAL | 1mg/g | 454 g in 1 JAR (71656-042-16) | Saptalis Pharmaceuticals, LLC. | 71656-042-16 | 71656-042 | ANDA040671 | ANDA | N/A |
| Triamcinolone Acetonide | CREAM | TOPICAL | 1mg/g | 1 TUBE in 1 CARTON (71656-042-30) / 30 g in 1 TUBE | Saptalis Pharmaceuticals, LLC. | 71656-042-30 | 71656-042 | ANDA040671 | ANDA | N/A |
| Triamcinolone Acetonide | CREAM | TOPICAL | 1mg/g | 1 TUBE in 1 CARTON (71656-042-80) / 80 g in 1 TUBE | Saptalis Pharmaceuticals, LLC. | 71656-042-80 | 71656-042 | ANDA040671 | ANDA | N/A |
| Triazolam | Tablet | Oral | .125mg/1 | 100 Tablet In 1 Bottle, Plastic (50742-645-01) | Ingenus Pharmaceuticals, LLC | 50742-645-01 | 50742-645 | ANDA214219 | ANDA | CIV |
| Triazolam | Tablet | Oral | .25mg/1 | 100 Tablet In 1 Bottle, Plastic (50742-646-01) | Ingenus Pharmaceuticals, LLC | 50742-646-01 | 50742-646 | ANDA214219 | ANDA | CIV |
| Trientine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (16571-810-01) | Rising Pharma Holdings, Inc. | 16571-810-01 | 16571-810 | ANDA212238 | ANDA | N/A |
| Trientine Hydrochloride | Capsule | Oral | 500mg/1 | 50 Capsule In 1 Bottle (16571-812-05) | Rising Pharma Holdings, Inc. | 16571-812-05 | 16571-812 | ANDA212238 | ANDA | N/A |
| Trientine Hydrochloride | Capsule | Oral | 250mg/1 | 100 Capsule In 1 Bottle (64980-450-01) | Rising Pharmaceuticals, Inc. | 64980-450-01 | 64980-450 | ANDA212238 | ANDA | N/A |
| Ursodiol | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (42806-503-01) | Epic Pharma, LLC | 42806-503-01 | 42806-503 | ANDA075517 | ANDA | N/A |
| Ursodiol | Capsule | Oral | 300mg/1 | 100 Capsule In 1 Bottle (64980-483-01) | Rising Pharma Holdings, Inc. | 64980-483-01 | 64980-483 | ANDA213200 | ANDA | N/A |
| Ursodiol | Capsule | Oral | 300mg/1 | 30 Capsule In 1 Bottle (64980-483-03) | Rising Pharma Holdings, Inc. | 64980-483-03 | 64980-483 | ANDA213200 | ANDA | N/A |
| Ursodiol | Capsule | Oral | 300mg/1 | 500 Capsule In 1 Bottle (64980-483-50) | Rising Pharma Holdings, Inc. | 64980-483-50 | 64980-483 | ANDA213200 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 100 Tablet, Film Coated In 1 Bottle (31722-704-01) | Camber Pharmaceuticals, Inc. | 31722-704-01 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-704-05) | Camber Pharmaceuticals, Inc. | 31722-704-05 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-704-30) | Camber Pharmaceuticals, Inc. | 31722-704-30 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-704-31) | Camber Pharmaceuticals, Inc. | 31722-704-31 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-704-32) | Camber Pharmaceuticals, Inc. | 31722-704-32 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-704-60) | Camber Pharmaceuticals, Inc. | 31722-704-60 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 500mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-704-90) | Camber Pharmaceuticals, Inc. | 31722-704-90 | 31722-704 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 1g/1 | 100 Tablet, Film Coated In 1 Bottle (31722-705-01) | Camber Pharmaceuticals, Inc. | 31722-705-01 | 31722-705 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 1g/1 | 500 Tablet, Film Coated In 1 Bottle (31722-705-05) | Camber Pharmaceuticals, Inc. | 31722-705-05 | 31722-705 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 1g/1 | 30 Tablet, Film Coated In 1 Bottle (31722-705-30) | Camber Pharmaceuticals, Inc. | 31722-705-30 | 31722-705 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 1g/1 | 60 Tablet, Film Coated In 1 Bottle (31722-705-60) | Camber Pharmaceuticals, Inc. | 31722-705-60 | 31722-705 | ANDA203047 | ANDA | N/A |
| Valacyclovir | Tablet, Film Coated | Oral | 1g/1 | 90 Tablet, Film Coated In 1 Bottle (31722-705-90) | Camber Pharmaceuticals, Inc. | 31722-705-90 | 31722-705 | ANDA203047 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 500 Tablet, Film Coated In 1 Bottle (57237-042-05) | Rising Pharma Holdings, Inc. | 57237-042-05 | 57237-042 | ANDA090682 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 30 Tablet, Film Coated In 1 Bottle (57237-042-30) | Rising Pharma Holdings, Inc. | 57237-042-30 | 57237-042 | ANDA090682 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 500mg/1 | 90 Tablet, Film Coated In 1 Bottle (57237-042-90) | Rising Pharma Holdings, Inc. | 57237-042-90 | 57237-042 | ANDA090682 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 500 Tablet, Film Coated In 1 Bottle (57237-043-05) | Rising Pharma Holdings, Inc. | 57237-043-05 | 57237-043 | ANDA090682 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 30 Tablet, Film Coated In 1 Bottle (57237-043-30) | Rising Pharma Holdings, Inc. | 57237-043-30 | 57237-043 | ANDA090682 | ANDA | N/A |
| Valacyclovir Hydrochloride | Tablet, Film Coated | Oral | 1g/1 | 90 Tablet, Film Coated In 1 Bottle (57237-043-90) | Rising Pharma Holdings, Inc. | 57237-043-90 | 57237-043 | ANDA090682 | ANDA | N/A |
| Valganciclovir | Tablet, Film Coated | Oral | 450mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-832-31) | Camber Pharmaceuticals, Inc. | 31722-832-31 | 31722-832 | ANDA205166 | ANDA | N/A |
| Valganciclovir | Tablet, Film Coated | Oral | 450mg/1 | 10 Tablet, Film Coated In 1 Carton (31722-832-32) | Camber Pharmaceuticals, Inc. | 31722-832-32 | 31722-832 | ANDA205166 | ANDA | N/A |
| Valganciclovir | Tablet, Film Coated | Oral | 450mg/1 | 60 Tablet, Film Coated In 1 Bottle (31722-832-60) | Camber Pharmaceuticals, Inc. | 31722-832-60 | 31722-832 | ANDA205166 | ANDA | N/A |
| VALGANCICLOVIR | Powder, For Solution | Oral | 50mg/mL | 1 Bottle, Glass In 1 Carton (31722-837-10) / 100 Ml In 1 Bottle, Glass | Camber Pharmaceuticals, Inc. | 31722-837-10 | 31722-837 | ANDA211475 | ANDA | N/A |
| Valproic Acid | Solution | Oral | 250mg/5mL | 473 Ml In 1 Bottle (62559-266-16) | ANI Pharmaceuticals, Inc. | 62559-266-16 | 62559-266 | ANDA073178 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 30 Tablet In 1 Bottle (65162-837-03) | Amneal Pharmaceuticals LLC | 65162-837-03 | 65162-837 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 60 Tablet In 1 Bottle (65162-837-06) | Amneal Pharmaceuticals LLC | 65162-837-06 | 65162-837 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 500 Tablet In 1 Bottle (65162-837-50) | Amneal Pharmaceuticals LLC | 65162-837-50 | 65162-837 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 90 Tablet In 1 Bottle (65162-838-09) | Amneal Pharmaceuticals LLC | 65162-838-09 | 65162-838 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (65162-838-11) | Amneal Pharmaceuticals LLC | 65162-838-11 | 65162-838 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 500 Tablet In 1 Bottle (65162-838-50) | Amneal Pharmaceuticals LLC | 65162-838-50 | 65162-838 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 90 Tablet In 1 Bottle (65162-839-09) | Amneal Pharmaceuticals LLC | 65162-839-09 | 65162-839 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle (65162-839-11) | Amneal Pharmaceuticals LLC | 65162-839-11 | 65162-839 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 500 Tablet In 1 Bottle (65162-839-50) | Amneal Pharmaceuticals LLC | 65162-839-50 | 65162-839 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 90 Tablet In 1 Bottle (65162-840-09) | Amneal Pharmaceuticals LLC | 65162-840-09 | 65162-840 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 1000 Tablet In 1 Bottle (65162-840-11) | Amneal Pharmaceuticals LLC | 65162-840-11 | 65162-840 | ANDA204011 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 500 Tablet In 1 Bottle (65162-840-50) | Amneal Pharmaceuticals LLC | 65162-840-50 | 65162-840 | ANDA204011 | ANDA | N/A |
| Valsartan | Solution | Oral | 4mg/mL | 120 Ml In 1 Bottle, Plastic (70954-310-10) | ANI Pharmaceuticals, Inc. | 70954-310-10 | 70954-310 | ANDA214102 | ANDA | N/A |
| Valsartan | Solution | Oral | 4mg/mL | 473 Ml In 1 Bottle, Plastic (70954-310-20) | ANI Pharmaceuticals, Inc. | 70954-310-20 | 70954-310 | ANDA214102 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-745-05) | Camber Pharmaceuticals, Inc. | 31722-745-05 | 31722-745 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-745-30) | Camber Pharmaceuticals, Inc. | 31722-745-30 | 31722-745 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-745-31) | Camber Pharmaceuticals, Inc. | 31722-745-31 | 31722-745 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-745-32) | Camber Pharmaceuticals, Inc. | 31722-745-32 | 31722-745 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-745-90) | Camber Pharmaceuticals, Inc. | 31722-745-90 | 31722-745 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-746-05) | Camber Pharmaceuticals, Inc. | 31722-746-05 | 31722-746 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-746-30) | Camber Pharmaceuticals, Inc. | 31722-746-30 | 31722-746 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-746-31) | Camber Pharmaceuticals, Inc. | 31722-746-31 | 31722-746 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-746-32) | Camber Pharmaceuticals, Inc. | 31722-746-32 | 31722-746 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-746-90) | Camber Pharmaceuticals, Inc. | 31722-746-90 | 31722-746 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 160mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-747-05) | Camber Pharmaceuticals, Inc. | 31722-747-05 | 31722-747 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 160mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-747-30) | Camber Pharmaceuticals, Inc. | 31722-747-30 | 31722-747 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 160mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-747-31) | Camber Pharmaceuticals, Inc. | 31722-747-31 | 31722-747 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 160mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-747-32) | Camber Pharmaceuticals, Inc. | 31722-747-32 | 31722-747 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 160mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-747-90) | Camber Pharmaceuticals, Inc. | 31722-747-90 | 31722-747 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 320mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-748-05) | Camber Pharmaceuticals, Inc. | 31722-748-05 | 31722-748 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 320mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-748-30) | Camber Pharmaceuticals, Inc. | 31722-748-30 | 31722-748 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 320mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-748-31) | Camber Pharmaceuticals, Inc. | 31722-748-31 | 31722-748 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 320mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-748-32) | Camber Pharmaceuticals, Inc. | 31722-748-32 | 31722-748 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 320mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-748-90) | Camber Pharmaceuticals, Inc. | 31722-748-90 | 31722-748 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-151-05) | Camber Pharmaceuticals, Inc. | 31722-151-05 | 31722-151 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-151-30) | Camber Pharmaceuticals, Inc. | 31722-151-30 | 31722-151 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-151-31) | Camber Pharmaceuticals, Inc. | 31722-151-31 | 31722-151 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-151-32) | Camber Pharmaceuticals, Inc. | 31722-151-32 | 31722-151 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 40mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-151-90) | Camber Pharmaceuticals, Inc. | 31722-151-90 | 31722-151 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 500 Tablet, Film Coated In 1 Bottle (31722-152-05) | Camber Pharmaceuticals, Inc. | 31722-152-05 | 31722-152 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 30 Tablet, Film Coated In 1 Bottle (31722-152-30) | Camber Pharmaceuticals, Inc. | 31722-152-30 | 31722-152 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 10 Tablet, Film Coated In 1 Blister Pack (31722-152-31) | Camber Pharmaceuticals, Inc. | 31722-152-31 | 31722-152 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 100 Tablet, Film Coated In 1 Blister Pack (31722-152-32) | Camber Pharmaceuticals, Inc. | 31722-152-32 | 31722-152 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet, Film Coated | Oral | 80mg/1 | 90 Tablet, Film Coated In 1 Bottle (31722-152-90) | Camber Pharmaceuticals, Inc. | 31722-152-90 | 31722-152 | ANDA203311 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 500 Tablet In 1 Bottle (50228-132-05) | ScieGen Pharmaceuticals, INC. | 50228-132-05 | 50228-132 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 30 Tablet In 1 Bottle (50228-132-30) | ScieGen Pharmaceuticals, INC. | 50228-132-30 | 50228-132 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle (50228-133-10) | ScieGen Pharmaceuticals, INC. | 50228-133-10 | 50228-133 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 30 Tablet In 1 Bottle (50228-133-30) | ScieGen Pharmaceuticals, INC. | 50228-133-30 | 50228-133 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (50228-134-10) | ScieGen Pharmaceuticals, INC. | 50228-134-10 | 50228-134 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (50228-134-30) | ScieGen Pharmaceuticals, INC. | 50228-134-30 | 50228-134 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (50228-135-10) | ScieGen Pharmaceuticals, INC. | 50228-135-10 | 50228-135 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 500 Tablet In 1 Bottle (50228-132-05) | ScieGen Pharmaceuticals, INC. | 50228-132-05 | 50228-132 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 320mg/1 | 30 Tablet In 1 Bottle (50228-132-30) | ScieGen Pharmaceuticals, INC. | 50228-132-30 | 50228-132 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 1000 Tablet In 1 Bottle (50228-133-10) | ScieGen Pharmaceuticals, INC. | 50228-133-10 | 50228-133 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 160mg/1 | 30 Tablet In 1 Bottle (50228-133-30) | ScieGen Pharmaceuticals, INC. | 50228-133-30 | 50228-133 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 1000 Tablet In 1 Bottle (50228-134-10) | ScieGen Pharmaceuticals, INC. | 50228-134-10 | 50228-134 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 80mg/1 | 30 Tablet In 1 Bottle (50228-134-30) | ScieGen Pharmaceuticals, INC. | 50228-134-30 | 50228-134 | ANDA204038 | ANDA | N/A |
| Valsartan | Tablet | Oral | 40mg/1 | 1000 Tablet In 1 Bottle (50228-135-10) | ScieGen Pharmaceuticals, INC. | 50228-135-10 | 50228-135 | ANDA204038 | ANDA | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 125mg/1 | 2 Blister Pack In 1 Carton (62559-310-20) / 10 Capsule In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-310-20 | 62559-310 | NDA050606 | NDA | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 250mg/1 | 2 Blister Pack In 1 Carton (62559-311-20) / 10 Capsule In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-311-20 | 62559-311 | NDA050606 | NDA | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 125mg/1 | 2 Blister Pack In 1 Carton (62559-390-20) / 10 Capsule In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-390-20 | 62559-390 | NDA050606 | NDA AUTHORIZED GENERIC | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 125mg/1 | 50 Capsule In 1 Bottle (62559-390-50) | ANI Pharmaceuticals, Inc. | 62559-390-50 | 62559-390 | NDA050606 | NDA AUTHORIZED GENERIC | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 250mg/1 | 2 Blister Pack In 1 Carton (62559-391-20) / 10 Capsule In 1 Blister Pack | ANI Pharmaceuticals, Inc. | 62559-391-20 | 62559-391 | NDA050606 | NDA AUTHORIZED GENERIC | N/A |
| Vancomycin Hydrochloride | Capsule | Oral | 250mg/1 | 50 Capsule In 1 Bottle (62559-391-50) | ANI Pharmaceuticals, Inc. | 62559-391-50 | 62559-391 | NDA050606 | NDA AUTHORIZED GENERIC | N/A |
| Vancomycin Hydrochloride | Powder, For Solution | Oral | 250mg/5mL | 300 Ml In 1 Bottle, Plastic (62559-830-03) | ANI Pharmaceuticals, Inc. | 62559-830-03 | 62559-830 | ANDA061667 | ANDA | N/A |
| Vancomycin Hydrochloride | Powder, For Solution | Oral | 250mg/5mL | 150 Ml In 1 Bottle, Plastic (62559-830-55) | ANI Pharmaceuticals, Inc. | 62559-830-55 | 62559-830 | ANDA061667 | ANDA | N/A |
| Vancomycin Hydrochloride | Powder, For Solution | Oral | 250mg/5mL | 80 Ml In 1 Bottle, Plastic (62559-830-80) | ANI Pharmaceuticals, Inc. | 62559-830-80 | 62559-830 | ANDA061667 | ANDA | N/A |
| VANCOMYCIN HYDROCHLORIDE | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 10 Vial In 1 Carton (31722-210-10) / 10 Ml In 1 Vial (31722-210-33) | Camber Pharmaceuticals, Inc. | 31722-210-10 | 31722-210 | ANDA216591 | ANDA | N/A |
| VANCOMYCIN HYDROCHLORIDE | Injection, Powder, Lyophilized, For Solution | Intravenous | 500mg/10mL | 25 Vial In 1 Carton (31722-210-32) / 10 Ml In 1 Vial (31722-210-33) | Camber Pharmaceuticals, Inc. | 31722-210-32 | 31722-210 | ANDA216591 | ANDA | N/A |
| VANCOMYCIN HYDROCHLORIDE | Injection, Powder, Lyophilized, For Solution | Intravenous | 1g/20mL | 10 Vial In 1 Carton (31722-211-10) / 20 Ml In 1 Vial (31722-211-33) | Camber Pharmaceuticals, Inc. | 31722-211-10 | 31722-211 | ANDA216591 | ANDA | N/A |
| Varenicline | Kit | N/A | N/A | 1 Kit In 1 Carton (31722-690-31) * 11 Tablet, Film Coated In 1 Blister Pack * 42 Tablet, Film Coated In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-690-31 | 31722-690 | ANDA214571 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (65162-300-09) | Amneal Pharmaceuticals LLC | 65162-300-09 | 65162-300 | ANDA079098 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 37.5mg/1 | 90 Tablet In 1 Bottle (65162-302-09) | Amneal Pharmaceuticals LLC | 65162-302-09 | 65162-302 | ANDA079098 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-392-05) | Ascent Pharmaceuticals, Inc. | 43602-392-05 | 43602-392 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-392-30) | Ascent Pharmaceuticals, Inc. | 43602-392-30 | 43602-392 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-393-05) | Ascent Pharmaceuticals, Inc. | 43602-393-05 | 43602-393 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-393-30) | Ascent Pharmaceuticals, Inc. | 43602-393-30 | 43602-393 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-394-05) | Ascent Pharmaceuticals, Inc. | 43602-394-05 | 43602-394 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-394-30) | Ascent Pharmaceuticals, Inc. | 43602-394-30 | 43602-394 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-395-05) | Ascent Pharmaceuticals, Inc. | 43602-395-05 | 43602-395 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-392-05) | Ascent Pharmaceuticals, Inc. | 43602-392-05 | 43602-392 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-392-30) | Ascent Pharmaceuticals, Inc. | 43602-392-30 | 43602-392 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-393-05) | Ascent Pharmaceuticals, Inc. | 43602-393-05 | 43602-393 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-393-30) | Ascent Pharmaceuticals, Inc. | 43602-393-30 | 43602-393 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-394-05) | Ascent Pharmaceuticals, Inc. | 43602-394-05 | 43602-394 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (43602-394-30) | Ascent Pharmaceuticals, Inc. | 43602-394-30 | 43602-394 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 500 Tablet, Extended Release In 1 Bottle (43602-395-05) | Ascent Pharmaceuticals, Inc. | 43602-395-05 | 43602-395 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-124-30) | Camber Pharmaceuticals, Inc. | 31722-124-30 | 31722-124 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 75mg/1 | 90 Tablet, Extended Release In 1 Bottle (31722-124-90) | Camber Pharmaceuticals, Inc. | 31722-124-90 | 31722-124 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-125-30) | Camber Pharmaceuticals, Inc. | 31722-125-30 | 31722-125 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (31722-125-90) | Camber Pharmaceuticals, Inc. | 31722-125-90 | 31722-125 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 225mg/1 | 30 Tablet, Extended Release In 1 Bottle (31722-126-30) | Camber Pharmaceuticals, Inc. | 31722-126-30 | 31722-126 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 225mg/1 | 90 Tablet, Extended Release In 1 Bottle (31722-126-90) | Camber Pharmaceuticals, Inc. | 31722-126-90 | 31722-126 | ANDA214419 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 10 Blister Pack In 1 Carton (31722-002-01) / 10 Capsule, Extended Release In 1 Blister Pack | Camber Pharmaceuticals, Inc. | 31722-002-01 | 31722-002 | ANDA212277 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 500 Capsule, Extended Release In 1 Bottle (31722-002-05) | Camber Pharmaceuticals, Inc. | 31722-002-05 | 31722-002 | ANDA212277 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 30 Capsule, Extended Release In 1 Bottle (31722-002-30) | Camber Pharmaceuticals, Inc. | 31722-002-30 | 31722-002 | ANDA212277 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 90 Capsule, Extended Release In 1 Bottle (31722-002-90) | Camber Pharmaceuticals, Inc. | 31722-002-90 | 31722-002 | ANDA212277 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 90 Capsule, Extended Release In 1 Bottle (42806-601-09) | Epic Pharma, LLC | 42806-601-09 | 42806-601 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 1000 Capsule, Extended Release In 1 Bottle (42806-601-10) | Epic Pharma, LLC | 42806-601-10 | 42806-601 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 37.5mg/1 | 30 Capsule, Extended Release In 1 Bottle (42806-601-30) | Epic Pharma, LLC | 42806-601-30 | 42806-601 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 75mg/1 | 90 Capsule, Extended Release In 1 Bottle (42806-602-09) | Epic Pharma, LLC | 42806-602-09 | 42806-602 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 75mg/1 | 1000 Capsule, Extended Release In 1 Bottle (42806-602-10) | Epic Pharma, LLC | 42806-602-10 | 42806-602 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 75mg/1 | 30 Capsule, Extended Release In 1 Bottle (42806-602-30) | Epic Pharma, LLC | 42806-602-30 | 42806-602 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 500 Capsule, Extended Release In 1 Bottle (42806-603-05) | Epic Pharma, LLC | 42806-603-05 | 42806-603 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 90 Capsule, Extended Release In 1 Bottle (42806-603-09) | Epic Pharma, LLC | 42806-603-09 | 42806-603 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Capsule, Extended Release | Oral | 150mg/1 | 30 Capsule, Extended Release In 1 Bottle (42806-603-30) | Epic Pharma, LLC | 42806-603-30 | 42806-603 | ANDA214654 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 25mg/1 | 100 Tablet In 1 Bottle (57237-172-01) | Rising Pharma Holdings, Inc. | 57237-172-01 | 57237-172 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 25mg/1 | 90 Tablet In 1 Bottle (57237-172-90) | Rising Pharma Holdings, Inc. | 57237-172-90 | 57237-172 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 37.5mg/1 | 100 Tablet In 1 Bottle (57237-173-01) | Rising Pharma Holdings, Inc. | 57237-173-01 | 57237-173 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 37.5mg/1 | 90 Tablet In 1 Bottle (57237-173-90) | Rising Pharma Holdings, Inc. | 57237-173-90 | 57237-173 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 50mg/1 | 100 Tablet In 1 Bottle (57237-174-01) | Rising Pharma Holdings, Inc. | 57237-174-01 | 57237-174 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 50mg/1 | 90 Tablet In 1 Bottle (57237-174-90) | Rising Pharma Holdings, Inc. | 57237-174-90 | 57237-174 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 75mg/1 | 100 Tablet In 1 Bottle (57237-175-01) | Rising Pharma Holdings, Inc. | 57237-175-01 | 57237-175 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 75mg/1 | 90 Tablet In 1 Bottle (57237-175-90) | Rising Pharma Holdings, Inc. | 57237-175-90 | 57237-175 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 100mg/1 | 100 Tablet In 1 Bottle (57237-176-01) | Rising Pharma Holdings, Inc. | 57237-176-01 | 57237-176 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet | Oral | 100mg/1 | 90 Tablet In 1 Bottle (57237-176-90) | Rising Pharma Holdings, Inc. | 57237-176-90 | 57237-176 | ANDA090555 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-578-03) | Rising Pharma Holdings, Inc. | 64980-578-03 | 64980-578 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 37.5mg/1 | 90 Tablet, Extended Release In 1 Bottle (64980-578-09) | Rising Pharma Holdings, Inc. | 64980-578-09 | 64980-578 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-579-03) | Rising Pharma Holdings, Inc. | 64980-579-03 | 64980-579 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 75mg/1 | 90 Tablet, Extended Release In 1 Bottle (64980-579-09) | Rising Pharma Holdings, Inc. | 64980-579-09 | 64980-579 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-580-03) | Rising Pharma Holdings, Inc. | 64980-580-03 | 64980-580 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (64980-580-09) | Rising Pharma Holdings, Inc. | 64980-580-09 | 64980-580 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 30 Tablet, Extended Release In 1 Bottle (64980-581-03) | Rising Pharma Holdings, Inc. | 64980-581-03 | 64980-581 | ANDA216044 | ANDA | N/A |
| Venlafaxine Hydrochloride | Tablet, Extended Release | Oral | 225mg/1 | 90 Tablet, Extended Release In 1 Bottle (64980-581-09) | Rising Pharma Holdings, Inc. | 64980-581-09 | 64980-581 | ANDA216044 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 150mg/1 | 30 Tablet, Extended Release In 1 Bottle (72865-199-30) | XLCare Pharmaceuticals, Inc. | 72865-199-30 | 72865-199 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 150mg/1 | 90 Tablet, Extended Release In 1 Bottle (72865-199-90) | XLCare Pharmaceuticals, Inc. | 72865-199-90 | 72865-199 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 225mg/1 | 30 Tablet, Extended Release In 1 Bottle (72865-200-30) | XLCare Pharmaceuticals, Inc. | 72865-200-30 | 72865-200 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 225mg/1 | 90 Tablet, Extended Release In 1 Bottle (72865-200-90) | XLCare Pharmaceuticals, Inc. | 72865-200-90 | 72865-200 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 37.5mg/1 | 30 Tablet, Extended Release In 1 Bottle (72865-197-30) | XLCare Pharmaceuticals, Inc. | 72865-197-30 | 72865-197 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 37.5mg/1 | 90 Tablet, Extended Release In 1 Bottle (72865-197-90) | XLCare Pharmaceuticals, Inc. | 72865-197-90 | 72865-197 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 75mg/1 | 30 Tablet, Extended Release In 1 Bottle (72865-198-30) | XLCare Pharmaceuticals, Inc. | 72865-198-30 | 72865-198 | ANDA214419 | ANDA | N/A |
| VENLAFAXINE HYDROCHLORIDE | Tablet, Extended Release | Oral | 75mg/1 | 90 Tablet, Extended Release In 1 Bottle (72865-198-90) | XLCare Pharmaceuticals, Inc. | 72865-198-90 | 72865-198 | ANDA214419 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 25 Vial In 1 Carton (70121-1585-5) / 2 Ml In 1 Vial (70121-1585-1) | Amneal Pharmaceuticals LLC | 70121-1585-5 | 70121-1585 | ANDA210994 | ANDA | N/A |
| Verapamil Hydrochloride | Injection, Solution | Intravenous | 2.5mg/mL | 5 Vial In 1 Carton (70121-1586-3) / 4 Ml In 1 Vial (70121-1586-1) | Amneal Pharmaceuticals LLC | 70121-1586-3 | 70121-1586 | ANDA210994 | ANDA | N/A |
| Voriconazole | Powder, For Suspension | Oral | 40mg/mL | 75 Ml In 1 Bottle (65162-913-22) | Amneal Pharmaceuticals LLC | 65162-913-22 | 65162-913 | ANDA205034 | ANDA | N/A |
| Voriconazole | Injection, Powder, Lyophilized, For Solution | Intravenous | 10mg/mL | 1 Vial, Single-Dose In 1 Carton (31722-224-31) / 20 Ml In 1 Vial, Single-Dose | Camber Pharmaceuticals, Inc. | 31722-224-31 | 31722-224 | ANDA218533 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (65162-761-10) | Amneal Pharmaceuticals LLC | 65162-761-10 | 65162-761 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (65162-761-11) | Amneal Pharmaceuticals LLC | 65162-761-11 | 65162-761 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 500 Tablet In 1 Bottle (65162-761-50) | Amneal Pharmaceuticals LLC | 65162-761-50 | 65162-761 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (65162-762-10) | Amneal Pharmaceuticals LLC | 65162-762-10 | 65162-762 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (65162-762-11) | Amneal Pharmaceuticals LLC | 65162-762-11 | 65162-762 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 500 Tablet In 1 Bottle (65162-762-50) | Amneal Pharmaceuticals LLC | 65162-762-50 | 65162-762 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (65162-763-10) | Amneal Pharmaceuticals LLC | 65162-763-10 | 65162-763 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (65162-763-11) | Amneal Pharmaceuticals LLC | 65162-763-11 | 65162-763 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 500 Tablet In 1 Bottle (65162-763-50) | Amneal Pharmaceuticals LLC | 65162-763-50 | 65162-763 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 100 Tablet In 1 Bottle (65162-764-10) | Amneal Pharmaceuticals LLC | 65162-764-10 | 65162-764 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 1000 Tablet In 1 Bottle (65162-764-11) | Amneal Pharmaceuticals LLC | 65162-764-11 | 65162-764 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 500 Tablet In 1 Bottle (65162-764-50) | Amneal Pharmaceuticals LLC | 65162-764-50 | 65162-764 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (65162-765-10) | Amneal Pharmaceuticals LLC | 65162-765-10 | 65162-765 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (65162-765-11) | Amneal Pharmaceuticals LLC | 65162-765-11 | 65162-765 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 500 Tablet In 1 Bottle (65162-765-50) | Amneal Pharmaceuticals LLC | 65162-765-50 | 65162-765 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (65162-766-10) | Amneal Pharmaceuticals LLC | 65162-766-10 | 65162-766 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (65162-766-11) | Amneal Pharmaceuticals LLC | 65162-766-11 | 65162-766 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 500 Tablet In 1 Bottle (65162-766-50) | Amneal Pharmaceuticals LLC | 65162-766-50 | 65162-766 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (65162-767-10) | Amneal Pharmaceuticals LLC | 65162-767-10 | 65162-767 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 1000 Tablet In 1 Bottle (65162-767-11) | Amneal Pharmaceuticals LLC | 65162-767-11 | 65162-767 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 500 Tablet In 1 Bottle (65162-767-50) | Amneal Pharmaceuticals LLC | 65162-767-50 | 65162-767 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (65162-768-10) | Amneal Pharmaceuticals LLC | 65162-768-10 | 65162-768 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (65162-768-11) | Amneal Pharmaceuticals LLC | 65162-768-11 | 65162-768 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 500 Tablet In 1 Bottle (65162-768-50) | Amneal Pharmaceuticals LLC | 65162-768-50 | 65162-768 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (65162-769-10) | Amneal Pharmaceuticals LLC | 65162-769-10 | 65162-769 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (65162-769-11) | Amneal Pharmaceuticals LLC | 65162-769-11 | 65162-769 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 500 Tablet In 1 Bottle (65162-769-50) | Amneal Pharmaceuticals LLC | 65162-769-50 | 65162-769 | ANDA202202 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 100 Tablet In 1 Bottle (57237-119-01) | Rising Health, LLC | 57237-119-01 | 57237-119 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 90 Tablet In 1 Bottle (57237-119-90) | Rising Health, LLC | 57237-119-90 | 57237-119 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 1mg/1 | 1000 Tablet In 1 Bottle (57237-119-99) | Rising Health, LLC | 57237-119-99 | 57237-119 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 100 Tablet In 1 Bottle (57237-120-01) | Rising Health, LLC | 57237-120-01 | 57237-120 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 90 Tablet In 1 Bottle (57237-120-90) | Rising Health, LLC | 57237-120-90 | 57237-120 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2mg/1 | 1000 Tablet In 1 Bottle (57237-120-99) | Rising Health, LLC | 57237-120-99 | 57237-120 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 100 Tablet In 1 Bottle (57237-121-01) | Rising Health, LLC | 57237-121-01 | 57237-121 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 90 Tablet In 1 Bottle (57237-121-90) | Rising Health, LLC | 57237-121-90 | 57237-121 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 2.5mg/1 | 1000 Tablet In 1 Bottle (57237-121-99) | Rising Health, LLC | 57237-121-99 | 57237-121 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 100 Tablet In 1 Bottle (57237-122-01) | Rising Health, LLC | 57237-122-01 | 57237-122 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 90 Tablet In 1 Bottle (57237-122-90) | Rising Health, LLC | 57237-122-90 | 57237-122 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 3mg/1 | 1000 Tablet In 1 Bottle (57237-122-99) | Rising Health, LLC | 57237-122-99 | 57237-122 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 100 Tablet In 1 Bottle (57237-123-01) | Rising Health, LLC | 57237-123-01 | 57237-123 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 90 Tablet In 1 Bottle (57237-123-90) | Rising Health, LLC | 57237-123-90 | 57237-123 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 4mg/1 | 1000 Tablet In 1 Bottle (57237-123-99) | Rising Health, LLC | 57237-123-99 | 57237-123 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 100 Tablet In 1 Bottle (57237-124-01) | Rising Health, LLC | 57237-124-01 | 57237-124 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 90 Tablet In 1 Bottle (57237-124-90) | Rising Health, LLC | 57237-124-90 | 57237-124 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 5mg/1 | 1000 Tablet In 1 Bottle (57237-124-99) | Rising Health, LLC | 57237-124-99 | 57237-124 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 100 Tablet In 1 Bottle (57237-125-01) | Rising Health, LLC | 57237-125-01 | 57237-125 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 90 Tablet In 1 Bottle (57237-125-90) | Rising Health, LLC | 57237-125-90 | 57237-125 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 6mg/1 | 1000 Tablet In 1 Bottle (57237-125-99) | Rising Health, LLC | 57237-125-99 | 57237-125 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 100 Tablet In 1 Bottle (57237-126-01) | Rising Health, LLC | 57237-126-01 | 57237-126 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 90 Tablet In 1 Bottle (57237-126-90) | Rising Health, LLC | 57237-126-90 | 57237-126 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 7.5mg/1 | 1000 Tablet In 1 Bottle (57237-126-99) | Rising Health, LLC | 57237-126-99 | 57237-126 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 100 Tablet In 1 Bottle (57237-127-01) | Rising Health, LLC | 57237-127-01 | 57237-127 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 90 Tablet In 1 Bottle (57237-127-90) | Rising Health, LLC | 57237-127-90 | 57237-127 | ANDA090935 | ANDA | N/A |
| Warfarin Sodium | Tablet | Oral | 10mg/1 | 1000 Tablet In 1 Bottle (57237-127-99) | Rising Health, LLC | 57237-127-99 | 57237-127 | ANDA090935 | ANDA | N/A |
| Zaleplon | Capsule | Oral | 5mg/1 | 100 Capsule In 1 Bottle (57237-239-01) | Rising Pharma Holdings, Inc. | 57237-239-01 | 57237-239 | ANDA078829 | ANDA | CIV |
| Zaleplon | Capsule | Oral | 10mg/1 | 100 Capsule In 1 Bottle (57237-240-01) | Rising Pharma Holdings, Inc. | 57237-240-01 | 57237-240 | ANDA078829 | ANDA | CIV |
| Zidovudine | Tablet | Oral | 300mg/1 | 12 Bottle In 1 Case (31722-509-60) / 60 Tablet In 1 Bottle | Camber Pharmaceuticals, Inc. | 31722-509-60 | 31722-509 | ANDA090092 | ANDA | N/A |
| Zileuton | Tablet, Extended Release | Oral | 600mg/1 | 120 Tablet, Extended Release In 1 Bottle (64980-206-12) | Rising Pharma Holdings, Inc. | 64980-206-12 | 64980-206 | ANDA204929 | ANDA | N/A |
| Zolmitriptan | Spray, Metered | Nasal | 5mg/1 | 1 Bottle, Spray In 1 Carton (64896-681-30) / 1 Spray, Metered In 1 Bottle, Spray | Amneal Pharmaceuticals | 64896-681-30 | 64896-681 | NDA021450 | NDA | N/A |
| Zolmitriptan | Spray, Metered | Nasal | 5mg/1 | 6 Bottle, Spray In 1 Carton (64896-681-51) / 1 Spray, Metered In 1 Bottle, Spray | Amneal Pharmaceuticals | 64896-681-51 | 64896-681 | NDA021450 | NDA | N/A |
| Zolmitriptan | Tablet, Film Coated | Oral | 2.5mg/1 | 1 Blister Pack In 1 Carton (60846-130-30) / 6 Tablet, Film Coated In 1 Blister Pack | Amneal Pharmaceuticals LLC | 60846-130-30 | 60846-130 | ANDA207867 | ANDA | N/A |
| Zolmitriptan | Tablet, Film Coated | Oral | 5mg/1 | 1 Blister Pack In 1 Carton (60846-133-60) / 3 Tablet, Film Coated In 1 Blister Pack | Amneal Pharmaceuticals LLC | 60846-133-60 | 60846-133 | ANDA207867 | ANDA | N/A |
| Zolmitriptan | Spray, Metered | Nasal | 2.5mg/1 | 6 Bottle, Spray In 1 Carton (64896-083-12) / 1 Spray, Metered In 1 Bottle, Spray | Amneal Pharmaceuticals LLC | 64896-083-12 | 64896-083 | NDA021450 | NDA | N/A |
| Zolmitriptan | Tablet, Film Coated | Oral | 2.5mg/1 | 1 Blister Pack In 1 Carton (16571-803-16) / 6 Tablet, Film Coated In 1 Blister Pack | Rising Pharma Holdings, Inc. | 16571-803-16 | 16571-803 | ANDA207021 | ANDA | N/A |
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