Application 078919
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 125MG VALPROIC ACID | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 17856-0109 | divalproex sodium | divalproex sodium | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0109 | divalproex sodium | divalproex sodium | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 50268-258 | divalproex sodium | divalproex sodium | AvPAK | ANDA | Current |
| 50268-258 | divalproex sodium | divalproex sodium | AvPAK | ANDA | Current |
| 55154-4759 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Cardinal Health | ANDA | Current |
| 55154-4759 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4759 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Cardinal Health | ANDA | Current |
| 65841-639 | divalproex sodium | divalproex sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-639 | divalproex sodium | divalproex sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-639 | divalproex sodium | divalproex sodium | Cadila Healthcare Limited | ANDA | Current |
| 68084-313 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-313 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-313 | divalproex sodium | divalproex sodium | American Health Packaging | ANDA | Current |
| 68084-313 | divalproex sodium | divalproex sodium | American Health Packaging | ANDA | Current |
| 68084-313 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-106 | divalproex sodium | divalproex sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-1749 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1749 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1749 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1749 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2527 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2527 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2527 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2527 | divalproex sodium | divalproex sodium | REMEDYREPACK INC. | ANDA | Current |