Application 078239
- 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 | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-637 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-637 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-637 | Divalproex Sodium | Divalproex Sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-637 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-638 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-638 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-638 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-638 | Divalproex Sodium | Divalproex Sodium | Zydus Lifesciences Limited | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-105 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-106 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68084-310 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-310 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-310 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-310 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-415 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-415 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-415 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-415 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68382-133 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-133 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-133 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-133 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-133 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-134 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-134 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-134 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-134 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-134 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-2033 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |