Application 078877
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOPIRAMATE | TOPIRAMATE | CAPSULE;ORAL | 15MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | CAPSULE;ORAL | 25MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | CAPSULE;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-651 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-651 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-651 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-651 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-652 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-652 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-652 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-652 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 68382-004 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-004 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-004 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-004 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-004 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-005 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-005 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-005 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-005 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-005 | topiramate | topiramate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |