Application 215707
- Type
- ANDA
- Sponsor
- ZYDUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIGABATRIN | VIGABATRIN | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1287 | vigabatrin | vigabatrin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1654 | vigabatrin | vigabatrin | Cadila Healthcare Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76262 | ORIG | 2023-11-03 |