Application 205301
- Type
- ANDA
- Sponsor
- CADILA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAZOLAMIDE | ACETAZOLAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-578 | acetazolamide | acetazolamide | American Health Packaging | ANDA | Current |
| 60687-578 | acetazolamide | acetazolamide | American Health Packaging | ANDA | Current |
| 65841-762 | acetazolamide | acetazolamide | Cadila Healthcare Limited | ANDA | Current |
| 65841-762 | acetazolamide | acetazolamide | Zydus Lifesciences Limited | ANDA | Current |
| 70710-1591 | acetazolamide | acetazolamide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1591 | acetazolamide | acetazolamide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |