Application 204373
- Type
- ANDA
- Sponsor
- CADILA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DUTASTERIDE | DUTASTERIDE | CAPSULE;ORAL | 0.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68382-641 | Dutasteride | Dutasteride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1347 | Dutasteride | Dutasteride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1347 | Dutasteride | Dutasteride | Cadila Healthcare Limited | ANDA | Current |
| 70771-1347 | Dutasteride | Dutasteride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1347 | Dutasteride | Dutasteride | Cadila Healthcare Limited | ANDA | Current |
| 72578-019 | Dutasteride | Dutasteride | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-019 | Dutasteride | Dutasteride | Viona Pharmaceuticals Inc | ANDA | Current |