Application 215234
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FULVESTRANT | FULVESTRANT | INJECTABLE;INTRAMUSCULAR | 50MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1688 | FULVESTRANT | fulvestrant | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1688 | FULVESTRANT | fulvestrant | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1626 | FULVESTRANT | fulvestrant | Cadila Healthcare Limited | ANDA | Current |
| 70771-1626 | FULVESTRANT | fulvestrant | Zydus Lifesciences Limited | ANDA | Current |