Application 215077
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FULVESTRANT | FULVESTRANT | SOLUTION;INTRAMUSCULAR | 250MG/5ML (50MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62332-650 | Fulvestrant | Fulvestrant | Alembic Pharmaceuticals Inc. | ANDA | Current |