Application 212613
- Type
- ANDA
- Sponsor
- AMPHASTAR PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GANIRELIX ACETATE | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0548-5001 | Ganirelix Acetate | Ganirelix Acetate | Amphastar Pharmaceuticals, Inc. | ANDA | Current |