Application 206698
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARGATROBAN | ARGATROBAN | INJECTABLE;INJECTION | 250MG/2.5ML (100MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70121-1037 | Argatroban | Argatroban | Amneal Biosciences LLC | ANDA | Current |
| 70121-1037 | Argatroban | Argatroban | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1037 | Argatroban | Argatroban | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1037 | Argatroban | Argatroban | Amneal Pharmaceuticals LLC | ANDA | Current |