Application 212570
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 267MG | No | No |
| 002 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 801MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60219-1640 | Pirfenidone | Pirfenidone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1640 | Pirfenidone | Pirfenidone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1641 | Pirfenidone | Pirfenidone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1641 | Pirfenidone | Pirfenidone | Amneal Pharmaceuticals NY LLC | ANDA | Current |