Application 212708
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-479 | Pirfenidone | Pirfenidone | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-480 | Pirfenidone | Pirfenidone | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 69097-988 | Pirfenidone | Pirfenidone | Cipla USA Inc. | ANDA | Current |
| 69097-988 | Pirfenidone | Pirfenidone | Cipla USA Inc. | ANDA | Current |
| 76282-717 | Pirfenidone | Pirfenidone | EXELAN PHARMACEUTICALS INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69655 | ORIG | 2021-12-20 |