Application 210476
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENOFIBRATE | FENOFIBRATE | TABLET;ORAL | 48MG | No | No |
| 002 | FENOFIBRATE | FENOFIBRATE | TABLET;ORAL | 145MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-360 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-361 | FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Inc. | ANDA | Current |