Application 208705
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | No | No |
| 002 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-244 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-245 | Fenofibric Acid | Fenofibric Acid | Alembic Pharmaceuticals Inc. | ANDA | Current |