Application 213842
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 67MG | No | No |
| 002 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 134MG | No | No |
| 003 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-084 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-085 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-086 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-084 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-084 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-084 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-084 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-085 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-085 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-085 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-085 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-086 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-086 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-086 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-086 | Fenofibrate | Fenofibrate | Alembic Pharmaceuticals Inc. | ANDA | Current |