Application 091369
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 10MG | No | No |
| 002 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13811-677 | Leflunomide | Leflunomide | Trigen Laboratories, LLC | ANDA | Current |
| 13811-677 | Leflunomide | Leflunomide | Trigen Laboratories, LLC | ANDA | Current |
| 13811-678 | Leflunomide | Leflunomide | Trigen Laboratories, LLC | ANDA | Current |
| 13811-678 | Leflunomide | Leflunomide | Trigen Laboratories, LLC | ANDA | Current |
| 46708-436 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-436 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-437 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-437 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-061 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-061 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-061 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-062 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-062 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-062 | Leflunomide | Leflunomide | Alembic Pharmaceuticals Inc. | ANDA | Current |