Application 091236
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-439 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-439 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-440 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-440 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-441 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-441 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50090-3431 | IRBESARTAN | IRBESARTAN | A-S Medication Solutions | ANDA | Current |
| 50090-3431 | IRBESARTAN | IRBESARTAN | A-S Medication Solutions | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-041 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-042 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-043 | IRBESARTAN | IRBESARTAN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 70518-1974 | IRBESARTAN | IRBESARTAN | REMEDYREPACK INC. | ANDA | Current |
| 70518-1974 | IRBESARTAN | IRBESARTAN | REMEDYREPACK INC. | ANDA | Current |
| 71335-0423 | IRBESARTAN | IRBESARTAN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0423 | IRBESARTAN | IRBESARTAN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0423 | IRBESARTAN | IRBESARTAN | Bryant Ranch Prepack | ANDA | Current |