Application 091367
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VALSARTAN | VALSARTAN | TABLET;ORAL | 40MG | No | No |
| 002 | VALSARTAN | VALSARTAN | TABLET;ORAL | 80MG | No | No |
| 003 | VALSARTAN | VALSARTAN | TABLET;ORAL | 160MG | No | No |
| 004 | VALSARTAN | VALSARTAN | TABLET;ORAL | 320MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-114 | Valsartan | Valsartan | Medsource Pharmaceuticals | ANDA | Current |
| 46708-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-044 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-045 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-046 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-047 | Valsartan | Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 71335-1436 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1436 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1436 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1561 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1561 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 72189-050 | VALSARTAN | VALSARTAN | Direct_Rx | ANDA | Current |