Application 210302
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 4MG | No | No |
| 002 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 8MG | No | No |
| 003 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 16MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-341 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-342 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-343 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 70518-2719 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | REMEDYREPACK INC. | ANDA | Current |
| 70518-2719 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | REMEDYREPACK INC. | ANDA | Current |
| 70518-2719 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | REMEDYREPACK INC. | ANDA | Current |
| 70518-2884 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | REMEDYREPACK INC. | ANDA | Current |
| 70518-2884 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | REMEDYREPACK INC. | ANDA | Current |