Application 202130
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 20MG | No | No |
| 002 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 40MG | No | No |
| 003 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-836 | Telmisartan | Telmisartan | medsource pharmaceuticals | ANDA | Current |
| 46708-608 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-609 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-610 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-087 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-087 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-087 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-088 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-088 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-088 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-089 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-089 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-089 | Telmisartan | Telmisartan | Alembic Pharmaceuticals Inc. | ANDA | Current |