Application 204809
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | TADALAFIL | TADALAFIL | TABLET;ORAL | 5MG | No | No |
| 003 | TADALAFIL | TADALAFIL | TABLET;ORAL | 10MG | No | No |
| 004 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-177 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-178 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-179 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-180 | Tadalafil | tadalafil | Alembic Pharmaceuticals Inc. | ANDA | Current |