Application 205575
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | TABLET;ORAL | 5MG | No | No |
| 002 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-192 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-193 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 60687-499 | Solifenacin Succinate | Solifenacin Succinate | American Health Packaging | ANDA | Current |
| 60687-499 | Solifenacin Succinate | Solifenacin Succinate | American Health Packaging | ANDA | Current |
| 62332-192 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-192 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-192 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-193 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-193 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-193 | Solifenacin Succinate | Solifenacin Succinate | Alembic Pharmaceuticals Inc. | ANDA | Current |