Application 209333
- Type
- ANDA
- Sponsor
- QILU
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-4702 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4702 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4702 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4702 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4703 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4703 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4703 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 60505-4703 | Solifenacin Succinate | Solifenacin Succinate | Apotex Corp. | ANDA | Current |
| 63629-8387 | Solifenacin Succinate | Solifenacin Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8387 | Solifenacin Succinate | Solifenacin Succinate | Bryant Ranch Prepack | ANDA | Current |
| 67184-0517 | Solifenacin Succinate | Solifenacin Succinate Tablets | Qilu Pharmaceutical Co., Ltd. | ANDA | Current |
| 67184-0517 | Solifenacin Succinate | Solifenacin Succinate Tablets | Qilu Pharmaceutical Co., Ltd. | ANDA | Current |
| 71205-559 | Solifenacin Succinate | Solifenacin Succinate | Proficient Rx LP | ANDA | Current |
| 71205-583 | Solifenacin Succinate | Solifenacin Succinate | Proficient Rx LP | ANDA | Current |
| 71205-583 | Solifenacin Succinate | Solifenacin Succinate | Proficient Rx LP | ANDA | Current |