| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VALBENAZINE TOSYLATE | 216137 | 001 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 40MG | No | No | 2022/10/13 (TA) | -- | ZYDUS WORLDWIDE DMCC | None (Tentative Approval) |
| VALBENAZINE TOSYLATE | 216137 | 002 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 60MG | No | No | 2022/10/13 (TA) | -- | ZYDUS WORLDWIDE DMCC | None (Tentative Approval) |
| VALBENAZINE TOSYLATE | 216137 | 003 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 80MG | No | No | 2022/10/13 (TA) | -- | ZYDUS WORLDWIDE DMCC | None (Tentative Approval) |
| VALBENAZINE TOSYLATE | 215984 | 001 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 40MG | No | No | 2022/11/25 (TA) | -- | TEVA PHARMS INC | None (Tentative Approval) |
| VALBENAZINE TOSYLATE | 215984 | 002 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 80MG | No | No | 2022/11/25 (TA) | -- | TEVA PHARMS INC | None (Tentative Approval) |
| VALBENAZINE TOSYLATE | 216064 | 001 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 40MG BASE | No | No | 2024/04/05 | 2024/04/05 | LUPIN LTD | Prescription |
| VALBENAZINE TOSYLATE | 216064 | 001 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 40MG BASE | No | No | 2024/04/05 (TA) | 2024/04/05 | LUPIN LTD | Prescription |
| VALBENAZINE TOSYLATE | 216064 | 002 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 80MG BASE | No | No | 2024/04/05 | 2024/04/05 | LUPIN LTD | Prescription |
| VALBENAZINE TOSYLATE | 216064 | 002 | ANDA | VALBENAZINE TOSYLATE | CAPSULE;ORAL | EQ 80MG BASE | No | No | 2024/04/05 (TA) | 2024/04/05 | LUPIN LTD | Prescription |