| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ENZALUTAMIDE | 209614 | 001 | ANDA | ENZALUTAMIDE | CAPSULE;ORAL | 40MG | No | No | 2021/05/14 | 2021/05/14 | ACTAVIS LABS FL INC | Discontinued |
| ENZALUTAMIDE | 209645 | 001 | ANDA | ENZALUTAMIDE | CAPSULE;ORAL | 40MG | No | No | 2022/04/22 | 2022/04/22 | APOTEX | Discontinued |
| ENZALUTAMIDE | 216068 | 001 | ANDA | ENZALUTAMIDE | TABLET;ORAL | 40MG | No | No | 2022/08/02 (TA) | -- | SANDOZ INC | None (Tentative Approval) |
| ENZALUTAMIDE | 216068 | 002 | ANDA | ENZALUTAMIDE | TABLET;ORAL | 80MG | No | No | 2022/08/02 (TA) | -- | SANDOZ INC | None (Tentative Approval) |
| ENZALUTAMIDE | 209667 | 001 | ANDA | ENZALUTAMIDE | CAPSULE;ORAL | 40MG | No | No | 2024/09/26 | 2024/09/26 | ZYDUS PHARMS | Prescription |
| ENZALUTAMIDE | 217322 | 001 | ANDA | ENZALUTAMIDE | TABLET;ORAL | 40MG | No | No | 2024/09/30 (TA) | -- | ZYDUS PHARMS USA INC | None (Tentative Approval) |
| ENZALUTAMIDE | 217322 | 002 | ANDA | ENZALUTAMIDE | TABLET;ORAL | 80MG | No | No | 2024/09/30 (TA) | -- | ZYDUS PHARMS USA INC | None (Tentative Approval) |