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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
BRIVARACETAM | 214748 | 001 | ANDA | BRIVARACETAM | TABLET;ORAL | 10MG | No | No | 2022/06/09 | 2022/06/09 | SUNSHINE | Discontinued |
BRIVARACETAM | 214748 | 002 | ANDA | BRIVARACETAM | TABLET;ORAL | 25MG | No | No | 2022/06/09 | 2022/06/09 | SUNSHINE | Discontinued |
BRIVARACETAM | 214748 | 003 | ANDA | BRIVARACETAM | TABLET;ORAL | 50MG | No | No | 2022/06/09 | 2022/06/09 | SUNSHINE | Discontinued |
BRIVARACETAM | 214748 | 004 | ANDA | BRIVARACETAM | TABLET;ORAL | 75MG | No | No | 2022/06/09 | 2022/06/09 | SUNSHINE | Discontinued |
BRIVARACETAM | 214748 | 005 | ANDA | BRIVARACETAM | TABLET;ORAL | 100MG | No | No | 2022/06/09 | 2022/06/09 | SUNSHINE | Discontinued |
BRIVARACETAM | 214501 | 001 | ANDA | BRIVARACETAM | TABLET;ORAL | 10MG | No | No | 2022/10/03 | 2022/10/03 | ZYDUS PHARMS | Discontinued |
BRIVARACETAM | 214501 | 002 | ANDA | BRIVARACETAM | TABLET;ORAL | 25MG | No | No | 2022/10/03 | 2022/10/03 | ZYDUS PHARMS | Discontinued |
BRIVARACETAM | 214501 | 003 | ANDA | BRIVARACETAM | TABLET;ORAL | 50MG | No | No | 2022/10/03 | 2022/10/03 | ZYDUS PHARMS | Discontinued |
BRIVARACETAM | 214501 | 004 | ANDA | BRIVARACETAM | TABLET;ORAL | 75MG | No | No | 2022/10/03 | 2022/10/03 | ZYDUS PHARMS | Discontinued |
BRIVARACETAM | 214501 | 005 | ANDA | BRIVARACETAM | TABLET;ORAL | 100MG | No | No | 2022/10/03 | 2022/10/03 | ZYDUS PHARMS | Discontinued |
BRIVARACETAM | 214918 | 001 | ANDA | BRIVARACETAM | TABLET;ORAL | 10MG | No | No | 2022/12/20 | 2022/12/20 | LUPIN LTD | Discontinued |
BRIVARACETAM | 214918 | 002 | ANDA | BRIVARACETAM | TABLET;ORAL | 25MG | No | No | 2022/12/20 | 2022/12/20 | LUPIN LTD | Discontinued |
BRIVARACETAM | 214918 | 003 | ANDA | BRIVARACETAM | TABLET;ORAL | 50MG | No | No | 2022/12/20 | 2022/12/20 | LUPIN LTD | Discontinued |
BRIVARACETAM | 214918 | 004 | ANDA | BRIVARACETAM | TABLET;ORAL | 75MG | No | No | 2022/12/20 | 2022/12/20 | LUPIN LTD | Discontinued |
BRIVARACETAM | 214918 | 005 | ANDA | BRIVARACETAM | TABLET;ORAL | 100MG | No | No | 2022/12/20 | 2022/12/20 | LUPIN LTD | Discontinued |
BRIVARACETAM | 214848 | 001 | ANDA | BRIVARACETAM | TABLET;ORAL | 50MG | No | No | 2023/01/06 | 2023/01/06 | AUROBINDO PHARMA LTD | Discontinued |
BRIVARACETAM | 214848 | 002 | ANDA | BRIVARACETAM | TABLET;ORAL | 100MG | No | No | 2023/01/06 | 2023/01/06 | AUROBINDO PHARMA LTD | Discontinued |
BRIVARACETAM | 214875 | 001 | ANDA | BRIVARACETAM | TABLET;ORAL | 10MG | No | No | 2023/11/06 (TA) | -- | APOTEX INC | None (Tentative Approval) |
BRIVARACETAM | 214875 | 002 | ANDA | BRIVARACETAM | TABLET;ORAL | 25MG | No | No | 2023/11/06 (TA) | -- | APOTEX INC | None (Tentative Approval) |
BRIVARACETAM | 214875 | 003 | ANDA | BRIVARACETAM | TABLET;ORAL | 50MG | No | No | 2023/11/06 (TA) | -- | APOTEX INC | None (Tentative Approval) |