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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | 213660 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |
BREXPIPRAZOLE | 213660 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |
BREXPIPRAZOLE | 213660 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |
BREXPIPRAZOLE | 213660 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |
BREXPIPRAZOLE | 213660 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |
BREXPIPRAZOLE | 213740 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213740 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213740 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213740 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213740 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213740 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/01/25 (TA) | -- | MSN PHARMS INC | None (Tentative Approval) |
BREXPIPRAZOLE | 213562 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213562 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213562 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213562 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213562 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213562 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/01/31 | 2023/01/31 | AMNEAL | Discontinued |
BREXPIPRAZOLE | 213718 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/02/03 | 2023/02/03 | AJANTA PHARMA LTD | Discontinued |
BREXPIPRAZOLE | 213718 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/02/03 | 2023/02/03 | AJANTA PHARMA LTD | Discontinued |
BREXPIPRAZOLE | 213718 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/02/03 | 2023/02/03 | AJANTA PHARMA LTD | Discontinued |