| 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 | 213788 | 001 | ANDA | BREXPIPRAZOLE | TABLET; ORAL | 0.25MG | No | No | 2021/08/17 (TA) | -- | ACCORD HLTHCARE INC | None (Tentative Approval) |
| BREXPIPRAZOLE | 213692 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213692 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213692 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213692 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213692 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213692 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2022/08/11 | 2022/08/11 | TEVA PHARMS USA INC | Discontinued |
| BREXPIPRAZOLE | 213477 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213477 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213477 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213477 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213477 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213477 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2022/08/29 (TA) | -- | ZENARA | None (Tentative Approval) |
| BREXPIPRAZOLE | 213570 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213570 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213570 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213570 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213570 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213570 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2022/09/26 | 2022/09/26 | SANDOZ | Discontinued |
| BREXPIPRAZOLE | 213660 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/01/10 | 2023/01/10 | ZYDUS PHARMS | Discontinued |