| 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 | 213587 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/03/21 (TA) | -- | PRINSTON PHARMA INC | None (Tentative Approval) |
| BREXPIPRAZOLE | 213758 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213758 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213758 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213758 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213758 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213758 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/10/25 | 2023/10/25 | OPTIMUS | Prescription |
| BREXPIPRAZOLE | 213659 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213659 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213659 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213659 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213659 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213659 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/11/02 | 2023/11/02 | AUROBINDO PHARMA LTD | Discontinued |
| BREXPIPRAZOLE | 213669 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213669 | 002 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213669 | 003 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213669 | 004 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213669 | 005 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213669 | 006 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No | 2023/11/20 | 2023/11/20 | HETERO LABS LTD V | Prescription |
| BREXPIPRAZOLE | 213782 | 001 | ANDA | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No | 2023/11/28 | 2023/11/28 | ALKEM LABS LTD | Prescription |