| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MACITENTAN | 211224 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2021/04/06 | 2021/04/06 | ZYDUS LIFESCIENCES | Discontinued |
| MACITENTAN | 214112 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2023/01/11 (TA) | -- | RHODES PHARMS | None (Tentative Approval) |
| MACITENTAN | 211198 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2023/04/18 | 2023/04/18 | AUROBINDO PHARMA LTD | Prescription |
| MACITENTAN | 211195 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2024/01/09 | 2024/01/09 | APOTEX | Discontinued |
| MACITENTAN | 211107 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2024/08/05 | 2024/08/05 | TORRENT | Discontinued |
| MACITENTAN | 211128 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2025/08/18 | 2025/08/18 | ALEMBIC | Prescription |
| MACITENTAN | 211136 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2025/08/20 | 2025/08/20 | MSN | Prescription |
| MACITENTAN | 211123 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2025/08/26 | 2025/08/26 | SUN PHARM | Prescription |
| MACITENTAN | 211120 | 001 | ANDA | MACITENTAN | TABLET;ORAL | 10MG | No | No | 2025/11/05 | 2025/11/05 | LAURUS | Prescription |