| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| METHYLNALTREXONE BROMIDE | 208592 | 001 | ANDA | METHYLNALTREXONE BROMIDE | INJECTABLE;SUBCUTANEOUS | 12MG/0.6ML | No | No | 2017/05/03 (TA) | -- | MYLAN LABS LTD | None (Tentative Approval) |
| METHYLNALTREXONE BROMIDE | 208038 | 001 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 12MG/0.6ML | No | No | 2021/08/12 (TA) | -- | US GENERICS, STERILES | None (Tentative Approval) |
| METHYLNALTREXONE BROMIDE | 208112 | 001 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 8MG/0.4ML (8MG/0.4ML) | No | No | 2024/08/26 | 2024/08/26 | ACTAVIS LLC | Prescription |
| METHYLNALTREXONE BROMIDE | 208112 | 002 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 12MG/0.6ML (12MG/0.6ML) | No | No | 2024/08/26 | 2024/08/26 | ACTAVIS LLC | Prescription |