| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BUMEX | 018225 | 001 | NDA | BUMETANIDE | TABLET;ORAL | 1MG | Yes | No | 1983/02/28 | 1983/02/28 | VALIDUS PHARMS | Prescription |
| BUMEX | 018225 | 002 | NDA | BUMETANIDE | TABLET;ORAL | 0.5MG | Yes | No | 1983/02/28 | 1983/02/28 | VALIDUS PHARMS | Prescription |
| BUMEX | 018225 | 003 | NDA | BUMETANIDE | TABLET;ORAL | 2MG | Yes | No | 1983/02/28 | 1985/06/14 | VALIDUS PHARMS | Prescription |
| BUMEX | 018226 | 001 | NDA | BUMETANIDE | INJECTABLE;INJECTION | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1983/02/28 | 1983/02/28 | VALIDUS PHARMS | Discontinued |