| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 209387 | 001 | NDA | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 50MG/100ML (0.5MG/ML) | Yes | Yes | 2017/03/08 | 2017/03/08 | EXELA PHARMA | Prescription |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 209387 | 002 | NDA | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2017/03/08 | 2017/12/07 | EXELA PHARMA | Discontinued |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | 209387 | 003 | NDA | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | Yes | Yes | 2017/03/08 | 2018/07/13 | EXELA PHARMA | Prescription |