| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EPANED KIT | 204308 | 001 | NDA | ENALAPRIL MALEATE | FOR SOLUTION;ORAL | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2013/08/13 | 2013/08/13 | AZURITY | Discontinued |
| EPANED | 208686 | 001 | NDA | ENALAPRIL MALEATE | SOLUTION;ORAL | 1MG/ML | Yes | Yes | 2016/09/20 | 2016/09/20 | AZURITY | Prescription |