| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VASOTEC | 018998 | 001 | NDA | ENALAPRIL MALEATE | TABLET;ORAL | 5MG | Yes | No | 1985/12/24 | 1985/12/24 | BAUSCH | Prescription |
| VASOTEC | 018998 | 002 | NDA | ENALAPRIL MALEATE | TABLET;ORAL | 10MG | Yes | No | 1985/12/24 | 1985/12/24 | BAUSCH | Prescription |
| VASOTEC | 018998 | 003 | NDA | ENALAPRIL MALEATE | TABLET;ORAL | 20MG | Yes | Yes | 1985/12/24 | 1985/12/24 | BAUSCH | Prescription |
| VASOTEC | 018998 | 005 | NDA | ENALAPRIL MALEATE | TABLET;ORAL | 2.5MG | Yes | No | 1985/12/24 | 1988/07/26 | BAUSCH | Prescription |
| VASOTEC | 019309 | 001 | NDA | ENALAPRILAT | INJECTABLE;INJECTION | 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1988/02/09 | 1988/02/09 | BIOVAIL LABS INTL | Discontinued |