| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| REVEX | 020459 | 001 | NDA | NALMEFENE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/04/17 | 1995/04/17 | HIKMA | Discontinued |
| REVEX | 020459 | 002 | NDA | NALMEFENE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/04/17 | 1995/04/17 | HIKMA | Discontinued |