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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DOLOPHINE HYDROCHLORIDE | 006134 | 002 | NDA | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1947/08/13 | Approved Prior to Jan 1, 1982 | HIKMA | Discontinued |
DOLOPHINE HYDROCHLORIDE | 006134 | 004 | NDA | METHADONE HYDROCHLORIDE | SYRUP;ORAL | 10MG/30ML | No | No | 1947/08/13 | Approved Prior to Jan 1, 1982 | HIKMA | Discontinued |
DOLOPHINE HYDROCHLORIDE | 006134 | 010 | NDA | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1947/08/13 | Approved Prior to Jan 1, 1982 | HIKMA | Discontinued |