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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
PREXXARTAN | 209139 | 001 | NDA | VALSARTAN | SOLUTION;ORAL | 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2017/12/19 | 2017/12/19 | CARMEL BIOSCIENCES | Discontinued |
PREXXARTAN | 209139 | 002 | NDA | VALSARTAN | SOLUTION;ORAL | 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2017/12/19 | 2017/12/19 | CARMEL BIOSCIENCES | Discontinued |