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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DORIBAX | 022106 | 001 | NDA | DORIPENEM | INJECTABLE;INTRAVENOUS | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/10/12 | 2007/10/12 | SHIONOGI INC | Discontinued |
DORIBAX | 022106 | 002 | NDA | DORIPENEM | INJECTABLE;INTRAVENOUS | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/10/12 | 2010/10/05 | SHIONOGI INC | Discontinued |