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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CAFCIT | 020793 | 001 | NDA | CAFFEINE CITRATE | SOLUTION;INTRAVENOUS | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | Yes | Yes | 1999/09/21 | 1999/09/21 | HIKMA | Prescription |
CAFCIT | 020793 | 002 | NDA | CAFFEINE CITRATE | SOLUTION;ORAL | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/09/21 | 2000/04/12 | HIKMA | Discontinued |