| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CEDAX | 050685 | 002 | NDA | CEFTIBUTEN DIHYDRATE | CAPSULE;ORAL | EQ 400MG BASE | No | No | 1995/12/20 | 1995/12/20 | SI PHARMS | Discontinued |
| CEDAX | 050686 | 001 | NDA | CEFTIBUTEN DIHYDRATE | FOR SUSPENSION;ORAL | EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/12/20 | 1995/12/20 | SI PHARMS | Discontinued |
| CEDAX | 050686 | 002 | NDA | CEFTIBUTEN DIHYDRATE | FOR SUSPENSION;ORAL | EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/12/20 | 1995/12/20 | SI PHARMS | Discontinued |