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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CERUBIDINE | 050484 | 001 | NDA | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1979/12/19 | Approved Prior to Jan 1, 1982 | WYETH AYERST | Discontinued |
CERUBIDINE | 061876 | 001 | ANDA | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | No | 1980/02/05 | Approved Prior to Jan 1, 1982 | SANOFI AVENTIS US | Discontinued |
CERUBIDINE | 064103 | 001 | ANDA | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | Yes | 1995/02/03 | 1995/02/03 | HIKMA | Prescription |