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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DESFERAL | 016267 | 001 | NDA | DEFEROXAMINE MESYLATE | INJECTABLE;INJECTION | 500MG/VIAL | Yes | Yes | 1968/04/01 | Approved Prior to Jan 1, 1982 | NOVARTIS | Prescription |
DESFERAL | 016267 | 002 | NDA | DEFEROXAMINE MESYLATE | INJECTABLE;INJECTION | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1968/04/01 | 2000/05/25 | NOVARTIS | Discontinued |