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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ADRUCIL | 017959 | 001 | NDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | -- | Approved Prior to Jan 1, 1982 | PHARMACIA AND UPJOHN | Discontinued |
ADRUCIL | 081222 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1991/06/28 | PHARMACIA AND UPJOHN | Discontinued |
ADRUCIL | 081225 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1991/08/28 | 1991/08/28 | TEVA PARENTERAL | Discontinued |
ADRUCIL | 040023 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1991/10/18 | 1991/10/18 | TEVA PARENTERAL | Discontinued |