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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 020635 | 002 | NDA | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/12/20 | 1996/12/20 | JANSSEN PHARMS | Discontinued |
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 020635 | 003 | NDA | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/12/20 | 1996/12/20 | JANSSEN PHARMS | Discontinued |
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 020635 | 005 | NDA | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/12/20 | 1996/12/20 | JANSSEN PHARMS | Discontinued |