药品名称FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号020087产品号005
活性成分OFLOXACIN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格400MG/100ML
治疗等效代码参比药物
批准日期1992/03/31申请机构ORTHO MCNEIL PHARMACEUTICAL INC
化学类型New dosage form审评分类Standard review drug
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申请号修订号审批结论公开文档类型文档创建时间获取文档
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020087024AP1999/12/08Labeling Revision
020087023AP1999/12/08Labeling Revision
020087022AP1999/03/25Manufacturing Change or Addition
020087021AP1999/12/08Labeling Revision
020087020AP1998/10/20Control Supplement
020087019AP1998/05/12Manufacturing Change or Addition
020087018AP1997/04/16Manufacturing Change or Addition
020087017AP1996/12/19New or Modified Indication
020087016AP1997/08/11Labeling Revision
020087015AP1996/09/11Labeling Revision
020087013AP1994/03/22Control Supplement
020087012AP1993/12/27Control Supplement
020087011AP1993/12/07Expiration Date Change
020087002AP1993/05/10Manufacturing Change or Addition
020087001AP1992/05/19Package Change
020087000AP1992/03/31Approval