药品名称FLOXIN
申请号019735产品号001
活性成分OFLOXACIN市场状态停止上市
剂型或给药途径TABLET;ORAL规格200MG
治疗等效代码参比药物
批准日期1990/12/28申请机构JANSSEN PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
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
019735061APLetter2011/03/03下载
019735061APMedication Guide2011/03/04下载
019735061APLabel2011/03/04下载
019735060APLetter2009/02/13下载
019735059APLetter2008/10/07下载
019735059APLabel2008/10/09下载
019735058APLabel2007/12/14下载
019735058APLetter2008/01/09下载
019735057APLabel2007/06/27下载
019735057APLetter2007/07/05下载
019735056APLetter2007/05/29下载
019735056APLabel2007/05/29下载
019735055APLabel2006/06/20下载
019735055APLetter2006/06/20下载
019735054APLabel2006/01/27下载
019735054APLetter2006/01/30下载
019735053APLetter2004/09/17下载
019735053APLabel2004/09/17下载
019735053APReview2009/09/16下载
019735052APReview2009/09/16下载
019735052APLetter2004/09/17下载
019735052APLabel2004/09/17下载
019735051APLetter2004/03/10下载
019735051APLabel2004/04/05下载
019735023APReview2008/04/04下载
019735022APReview2008/04/04下载
019735019APReview2008/04/04下载
019735018APReview2008/04/04下载
019735016APReview2006/05/10下载
019735008APReview2006/05/10下载
019735007APReview2006/05/10下载
019735004APReview2006/05/10下载
019735001APReview2006/05/10下载
019735000APMedication Guide2009/11/19下载
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
019735061AP2011/02/25Labeling Revision
019735060AP2009/02/12Labeling Revision
019735059AP2008/10/03Labeling Revision
019735058AP2007/12/13Labeling Revision
019735057AP2007/06/19Labeling Revision
019735056AP2007/05/16Labeling Revision
019735055AP2006/06/14Labeling Revision
019735054AP2006/01/20Labeling Revision
019735053AP2004/09/15Labeling Revision
019735052AP2004/09/15Labeling Revision
019735051AP2004/03/06Labeling Revision
019735050AP2000/10/30Control Supplement
019735049AP1999/12/08Labeling Revision
019735048AP1999/09/08Manufacturing Change or Addition
019735047AP1999/12/08Labeling Revision
019735046AP1999/03/25Manufacturing Change or Addition
019735045AP1999/12/08Labeling Revision
019735044AP1998/09/21Labeling Revision
019735043AP1996/06/28Manufacturing Change or Addition
019735042AP1996/12/19New or Modified Indication
019735041AP1995/11/09Manufacturing Change or Addition
019735040AP1995/09/22Package Change
019735039AP1997/08/11Labeling Revision
019735038AP1996/09/11Labeling Revision
019735036AP1994/08/08Control Supplement
019735035AP1995/01/09Manufacturing Change or Addition
019735034AP1993/12/07Expiration Date Change
019735032AP1993/11/30Manufacturing Change or Addition
019735031AP1993/11/30Manufacturing Change or Addition
019735030AP1993/11/30Manufacturing Change or Addition
019735024AP1994/07/21Labeling Revision
019735023AP1992/09/03Manufacturing Change or Addition
019735022AP1992/09/03Manufacturing Change or Addition
019735021AP1993/08/11Manufacturing Change or Addition
019735019AP1992/09/10Formulation Revision
019735018AP1992/12/08Manufacturing Change or Addition
019735016AP1992/07/14Control Supplement
019735015AP1993/09/20Control Supplement
019735008AP1992/06/23Control Supplement
019735007AP1992/05/15Control Supplement
019735004AP1991/12/13Manufacturing Change or Addition
019735001AP1991/02/28Control Supplement
019735000AP1990/12/28Approval