药品名称CIPRO
申请号019537产品号004
活性成分CIPROFLOXACIN HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 750MG BASE
治疗等效代码AB参比药物
批准日期1987/10/22申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority 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
52867542011/02/15PDF格式
5286754*PED2011/08/15PDF格式
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
I-4212007/03/25
PED2007/09/25
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
019537086APLabel2016/07/26下载
019537086APLetter2016/07/26下载
019537085APLabel2016/09/15下载
019537085APLetter2016/09/19下载
019537083APLetter2015/02/12下载
019537083APLabel2015/03/02下载
019537082APLabel2013/08/15下载
019537082APLetter2013/08/16下载
019537081APLetter2013/01/31下载
019537081APLabel2013/02/01下载
019537080APLetter2011/10/20下载
019537080APLabel2011/11/04下载
019537080APMedication Guide2011/11/04下载
019537079APMedication Guide2011/08/05下载
019537079APLetter2011/08/08下载
019537078APLabel2011/06/14下载
019537078APLetter2011/06/14下载
019537075APLetter2011/03/02下载
019537075APLabel2011/03/04下载
019537074APLabel2011/11/16下载
019537074APMedication Guide2011/11/16下载
019537074APLetter2011/11/21下载
019537073APLetter2009/04/10下载
019537073APLabel2009/04/16下载
019537071APLetter2009/06/30下载
019537070APLetter2009/05/07下载
019537070APLabel2009/05/11下载
019537070APReview2012/09/17下载
019537069APLetter2009/02/18下载
019537069APLabel2009/02/20下载
019537068APLetter2008/10/07下载
019537068APLabel2008/10/09下载
019537068APReview2012/09/17下载
019537067APLetter2008/01/22下载
019537067APLabel2008/01/23下载
019537065APLabel2007/06/27下载
019537065APLetter2007/07/05下载
019537062APLetter2006/06/28下载
019537060APReview2007/07/09下载
019537060APLabel2005/11/17下载
019537060APLetter2005/11/18下载
019537057APLetter2005/05/20下载
019537057APLabel2005/05/20下载
019537054APLabel2004/07/21下载
019537054APLetter2004/07/21下载
019537054APReview2008/04/04下载
019537053APReview2008/04/04下载
019537053APLabel2004/07/21下载
019537053APLetter2004/07/21下载
019537052APLetter2005/01/11下载
019537052APLabel2005/01/11下载
019537051APReview2007/11/19下载
019537051APLetter2004/03/28下载
019537051APLabel2004/04/05下载
019537050APLabel2004/04/05下载
019537050APLetter2004/03/28下载
019537050APReview2007/11/19下载
019537049APLetter2004/03/28下载
019537049APLabel2004/04/05下载
019537049APReview2008/04/04下载
019537048APLabel2004/04/05下载
019537048APLetter2004/03/28下载
019537048APReview2007/11/19下载
019537045APReview2008/04/04下载
019537044APReview2008/04/04下载
019537043APReview2007/11/19下载
019537043APLetter2002/12/16下载
019537042APReview2007/07/09下载
019537041APLetter2002/04/17下载
019537041APLabel2002/04/17下载
019537041APReview2008/04/04下载
019537038APReview2000/08/30下载
019537038APLetter2000/08/30下载
019537038APLabel2000/08/30下载
019537035APReview2007/07/09下载
019537033APReview2008/08/11下载
019537032APReview2007/07/09下载
019537031APReview2008/08/11下载
019537030APReview2008/08/11下载
019537025APReview2008/04/04下载
019537015APReview2004/10/08下载
019537013APReview2004/09/29下载
019537000APMedication Guide2011/03/15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
019537086AP2016/07/26Labeling Revision
019537085AP2016/09/14Labeling Revision
019537084AP2014/11/21Manufacturing Change or Addition
019537083AP2015/02/02New or Modified Indication
019537082AP2013/08/14Labeling Revision
019537081AP2013/01/30Labeling Revision
019537080AP2011/10/18Labeling Revision
019537079AP2011/08/03Labeling Revision
019537078AP2011/06/10Labeling Revision
019537075AP2011/02/25Labeling Revision
019537074AP2011/11/15Labeling Revision
019537073AP2009/04/06Labeling Revision
019537071AP2009/06/24Labeling Revision
019537070AP2009/04/27Labeling Revision
019537069AP2009/02/13Labeling Revision
019537068AP2008/10/03Labeling Revision
019537067AP2008/01/18Labeling Revision
019537065AP2007/06/25Labeling Revision
019537062AP2006/06/19Labeling Revision
019537060AP2005/11/09Labeling Revision
019537057AP2005/05/18Labeling Revision
019537054AP2004/07/14Labeling Revision
019537053AP2004/07/14Labeling Revision
019537052AP2005/01/07Accelerated Approval
019537051AP2004/03/15Labeling Revision
019537050AP2004/03/15Labeling Revision
019537049AP2004/03/25Patient Population Altered
019537048AP2004/03/15Labeling Revision
019537045AP2002/12/10Manufacturing Change or Addition
019537044AP2002/08/02Expiration Date Change
019537043AP2002/12/13Package Change
019537042AP2001/12/04Manufacturing Change or Addition
019537041AP2002/04/17Labeling Revision
019537040AP2000/06/28Labeling Revision
019537039AP2000/06/28Labeling Revision
019537038AP2000/08/30New or Modified Indication
019537036AP2000/06/28Labeling Revision
019537035AP1999/06/09Control Supplement
019537034AP2000/06/28Labeling Revision
019537033AP1998/09/17Labeling Revision
019537032AP1998/11/18Package Change
019537031AP1998/09/17Labeling Revision
019537030AP1998/09/17Labeling Revision
019537029AP1997/06/03New or Modified Indication
019537028AP1996/11/22Labeling Revision
019537027AP1998/04/03Patient Population Altered
019537026AP1996/04/08New or Modified Indication
019537025AP1997/09/26Labeling Revision
019537022AP1996/10/10New or Modified Indication
019537021AP1996/09/11New or Modified Indication
019537020AP1994/03/14Control Supplement
019537019AP1995/09/13New or Modified Indication
019537018AP2011/10/18Labeling Revision
019537017AP1992/09/10Control Supplement
019537016AP1997/05/15New or Modified Indication
019537015AP1994/07/21New or Modified Indication
019537013AP1994/07/21New or Modified Indication
019537009AP1991/11/19Manufacturing Change or Addition
019537008AP1993/01/22Labeling Revision
019537007AP1989/10/25Control Supplement
019537005AP1988/11/01Control Supplement
019537004AP1988/10/12Control Supplement
019537002AP1988/02/24Control Supplement
019537001AP1988/02/24Expiration Date Change
019537000AP1987/10/22Approval