药品名称CIPRO
申请号019847产品号002
活性成分CIPROFLOXACIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格200MG/20ML (10MG/ML)
治疗等效代码AP参比药物
批准日期1990/12/26申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
化学类型New dosage form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
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
019847057APLabel2016/07/26下载
019847057APLetter2016/07/26下载
019847056APLetter2015/03/20下载
019847056APLabel2015/03/20下载
019847055APLetter2015/02/12下载
019847055APLabel2015/03/02下载
019847054APLabel2013/08/15下载
019847054APLetter2013/08/16下载
019847053APLetter2013/01/31下载
019847053APLabel2013/02/01下载
019847052APLetter2011/10/20下载
019847052APLabel2011/11/04下载
019847052APMedication Guide2011/11/04下载
019847051APMedication Guide2011/08/05下载
019847051APLetter2011/08/08下载
019847050APLetter2011/08/15下载
019847050APLabel2011/08/16下载
019847050APMedication Guide2011/08/16下载
019847047APLetter2011/03/02下载
019847047APLabel2011/03/04下载
019847046APLabel2011/11/16下载
019847046APMedication Guide2011/11/16下载
019847046APLetter2011/11/21下载
019847045APLetter2009/06/30下载
019847044APLetter2009/05/07下载
019847044APLabel2009/05/11下载
019847043APLetter2009/02/18下载
019847043APLabel2009/02/20下载
019847042APLetter2008/10/07下载
019847042APLabel2008/10/09下载
019847041APLabel2008/01/23下载
019847041APLetter2008/01/24下载
019847039APLabel2007/06/27下载
019847039APLetter2007/07/05下载
019847037APLetter2006/06/28下载
019847036APReview2007/07/09下载
019847036APLabel2005/11/17下载
019847036APLetter2005/11/18下载
019847032APLetter2005/05/20下载
019847032APLabel2005/05/20下载
019847031APLetter2004/07/21下载
019847031APLabel2004/07/21下载
019847031APReview2008/07/31下载
019847030APLetter2005/01/11下载
019847030APLabel2005/01/11下载
019847029APLetter2004/07/21下载
019847029APReview2008/07/31下载
019847029APLabel2004/07/21下载
019847028APReview2008/07/31下载
019847028APLetter2004/07/21下载
019847028APLabel2004/07/21下载
019847027APLetter2004/03/28下载
019847027APLabel2004/04/05下载
019847027APReview2008/07/31下载
019847026APReview2008/08/04下载
019847026APLetter2002/04/17下载
019847026APLabel2002/04/17下载
019847024APLetter2000/08/30下载
019847024APLabel2000/08/30下载
019847024APReview2000/08/30下载
019847022APReview2008/08/08下载
019847012APReview2008/08/11下载
019847000APMedication 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
019847057AP2016/07/26Labeling Revision
019847056AP2015/03/19Labeling Revision
019847055AP2015/02/02Efficacy Supplement with Clinical Data to Support
019847054AP2013/08/14Labeling Revision
019847053AP2013/01/30Labeling Revision
019847052AP2011/10/18Labeling Revision
019847051AP2011/08/03Labeling Revision
019847050AP2011/08/12Labeling Revision
019847047AP2011/02/25Labeling Revision
019847046AP2011/11/15Labeling Revision
019847045AP2009/06/24Labeling Revision
019847044AP2009/04/27Labeling Revision
019847043AP2009/02/13Labeling Revision
019847042AP2008/10/03Labeling Revision
019847041AP2008/01/18Labeling Revision
019847039AP2007/06/25Labeling Revision
019847037AP2006/06/19Labeling Revision
019847036AP2005/11/09Labeling Revision
019847032AP2005/05/18Labeling Revision
019847031AP2004/07/14Labeling Revision
019847030AP2005/01/07Accelerated Approval
019847029AP2004/07/14Labeling Revision
019847028AP2004/07/14Labeling Revision
019847027AP2004/03/25Patient Population Altered
019847026AP2002/04/17Labeling Revision
019847025AP2000/10/31Manufacturing Change or Addition
019847024AP2000/08/30New or Modified Indication
019847022AP1999/11/01Manufacturing Change or Addition
019847021AP2000/06/28Labeling Revision
019847020AP1998/09/24Labeling Revision
019847018AP1998/09/24New or Modified Indication
019847017AP1998/09/24Labeling Revision
019847016AP1998/09/24New or Modified Indication
019847015AP1997/08/07New or Modified Indication
019847014AP1996/08/09Labeling Revision
019847013AP1998/04/03Patient Population Altered
019847012AP1997/09/26Labeling Revision
019847010AP1996/10/10New or Modified Indication
019847009AP1993/06/14Expiration Date Change
019847008AP1996/10/21New or Modified Indication
019847007AP1993/02/12Manufacturing Change or Addition
019847005AP1995/10/25Labeling Revision
019847004AP1992/04/23Control Supplement
019847003AP1992/05/13Control Supplement
019847001AP1992/05/13Control Supplement
019847000AP1990/12/26Approval