药品名称CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号019857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400MG/200ML
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)
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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
019857065APLabel2016/07/26下载
019857065APLetter2016/07/26下载
019857064APLetter2015/03/20下载
019857064APLabel2015/03/20下载
019857063APLetter2015/02/12下载
019857063APLabel2015/03/02下载
019857062APLabel2013/08/15下载
019857062APLetter2013/08/16下载
019857060APLetter2013/01/31下载
019857060APLabel2013/02/01下载
019857059APLetter2011/10/20下载
019857059APLabel2011/11/04下载
019857059APMedication Guide2011/11/04下载
019857058APLetter2011/08/08下载
019857058APLabel2011/08/12下载
019857057APLetter2011/08/15下载
019857057APMedication Guide2011/08/16下载
019857057APLabel2011/08/16下载
019857054APLetter2011/03/02下载
019857054APLabel2011/03/04下载
019857053APLabel2011/11/16下载
019857053APMedication Guide2011/11/16下载
019857053APLetter2011/11/21下载
019857052APLetter2009/06/30下载
019857051APLetter2009/05/07下载
019857051APLabel2009/05/11下载
019857050APLetter2009/02/18下载
019857050APLabel2009/02/20下载
019857050APMedication Guide2009/02/20下载
019857049APLabel2008/10/09下载
019857048APLabel2008/01/23下载
019857048APLetter2008/01/24下载
019857046APLabel2007/06/27下载
019857046APLetter2007/07/05下载
019857042APLetter2006/06/28下载
019857041APReview2007/07/09下载
019857041APLabel2005/11/17下载
019857041APLetter2005/11/18下载
019857038APLetter2005/05/20下载
019857038APLabel2005/05/20下载
019857036APLetter2004/07/21下载
019857036APLabel2004/07/21下载
019857036APReview2008/07/31下载
019857035APLetter2005/01/11下载
019857035APLabel2005/01/11下载
019857034APLetter2004/07/21下载
019857034APReview2008/07/31下载
019857034APLabel2004/07/21下载
019857033APReview2008/07/31下载
019857033APLetter2004/07/21下载
019857033APLabel2004/07/21下载
019857031APLetter2004/03/28下载
019857031APLabel2004/04/05下载
019857031APReview2008/07/31下载
019857028APReview2008/08/04下载
019857028APLetter2002/04/17下载
019857028APLabel2002/04/17下载
019857027APLetter2000/08/30下载
019857027APLabel2000/08/30下载
019857027APReview2000/08/30下载
019857013APReview2008/08/11下载
019857000APMedication Guide2013/08/16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
019857065AP2016/07/26Labeling Revision
019857064AP2015/03/19Labeling Revision
019857063AP2015/02/02Efficacy Supplement with Clinical Data to Support
019857062AP2013/08/14Labeling Revision
019857061AP2013/10/14Manufacturing Change or Addition
019857060AP2013/01/30Labeling Revision
019857059AP2011/10/18Labeling Revision
019857058AP2011/08/03Labeling Revision
019857057AP2011/08/12Labeling Revision
019857054AP2011/02/25Labeling Revision
019857053AP2011/11/15Labeling Revision
019857052AP2009/06/24Labeling Revision
019857051AP2009/04/27Labeling Revision
019857050AP2009/02/13Labeling Revision
019857049AP2008/10/03Labeling Revision
019857048AP2008/01/18Labeling Revision
019857046AP2007/06/25Labeling Revision
019857042AP2006/06/19Labeling Revision
019857041AP2005/11/09Labeling Revision
019857038AP2005/05/18Labeling Revision
019857036AP2004/07/14Labeling Revision
019857035AP2005/01/07Accelerated Approval
019857034AP2004/07/14Labeling Revision
019857033AP2004/07/14Labeling Revision
019857031AP2004/03/25Patient Population Altered
019857029AP2002/12/10Manufacturing Change or Addition
019857028AP2002/04/17Labeling Revision
019857027AP2000/08/30New or Modified Indication
019857026AP1999/06/09Control Supplement
019857025AP2000/06/28Labeling Revision
019857024AP1998/09/24Labeling Revision
019857023AP1999/01/07Manufacturing Change or Addition
019857022AP1998/11/13Control Supplement
019857021AP1998/09/24New or Modified Indication
019857020AP1998/09/24Labeling Revision
019857019AP1998/09/24New or Modified Indication
019857018AP1997/08/15Manufacturing Change or Addition
019857017AP1997/08/07New or Modified Indication
019857016AP1996/08/09Labeling Revision
019857015AP1996/06/28Package Change
019857014AP1998/04/03Patient Population Altered
019857013AP1997/09/26Labeling Revision
019857011AP1996/10/10New or Modified Indication
019857010AP1994/04/28Control Supplement
019857009AP1993/12/27Control Supplement
019857008AP1996/10/21New or Modified Indication
019857006AP1995/10/25Labeling Revision
019857005AP1992/04/23Control Supplement
019857003AP1992/05/13Control Supplement
019857002AP1991/04/24Package Change
019857001AP1991/04/24Package Change
019857000AP1990/12/26Approval