药品名称CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号019857产品号001
活性成分CIPROFLOXACIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格200MG/100ML
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
4808583*PED2006/08/28PDF格式
49579222007/09/18PDF格式
4957922*PED2008/03/18PDF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
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