药品名称LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号020635产品号002
活性成分LEVOFLOXACIN市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 250MG/50ML (EQ 5MG/ML)
治疗等效代码参比药物
批准日期1996/12/20申请机构JANSSEN 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
50534072010/12/20PDF格式
5053407*PED2011/06/20PDF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
D-1002008/08/04
D-1082010/09/14
D-832006/10/23
M-612010/09/10
PED2007/04/23
PED2009/02/04
PED2011/03/10
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
020635073APLabel2016/07/26下载
020635073APLetter2016/07/26下载
020635072APLetter2014/05/28下载
020635072APLabel2014/05/28下载
020635071APLabel2013/08/15下载
020635071APLetter2013/08/16下载
020635070APReview2012/06/22下载
020635070APLabel2011/10/12下载
020635070APLetter2011/10/13下载
020635068APLetter2011/10/13下载
020635068APLabel2011/10/12下载
020635068APReview2012/06/22下载
020635067APReview2015/03/11下载
020635067APMedication Guide2012/04/30下载
020635067APLabel2012/04/30下载
020635067APLetter2012/05/01下载
020635065APLabel2011/06/14下载
020635065APLetter2011/06/14下载
020635064APLetter2011/03/03下载
020635064APLabel2011/03/04下载
020635059APLetter2009/03/13下载
020635058APLetter2009/05/05下载
020635058APLabel2009/05/11下载
020635057APLetter2008/10/07下载
020635057APLabel2008/10/08下载
020635055APLetter2008/04/18下载
020635055APLabel2008/06/05下载
020635054APLabel2007/12/14下载
020635054APLetter2008/01/09下载
020635053APLabel2007/11/19下载
020635053APLetter2007/11/19下载
020635052APLetter2007/11/19下载
020635052APLabel2007/11/19下载
020635051APSummary Review2008/07/16下载
020635051APLetter2008/05/08下载
020635048APLabel2007/06/27下载
020635048APLetter2007/07/05下载
020635047APLetter2007/05/16下载
020635047APLabel2007/05/16下载
020635046APLetter2007/09/25下载
020635046APLabel2007/09/19下载
020635045APLetter2007/06/04下载
020635045APLabel2007/06/04下载
020635044APLabel2007/09/19下载
020635044APLetter2007/09/25下载
020635043APLetter2006/06/28下载
020635043APLabel2006/06/28下载
020635042APLabel2006/01/27下载
020635038APLetter2005/08/08下载
020635038APLabel2005/08/08下载
020635037APLetter2004/11/08下载
020635037APLabel2004/11/08下载
020635035APLetter2004/12/02下载
020635035APLabel2004/12/03下载
020635034APLetter2004/09/15下载
020635034APLabel2004/09/15下载
020635033APLabel2004/09/15下载
020635033APLetter2004/09/15下载
020635030APLetter2004/07/21下载
020635029APLetter2004/03/10下载
020635029APLabel2004/04/05下载
020635027APLetter2003/12/04下载
020635027APReview2008/08/01下载
020635026APReview2008/08/01下载
020635026APLetter2003/06/08下载
020635026APLabel2003/06/08下载
020635022APLetter2002/10/30下载
020635020APLetter2001/12/18下载
020635020APLabel2001/12/18下载
020635020APReview2005/06/27下载
020635019APReview2005/06/27下载
020635019APLetter2001/12/18下载
020635019APLabel2001/12/18下载
020635012APLetter2001/12/18下载
020635012APLabel2001/12/18下载
020635012APReview2005/06/27下载
020635010APLetter2000/09/08下载
020635010APLabel2000/09/08下载
020635008APReview2004/09/09下载
020635007APReview2004/09/09下载
020635007APLetter2000/02/02下载
020635003APReview1999/07/02下载
020635003APLetter1998/12/17下载
020635003APLabel2004/06/08下载
020635000APReview1997/12/11下载
020635000APMedication 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
020635073AP2016/07/26Labeling Revision
020635072AP2014/05/23Labeling Revision
020635071AP2013/08/14Labeling Revision
020635070AP2011/10/11Labeling Revision
020635068AP2011/10/11Labeling Revision
020635067AP2012/04/27Efficacy Supplement with Clinical Data to Support
020635065AP2011/06/09Labeling Revision
020635064AP2011/02/25Labeling Revision
020635059AP2009/03/12Labeling Revision
020635058AP2009/04/27Labeling Revision
020635057AP2008/10/03Labeling Revision
020635055AP2008/04/16Labeling Revision
020635054AP2007/12/13Labeling Revision
020635053AP2007/11/16Labeling Revision
020635052AP2007/11/15Labeling Revision
020635051AP2008/05/05Patient Population Altered
020635048AP2007/06/19Labeling Revision
020635047AP2007/05/10Labeling Revision
020635046AP2007/09/11Patient Population Altered
020635045AP2007/05/31Labeling Revision
020635044AP2007/09/14New Dosage Regimen
020635043AP2006/06/23Labeling Revision
020635042AP2006/01/20Labeling Revision
020635038AP2005/08/04New Dosage Regimen
020635037AP2004/11/04Labeling Revision
020635035AP2004/11/24New or Modified Indication
020635034AP2004/09/14Labeling Revision
020635033AP2004/09/14Labeling Revision
020635030AP2004/07/14New or Modified Indication
020635029AP2004/03/05Labeling Revision
020635027AP2003/10/23New Dosage Regimen
020635026AP2003/05/23New or Modified Indication
020635025AP2002/11/21Package Change
020635024AP2002/11/06Manufacturing Change or Addition
020635022AP2002/10/30New or Modified Indication
020635021AP2002/01/11Control Supplement
020635020AP2001/12/18Labeling Revision
020635019AP2001/12/18Labeling Revision
020635018AP2001/09/25Manufacturing Change or Addition
020635017AP2001/01/04Manufacturing Change or Addition
020635016AP2000/10/27Manufacturing Change or Addition
020635015AP2000/09/15Control Supplement
020635014AP2000/12/13Package Change
020635013AP2000/09/08Package Change
020635012AP2001/12/18Labeling Revision
020635011AP2000/09/08Control Supplement
020635010AP2000/09/08New or Modified Indication
020635009AP1999/09/29Control Supplement
020635008AP2000/02/02Labeling Revision
020635007AP2000/02/02New or Modified Indication
020635006AP1999/07/29Labeling Revision
020635005AP1999/07/29Labeling Revision
020635004AP1999/07/29Labeling Revision
020635003AP1998/12/17New or Modified Indication
020635002AP1998/10/20Control Supplement
020635001AP1997/04/08Control Supplement
020635000AP1996/12/20Approval