药品名称LEVAQUIN
申请号020634产品号003
活性成分LEVOFLOXACIN市场状态处方药
剂型或给药途径TABLET;ORAL规格750MG
治疗等效代码AB参比药物
批准日期2000/09/08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
020634067APLabel2016/07/26下载
020634067APLetter2016/07/26下载
020634066APLetter2014/05/28下载
020634066APLabel2014/05/28下载
020634065APLabel2013/08/15下载
020634065APLetter2013/08/16下载
020634064APReview2012/06/22下载
020634064APLetter2011/10/13下载
020634064APLabel2011/10/12下载
020634062APLetter2011/10/13下载
020634062APLabel2011/10/12下载
020634062APReview2012/06/22下载
020634061APLabel2012/04/30下载
020634061APMedication Guide2012/04/30下载
020634061APLetter2012/05/01下载
020634061APReview2015/03/11下载
020634059APLabel2011/06/14下载
020634059APLetter2011/06/14下载
020634058APLetter2011/03/03下载
020634058APLabel2011/03/04下载
020634054APLetter2009/03/13下载
020634053APLetter2009/05/05下载
020634053APLabel2009/05/11下载
020634052APLetter2008/10/07下载
020634052APLabel2008/10/08下载
020634051APLabel2008/06/05下载
020634051APLetter2008/04/18下载
020634050APLabel2007/12/14下载
020634050APLetter2008/01/09下载
020634049APLabel2007/11/19下载
020634049APLetter2007/11/19下载
020634048APLetter2007/11/19下载
020634048APLabel2007/11/19下载
020634047APLetter2008/05/08下载
020634047APSummary Review2008/07/16下载
020634045APLabel2007/06/27下载
020634045APLetter2007/07/05下载
020634044APLetter2007/05/16下载
020634044APLabel2007/05/16下载
020634043APLabel2007/09/19下载
020634043APLetter2007/09/25下载
020634042APLetter2007/06/04下载
020634042APLabel2007/06/04下载
020634041APLetter2007/09/25下载
020634041APLabel2007/09/19下载
020634040APLetter2006/06/28下载
020634040APLabel2006/06/28下载
020634039APLabel2006/01/27下载
020634037APLetter2005/08/08下载
020634037APLabel2005/08/08下载
020634036APLetter2004/11/08下载
020634036APLabel2004/11/08下载
020634035APLetter2004/12/02下载
020634035APLabel2004/12/03下载
020634034APLetter2004/09/15下载
020634034APLabel2004/09/15下载
020634034APReview2009/09/17下载
020634033APLabel2004/09/15下载
020634033APLetter2004/09/15下载
020634033APReview2009/09/17下载
020634030APLabel2004/07/21下载
020634029APLetter2004/03/10下载
020634029APLabel2004/04/05下载
020634028APLetter2003/12/04下载
020634028APReview2008/08/01下载
020634027APReview2008/08/01下载
020634027APLetter2003/06/08下载
020634027APLabel2003/06/08下载
020634025APLetter2002/10/30下载
020634022APLetter2001/12/18下载
020634022APLabel2001/12/18下载
020634022APReview2005/06/27下载
020634021APReview2005/06/27下载
020634021APLabel2001/12/18下载
020634021APLetter2001/12/18下载
020634015APLetter2001/12/18下载
020634015APLabel2001/12/18下载
020634015APReview2005/06/27下载
020634013APLetter2000/09/08下载
020634013APLabel2000/09/08下载
020634012APLetter2000/09/08下载
020634012APLabel2000/09/08下载
020634009APLetter2000/02/02下载
020634009APReview2004/09/09下载
020634008APReview2004/09/09下载
020634008APLetter2000/02/02下载
020634004APReview1999/07/02下载
020634004APLetter1998/12/17下载
020634004APLabel2004/06/08下载
020634004APOther2004/06/08下载
020634000APReview2007/04/24下载
020634000APMedication 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
020634067AP2016/07/26Labeling Revision
020634066AP2014/05/23Labeling Revision
020634065AP2013/08/14Labeling Revision
020634064AP2011/10/11Labeling Revision
020634062AP2011/10/11Labeling Revision
020634061AP2012/04/27Efficacy Supplement with Clinical Data to Support
020634059AP2011/06/09Labeling Revision
020634058AP2011/02/25Labeling Revision
020634054AP2009/03/12Labeling Revision
020634053AP2009/04/27Labeling Revision
020634052AP2008/10/03Labeling Revision
020634051AP2008/04/16Labeling Revision
020634050AP2007/12/13Labeling Revision
020634049AP2007/11/16Labeling Revision
020634048AP2007/11/15Labeling Revision
020634047AP2008/05/05Patient Population Altered
020634045AP2007/06/19Labeling Revision
020634044AP2007/05/10Labeling Revision
020634043AP2007/09/11Patient Population Altered
020634042AP2007/05/31Labeling Revision
020634041AP2007/09/14New Dosage Regimen
020634040AP2006/06/23Labeling Revision
020634039AP2006/01/20Labeling Revision
020634037AP2005/08/04New Dosage Regimen
020634036AP2004/11/04Labeling Revision
020634035AP2004/11/24New or Modified Indication
020634034AP2004/09/14Labeling Revision
020634033AP2004/09/14Labeling Revision
020634030AP2004/07/14New or Modified Indication
020634029AP2004/03/05Labeling Revision
020634028AP2003/10/23New Dosage Regimen
020634027AP2003/05/23New or Modified Indication
020634026AP2002/06/12Control Supplement
020634025AP2002/10/30New or Modified Indication
020634024AP2002/04/30Control Supplement
020634023AP2002/01/11Control Supplement
020634022AP2001/12/18Labeling Revision
020634021AP2001/12/18Labeling Revision
020634020AP2001/06/08Manufacturing Change or Addition
020634019AP2001/02/13Control Supplement
020634018AP2001/01/04Manufacturing Change or Addition
020634017AP2000/09/15Control Supplement
020634016AP2000/12/13Package Change
020634015AP2001/12/18Labeling Revision
020634014AP2000/08/28Manufacturing Change or Addition
020634013AP2000/09/08New or Modified Indication
020634012AP2000/09/08Control Supplement
020634011AP2000/02/11Control Supplement
020634010AP1999/09/29Control Supplement
020634009AP2000/02/02Labeling Revision
020634008AP2000/02/02New or Modified Indication
020634007AP1999/07/29Labeling Revision
020634006AP1999/07/29Labeling Revision
020634005AP1999/07/29Labeling Revision
020634004AP1998/12/17New or Modified Indication
020634003AP1998/03/24Manufacturing Change or Addition
020634002AP1998/05/11Manufacturing Change or Addition
020634001AP1998/01/30Control Supplement
020634000AP1996/12/20Approval