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FDA Drug Application 020635 by JANSSEN PHARMS

Application Number020635
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/1996N3744000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020635ap.pdf 12/11/1997
AP012/20/1996N24004000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf 11/19/2009
AP04/8/1997SCS       
AP010/20/1998SCS       
AP012/17/1998SE13079003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm 7/2/1999
AP012/17/1998SE14788003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf 12/17/1998
AP012/17/1998SE19166003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf 6/8/2004
AP07/29/1999SLR       
AP07/29/1999SLR       
AP07/29/1999SLR       
AP02/2/2000SE12861007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF 2/2/2000
AP02/2/2000SE110155007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm 9/9/2004
AP02/2/2000SLR10156008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm 9/9/2004
AP09/29/1999SCS       
AP09/8/2000SE12859010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf 9/8/2000
AP09/8/2000SE12860010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf 9/8/2000
AP09/8/2000SCS       
AP012/18/2001SLR2853012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR2854012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR11898012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP09/8/2000SCP       
AP012/13/2000SCP       
AP09/15/2000SCS       
AP010/27/2000SCM       
AP01/4/2001SCM       
AP09/25/2001SCM       
AP012/18/2001SLR2855019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR2856019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR11899019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP012/18/2001SLR2857020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR2858020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR11900020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP01/11/2002SCS       
AP010/30/2002SE13081022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf 10/30/2002
AP011/6/2002SCM       
AP011/21/2002SCP       
AP05/23/2003SE15821026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf 6/8/2003
AP05/23/2003SE15885026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf 6/8/2003
AP05/23/2003SE120428026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020635_S026_LEVAQUIN.pdf 8/1/2008
AP010/23/2003SE27050027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf 12/4/2003
AP010/23/2003SE220427027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020635_S027_LEVAQUIN.pdf 8/1/2008
AP03/5/2004SLR7855029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf 3/10/2004
AP03/5/2004SLR8250029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf 4/5/2004
AP07/14/2004SE19775030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s030,20635s030ltr.pdf 7/21/2004
AP09/14/2004SLR10208033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf 9/15/2004
AP09/14/2004SLR10210033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf 9/15/2004
AP09/14/2004SLR10209034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf 9/15/2004
AP09/14/2004SLR10211034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf 9/15/2004
AP011/24/2004SE110686035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf 12/2/2004
AP011/24/2004SE110709035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf 12/3/2004
AP011/4/2004SLR10545037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf 11/8/2004
AP011/4/2004SLR10559037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf 11/8/2004
AP08/4/2005SE212549038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf 8/8/2005
AP08/4/2005SE212565038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf 8/8/2005
AP01/20/2006SLR13508042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf 1/27/2006
AP06/23/2006SLR14356043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf 6/28/2006
AP06/23/2006SLR14378043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf 6/28/2006
AP09/14/2007SE217897044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf 9/19/2007
AP09/14/2007SE217961044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf 9/25/2007
AP05/31/2007SLR16674045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf 6/4/2007
AP05/31/2007SLR16691045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf 6/4/2007
AP09/11/2007SE517911046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf 9/19/2007
AP09/11/2007SE517965046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf 9/25/2007
AP05/10/2007SLR16569047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf 5/16/2007
AP05/10/2007SLR16576047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf 5/16/2007
AP06/19/2007SLR16837048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf 6/27/2007
AP06/19/2007SLR16910048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf 7/5/2007
AP05/5/2008SE519787051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf 5/8/2008
AP05/5/2008SE520219051   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf 7/16/2008
AP011/15/2007SLR18428052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf 11/19/2007
AP011/15/2007SLR18467052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf 11/19/2007
AP011/16/2007SLR18433053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf 11/19/2007
AP011/16/2007SLR18470053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf 11/19/2007
AP012/13/2007SLR18651054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf 12/14/2007
AP012/13/2007SLR18839054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf 1/9/2008
AP04/16/2008SLR19677055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf 4/18/2008
AP04/16/2008SLR19931055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf 6/5/2008
AP010/3/2008SLR20965057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf 10/7/2008
AP010/3/2008SLR20977057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf 10/8/2008
AP04/27/2009SLR22420058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf 5/5/2009
AP04/27/2009SLR22501058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf 5/11/2009
AP03/12/2009SLR21994059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf 3/13/2009
AP02/25/2011SLR28025064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf 3/3/2011
AP02/25/2011SLR28068064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf 3/4/2011
AP06/9/2011SLR29133065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf 6/14/2011
AP06/9/2011SLR29138065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf 6/14/2011
AP04/27/2012SE832560067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028mg.pdf 4/30/2012
AP04/27/2012SE832561067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf 4/30/2012
AP04/27/2012SE832565067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf 5/1/2012
AP04/27/2012SE842098067   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm 3/11/2015
AP010/11/2011SLR30292068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30321068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32976068   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020635Orig1s068s070.pdf 6/22/2012
AP010/11/2011SLR30293070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30322070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32977070   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020635Orig1s068s070.pdf 6/22/2012
AP08/14/2013SLR36800071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf 8/15/2013
AP08/14/2013SLR36819071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf 8/16/2013
AP05/23/2014SLR39367072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf 5/28/2014
AP05/23/2014SLR39372072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf 5/28/2014
AP07/26/2016SLR46622073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf 7/26/2016
AP07/26/2016SLR46631073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf 7/26/2016




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