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FDA Drug Application 020634 by JANSSEN PHARMS

Application Number020634
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
AP012/20/1996N16285000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020634_levaquin_toc.cfm 4/24/2007
AP012/20/1996N24003000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf 11/19/2009
AP01/30/1998SCS       
AP05/11/1998SCM       
AP03/24/1998SCM       
AP012/17/1998SE1916004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm 7/2/1999
AP012/17/1998SE14787004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf 12/17/1998
AP012/17/1998SE19164004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf 6/8/2004
AP012/17/1998SE19165004Label Pt. 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P2.pdf 6/8/2004
AP07/29/1999SLR       
AP07/29/1999SLR       
AP07/29/1999SLR       
AP02/2/2000SE11260008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF 2/2/2000
AP02/2/2000SE110153008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm 9/9/2004
AP02/2/2000SLR1265009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF 2/2/2000
AP02/2/2000SLR10154009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm 9/9/2004
AP09/29/1999SCS       
AP02/11/2000SCS       
AP09/8/2000SCS1459012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf 9/8/2000
AP09/8/2000SCS1460012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf 9/8/2000
AP09/8/2000SE11468013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf 9/8/2000
AP09/8/2000SE11469013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf 9/8/2000
AP08/28/2000SCM       
AP012/18/2001SLR2806015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR2807015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR11895015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP012/13/2000SCP       
AP09/15/2000SCS       
AP01/4/2001SCM       
AP02/13/2001SCS       
AP06/8/2001SCM       
AP012/18/2001SLR2849021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR2850021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR11896021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP012/18/2001SLR2851022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf 12/18/2001
AP012/18/2001SLR2852022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf 12/18/2001
AP012/18/2001SLR11897022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm 6/27/2005
AP01/11/2002SCS       
AP04/30/2002SCS       
AP010/30/2002SE13080025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf 10/30/2002
AP06/12/2002SCS       
AP05/23/2003SE15820027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf 6/8/2003
AP05/23/2003SE15884027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf 6/8/2003
AP05/23/2003SE120403027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S027_LEVAQUIN.pdf 8/1/2008
AP010/23/2003SE27049028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf 12/4/2003
AP010/23/2003SE220404028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S028_LEVAQUIN.pdf 8/1/2008
AP03/5/2004SLR7854029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf 3/10/2004
AP03/5/2004SLR8249029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf 4/5/2004
AP07/14/2004SE19774030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s030,20635s030lbl.pdf 7/21/2004
AP09/14/2004SLR10207033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf 9/15/2004
AP09/14/2004SLR10213033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf 9/15/2004
AP09/14/2004SLR23448033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S033_Levaquin.pdf 9/17/2009
AP09/14/2004SLR10206034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf 9/15/2004
AP09/14/2004SLR10212034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf 9/15/2004
AP09/14/2004SLR23449034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S034_Levaquin.pdf 9/17/2009
AP011/24/2004SE110685035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf 12/2/2004
AP011/24/2004SE110708035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf 12/3/2004
AP011/4/2004SLR10546036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf 11/8/2004
AP011/4/2004SLR10560036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf 11/8/2004
AP08/4/2005SE212550037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf 8/8/2005
AP08/4/2005SE212566037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf 8/8/2005
AP01/20/2006SLR13507039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf 1/27/2006
AP06/23/2006SLR14355040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf 6/28/2006
AP06/23/2006SLR14379040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf 6/28/2006
AP09/14/2007SE217898041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf 9/19/2007
AP09/14/2007SE217960041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf 9/25/2007
AP05/31/2007SLR16675042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf 6/4/2007
AP05/31/2007SLR16692042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf 6/4/2007
AP09/11/2007SE517912043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf 9/19/2007
AP09/11/2007SE517964043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf 9/25/2007
AP05/10/2007SLR16570044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf 5/16/2007
AP05/10/2007SLR16577044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf 5/16/2007
AP06/19/2007SLR16836045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf 6/27/2007
AP06/19/2007SLR16911045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf 7/5/2007
AP05/5/2008SE519786047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf 5/8/2008
AP05/5/2008SE520220047   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf 7/16/2008
AP011/15/2007SLR18429048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf 11/19/2007
AP011/15/2007SLR18468048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf 11/19/2007
AP011/16/2007SLR18434049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf 11/19/2007
AP011/16/2007SLR18469049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf 11/19/2007
AP012/13/2007SLR18652050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf 12/14/2007
AP012/13/2007SLR18840050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf 1/9/2008
AP04/16/2008SLR19676051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf 4/18/2008
AP04/16/2008SLR19932051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf 6/5/2008
AP010/3/2008SLR20964052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf 10/7/2008
AP010/3/2008SLR20978052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf 10/8/2008
AP04/27/2009SLR22419053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf 5/5/2009
AP04/27/2009SLR22502053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf 5/11/2009
AP03/12/2009SLR21993054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf 3/13/2009
AP02/25/2011SLR28024058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf 3/3/2011
AP02/25/2011SLR28069058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf 3/4/2011
AP06/9/2011SLR29134059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf 6/14/2011
AP06/9/2011SLR29137059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf 6/14/2011
AP04/27/2012SE832562061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf 4/30/2012
AP04/27/2012SE832563061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028mg.pdf 4/30/2012
AP04/27/2012SE832564061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf 5/1/2012
AP04/27/2012SE842097061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm 3/11/2015
AP010/11/2011SLR30290062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30319062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32978062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf 6/22/2012
AP010/11/2011SLR30291064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30320064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32979064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf 6/22/2012
AP08/14/2013SLR36801065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf 8/15/2013
AP08/14/2013SLR36818065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf 8/16/2013
AP05/23/2014SLR39366066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf 5/28/2014
AP05/23/2014SLR39373066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf 5/28/2014
AP07/26/2016SLR46621067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf 7/26/2016
AP07/26/2016SLR46630067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf 7/26/2016




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