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FDA Drug Application 021721 by JANSSEN PHARMS

Application Number021721
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
AP010/21/2004N10502000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21721ltr.pdf 10/29/2004
AP010/21/2004N10524000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21721lbl.pdf 11/1/2004
AP010/21/2004N16284000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021721s000TOC.cfm 4/20/2007
AP010/21/2004N24005000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf 11/19/2009
AP08/4/2005SE212548002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf 8/8/2005
AP08/4/2005SE212564002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf 8/8/2005
AP011/24/2004SE110687003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf 12/2/2004
AP011/24/2004SE110710003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf 12/3/2004
AP01/20/2006SLR13509006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf 1/27/2006
AP01/20/2006SLR13557006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021721s006ltr.pdf 1/30/2006
AP06/23/2006SLR14357007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf 6/28/2006
AP06/23/2006SLR14377007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf 6/28/2006
AP09/14/2007SE217896009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf 9/19/2007
AP09/14/2007SE217962009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf 9/25/2007
AP05/31/2007SLR16673010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf 6/4/2007
AP05/31/2007SLR16690010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf 6/4/2007
AP09/11/2007SE517910011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf 9/19/2007
AP09/11/2007SE517963011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf 9/25/2007
AP05/10/2007SLR16568012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf 5/16/2007
AP05/10/2007SLR16575012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf 5/16/2007
AP06/19/2007SLR16838013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf 6/27/2007
AP06/19/2007SLR16909013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf 7/5/2007
AP05/5/2008SE519788015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf 5/8/2008
AP05/5/2008SE520218015   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf 7/16/2008
AP011/15/2007SLR18427016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf 11/19/2007
AP011/15/2007SLR18466016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf 11/19/2007
AP011/16/2007SLR18432017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf 11/19/2007
AP011/16/2007SLR18471017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf 11/19/2007
AP012/13/2007SLR18650018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf 12/14/2007
AP012/13/2007SLR18838018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf 1/9/2008
AP04/16/2008SLR19678019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf 4/18/2008
AP04/16/2008SLR19930019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf 6/5/2008
AP010/3/2008SLR20966020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf 10/7/2008
AP010/3/2008SLR20976020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf 10/8/2008
AP04/27/2009SLR22421021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf 5/5/2009
AP04/27/2009SLR22500021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf 5/11/2009
AP03/12/2009SLR21995022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf 3/13/2009
AP02/25/2011SLR28026025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf 3/3/2011
AP02/25/2011SLR28067025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf 3/4/2011
AP06/9/2011SLR29132026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf 6/14/2011
AP06/9/2011SLR29139026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf 6/14/2011
AP04/27/2012SE832558028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf 4/30/2012
AP04/27/2012SE832559028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028mg.pdf 4/30/2012
AP04/27/2012SE832566028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf 5/1/2012
AP04/27/2012SE842067028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm 3/10/2015
AP04/27/2012SE842068028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,%20020635Orig1s067,%20021721Orig1s028SumR.pdf 3/10/2015
AP010/11/2011SLR30294029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30323029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32974029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf 6/22/2012
AP010/11/2011SLR30295031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf 10/12/2011
AP010/11/2011SLR30324031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf 10/13/2011
AP010/11/2011SLR32975031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf 6/22/2012
AP08/14/2013SLR36799032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf 8/15/2013
AP08/14/2013SLR36820032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf 8/16/2013
AP05/23/2014SLR39368033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf 5/28/2014
AP05/23/2014SLR39371033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf 5/28/2014
AP07/26/2016SLR46623034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf 7/26/2016
AP07/26/2016SLR46632034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf 7/26/2016




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