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FDA Drug Application 022406 by JANSSEN PHARMS

Application Number022406
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/1/2011N29444000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf 7/7/2011
AP07/1/2011N29445000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf 7/7/2011
AP07/1/2011N35370000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf 3/8/2013
AP07/1/2011N36954000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000TOC.cfm 9/5/2013
AP011/2/2012SE134298001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf 11/6/2012
AP011/2/2012SE134309001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003mg.pdf 11/6/2012
AP011/2/2012SE134306001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf 11/6/2012
AP011/2/2012SE134307002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf 11/6/2012
AP011/2/2012SE134310002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003mg.pdf 11/6/2012
AP011/2/2012SE134300002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf 11/6/2012
AP011/2/2012SE134301003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf 11/6/2012
AP011/2/2012SE134311003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003mg.pdf 11/6/2012
AP011/2/2012SE134308003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf 11/6/2012
AP03/1/2013SE835325004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022406Orig1s004ltr.pdf 3/4/2013
AP03/1/2013SE835339004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022406s004lbl.pdf 3/5/2013
AP01/31/2013SCM       
AP01/7/2014SLR38235007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s007ltr.pdf 1/9/2014
AP01/7/2014SLR38249007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s007lbl.pdf 1/10/2014
AP03/6/2014SLR38715009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s009ltr.pdf 3/7/2014
AP03/6/2014SLR38721009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s009lbl.pdf 3/7/2014
AP02/13/2014SLR38525010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s010ltr.pdf 2/14/2014
AP02/13/2014SLR38526010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s010lbl.pdf 2/14/2014
AP09/15/2014SCM40520011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s011lbl.pdf 9/19/2014
AP01/15/2015SLR41646012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022406Orig1s012ltr.pdf 1/20/2015
AP01/15/2015SLR41656012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022406s012lbl.pdf 1/20/2015
AP02/16/2015SCM       
AP05/5/2015SCM       
AP012/19/2014SLR41400015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s015ltr.pdf 12/24/2014
AP012/19/2014SLR41584015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s015lbl.pdf 1/9/2015
AP010/26/2015SCM       
AP08/17/2016SLR46807017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s017ltr.pdf 8/19/2016
AP08/17/2016SLR46840017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s017lbl.pdf 8/22/2016
AP08/22/2016SCM       
AP08/25/2016SLR46891019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf 8/29/2016
AP08/25/2016SLR46904019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf 8/29/2016
AP08/25/2016SLR46905020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf 8/29/2016
AP08/25/2016SLR46892020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf 8/29/2016




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