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FDA Drug Application 202895 by JANSSEN PRODS

Application Number202895
Application Type New Drug Application
Sponsor ApplicantJANSSEN PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/16/2011N31240000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf 12/23/2011
AP012/16/2011N31268000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf 12/27/2011
AP012/16/2011N33662000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895_prezista_toc.cfm 9/6/2012
AP012/16/2011N33663000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895Orig1s000SumR.pdf 9/6/2012
AP02/17/2012SLR31968001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895s001ltr.pdf 2/29/2012
AP02/17/2012SLR32116001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s001lbl.pdf 3/15/2012
AP06/1/2012SLR32814002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf 6/5/2012
AP06/1/2012SLR32843002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf 6/7/2012
AP011/9/2012SLR34370003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895Orig1s003ltr.pdf 11/14/2012
AP011/9/2012SLR34395003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf 11/15/2012
AP04/24/2013SE835845004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf 4/25/2013
AP04/24/2013SE835869004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf 4/29/2013
AP02/1/2013SE835063005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf 2/4/2013
AP02/1/2013SE835085005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf 2/6/2013
AP02/1/2013SE835065006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf 2/4/2013
AP02/1/2013SE835082006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf 2/6/2013
AP02/22/2013SLR35238007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf 2/26/2013
AP02/22/2013SLR35254007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf 2/26/2013
AP06/14/2013SCM       
AP011/7/2013SLR37768010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf 11/8/2013
AP011/7/2013SLR37776010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf 11/8/2013
AP04/7/2014SLR38997011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf 4/8/2014
AP04/7/2014SLR39011011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf 4/8/2014
AP05/8/2014SCM       
AP05/27/2015SLR42937013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf 5/28/2015
AP05/27/2015SLR42939013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf 5/29/2015
AP03/27/2015SLR42354016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf 4/1/2015
AP03/27/2015SLR42399016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf 4/2/2015
AP06/17/2016SE846365017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf 6/21/2016
AP06/17/2016SE846386017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf 6/21/2016
AP09/15/2016SLR47088019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf 9/20/2016
AP09/15/2016SLR47109019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf 9/20/2016




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