Back to FDA Applications sponsored by JANSSEN PHARMS

FDA Drug Application 204042 by JANSSEN PHARMS

Application Number204042
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
AP03/29/2013N35590000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204042Orig1s000ltr.pdf 4/1/2013
AP03/29/2013N35625000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204042s000lbl.pdf 4/1/2013
AP03/29/2013N35635000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM346637.pdf 4/4/2013
AP03/29/2013N36028000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000TOC.cfm 5/10/2013
AP03/29/2013N36029000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204042Orig1s000SumR.pdf 5/10/2013
AP011/26/2013SCM       
AP05/15/2014SLR39321002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204042s002lbl.pdf 5/19/2014
AP05/15/2014SLR39333002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204042Orig1s002ltr.pdf 5/20/2014
AP06/5/2014SCM       
AP03/3/2015SLR42011005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s005ltr.pdf 3/4/2015
AP03/3/2015SLR42031005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s005lbl.pdf 3/5/2015
AP09/10/2015SE843848006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s006lbl.pdf 9/11/2015
AP09/9/2015SCM       
AP03/28/2016SLR45536011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s011lbl.pdf 3/30/2016
AP03/28/2016SLR45538011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s011ltr.pdf 3/30/2016
AP03/8/2016SCM       
AP012/4/2015SLR44673013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204042Orig1s013ltr.pdf 12/8/2015
AP012/4/2015SLR44706013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204042s013lbl.pdf 12/8/2015
AP05/20/2016SE846104015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf 5/23/2016
AP05/20/2016SE846121015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf 5/24/2016
AP06/16/2016SCM       
AP05/20/2016S46122019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s015,s019ltr.pdf 5/24/2016
AP05/20/2016S46105019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s015s019lbl.pdf 5/23/2016
AP08/17/2016SLR46811022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204042Orig1s022ltr.pdf 8/19/2016
AP08/17/2016SLR46839022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204042s022lbl.pdf 8/22/2016




Back to FDA Applications sponsored by JANSSEN PHARMS

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.