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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 4/1/2013
AP03/29/2013N35625000 4/1/2013
AP03/29/2013N35635000 4/4/2013
AP03/29/2013N36028000 5/10/2013
AP03/29/2013N36029000 5/10/2013
AP05/15/2014SLR39321002 5/19/2014
AP05/15/2014SLR39333002 5/20/2014
AP03/3/2015SLR42011005 3/4/2015
AP03/3/2015SLR42031005 3/5/2015
AP09/10/2015SE843848006 9/11/2015
AP03/28/2016SLR45536011 3/30/2016
AP03/28/2016SLR45538011 3/30/2016
AP012/4/2015SLR44673013 12/8/2015
AP012/4/2015SLR44706013 12/8/2015
AP05/20/2016SE846104015 5/23/2016
AP05/20/2016SE846121015,s019ltr.pdf 5/24/2016
AP05/20/2016S46122019,s019ltr.pdf 5/24/2016
AP05/20/2016S46105019 5/23/2016
AP08/17/2016SLR46811022 8/19/2016
AP08/17/2016SLR46839022 8/22/2016

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