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FDA Drug Application 204353 by JANSSEN PHARMS

Application Number204353
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
AP08/8/2014N40189000 8/11/2014
AP08/8/2014N40210000 8/12/2014
AP08/8/2014N40407000 9/3/2014
AP08/8/2014N40408000 9/3/2014
AP03/3/2015SLR42012002 3/4/2015
AP03/3/2015SLR42223002 3/20/2015
AP09/10/2015SE843847003 9/11/2015
AP09/10/2015SE843858003 9/14/2015
AP05/20/2016SE846106006 5/23/2016
AP05/20/2016SE846124006,s015ltr.pdf 5/24/2016
AP03/28/2016SLR45535010 3/30/2016
AP03/28/2016SLR45537010 3/30/2016
AP012/4/2015SLR44672012 12/8/2015
AP012/4/2015SLR44705012 12/8/2015
AP05/20/2016S46107015 5/23/2016
AP05/20/2016S46125015,s015ltr.pdf 5/24/2016
AP08/17/2016SLR46805020 8/18/2016
AP08/17/2016SLR46837020 8/22/2016

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