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FDA Drug Application 021468 by SHIRE LLC

Application Number021468
Application Type New Drug Application
Sponsor ApplicantSHIRE LLC
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
AP010/26/2004N10498000 10/29/2004
AP010/26/2004N10521000 11/1/2004
AP010/26/2004N11059000 1/28/2005
AP03/3/2006SLR27429004 1/4/2011
AP03/3/2006SLR27430005 1/4/2011
AP03/3/2006SLR13824005 3/23/2006
AP04/10/2008SLR19638010 4/11/2008
AP010/23/2008SLR21088011 10/28/2008
AP04/27/2011SLR28628014,s015ltr.pdf 4/29/2011
AP04/27/2011SLR28651014 4/29/2011
AP04/27/2011SLR28652015 4/29/2011
AP04/27/2011SLR28629015,s015ltr.pdf 4/29/2011
AP09/2/2011SLR29957016 9/7/2011
AP09/2/2011SLR29958016 9/7/2011
AP09/2/2011SLR29960016 9/7/2011
AP010/31/2012SLR34224018 11/2/2012
AP010/31/2012SLR34225018 11/2/2012
AP010/31/2012SLR34259018 11/5/2012
AP09/24/2014SLR40612019 9/26/2014
AP09/24/2014SLR40631019 9/26/2014
AP02/24/2016SLR45282020,204734Orig1s001ltr.pdf 2/26/2016
AP02/24/2016SLR45288020,204734s001lbl.pdf 2/26/2016

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