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FDA Drug Application 021610 by ENDO PHARMS

Application Number021610
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/2006N36164000REMS 5/31/2013
AP08/2/2006SLR14588001,021611s001lbl.pdf 8/4/2006
AP08/2/2006SLR14632001, 021611s001LTR.pdf 8/7/2006
AP07/9/2007SLR17271003 7/10/2007
AP07/9/2007SLR17277003 7/16/2007
AP01/10/2008SCS18897005 1/18/2008
AP01/10/2008SCS18908005 1/18/2008
AP02/29/2008SCM19369006 3/5/2008
AP02/29/2008SCM19382006 3/5/2008
AP010/4/2010SLR26609009 10/4/2010
AP010/4/2010SLR26638009 10/12/2010
AP07/9/2012SLR33139012 7/11/2012
AP07/9/2012SLR33162012 7/12/2012
AP07/9/2012SLR33167013 7/13/2012
AP07/9/2012SLR33183013 7/13/2012
AP04/15/2013SLR35742014 4/18/2013
AP04/16/2014SLR39062018 4/16/2014
AP04/16/2014SLR39080018 4/17/2014
AP08/19/2014S40274019 8/20/2014
AP06/26/2015S43230020 7/6/2015
AP04/20/2016S45720021 4/22/2016
AP09/30/2016S47269023 10/4/2016

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