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FDA Drug Application 021306 by PURDUE PHARMA LP

Application Number021306
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA LP
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
AP06/30/2010N30076000 9/26/2011
AP06/30/2010N30077000 9/26/2011
AP06/30/2010N25909000 7/2/2010
AP06/30/2010N25925000 7/6/2010
AP06/30/2010N25972000 7/16/2010
AP06/30/2010N26103000REMS 8/5/2010
AP07/1/2011SLR29423001 7/6/2011
AP07/1/2011SLR29439001,s003ltr.pdf 7/7/2011
AP07/1/2011SLR29440003,s003ltr.pdf 7/7/2011
AP07/1/2011SLR29424003 7/6/2011
AP07/9/2012SLR33121008 7/11/2012
AP07/9/2012SLR33156008 7/12/2012
AP04/15/2013SLR35710012 4/16/2013
AP06/30/2014SLR39737015 7/2/2014
AP06/30/2014SLR39720015,s019ltr.pdf 7/1/2014
AP07/25/2013SCM36635016 7/29/2013
AP07/25/2013SCM36656016 7/30/2013
AP04/16/2014SLR39063018 4/16/2014
AP04/16/2014SLR39072018 4/17/2014
AP06/30/2014SCM39719019,s019ltr.pdf 7/1/2014
AP06/30/2014SCM39736019 7/2/2014
AP08/19/2014S40273020 8/20/2014
AP06/26/2015S43229022 7/6/2015
AP04/20/2016S45719023 4/22/2016
AP09/30/2016S47268026 10/4/2016

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