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FDA Drug Application 205777 by PURDUE PHARMA LP

Application Number205777
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA LP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2014N39957000 7/23/2014
AP07/23/2014N39958000 7/23/2014
AP07/23/2014N40149000 at CD's request 8/5/2014
AP07/23/2014N40318000 8/27/2014
AP07/23/2014N43170000REMS 6/30/2015
AP07/23/2014N44376000FDA has determined that this product has abuse-deterrent properties 11/4/2015
AP08/19/2014S40268001 8/20/2014
AP06/26/2015S43267002 7/7/2015
AP04/20/2016S45728003 4/22/2016
AP09/30/2016S47258005 10/3/2016

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