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FDA Drug Application 206627 by PURDUE PHARMA LP

Application Number206627
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 Priority
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/20/2014N41031000 11/20/2014
AP011/20/2014N41032000 11/20/2014
AP011/20/2014N41033000 11/20/2014
AP011/20/2014N41034000 11/20/2014
AP011/20/2014N41209000REMS 12/11/2014
AP011/20/2014N41779000 2/5/2015
AP011/20/2014N42446000 4/7/2015
AP011/20/2014N42447000 4/7/2015
AP011/20/2014N44382000FDA has determined that this product has abuse-deterrent properties 11/4/2015
AP06/26/2015S43270001 7/8/2015
AP04/20/2016S45726003 4/22/2016
AP09/30/2016S47256005 10/3/2016

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