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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   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206627Orig1s000ltr.pdf 11/20/2014
AP011/20/2014N41032000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206627s000lbl.pdf 11/20/2014
AP011/20/2014N41033000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm420978.htm 11/20/2014
AP011/20/2014N41034000   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm 11/20/2014
AP011/20/2014N41209000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 12/11/2014
AP011/20/2014N41779000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM433047.pdf 2/5/2015
AP011/20/2014N42446000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000TOC.cfm 4/7/2015
AP011/20/2014N42447000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000SumR.pdf 4/7/2015
AP011/20/2014N44382000FDA has determined that this product has abuse-deterrent properties  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 11/4/2015
AP06/26/2015S43270001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206627Orig1s001ltr.pdf 7/8/2015
AP04/20/2016S45726003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s003ltr.pdf 4/22/2016
AP09/30/2016S47256005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s005ltr.pdf 10/3/2016




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