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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   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf 7/23/2014
AP07/23/2014N39958000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s000ltr.pdf 7/23/2014
AP07/23/2014N40149000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/Removed at CD's request 8/5/2014
AP07/23/2014N40318000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205777Orig1s000TOC.cfm 8/27/2014
AP07/23/2014N43170000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP07/23/2014N44376000FDA has determined that this product has abuse-deterrent properties  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 11/4/2015
AP08/19/2014S40268001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s001ltr.pdf 8/20/2014
AP06/26/2015S43267002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205777Orig1s002ltr.pdf 7/7/2015
AP04/20/2016S45728003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s003ltr.pdf 4/22/2016
AP09/30/2016S47258005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s005ltr.pdf 10/3/2016




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