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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
AP06/30/2010N25909000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021306s000ltr.pdf 7/2/2010
AP06/30/2010N25925000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf 7/6/2010
AP06/30/2010N25972000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219146.pdf 7/16/2010
AP06/30/2010N26103000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 8/5/2010
AP06/30/2010N30076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306_butrans_toc.cfm 9/26/2011
AP06/30/2010N30077000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306Orig1s000SumR.pdf 9/26/2011
AP07/1/2011SLR29423001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf 7/6/2011
AP07/1/2011SLR29439001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf 7/7/2011
AP07/1/2011SLR29424003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf 7/6/2011
AP07/1/2011SLR29440003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf 7/7/2011
AP07/9/2012SLR33121008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021306Orig1s008ltr.pdf 7/11/2012
AP07/9/2012SLR33156008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf 7/12/2012
AP04/15/2013SLR35710012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s012ltr.pdf 4/16/2013
AP03/8/2013SCM       
AP06/30/2014SLR39720015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf 7/1/2014
AP06/30/2014SLR39737015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf 7/2/2014
AP07/25/2013SCM36635016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s016ltr.pdf 7/29/2013
AP07/25/2013SCM36656016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf 7/30/2013
AP04/16/2014SLR39063018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf 4/16/2014
AP04/16/2014SLR39072018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s018ltr.pdf 4/17/2014
AP06/30/2014SCM39719019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf 7/1/2014
AP06/30/2014SCM39736019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf 7/2/2014
AP08/19/2014S40273020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s020ltr.pdf 8/20/2014
AP06/26/2015S43229022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021306Orig1s022ltr.pdf 7/6/2015
AP04/20/2016S45719023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s023ltr.pdf 4/22/2016
AP09/30/2016S47268026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s026ltr.pdf 10/4/2016




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