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FDA Drug Application 022272 by PURDUE PHARMA LP

Application Number022272
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA LP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/5/2010N25226000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf 4/6/2010
AP04/5/2010N25245000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s000ltr.pdf 4/9/2010
AP04/5/2010N25269000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM208530.pdf 4/16/2010
AP04/5/2010N26107000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 8/6/2010
AP04/5/2010N26582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000TOC.cfm 9/29/2010
AP04/5/2010N27918000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000SumR.pdf 2/17/2011
AP04/5/2010N35180000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm207173.htm 2/15/2013
AP04/5/2010N44375000FDA has determined that this product has abuse-deterrent properties  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 11/4/2015
AP06/29/2010SLR25889005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s005ltr.pdf 7/1/2010
AP06/29/2010SLR25894005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf 7/1/2010
AP011/15/2010SLR26994006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s006ltr.pdf 11/22/2010
AP011/15/2010SLR27027006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf 11/26/2010
AP010/5/2011SLR30235009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022272s009ltr.pdf 10/11/2011
AP010/5/2011SLR30253009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf 10/12/2011
AP07/9/2012SLR33118010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s010ltr.pdf 7/11/2012
AP07/9/2012SLR33155010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf 7/12/2012
AP07/9/2012SLR33186011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf 7/13/2012
AP07/9/2012SLR33150011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s011ltr.pdf 7/11/2012
AP04/16/2013SLR35733014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf 4/16/2013
AP04/16/2013SLR35734014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf 4/16/2013
AP04/16/2013SLR35852014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022272Orig1s014TOC.cfm 4/26/2013
AP02/4/2014SCM       
AP01/11/2013SLR34881016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020553Orig1s065,022272Orig1s016ltr.pdf 1/14/2013
AP01/11/2013SLR34888016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf 1/15/2013
AP04/15/2013S35704017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s017ltr.pdf 4/16/2013
AP01/31/2014SCM       
AP04/16/2014SLR39061022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf 4/16/2014
AP04/16/2014SLR39082022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s022ltr.pdf 4/17/2014
AP010/22/2014SLR40896023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf 10/30/2014
AP010/22/2014SLR40902023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf 10/30/2014
AP08/19/2014S40275024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s024ltr.pdf 8/20/2014
AP010/13/2014SCM       
AP08/13/2015SE843646027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s027ltr.pdf 8/13/2015
AP08/13/2015SE843647027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf 8/13/2015
AP08/13/2015SE844021027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022272Orig1s027TOC.cfm 9/29/2015
AP06/26/2015S43231028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s028ltr.pdf 7/6/2015
AP09/10/2015SCM       
AP011/12/2015SCM       
AP03/25/2016SCM       
AP03/28/2016SCM       
AP04/20/2016S       
AP09/30/2016S47270036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s036ltr.pdf 10/4/2016




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