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FDA Drug Application 022328 by PURDUE PHARMA

Application Number022328
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA
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
AP011/23/2011N30779000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022328lbl.pdf 11/28/2011
AP011/23/2011N30781000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022328s000ltr.pdf 11/28/2011
AP011/23/2011N30786000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM281854.pdf 11/29/2011
AP011/23/2011N33645000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000TOC.cfm 9/5/2012
AP011/23/2011N33646000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000SumR.pdf 9/5/2012
AP011/23/2011N35855000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 4/29/2013
AP02/6/2013SCM35115001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf 2/8/2013
AP06/14/2013SCM       
AP011/13/2015SCM       
AP09/11/2015SLR43865004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf 9/14/2015
AP09/11/2015SLR43875004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022328Orig1s004ltr.pdf 9/15/2015




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