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FDA Drug Application 021745 by PURDUE PHARMA

Application Number021745
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/2008N21442000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021745s000lbl.pdf 1/2/2009
AP012/30/2008N21444000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021745s000ltr.pdf 1/2/2009
AP012/30/2008N22864000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745_ryzolt_toc.cfm 7/6/2009
AP012/30/2008N22865000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021745s000_SumR.pdf 7/6/2009




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