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FDA Drug Application 021044 by PURDUE PHARMA LP

Application Number021044
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
AP09/24/2004N10276000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021044lbl.pdf 9/24/2004
AP09/24/2004N10280000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21044ltr.pdf 9/27/2004
AP09/24/2004N11420000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129288.htm 4/15/2005
AP09/24/2004N13184000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021044s000_PalladoneTOC.cfm 11/30/2005
AP09/24/2004N24044000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf 11/20/2009
AP04/16/2014SLR39066013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf 4/16/2014
AP04/16/2014SLR39083013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021044Orig1s013ltr.pdf 4/17/2014




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