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FDA Drug Application 021609 by DURAMED

Application Number021609
Application Type New Drug Application
Sponsor ApplicantDURAMED
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2004N10847000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21609ltr.pdf 12/30/2004
AP012/20/2004N10885000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21609lbl.pdf 12/30/2004
AP012/20/2004N14256000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021609s000_EnjuviaTOC.cfm 6/8/2006




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