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FDA Drug Application 021763 by BIOVAIL LABS INTL

Application Number021763
Application Type New Drug Application
Sponsor ApplicantBIOVAIL LABS INTL
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
AP012/20/2005N13347000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021763lbl.pdf 1/6/2006
AP012/20/2005N13418000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021763ltr.pdf 1/19/2006
AP012/20/2005N17815000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021763s000TOC.cfm 9/10/2007




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