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FDA Drug Application 021963 by SANOFI AVENTIS US

Application Number021963
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
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
AP010/16/2006N15125000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021963lbl.pdf 10/18/2006
AP010/16/2006N15189000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021963s000ltr.pdf 10/23/2006
AP010/16/2006N19463000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021963TOC.cfm 3/14/2008
AP06/25/2008SLR20099002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf 6/30/2008
AP06/25/2008SLR20104002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf 6/30/2008




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