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FDA Drug Application 021704 by SANOFI AVENTIS US

Application Number021704
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
AP010/19/2004N10457000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21704ltr.pdf 10/26/2004
AP010/19/2004N10467000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf 10/26/2004
AP010/19/2004N12762000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021704s000_AllegraTOC.cfm 9/13/2005
AP04/14/2010SLR25285007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021704s007ltr.pdf 4/19/2010
AP04/14/2010SLR25297007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf 4/19/2010
AP01/24/2011SE627626008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021704s008ltr.pdf 1/27/2011
AP01/24/2011SE637916008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf 11/26/2013
AP02/3/2012SCM31755010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf 2/13/2012
AP08/23/2012SLR33558011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Org1s011ltr.pdf 8/27/2012
AP012/5/2012SLR34589013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Orig1s013ltr.pdf 12/11/2012
AP012/5/2012SLR37095013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf 9/13/2013
AP01/6/2014SCM       
AP010/18/2013SCM       
AP01/30/2014SCM       
AP06/8/2015SE843033017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf 6/10/2015
AP06/8/2015SE843079017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf 6/19/2015
AP06/2/2016SLR46267018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf 6/7/2016
AP06/2/2016SLR46291018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf 6/10/2016
AP08/16/2016SCM       




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