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FDA Drug Application 021759 by SANOFI AVENTIS US

Application Number021759
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/31/2005N16870000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021759s000TOC.cfm 7/2/2007
AP01/31/2005N11073000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021759ltr.pdf 2/3/2005
AP01/31/2005N11077000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021759lbl.pdf 2/3/2005
AP03/9/2006SLR13762001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf 3/14/2006
AP03/9/2006SLR13767001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf 3/14/2006
AP05/21/2008SLR19885008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf 5/28/2008
AP03/13/2009SLR22006009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf 3/17/2009
AP03/13/2009SLR22120009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf 3/26/2009
AP012/28/2011SLR31307012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf 12/28/2011
AP012/28/2011SLR31322012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf 1/3/2012
AP010/12/2012SLR34099015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021759s015lbl.pdf 10/15/2012
AP010/12/2012SLR34110015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021759Orig1s015ltr.pdf 10/16/2012
AP07/16/2013SLR36566016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021759s016lbl.pdf 7/17/2013
AP07/16/2013SLR36573016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021759Orig1s016ltr.pdf 7/18/2013
AP011/15/2013SCM       
AP01/20/2015SCM       
AP010/1/2015SLR44114019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021759Orig1s019ltr.pdf 10/6/2015
AP010/1/2015SLR44165019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021759s019lbledt.pdf 10/7/2015




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