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FDA Drug Application 021629 by SANOFI AVENTIS US

Application Number021629
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/16/2004N8354000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21629ltr.pdf 4/20/2004
AP04/16/2004N8396000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021629lbl.pdf 4/22/2004
AP04/16/2004N9600000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-629_Apidra.cfm 6/29/2004
AP012/20/2005SLR13345001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf 1/6/2006
AP012/20/2005SCP13346002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf 1/6/2006
AP02/24/2009SCP21914008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021629s008ltr.pdf 2/27/2009
AP02/24/2009SCP22021008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021629s008lbl.pdf 3/17/2009
AP02/24/2009SCP34991008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021629Orig1s008.pdf 1/28/2013
AP04/12/2007SE316237010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021629s010ltr.pdf 4/20/2007
AP04/12/2007SE316275010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021629s010lbl.pdf 4/20/2007
AP010/24/2008SE521089015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021629s015ltr.pdf 10/28/2008
AP010/24/2008SE521177015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf 11/7/2008
AP07/22/2013SCM       
AP06/5/2013SCM       
AP02/15/2013SCM       
AP09/6/2013SLR37004028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021629s028lbl.pdf 9/9/2013
AP09/6/2013SLR37041028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021629Orig1s028ltr.pdf 9/11/2013
AP05/14/2014SLR39310029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf 5/15/2014
AP05/14/2014SLR39320029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021629Orig1s029ltr.pdf 5/19/2014
AP02/25/2015SLR41936030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021629Orig1s030ltr.pdf 2/27/2015
AP02/25/2015SLR42006030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021629s030lbl.pdf 3/3/2015
AP03/3/2015SCM       




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