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FDA Drug Application 020758 by SANOFI AVENTIS US

Application Number020758
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1997N23258000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.cfm 9/1/2009
AP01/30/1998SCS       
AP01/30/1998SCS       
AP08/31/1998SCF723003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20758S003.cfm 8/31/1998
AP04/6/1998SCM       
AP09/3/1998SCM       
AP07/15/1998SCF       
AP07/14/1998SLR       
AP01/21/1999SCM       
AP03/16/1999SCM       
AP03/16/1999SCM       
AP04/20/1999SLR       
AP08/23/2000SCS       
AP09/26/2001SLR       
AP04/28/2000SCS       
AP08/1/2000SCS       
AP05/9/2000SLR8773016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20758-s016_avalide.pdf 5/27/2004
AP05/10/2000SCM       
AP09/20/2000SLR       
AP02/21/2001SCS       
AP03/6/2001SCM       
AP06/7/2001SCM       
AP05/1/2003S11593023Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P2.PDF 5/5/2005
AP05/1/2003S11594023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF 5/5/2005
AP010/10/2003S11580028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s029_Avapro_P1.PDF 5/3/2005
AP010/10/2003S11581028Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s029_Avapro_P2.pdf 5/3/2005
AP01/2/2004S11575029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF 5/3/2005
AP07/21/2004S11454030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s030_Avalide.pdf 4/27/2005
AP010/29/2004S11455031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s031_Avalide.pdf 4/27/2005
AP03/15/2005SCF11260032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20758s032ltr.pdf 3/18/2005
AP011/21/2005SLR13158035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020758s035ltr.pdf 11/30/2005
AP04/21/2006SLR13979036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020758s036lbl.pdf 4/25/2006
AP04/21/2006SLR13987036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020758s036LTR.pdf 4/25/2006
AP011/16/2007SE118439037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf 11/19/2007
AP011/16/2007SE118475037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020758s037ltr.pdf 11/19/2007
AP09/7/2010SLR26439050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020758s050ltr.pdf 9/9/2010
AP09/7/2010SLR26452050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020758s050lbl.pdf 9/10/2010
AP06/6/2011SLR29047058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s058lbl.pdf 6/6/2011
AP06/6/2011SLR29081058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf 6/9/2011
AP06/6/2011SLR29048059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s059lbl.pdf 6/6/2011
AP06/6/2011SLR29082059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf 6/9/2011
AP02/9/2012SLR31746060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s060ltr.pdf 2/13/2012
AP02/9/2012SLR31834060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s060lbl.pdf 2/17/2012
AP01/18/2012SLR31431062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s062ltr.pdf 1/23/2012
AP01/18/2012SLR31458062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s062lbl.pdf 1/23/2012
AP010/26/2012SLR34187064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf 10/26/2012
AP010/26/2012SLR34195064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758Orig1s064ltr.pdf 10/29/2012
AP05/28/2014SLR39404067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020758s067lbl.pdf 5/30/2014
AP05/28/2014SLR39410067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020758Orig1s067ltr.pdf 6/2/2014
AP02/5/2016SLR45135070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020758Orig1s070ltr.pdf 2/9/2016
AP02/5/2016SLR45192070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020758s070lbl.pdf 2/18/2016




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