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FDA Drug Application 020757 by SANOFI AVENTIS US

Application Number020757
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
AP09/30/1997N23259000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.cfm 9/1/2009
AP09/30/1997N31204000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP011/10/1997SCS11452001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-757s001_Avapro.PDF 4/27/2005
AP01/30/1998SCS11487002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s002_Avapro.PDF 4/27/2005
AP01/30/1998SCF       
AP04/6/1998SCM11488004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s004_Avapro.PDF 4/27/2005
AP09/3/1998SCM11489005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s005_Avapro.PDF 4/27/2005
AP012/8/1998SLR       
AP03/16/1999SCM11484007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s007_Avapro.PDF 4/27/2005
AP03/16/1999SCM11485008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s008_Avapro.PDF 4/27/2005
AP011/2/1999SCM11486009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s009_Avapro.PDF 4/27/2005
AP08/23/2000SCS       
AP09/26/2001SLR11474011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s011_Avapro.PDF 4/27/2005
AP04/28/2000SCS11479012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s012_Avapro.PDF 4/27/2005
AP08/1/2000SCS11480013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s013_Avapro.pdf 4/27/2005
AP05/26/2001SE58779014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757S014_Avapro.pdf 5/27/2004
AP05/9/2000SLR8778015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s015_avapro.pdf 5/27/2004
AP05/10/2000SCM8777016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s016_avapro.pdf 5/27/2004
AP09/20/2000SLR11481017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s017_Avapro.PDF 4/27/2005
AP02/2/2001SCP11477018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P1.pdf 4/27/2005
AP02/2/2001SCP11478018Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P2.pdf 4/27/2005
AP03/6/2001SCM11475019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s019_Avapro.PDF 4/27/2005
AP06/7/2001SCM11476020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s020_Avapro.PDF 4/27/2005
AP09/17/2002SE14584021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757se1-021ltr.pdf 9/20/2002
AP09/17/2002SE14585021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20757s21lbl.pdf 9/17/2002
AP09/17/2002SE18776021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s021_Avapro.cfm 5/27/2004
AP07/19/2002SCM4583022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757scm022ltr.pdf 7/19/2002
AP07/19/2002SCM11471022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s022_Avapro.PDF 4/27/2005
AP03/21/2003S11589023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s023_Avapro_P1.PDF 5/5/2005
AP03/21/2003S11590023Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020757s023.pdf 5/5/2005
AP05/1/2003S11591024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF 5/5/2005
AP05/1/2003S11592024Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P2.PDF 5/5/2005
AP03/21/2003S12356025Review Part 1  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s025_Avapro_P1.pdf 7/29/2005
AP03/21/2003S12357025Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s025_Avapro_P2.pdf 7/29/2005
AP05/21/2003S12358026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s026_Avapro.PDF 7/29/2005
AP010/9/2003S12359027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s027_Avapro.PDF 7/29/2005
AP09/9/2003S12360028Review Part 1  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P1.PDF 7/29/2005
AP09/9/2003S12361028Review Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P2.PDF 7/29/2005
AP01/2/2004S11576030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF 5/3/2005
AP05/20/2004S11577031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s031_Avapro.PDF 5/3/2005
AP07/21/2004S11578032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s032_Avapro.PDF 5/3/2005
AP010/29/2004S11579033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s033_Avapro.PDF 5/3/2005
AP011/21/2005SLR13157037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020757s037ltr.pdf 11/30/2005
AP04/21/2006SLR13980038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf 4/25/2006
AP04/21/2006SLR13986038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s038LTR.pdf 4/25/2006
AP03/16/2006SLR13773039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s039lbl.pdf 3/22/2006
AP03/16/2006SLR13800039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s039ltr.pdf 3/23/2006
AP03/16/2006SLR27872039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020757_s039_avapro.pdf 2/15/2011
AP08/1/2011SLR29645055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s055lbl.pdf 8/1/2011
AP08/1/2011SLR29652055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s055ltr.pdf 8/2/2011
AP012/8/2011SLR30944056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf 12/13/2011
AP012/8/2011SLR30948056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s056ltr.pdf 12/14/2011
AP01/18/2012SLR31428058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s058ltr.pdf 1/23/2012
AP01/18/2012SLR31457058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf 1/23/2012
AP02/5/2016SLR45134059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf 2/9/2016
AP02/5/2016SLR45367059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf 3/4/2016
AP09/12/2012SLR33741060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s060lbl.pdf 9/14/2012
AP09/12/2012SLR33746060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s060ltr.pdf 9/14/2012
AP02/28/2013SCM       
AP010/10/2013SCM       
AP05/28/2014SLR39403064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020757s064lbl.pdf 5/30/2014
AP05/28/2014SLR39413064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020757Orig1s064ltr.pdf 6/2/2014
AP01/5/2015SCM       
AP02/5/2016SLR45366067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf 3/4/2016
AP02/5/2016SLR45133067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf 2/9/2016




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