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FDA Drug Application 020839 by SANOFI AVENTIS US

Application Number020839
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/17/1997N24962000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf 3/4/2010
AP011/17/1997N26148000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm190836.htm 8/9/2010
AP011/17/1997N27836000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243349.pdf 2/15/2011
AP05/12/1998SCE12516001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-001.PDF 8/4/2005
AP05/21/1998SCM12517002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF 8/4/2005
AP08/20/1999SCS12518003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020-839_S-003.PDF 8/4/2005
AP01/27/2000SCM12519004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF 8/4/2005
AP03/15/2000SCS12520005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF 8/4/2005
AP02/22/2000SLR12521006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-006.PDF 8/4/2005
AP07/10/2000SCM12522007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-007.PDF 8/4/2005
AP04/28/2000SLR       
AP07/25/2000SCF12523009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-009.PDF 8/4/2005
AP011/9/2000SCM12524010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-010.PDF 8/4/2005
AP010/24/2000SCM12525011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-011.PDF 8/4/2005
AP03/7/2001SCM12526013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF 8/4/2005
AP03/7/2001SCM12527014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF 8/4/2005
AP06/18/2001SCS12528015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF 8/4/2005
AP07/19/2001SCM12529016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF 8/4/2005
AP012/5/2001SCM12530017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF 8/4/2005
AP01/28/2002SLR12531018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-018.PDF 8/4/2005
AP01/28/2002SLR3512018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s18ltr.pdf 1/28/2002
AP02/27/2002SE13509019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s19ltr.pdf 2/27/2002
AP02/27/2002SE13510019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.htm 2/27/2002
AP02/27/2002SE13511019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.cfm 2/27/2002
AP09/10/2002SCE12532020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-020.PDF 8/4/2005
AP09/29/2003SLR6753021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf 10/9/2003
AP06/10/2002SCM       
AP010/13/2004SLR10410023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20839s023ltr.pdf 10/15/2004
AP09/29/2003SLR6754024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf 10/9/2003
AP04/26/2005SLR11530028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s028ltr.pdf 4/28/2005
AP04/25/2005SLR11538030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf 4/28/2005
AP04/25/2005SLR11528030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf 4/28/2005
AP04/25/2005SLR11529031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf 4/28/2005
AP04/25/2005SLR11539031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf 4/28/2005
AP010/14/2005SLR12895033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s033ltr.pdf 10/19/2005
AP010/14/2005SLR12907033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf 10/19/2005
AP08/17/2006SE114713034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s034lbl.pdf 8/18/2006
AP08/17/2006SE114736034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s034LTR.pdf 8/21/2006
AP08/17/2006SE127033034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf 8/17/2006
AP08/4/2006SLR14622035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf 8/7/2006
AP08/4/2006SLR14637035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s035LTR.pdf 8/7/2006
AP05/1/2007SLR16447037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s037lbl.pdf 5/7/2007
AP05/1/2007SLR16482037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s037ltr.pdf 5/9/2007
AP09/20/2007SCF17967038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s038ltr.pdf 9/25/2007
AP09/20/2007SCF18021038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf 9/26/2007
AP09/20/2007SCF31988038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020839Orig1s038.pdf 3/2/2012
AP05/5/2009SLR22481040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf 5/11/2009
AP05/5/2009SLR23240040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s040ltr.pdf 8/26/2009
AP03/12/2010SLR25031042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf 3/12/2010
AP03/12/2010SLR25069042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s042ltr.pdf 3/18/2010
AP011/12/2009SLR23899044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf 11/16/2009
AP011/12/2009SLR24541044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s044ltr.pdf 1/20/2010
AP08/24/2010SLR26214048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s048ltr.pdf 8/16/2010
AP08/24/2010SLR26245048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf 8/19/2010
AP05/6/2011SE828744051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s051lbl.pdf 5/6/2011
AP05/6/2011SE828753051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s051ltr.pdf 5/10/2011
AP05/6/2011SE829465051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051TOC.cfm 7/8/2011
AP05/6/2011SE829466051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051SumR.pdf 7/8/2011
AP02/1/2011SLR27724052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s052lbl.pdf 2/4/2011
AP02/1/2011SLR27754052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s052ltr.pdf 2/7/2011
AP05/3/2011SLR28726053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s053ltr.pdf 5/6/2011
AP012/20/2011SLR31187055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s055ltr.pdf 12/22/2011
AP012/20/2011SLR31224055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s055lbl.pdf 12/23/2011
AP05/24/2013SCM       
AP09/12/2013SLR37091057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s057ltr.pdf 9/13/2013
AP09/12/2013SLR37117057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf 9/17/2013
AP012/12/2013SLR38043058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s058ltr.pdf 12/16/2013
AP012/12/2013SLR38096058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf 12/17/2013
AP03/12/2014SCM       
AP05/14/2014SCM       
AP07/16/2015SLR43404061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061lbl.pdf 7/17/2015
AP07/16/2015SLR43409061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020839Orig1s061ltr.pdf 7/20/2015
AP09/16/2016SLR47118062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf 9/20/2016
AP09/16/2016SLR47126062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf 9/21/2016
AP03/24/2016SCM       
AP09/16/2016SLR47127064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf 9/21/2016
AP09/16/2016SLR47119064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf 9/20/2016




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