Back to FDA Applications sponsored by SANOFI AVENTIS US

FDA Drug Application 020839 by SANOFI AVENTIS US

Application Number	020839
Application Type	New Drug Application
Sponsor Applicant	SANOFI 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 Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/17/1997	N	24962	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf	3/4/2010
AP	11/17/1997	N	26148	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm190836.htm	8/9/2010
AP	11/17/1997	N	27836	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243349.pdf	2/15/2011
AP	5/12/1998	SCE	12516	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-001.PDF	8/4/2005
AP	5/21/1998	SCM	12517	002	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF	8/4/2005
AP	8/20/1999	SCS	12518	003	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020-839_S-003.PDF	8/4/2005
AP	1/27/2000	SCM	12519	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF	8/4/2005
AP	3/15/2000	SCS	12520	005	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF	8/4/2005
AP	2/22/2000	SLR	12521	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-006.PDF	8/4/2005
AP	7/10/2000	SCM	12522	007	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-007.PDF	8/4/2005
AP	4/28/2000	SLR
AP	7/25/2000	SCF	12523	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-009.PDF	8/4/2005
AP	11/9/2000	SCM	12524	010	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-010.PDF	8/4/2005
AP	10/24/2000	SCM	12525	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-011.PDF	8/4/2005
AP	3/7/2001	SCM	12526	013	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF	8/4/2005
AP	3/7/2001	SCM	12527	014	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF	8/4/2005
AP	6/18/2001	SCS	12528	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF	8/4/2005
AP	7/19/2001	SCM	12529	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF	8/4/2005
AP	12/5/2001	SCM	12530	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF	8/4/2005
AP	1/28/2002	SLR	3512	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s18ltr.pdf	1/28/2002
AP	1/28/2002	SLR	12531	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-018.PDF	8/4/2005
AP	2/27/2002	SE1	3509	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s19ltr.pdf	2/27/2002
AP	2/27/2002	SE1	3510	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.htm	2/27/2002
AP	2/27/2002	SE1	3511	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.cfm	2/27/2002
AP	9/10/2002	SCE	12532	020	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-020.PDF	8/4/2005
AP	9/29/2003	SLR	6753	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf	10/9/2003
AP	6/10/2002	SCM
AP	10/13/2004	SLR	10410	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20839s023ltr.pdf	10/15/2004
AP	9/29/2003	SLR	6754	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf	10/9/2003
AP	4/26/2005	SLR	11530	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s028ltr.pdf	4/28/2005
AP	4/25/2005	SLR	11528	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf	4/28/2005
AP	4/25/2005	SLR	11538	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf	4/28/2005
AP	4/25/2005	SLR	11529	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf	4/28/2005
AP	4/25/2005	SLR	11539	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf	4/28/2005
AP	10/14/2005	SLR	12895	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s033ltr.pdf	10/19/2005
AP	10/14/2005	SLR	12907	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf	10/19/2005
AP	8/17/2006	SE1	14713	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s034lbl.pdf	8/18/2006
AP	8/17/2006	SE1	14736	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s034LTR.pdf	8/21/2006
AP	8/17/2006	SE1	27033	034	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf	8/17/2006
AP	8/4/2006	SLR	14622	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf	8/7/2006
AP	8/4/2006	SLR	14637	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s035LTR.pdf	8/7/2006
AP	5/1/2007	SLR	16447	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s037lbl.pdf	5/7/2007
AP	5/1/2007	SLR	16482	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s037ltr.pdf	5/9/2007
AP	9/20/2007	SCF	17967	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s038ltr.pdf	9/25/2007
AP	9/20/2007	SCF	18021	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf	9/26/2007
AP	9/20/2007	SCF	31988	038	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020839Orig1s038.pdf	3/2/2012
AP	5/5/2009	SLR	22481	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf	5/11/2009
AP	5/5/2009	SLR	23240	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s040ltr.pdf	8/26/2009
AP	3/12/2010	SLR	25031	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf	3/12/2010
AP	3/12/2010	SLR	25069	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s042ltr.pdf	3/18/2010
AP	11/12/2009	SLR	23899	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf	11/16/2009
AP	11/12/2009	SLR	24541	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s044ltr.pdf	1/20/2010
AP	8/24/2010	SLR	26214	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s048ltr.pdf	8/16/2010
AP	8/24/2010	SLR	26245	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf	8/19/2010
AP	5/6/2011	SE8	28744	051	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s051lbl.pdf	5/6/2011
AP	5/6/2011	SE8	28753	051	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s051ltr.pdf	5/10/2011
AP	5/6/2011	SE8	29465	051	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051TOC.cfm	7/8/2011
AP	5/6/2011	SE8	29466	051	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051SumR.pdf	7/8/2011
AP	2/1/2011	SLR	27724	052	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s052lbl.pdf	2/4/2011
AP	2/1/2011	SLR	27754	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s052ltr.pdf	2/7/2011
AP	5/3/2011	SLR	28726	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s053ltr.pdf	5/6/2011
AP	12/20/2011	SLR	31187	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s055ltr.pdf	12/22/2011
AP	12/20/2011	SLR	31224	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s055lbl.pdf	12/23/2011
AP	5/24/2013	SCM
AP	9/12/2013	SLR	37091	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s057ltr.pdf	9/13/2013
AP	9/12/2013	SLR	37117	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf	9/17/2013
AP	12/12/2013	SLR	38043	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s058ltr.pdf	12/16/2013
AP	12/12/2013	SLR	38096	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf	12/17/2013
AP	3/12/2014	SCM
AP	5/14/2014	SCM
AP	7/16/2015	SLR	43404	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061lbl.pdf	7/17/2015
AP	7/16/2015	SLR	43409	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020839Orig1s061ltr.pdf	7/20/2015
AP	9/16/2016	SLR	47118	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf	9/20/2016
AP	9/16/2016	SLR	47126	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf	9/21/2016
AP	3/24/2016	SCM
AP	9/16/2016	SLR	47119	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf	9/20/2016
AP	9/16/2016	SLR	47127	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf	9/21/2016

Back to FDA Applications sponsored by SANOFI AVENTIS US