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FDA Drug Application 050420 by SANOFI AVENTIS US

Application Number	050420
Application Type	New Drug Application
Sponsor Applicant	SANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type
Therapeutic Potential
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	5/21/1971	N
AP	10/5/1982	SCM
AP	10/26/1982	SCS
AP	11/15/1982	SCS
AP	11/15/1982	SCS
AP	11/17/1982	SCS
AP	5/25/1977	SCS
AP	2/12/1990	SLR
AP	9/2/1983	SLR
AP	2/12/1990	SCS
AP	2/8/1984	SCP
AP	2/18/1986	SCM
AP	9/12/1984	SLR
AP	5/18/1989	SCS
AP	11/16/1987	SCS
AP	8/9/1971	SLR
AP	12/6/1971	SCS
AP	1/26/1972	SLR
AP	3/22/1982	SLR
AP	6/16/1972	SCM
AP	8/31/1972	SCF
AP	9/25/1972	SLR
AP	10/5/1972	SCP
AP	1/19/1973	SLR
AP	5/9/1973	SCS
AP	11/20/1973	SLR
AP	10/11/1973	SLR
AP	1/24/1974	SLR
AP	3/28/1974	SLR
AP	3/28/1974	SCM
AP	5/29/1974	SLR
AP	5/21/1974	SLR
AP	11/26/1974	SLR
AP	1/30/1975	SLR
AP	9/16/1975	SLR
AP	10/15/1975	SCP
AP	8/28/1975	SCP
AP	3/29/1976	SLR
AP	1/19/1976	SLR
AP	1/28/1976	SLR
AP	2/18/1976	SLR
AP	3/1/1976	SCS
AP	8/3/1976	SCS
AP	8/9/1976	SCP
AP	12/21/1976	SLR
AP	6/29/1977	SLR
AP	2/10/1978	SLR
AP	5/30/1978	SLR
AP	6/29/1978	SLR
AP	6/26/1979	SLR
AP	3/23/1979	SLR
AP	4/16/1979	SCF
AP	4/16/1979	SLR
AP	5/1/1979	SLR
AP	7/25/1979	SLR
AP	10/25/1979	SCP
AP	10/29/1979	SCM
AP	7/25/1980	SCS
AP	12/31/1980	SCS
AP	9/11/1982	SCM
AP	10/20/1981	SLR
AP	10/20/1981	SCM
AP	6/18/1993	SLR
AP	1/5/1996	SCS
AP	7/12/1994	SCM
AP	9/17/1996	SLR
AP	9/5/1995	SCM
AP	4/12/2000	SLR
AP	4/12/2000	SLR
AP	8/20/2004	SLR	10028	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf	8/25/2004
AP	8/20/2004	SLR	10081	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf	8/25/2004
AP	11/10/2010	SLR	26947	073	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf	11/12/2010
AP	11/10/2010	SLR	26996	073	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf	11/22/2010
AP	2/27/2013	SLR	35289	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf	3/1/2013
AP	2/27/2013	SLR	35303	075	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf	3/1/2013

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