FDA Drug Application 016131 by SANOFI AVENTIS US

Application Number	016131
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	2/1/1967	N
AP	6/23/1980	SLR
AP	6/23/1980	SCS
AP	11/18/1981	SDS
AP	12/21/1993	SLR
AP	4/27/1988	SCP
AP	8/14/1991	SCS
AP	2/22/1994	SCM
AP	9/30/1994	SLR
AP	10/25/1995	SLR
AP	12/10/2002	SCS
AP	10/22/2012	SLR	34167	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf	10/22/2012
AP	10/22/2012	SLR	34168	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016131s026ltr.pdf	10/24/2012
AP	10/22/2012	SLR	45076	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/016131Orig1s026.pdf	2/2/2016

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