FDA Drug Application 016466 by SANDOZ

Application Number	016466
Application Type	New Drug Application
Sponsor Applicant	SANDOZ
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	7/29/1969	N
AP	4/18/1979	SLR
AP	4/13/1979	SLR
AP	4/18/1979	SCF
AP	8/4/1978	SCE
AP	10/7/1980	SCM
AP	6/12/1985	SLR
AP	5/30/1990	SCP
AP	11/26/1991	SCS
AP	1/6/1992	SCS
AP	9/7/1993	SLR
AP	1/30/2006	SLR	13584	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016466s027ltr.pdf	2/2/2006
AP	1/30/2006	SLR	13586	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf	2/7/2006
AP	8/4/1994	SCS
AP	9/8/1995	SCS
AP	1/18/1996	SCS
AP	10/25/1999	SCS
AP	2/12/2002	SCS
AP	3/1/2007	SLR	15976	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016466s036ltr.pdf	3/7/2007
AP	3/1/2007	SLR	15992	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf	3/7/2007
AP	6/3/2009	SLR	22692	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf	6/4/2009
AP	6/3/2009	SLR	22712	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf	6/8/2009
AP	6/3/2009	SLR	22693	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf	6/4/2009
AP	6/3/2009	SLR	22713	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf	6/8/2009
AP	9/4/2014	SCM
AP	7/3/2014	SLR	39781	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf	7/8/2014
AP	7/3/2014	SLR	39807	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf	7/8/2014

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