FDA Drug Application 016023 by ENDO PHARMS

Application Number	016023
Application Type	New Drug Application
Sponsor Applicant	ENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	2/14/1968	N
AP	1/7/1976	SCS
AP	11/16/1977	SCM
AP	8/10/1977	SCM
AP	12/8/1982	SCP
AP	1/4/1985	SCP
AP	2/14/1986	SLR
AP	1/16/1987	SE1
AP	4/19/1993	SE2
AP	10/23/1989	SLR
AP	2/6/1992	SCP
AP	2/4/1992	SCM
AP	8/11/1992	SCM
AP	1/5/1996	SCS
AP	6/8/1999	SCP
AP	12/6/2000	SLR
AP	1/11/2002	SCS
AP	11/18/2003	SLR	6947	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf	11/25/2003
AP	11/18/2003	SLR	8403	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf	4/27/2004
AP	11/18/2003	SLR	14070	037	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm	5/8/2006
AP	3/2/2007	SLR	15975	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf	3/7/2007
AP	3/2/2007	SLR	15988	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf	3/7/2007
AP	9/24/2008	SLR	20888	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf	9/26/2008
AP	9/24/2008	SLR	20938	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf	10/3/2008
AP	2/2/2009	SLR	21701	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf	2/3/2009
AP	2/2/2009	SLR	21746	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf	2/4/2009

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