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FDA Drug Application 017111 by ENDO PHARMS

Application Number	017111
Application Type	New Drug Application
Sponsor Applicant	ENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/18/1974	N
AP	9/23/1974	SCS
AP	9/20/1976	SLR
AP	8/26/1976	SCP
AP	3/14/1977	SCS
AP	5/27/1977	SCP
AP	2/7/1977	SCF
AP	2/7/1977	SCF
AP	6/7/1977	SCS
AP	1/5/1981	SCF
AP	12/20/1979	SCE
AP	5/10/1979	SLR
AP	9/27/1979	SCP
AP	8/16/1979	SLR
AP	1/6/1981	SCF
AP	3/24/1981	SLR
AP	11/19/1982	SLR
AP	6/26/1985	SCP
AP	6/11/1986	SCP
AP	9/23/1987	SCM
AP	6/28/1988	SCP
AP	6/28/1988	SLR
AP	8/8/1988	SCM
AP	8/12/1994	SCM
AP	8/28/1995	SCS
AP	8/28/1995	SCS
AP	8/28/1995	SCS
AP	4/25/1996	SCS
AP	8/21/1998	SCM
AP	8/21/1998	SCS
AP	5/22/2001	SLR	5115	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf	4/9/2003
AP	3/12/2008	SLR	19467	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s062ltr.pdf	3/17/2008
AP	3/12/2008	SLR	19472	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf	3/17/2008
AP	8/14/2008	SLR	20622	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s063ltr.pdf	8/19/2008
AP	8/14/2008	SLR	20710	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf	8/29/2008
AP	7/19/2009	SLR	23022	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf	7/23/2009
AP	7/19/2009	SLR	23026	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017111s066ltr.pdf	7/23/2009
AP	12/1/2010	SLR	27183	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf	12/4/2010
AP	12/1/2010	SLR	27197	067	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017111s067ltr.pdf	12/6/2010

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