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FDA Drug Application 010997 by XANODYNE PHARM

Application Number	010997
Application Type	New Drug Application
Sponsor Applicant	XANODYNE PHARM
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 Title	Document URL	Document Date
AP	8/16/1957	N
AP	1/6/1975	SLR
AP	7/23/1976	SLR
AP	5/3/1977	SCP
AP	5/3/1977	SCP
AP	1/21/1980	SCS
AP	2/27/1979	SCE
AP	5/26/1978	SCF
AP	10/13/1978	SCP
AP	9/26/1979	SLR
AP	4/15/1980	SLR
AP	8/10/1981	SCF
AP	5/20/1981	SLR
AP	10/28/1981	SLR
AP	1/28/1985	SCS
AP	4/21/1986	SLR
AP	4/21/1986	SLR
AP	4/21/1986	SLR
AP	11/5/1986	SCS
AP	10/16/1986	SLR
AP	12/8/1986	SCS
AP	8/23/1994	SLR
AP	9/15/1992	SCS
AP	9/2/1994	SLR
AP	8/1/2002	SLR	4751	043		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf	8/1/2002
AP	4/2/1998	SCP
AP	8/10/1998	SCS
AP	10/5/1998	SCM
AP	2/24/1999	SCM
AP	9/25/2009	SLR	23478	051		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf	9/30/2009
AP	9/25/2009	SLR	23493	051		http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf	10/1/2009
AP	9/25/2009	SLR	23869	051		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf	11/13/2009
AP	9/25/2009	SLR	23486	052		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf	10/1/2009
AP	9/25/2009	SLR	23494	052		http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf	10/1/2009
AP	9/25/2009	SLR	23500	052	REMS	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052,016862s041s042REMS.pdf	10/1/2009
AP	9/25/2009	SLR	23688	052		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf	10/26/2009

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