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FDA Drug Application 016418 by WYETH PHARMS INC

Application Number	016418
Application Type	New Drug Application
Sponsor Applicant	WYETH PHARMS INC
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	11/13/1967	N
AP	2/18/1975	SLR
AP	8/21/1978	SLR
AP	9/21/1976	SCS
AP	11/3/1977	SCS
AP	12/8/1977	SCP
AP	3/7/1979	SLR
AP	1/17/1979	SES
AP	4/24/1978	SCP
AP	4/24/1978	SCS
AP	2/14/1978	SCP
AP	12/12/1978	SLR
AP	8/3/1978	SCP
AP	2/12/1979	SCS
AP	5/3/1979	SCF
AP	3/21/1979	SCS
AP	3/7/1979	SCS
AP	10/31/1986	SE1
AP	3/24/1980	SCF
AP	3/24/1980	SCP
AP	9/16/1980	SCS
AP	9/19/1980	SCS
AP	3/21/1983	SCM
AP	1/26/1982	SLR
AP	10/31/1986	SE1
AP	10/15/1981	SCM
AP	2/8/1982	SCS
AP	9/30/1983	SES
AP	10/18/1982	SES
AP	10/18/1982	SLR
AP	10/31/1986	SE1
AP	11/12/1982	SCF
AP	1/7/1983	SCS
AP	1/21/1983	SLR
AP	6/18/1985	SCS
AP	1/12/1984	SCS
AP	2/22/1985	SCM
AP	5/21/1984	SCF
AP	2/25/1985	SCP
AP	12/20/1984	SCS
AP	2/28/1985	SCP
AP	10/9/1985	SCE
AP	1/20/1987	SCS
AP	5/25/1988	SCP
AP	3/30/1989	SCE
AP	2/15/1990	SLR
AP	11/7/1997	SLR
AP	8/22/1999	SLR
AP	2/6/2002	SLR
AP	8/18/2004	SLR	10062	073	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16418s073ltr.pdf	8/25/2004
AP	8/18/2004	SLR	10066	073	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16418s073lbl.pdf	8/25/2004
AP	12/29/2006	SLR	15587	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016418s076ltr.pdf	1/8/2007
AP	2/21/2007	SLR	15950	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s077;018031s034ltr.pdf	3/6/2007
AP	9/6/2007	SLR	17777	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf	9/7/2007
AP	9/6/2007	SLR	17809	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016418s078_ltr.pdf	9/7/2007
AP	5/6/2008	SLR	19793	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016418s079ltr.pdf	5/9/2008
AP	3/17/2011	SLR	28307	080	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf	3/22/2011
AP	3/17/2011	SLR	28312	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf	3/23/2011

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