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FDA Drug Application 004782 by WYETH PHARMS INC

Application Number	004782
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	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	5/8/1942	N	22675	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103324.htm	6/2/2009
AP	1/26/1984	SCF
AP	5/29/1985	SCP
AP	4/29/1985	SLR
AP	5/29/1985	SCS
AP	4/29/1985	SLR
AP	4/29/1985	SLR
AP	5/28/1986	SLR
AP	9/30/1985	SCS
AP	10/25/1985	SCP
AP	1/7/1986	SCF
AP	5/19/1989	SLR
AP	5/12/1986	SCS
AP	7/10/1986	SCS
AP	5/19/1989	SLR
AP	12/3/1986	SCS
AP	9/24/1986	SCM
AP	10/16/1987	SCS
AP	5/14/1987	SCM
AP	4/17/1988	SCS
AP	5/19/1989	SLR
AP	12/20/1988	SCP
AP	2/3/1989	SCF
AP	5/19/1989	SLR
AP	5/14/1991	SCS
AP	5/9/1991	SCE
AP	5/19/1989	SLR
AP	12/22/1989	SLR
AP	2/23/1990	SCF
AP	4/26/1999	SCS
AP	3/11/1992	SCP
AP	12/23/1993	SLR
AP	9/8/1998	SE2	3688	093	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093.cfm	9/8/1998
AP	9/8/1998	SE2	4994	093	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/04782s093_premarin_appltrs.pdf	9/8/1998
AP	11/9/1994	SCS
AP	2/6/1995	SCM
AP	5/6/1998	SLR
AP	4/11/1995	SCS
AP	12/13/1995	SCS
AP	12/14/1995	SCS
AP	2/27/1998	SCS
AP	6/27/1996	SCS
AP	6/28/1996	SCS
AP	5/6/1998	SLR
AP	10/29/1998	SCS
AP	6/8/1999	SLR
AP	7/5/2000	SCS
AP	4/24/2003	SE2	5509	115	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf	4/28/2003
AP	4/24/2003	SE2	5640	115	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf	5/16/2003
AP	4/24/2003	SE2	16187	115	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf	4/9/2007
AP	4/24/2001	SCE
AP	8/6/2001	SCS
AP	12/3/2001	SCS
AP	8/21/2002	SCS
AP	7/16/2003	SLR	6177	125	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr125ltr.pdf	7/28/2003
AP	12/20/2002	SCS
AP	11/27/2002	SLR	3686	128	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/04782slr128ltr.pdf	11/27/2002
AP	11/27/2002	SLR	3687	128	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf	11/27/2002
AP	1/7/2003	SLR	3684	129	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782slr129ltr.pdf	1/7/2003
AP	1/7/2003	SLR	3685	129	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf	1/7/2003
AP	4/24/2003	SLR	5524	130	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf	4/30/2003
AP	4/24/2003	SLR	5641	130	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/04782se2-115,slr130ltr.pdf	5/16/2003
AP	4/24/2003	SLR	16188	130	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/004782_S115&S130_PREMARIN_TABLETS.pdf	4/9/2007
AP	4/20/2004	SLR	8425	133	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf	4/29/2004
AP	4/20/2004	SLR	8475	133	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf	5/4/2004
AP	4/20/2004	SLR	8424	136	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782slr133,136ltr.pdf	4/29/2004
AP	4/20/2004	SLR	10624	136	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf	11/17/2004
AP	8/26/2004	SCF	10106	137	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/04782s137ltr.pdf	8/31/2004
AP	8/26/2004	SCF	10107	137	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf	8/31/2004
AP	4/7/2005	SLR	11378	138	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf	4/12/2005
AP	4/7/2005	SLR	11386	138	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf	4/12/2005
AP	4/7/2005	SLR	11379	139	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s138,139ltr.pdf	4/12/2005
AP	4/7/2005	SLR	11387	139	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf	4/12/2005
AP	8/1/2005	SCF	12534	141	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf	8/4/2005
AP	8/1/2005	SCF	12541	141	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s141ltr.pdf	8/4/2005
AP	11/1/2005	SCF	13014	142	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/004782s142ltr.pdf	11/3/2005
AP	11/1/2005	SCF	13017	142	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf	11/3/2005
AP	4/24/2006	SLR	13982	146	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf	4/25/2006
AP	4/24/2006	SLR	13990	146	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/004782s146LTR.pdf	4/25/2006
AP	9/5/2006	SLR	14802	147	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf	9/12/2006
AP	9/5/2006	SLR	14851	147	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/04782s147_ltr.pdf	9/18/2006
AP	3/3/2008	SLR	19360	155	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf	3/5/2008
AP	3/3/2008	SLR	19376	155	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/004782s155ltr.pdf	3/5/2008
AP	10/28/2011	SLR	30435	162	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf	10/31/2011
AP	10/28/2011	SLR	30450	162	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf	11/1/2011
AP	4/11/2014	SCM
AP	10/28/2011	SLR	30436	164	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf	10/31/2011
AP	10/28/2011	SLR	30451	164	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf	11/1/2011
AP	10/28/2011	SLR	30437	167	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/004782s162,s164,s0167ltr.pdf	10/31/2011
AP	10/28/2011	SLR	30452	167	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf	11/1/2011
AP	12/3/2014	SLR	41154	171	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/004782Orig1s171ltr.pdf	12/4/2014
AP	12/3/2014	SLR	41190	171	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf	12/10/2014
AP	6/9/2015	SCM
AP	9/1/2015	SCM

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