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FDA Drug Application 018998 by VALEANT PHARMS NORTH

Application Number	018998
Application Type	New Drug Application
Sponsor Applicant	VALEANT PHARMS NORTH
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	12/24/1985	N	11451	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_Vasotec.cfm	4/27/2005
AP	12/24/1985	N	14272	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm	6/9/2006
AP	10/27/1986	SCS
AP	11/7/1986	SCS
AP	10/3/1986	SLR
AP	5/14/1987	SLR	15269	005	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S005_Vasotec_APPROVAL PACKAGE.pdf	10/26/2006
AP	1/28/1987	SLR	15270	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S006_Vasotec_APPROVAL PACKAGE.pdf	10/26/2006
AP	6/24/1988	SE1
AP	7/10/1987	SCP	15271	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S009_Vasotec_APPROVAL PACKAGE.pdf	10/26/2006
AP	4/25/1988	SLR	18572	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S011_VASOTEC.pdf	11/19/2007
AP	7/26/1988	SCF
AP	8/3/1988	SCM	18571	013	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S013_VASOTEC.pdf	11/19/2007
AP	3/29/1989	SLR	17063	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S015_ VASOTEC_AP.pdf	7/6/2007
AP	1/10/1989	SLR	18570	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S016_VASOTEC.pdf	11/19/2007
AP	2/20/1991	SCM	17881	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S017_VASOTEC.pdf	9/14/2007
AP	4/18/1989	SLR	17062	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S018_VASOTEC_AP.pdf	7/6/2007
AP	11/30/1989	SLR	17061	020	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S020_VASOTEC_AP.pdf	7/6/2007
AP	3/9/1990	SLR	17317	021	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S021_VASOTEC.pdf	7/20/2007
AP	6/12/1990	SE1	17318	022	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S022_VASOTEC.pdf	7/20/2007
AP	7/19/1990	SCP	17319	023	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S023_VASOTEC.pdf	7/20/2007
AP	11/28/1990	SLR	17882	024	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S024_VASOTEC.pdf	9/14/2007
AP	2/6/1991	SLR	17883	025	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S025_VASOTEC.pdf	9/14/2007
AP	8/2/1991	SCP
AP	4/8/1992	SE5
AP	9/30/1992	SCP
AP	5/13/1992	SLR
AP	5/7/1992	SLR
AP	11/4/1993	SE1
AP	9/30/1992	SLR
AP	7/31/1996	SLR	17020	034	http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S034_VASOTEC_AP.pdf	7/6/2007
AP	7/26/1993	SCM
AP	2/24/1993	SLR
AP	7/1/1993	SLR
AP	5/11/1994	SLR	27423	038	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s038_vasotec.pdf	1/4/2011
AP	1/14/1994	SLR	27424	039	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s039_vasotec.pdf	1/4/2011
AP	10/21/1993	SLR	27425	040	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s040_vasotec.pdf	1/4/2011
AP	12/12/1994	SCM	16756	041	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S041_VASOTEC_AP.pdf	6/12/2007
AP	7/15/1994	SCS	16757	042	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S042_VASOTEC_AP.pdf	6/12/2007
AP	2/18/1994	SLR	27840	043	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s043_vasotec.pdf	2/15/2011
AP	5/16/1994	SLR	27841	044	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s044_vasotec.pdf	2/15/2011
AP	7/25/1994	SLR	16758	045	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S045_VASOTEC_AP.pdf	6/12/2007
AP	9/28/1995	SLR	17019	046	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S046_VASOTEC_AP.pdf	7/6/2007
AP	9/19/1995	SCS
AP	9/19/1995	SCS
AP	9/19/1995	SCS
AP	3/22/1996	SCM	17018	050	http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S050_VASOTEC_AP.pdf	7/6/2007
AP	1/9/1997	SCM	16191	051	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018998_S051_VASOTEC_AP.pdf	4/9/2007
AP	2/3/1997	SCM	16192	052	http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/018998_S052_VASOTEC_AP.pdf	4/9/2007
AP	6/11/1997	SLR	4351	053	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf	6/11/1997
AP	7/23/1997	SCP
AP	7/21/1997	SCM
AP	12/10/1997	SCS
AP	2/17/1999	SLR	3910	057	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf	6/22/2001
AP	11/27/2001	SLR	2255	058	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm	11/27/2001
AP	11/27/2001	SLR	5192	058	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf	11/27/2001
AP	11/27/2001	SLR	5193	058	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf	11/27/2001
AP	2/13/2001	SE8	2258	059	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec.cfm	2/13/2001
AP	2/13/2001	SE8	5196	059	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_Approv.pdf	2/13/2001
AP	2/13/2001	SE8	5197	059	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf	2/13/2001
AP	2/4/2002	SCM	15221	061	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S061_Vasotec_APPROVAL PACKAGE.pdf	10/25/2006
AP	4/3/2002	SCS	15222	062	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S062_Vasotec_APPROVAL_PACKAGE.pdf	10/25/2006
AP	8/30/2002	SCM	2257	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18998scm063ltr.pdf	8/30/2002
AP	10/10/2002	SCM	15258	064	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S064_Vasotec_APPROVAL PACKAGE.pdf	10/26/2006
AP	10/31/2007	SLR	18364	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf	11/8/2007
AP	9/25/2008	SLR	20898	071	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf	9/29/2008
AP	9/25/2008	SLR	25586	071	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf	5/18/2010
AP	2/17/2012	SLR	31846	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf	2/22/2012
AP	2/17/2012	SLR	31869	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998s076ltr.pdf	2/23/2012
AP	9/13/2012	SLR	33754	077	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf	9/14/2012
AP	9/13/2012	SLR	33764	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998Origs077ltr.pdf	9/17/2012
AP	12/24/2014	SLR	41441	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018998Orig1s079ltr.pdf	12/30/2014
AP	12/24/2014	SLR	41603	079	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf	1/9/2015
AP	8/25/2015	SLR	43719	080	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf	8/26/2015
AP	8/25/2015	SLR	43726	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018998Orig1s080ltr.pdf	8/27/2015

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