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FDA Drug Application 019558 by MERCK

Application Number	019558
Application Type	New Drug Application
Sponsor Applicant	MERCK
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	12/29/1987	N	9341	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf	6/14/2004
AP	12/29/1987	N	9342	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf	6/14/2004
AP	12/29/1987	N	14276	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm	6/9/2006
AP	10/25/1988	SLR
AP	10/25/1988	SLR
AP	8/19/1988	SCS
AP	3/29/1989	SLR
AP	1/31/1989	SLR
AP	8/9/1989	SLR
AP	6/14/1993	SE1
AP	4/11/1990	SLR
AP	1/7/1991	SCS
AP	2/6/1991	SLR
AP	3/28/1991	SLR
AP	9/9/1991	SCS
AP	9/30/1992	SCP
AP	1/23/1992	SCP
AP	5/7/1992	SLR
AP	5/13/1992	SLR
AP	9/30/1992	SLR
AP	9/3/1996	SLR
AP	3/10/1993	SLR
AP	1/14/1994	SLR
AP	5/11/1994	SLR
AP	1/28/1994	SCF
AP	9/23/1993	SLR
AP	3/10/1994	SLR
AP	7/24/1994	SLR
AP	11/24/1995	SE1
AP	2/22/1995	SLR
AP	3/21/1995	SCS
AP	6/8/1995	SCM
AP	9/28/1995	SLR
AP	6/26/1995	SCS
AP	9/28/1995	SLR
AP	11/1/1995	SCS
AP	9/3/1996	SLR
AP	2/17/1999	SLR	3390	036	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf	6/22/2001
AP	3/15/1999	SCM
AP	8/7/2001	SLR
AP	6/9/2000	SCM
AP	5/5/2004	SLR	8551	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr040ltr.pdf	5/7/2004
AP	4/26/2001	SCM
AP	8/23/2001	SCM
AP	5/29/2003	SE5	5797	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf	6/8/2003
AP	5/29/2003	SE5	5872	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf	6/8/2003
AP	5/29/2003	SE5	11432	043	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm	4/17/2005
AP	3/2/2004	SLR	7805	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf	3/3/2004
AP	10/5/2005	SLR	12866	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019558s046ltr.pdf	10/11/2005
AP	6/16/2006	SLR	14337	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf	6/20/2006
AP	10/18/2006	SLR	15185	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf	10/23/2006
AP	2/2/2007	SLR	15801	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf	2/12/2007
AP	10/9/2008	SLR	21013	051	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf	10/14/2008
AP	10/9/2008	SLR	21014	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf	10/14/2008
AP	6/10/2011	SLR	29210	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf	6/17/2011
AP	11/17/2011	SLR	30694	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf	11/21/2011
AP	11/17/2011	SLR	30720	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf	11/21/2011
AP	6/6/2012	SLR	32859	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf	6/8/2012
AP	6/6/2012	SLR	32877	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf	6/11/2012
AP	2/26/2013	SLR	35272	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019558Orig1s056ltr.pdf	2/28/2013
AP	2/26/2013	SLR	35319	056	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf	3/1/2013
AP	7/8/2015	SLR	43324	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s057ltr.pdf	7/13/2015
AP	7/8/2015	SLR	43335	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf	7/13/2015
AP	8/22/2014	SCM
AP	8/28/2015	SLR	43772	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s059ltr.pdf	9/1/2015
AP	8/28/2015	SLR	43785	059	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf	9/3/2015
AP	10/14/2016	SLR	47382	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf	10/17/2016
AP	10/14/2016	SLR	47385	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019558Orig1s060ltr.pdf	10/19/2016

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