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FDA Drug Application 020386 by MERCK SHARP DOHME

Application Number	020386
Application Type	New Drug Application
Sponsor Applicant	MERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	4/14/1995	N	31205	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm	12/22/2011
AP	0	12/29/1995	SE4
AP	0	11/22/1995	SLR
AP	0	12/1/1995	SCM
AP	0	7/18/1996	SLR
AP	0	8/7/1996	SCS
AP	0	2/25/1998	SLR
AP	0	11/7/1997	SLR	3673	007	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf	11/7/1997
AP	0	10/13/1998	SCS	2613	008	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386-s008_cozaar.pdf	10/13/1998
AP	0	3/9/1998	SCM
AP	0	3/27/1998	SCM
AP	0	8/31/1998	SLR
AP	0	4/3/1998	SLR
AP	0	8/31/1998	SLR
AP	0	8/31/1998	SLR
AP	0	11/24/1998	SLR	1081	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386s015_Cozaar.pdf	11/24/1998
AP	0	5/13/1999	SCS
AP	0	6/9/1999	SLR	1202	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20386S017_Cozaar.pdf	6/9/1999
AP	0	1/28/2000	SLR	2610	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf	1/28/2000
AP	0	3/11/2004	SLR	7945	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf	3/16/2004
AP	0	3/11/2004	SLR	8518	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf	5/6/2004
AP	0	3/11/2004	SLR	9039	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm	6/4/2004
AP	0	1/19/2000	SLR	2609	020	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf	6/6/2001
AP	0	2/23/2000	SCS
AP	0	10/3/2001	SLR
AP	0	7/3/2001	SCS
AP	0	5/16/2001	SCS
AP	0	6/22/2001	SCM
AP	0	8/24/2001	SLR
AP	0	1/10/2002	SCM
AP	0	9/17/2002	SE1	2607	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-028ltr.pdf	9/17/2002
AP	0	9/17/2002	SE1	2608	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf	9/17/2002
AP	0	9/17/2002	SE1	8879	028	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-386s028_Cozaar.cfm	6/2/2004
AP	0	3/11/2004	SLR	7946	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf	3/16/2004
AP	0	3/11/2004	SLR	8517	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf	5/6/2004
AP	0	3/11/2004	SLR	11062	029	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm	2/2/2005
AP	0	10/23/2002	SCS
AP	0	3/25/2003	SE1	4474	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf	3/25/2003
AP	0	3/25/2003	SE1	4655	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-032ltr.pdf	3/28/2003
AP	0	3/25/2003	SE1	6113	032	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-386s032_Cozaar.cfm	7/8/2003
AP	0	4/12/2005	SLR	11396	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf	4/13/2005
AP	0	4/12/2005	SLR	11397	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf	4/13/2005
AP	0	4/12/2005	SLR	11395	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf	4/13/2005
AP	0	4/12/2005	SLR	11398	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf	4/13/2005
AP	0	3/31/2006	SLR	13889	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s042ltr.pdf	4/7/2006
AP	0	4/13/2006	SLR	13941	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf	4/14/2006
AP	0	4/13/2006	SLR	14949	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf	9/25/2006
AP	0	4/13/2006	SLR	14967	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf	9/25/2006
AP	1	9/21/2006	SLR	13941	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf	4/14/2006
AP	1	9/21/2006	SLR	14949	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf	9/25/2006
AP	1	9/21/2006	SLR	14967	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf	9/25/2006
AP	0	8/29/2006	SLR	14774	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf	8/30/2006
AP	0	8/29/2006	SLR	14870	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s045ltr.pdf	9/18/2006
AP	0	9/21/2006	SLR	14950	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf	9/25/2006
AP	0	9/21/2006	SLR	14968	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf	9/25/2006
AP	0	6/4/2009	SLR	22697	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf	6/4/2009
AP	0	6/4/2009	SLR	22748	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020386s049ltr.pdf	6/16/2009
AP	0	9/21/2010	SLR	26532	052	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf	9/23/2010
AP	0	9/21/2010	SLR	26540	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020386s052ltr.pdf	9/27/2010
AP	0	6/10/2011	SLR	29211	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf	6/17/2011
AP	0	12/11/2015	SLR	44764	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf	12/15/2015
AP	0	12/11/2015	SLR	44774	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf	12/15/2015
AP	0	11/17/2011	SLR	30696	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf	11/21/2011
AP	0	11/17/2011	SLR	30719	056	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf	11/21/2011
AP	0	9/28/2012	SLR	33924	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf	10/2/2012
AP	0	9/28/2012	SLR	33944	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf	10/3/2012
AP	0	3/27/2013	SLR	35573	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf	3/29/2013
AP	0	3/27/2013	SLR	35606	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf	4/1/2013
AP	0	2/20/2014	SCM
AP	0	1/17/2014	SLR	38337	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_replace.pdf	1/21/2014
AP	0	1/17/2014	SLR	38343	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf	1/22/2014
AP	0	9/29/2014	SLR	40671	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf	9/30/2014
AP	0	9/29/2014	SLR	40682	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf	10/1/2014

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