NDA 020387

MERCK SHARP DOHME

FDA Drug Application

Application #020387

Documents

• Letter: 2003-09-30
• Letter: 2003-09-30
• Letter: 2005-04-12
• Letter: 2005-04-13
• Letter: 2006-04-25
• Letter: 2015-12-15
• Letter: 2010-09-27
• Letter: 2012-10-03
• Letter: 2013-03-29
• Letter: 2014-10-01
• Label: 2003-10-10
• Label: 2003-10-10
• Label: 2003-10-09
• Label: 2005-04-12
• Label: 2005-04-13
• Label: 2005-10-24
• Label: 2006-08-30
• Label: 2010-09-23
• Label: 2011-08-24
• Label: 2011-08-30
• Label: 2012-10-02
• Label: 2013-04-01
• Label: 2014-01-22
• Review: 1997-11-07
• Review: 1998-08-24
• Review: 1998-11-10
• Review: 1998-08-25
• Review: 1998-11-24
• Review: 2003-11-25
• Letter: 2002-11-07
• Letter: 2003-09-30
• Letter: 2005-04-13
• Letter: 2005-10-25
• Letter: 2007-01-08
• Letter: 2006-09-18
• Letter: 2009-06-17
• Letter: 2011-06-17
• Letter: 2011-08-18
• Letter: 2011-11-21
• Letter: 2011-08-31
• Letter: 2014-01-21
• Label: 2005-04-13
• Label: 2006-04-21
• Label: 2009-06-22
• Label: 2015-12-15
• Label: 2011-11-21
• Label: 2014-09-30
• Review: 2002-04-30
• Review: 1999-06-09
• Review: 2003-11-25
• Review: 2001-01-28
• Review: 2003-11-25
• Review: 2000-01-19
• Review: 2011-02-15
• Label: 2018-10-15
• Letter: 2018-10-17
• Letter: 2019-11-12
• Label: 2019-11-15
• Label: 2020-08-20
• Letter: 2020-08-24
• Label: 2021-03-08

Application Sponsors

NDA 020387

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	12.5MG;50MG	1	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
002	TABLET;ORAL	25MG;100MG	1	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
003	TABLET;ORAL	12.5MG;100MG	1	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1995-04-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-12-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-07-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-11-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	1998-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-11-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	1998-04-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-08-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	1998-11-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	1999-06-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-09-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	2000-01-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-02-23	STANDARD
LABELING; Labeling	SUPPL	17	AP	2000-01-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2001-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-06-22	STANDARD
LABELING; Labeling	SUPPL	22	AP	2001-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-01-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	2002-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2003-01-08	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2003-09-30	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2005-04-05	STANDARD
LABELING; Labeling	SUPPL	34	AP	2005-04-12	STANDARD
LABELING; Labeling	SUPPL	35	AP	2005-04-12	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2005-10-20	STANDARD
LABELING; Labeling	SUPPL	38	AP	2006-04-20	STANDARD
LABELING; Labeling	SUPPL	40	AP	2006-12-21	STANDARD
LABELING; Labeling	SUPPL	41	AP	2006-08-29	STANDARD
LABELING; Labeling	SUPPL	45	AP	2009-06-12	STANDARD
LABELING; Labeling	SUPPL	47	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	48	AP	2010-09-21	UNKNOWN
LABELING; Labeling	SUPPL	50	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	52	AP	2011-08-17	UNKNOWN
LABELING; Labeling	SUPPL	54	AP	2011-11-17	UNKNOWN
LABELING; Labeling	SUPPL	55	AP	2011-08-26	UNKNOWN
LABELING; Labeling	SUPPL	56	AP	2012-09-28	UNKNOWN
LABELING; Labeling	SUPPL	57	AP	2013-03-27	STANDARD
LABELING; Labeling	SUPPL	59	AP	2014-01-17	STANDARD
LABELING; Labeling	SUPPL	60	AP	2014-09-30	STANDARD
LABELING; Labeling	SUPPL	63	AP	2018-10-12	STANDARD
LABELING; Labeling	SUPPL	64	AP	2019-11-07	STANDARD
LABELING; Labeling	SUPPL	66	AP	2020-08-20	STANDARD
LABELING; Labeling	SUPPL	67	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	47	Null	15
SUPPL	48	Null	6
SUPPL	50	Null	4
SUPPL	52	Null	15
SUPPL	54	Null	7
SUPPL	55	Null	15
SUPPL	56	Null	6
SUPPL	57	Null	6
SUPPL	59	Null	15
SUPPL	60	Null	6
SUPPL	63	Null	15
SUPPL	64	Null	15
SUPPL	67	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20387
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYZAAR","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"12.5MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYZAAR","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYZAAR","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"12.5MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-66","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022387s066lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2019","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020387s064lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2018","submission":"SUPPL-63","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020387s063lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2018","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020387s063lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2015","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020387s047lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2014","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020387s060lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"SUPPL-59","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020387s059lbledt.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020387s059lbledt.pdf\"}]","notes":""},{"actionDate":"03\/27\/2013","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020387s057lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-56","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020387s056lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020387s056lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2011","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020387Orig1s054Lbl_REPLACEMENT.pdf\"}]","notes":""},{"actionDate":"08\/26\/2011","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020387s055lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2011","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020387s052lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2010","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020387s048lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2009","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020387s045lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2006","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020387s041lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2006","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020387s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2005","submission":"SUPPL-37","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020387s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2005","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020386s039,020387s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2005","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020386s040,020387s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2005","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020387s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2003","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20387se1-027,slr015_hyzaar_lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2003","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20387se1-027,slr015_hyzaar_lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2003","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20387se1-027,slr015_hyzaar_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYZAAR","submission":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","actionType":"12.5MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYZAAR","submission":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYZAAR","submission":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","actionType":"12.5MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)