NDA 020386

MERCK SHARP DOHME

FDA Drug Application

Application #020386

Documents

• Letter: 2004-03-16
• Letter: 2002-09-17
• Letter: 2004-03-16
• Letter: 2003-03-28
• Letter: 2005-04-13
• Letter: 2006-04-07
• Letter: 2006-09-18
• Letter: 2015-12-15
• Letter: 2011-11-21
• Letter: 2012-10-03
• Letter: 2013-03-29
• Letter: 2014-01-21
• Letter: 2014-10-01
• Label: 2002-09-17
• Label: 2003-03-25
• Label: 2005-04-13
• Label: 2005-04-13
• Label: 2006-08-30
• Label: 2015-12-15
• Label: 2013-04-01
• Label: 2014-01-22
• Label: 2014-09-30
• Review: 1997-11-07
• Review: 1998-11-24
• Review: 2005-02-02
• Patient Information Sheet: 2006-09-25
• Patient Information Sheet: 2006-09-25
• Letter: 2005-04-13
• Letter: 2006-09-25
• Letter: 2006-09-25
• Letter: 2009-06-16
• Letter: 2010-09-27
• Letter: 2011-06-17
• Label: 2004-05-06
• Label: 2004-05-06
• Label: 2009-06-04
• Label: 2010-09-23
• Label: 2011-11-21
• Label: 2012-10-02
• Review: 1998-10-13
• Review: 1999-06-09
• Review: 2000-01-28
• Review: 2004-06-04
• Review: 2001-06-06
• Review: 2004-06-02
• Review: 2003-07-08
• Patient Package Insert: 2006-04-14
• Other Important Information from FDA: 2011-12-22
• Label: 2018-10-15
• Letter: 2018-10-17
• Review: 1996-03-16
• Letter: 2021-10-21
• Label: 2021-10-22

Application Sponsors

NDA 020386

MERCK SHARP DOHME

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	1	COZAAR	LOSARTAN POTASSIUM
002	TABLET;ORAL	50MG	1	COZAAR	LOSARTAN POTASSIUM
003	TABLET;ORAL	100MG	1	COZAAR	LOSARTAN POTASSIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-04-14	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
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-08-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	1998-02-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	1997-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-03-27	STANDARD
LABELING; Labeling	SUPPL	11	AP	1998-08-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	1998-04-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	1998-08-31	STANDARD
LABELING; Labeling	SUPPL	14	AP	1998-08-31	STANDARD
LABELING; Labeling	SUPPL	15	AP	1998-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-05-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	1999-06-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2000-01-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-03-11	STANDARD
LABELING; Labeling	SUPPL	20	AP	2000-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-02-23	STANDARD
LABELING; Labeling	SUPPL	22	AP	2001-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2001-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-06-22	STANDARD
LABELING; Labeling	SUPPL	26	AP	2001-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2002-01-10	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2002-09-17	PRIORITY
EFFICACY; Efficacy	SUPPL	29	AP	2004-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-10-23	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2003-03-25	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2005-04-12	STANDARD
LABELING; Labeling	SUPPL	40	AP	2005-04-12	STANDARD
LABELING; Labeling	SUPPL	42	AP	2006-03-31	STANDARD
LABELING; Labeling	SUPPL	43	AP	2006-09-21	STANDARD
LABELING; Labeling	SUPPL	45	AP	2006-08-29	STANDARD
LABELING; Labeling	SUPPL	46	AP	2006-09-21	STANDARD
LABELING; Labeling	SUPPL	49	AP	2009-06-05	STANDARD
LABELING; Labeling	SUPPL	52	AP	2010-09-23	UNKNOWN
LABELING; Labeling	SUPPL	53	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	54	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	56	AP	2011-11-17	UNKNOWN
LABELING; Labeling	SUPPL	57	AP	2012-09-28	UNKNOWN
LABELING; Labeling	SUPPL	58	AP	2013-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2014-02-20	STANDARD
LABELING; Labeling	SUPPL	60	AP	2014-01-17	STANDARD
LABELING; Labeling	SUPPL	61	AP	2014-09-29	STANDARD
LABELING; Labeling	SUPPL	62	AP	2018-10-12	STANDARD
LABELING; Labeling	SUPPL	64	AP	2021-10-15	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	8
SUPPL	31	Null	0
SUPPL	52	Null	7
SUPPL	53	Null	4
SUPPL	54	Null	6
SUPPL	56	Null	15
SUPPL	57	Null	15
SUPPL	58	Null	6
SUPPL	59	Null	0
SUPPL	60	Null	15
SUPPL	61	Null	6
SUPPL	62	Null	7
SUPPL	64	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20386
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"COZAAR","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COZAAR","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COZAAR","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/12\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020386s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020386s062lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2015","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020386s054lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2014","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020386s061lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020386s060lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"SUPPL-60","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020386s060lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2013","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020386s058lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020386s057lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2011","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020386Orig1s056Lbl_REPLACEMENT.pdf\"}]","notes":""},{"actionDate":"09\/23\/2010","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020386s052lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2009","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020386s049lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2006","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020386s045lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2005","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020386s040,020387s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2005","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020386s039,020387s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2004","submission":"SUPPL-29","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020386s019s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2004","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020386s019s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2003","submission":"SUPPL-32","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020386s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2002","submission":"SUPPL-28","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20386s28lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COZAAR","submission":"LOSARTAN POTASSIUM","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COZAAR","submission":"LOSARTAN POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COZAAR","submission":"LOSARTAN POTASSIUM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-12
        )

)