FDA.reportPublic FDA data

Application 020386

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COZAARLOSARTAN POTASSIUMTABLET;ORAL25MGYesNo
002COZAARLOSARTAN POTASSIUMTABLET;ORAL50MGYesNo
003COZAARLOSARTAN POTASSIUMTABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0951COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0951COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0951COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0951COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0952COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0952COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0952COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0952COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0960COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0960COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0960COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0006-0960COZAARlosartan potassiumMerck Sharp & Dohme Corp.NDACurrent
0781-5805Losartan Potassiumlosartan potassiumSandoz Inc.NDACurrent
0781-5806Losartan Potassiumlosartan potassiumSandoz Inc.NDACurrent
0781-5807Losartan Potassiumlosartan potassiumSandoz Inc.NDACurrent
55289-238COZAARlosartan potassiumPD-Rx Pharmaceuticals, InNDACurrent
55289-238COZAARlosartan potassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-238COZAARlosartan potassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-238COZAARlosartan potassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-238COZAARlosartan potassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
63629-2912COZAARlosartan potassiumBryant Ranch PrepackNDACurrent
78206-121COZAARlosartan potassiumOrganon LLCNDACurrent
78206-121COZAARlosartan potassiumOrganon LLCNDACurrent
78206-121COZAARlosartan potassiumOrganon LLCNDACurrent
78206-122COZAARlosartan potassiumOrganon LLCNDACurrent
78206-122COZAARlosartan potassiumOrganon LLCNDACurrent
78206-122COZAARlosartan potassiumOrganon LLCNDACurrent
78206-123COZAARlosartan potassiumOrganon LLCNDACurrent
78206-123COZAARlosartan potassiumOrganon LLCNDACurrent
78206-123COZAARlosartan potassiumOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82680SUPPL 2025-06-27
82662SUPPL 2025-06-25
69065SUPPL2021-10-22
69041SUPPL2021-10-21
55965SUPPL2018-10-17
55911SUPPL2018-10-15
12512SUPPL2015-12-15
2447SUPPL2015-12-15
2452SUPPL2014-10-01
12515SUPPL2014-09-30
12514SUPPL2014-01-22
2451SUPPL2014-01-21
12513SUPPL2013-04-01
2450SUPPL2013-03-29
2449SUPPL2012-10-03
34590SUPPL2012-10-02
44056ORIG2011-12-22
34589SUPPL2011-11-21
2448SUPPL2011-11-21
24885SUPPL2011-06-17
24884SUPPL2010-09-27
34588SUPPL2010-09-23
24883SUPPL2009-06-16
34587SUPPL2009-06-04
24882SUPPL2006-09-25
24881SUPPL2006-09-25
24136SUPPL2006-09-25
24135SUPPL2006-09-25
2446SUPPL2006-09-18
12511SUPPL2006-08-30
43561SUPPL2006-04-14
2445SUPPL2006-04-07
24880SUPPL2005-04-13
12510SUPPL2005-04-13
12509SUPPL2005-04-13
2444SUPPL2005-04-13
20622SUPPL2005-02-02
41318SUPPL2004-06-04
41320SUPPL2004-06-02
34586SUPPL2004-05-06
34585SUPPL2004-05-06
2442SUPPL2004-03-16
2440SUPPL2004-03-16
41321SUPPL2003-07-08
2443SUPPL2003-03-28
12508SUPPL2003-03-25
12507SUPPL2002-09-17
2441SUPPL2002-09-17
41319SUPPL2001-06-06
41317SUPPL2000-01-28
41316SUPPL1999-06-09
20621SUPPL1998-11-24
41315SUPPL1998-10-13
20620SUPPL1997-11-07
57423ORIG1996-03-16