FDA.reportPublic FDA data

Application 020387

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYZAARHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;50MGYesNo
002HYZAARHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL25MG;100MGYesNo
003HYZAARHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0717HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0717HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0717HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0717HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0745HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0745HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0745HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0745HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0747HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0747HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0747HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0006-0747HYZAARlosartan potassium and hydrochlorothiazideMerck Sharp & Dohme Corp.NDACurrent
0781-5816losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideSandoz Inc.NDACurrent
0781-5817losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideSandoz Inc.NDACurrent
0781-5818losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideSandoz Inc.NDACurrent
21695-788HYZAARlosartan potassium and hydrochlorothiazideRebel Distributors CorpNDACurrent
43353-926HYZAARlosartan potassium and hydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDACurrent
55289-522HYZAARlosartan potassium and hydrochlorothiazidePD-Rx Pharmaceuticals, InNDACurrent
55289-522HYZAARlosartan potassium and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-522HYZAARlosartan potassium and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-522HYZAARlosartan potassium and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-522HYZAARlosartan potassium and hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
63629-3183HYZAARlosartan potassium and hydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-3183HYZAARlosartan potassium and hydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-3183HYZAARlosartan potassium and hydrochlorothiazideBryant Ranch PrepackNDACurrent
78206-139HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent
78206-139HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent
78206-140HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent
78206-140HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent
78206-141HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent
78206-141HYZAARlosartan potassium and hydrochlorothiazideOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82663SUPPL 2025-06-25
82643SUPPL 2025-06-24
73805SUPPL 2023-03-28
73812SUPPL 2023-03-21
66563SUPPL2021-03-08
64399SUPPL2020-08-24
64335SUPPL2020-08-20
60847SUPPL2019-11-15
60814SUPPL2019-11-12
55966SUPPL2018-10-17
55910SUPPL2018-10-15
34594SUPPL2015-12-15
2458SUPPL2015-12-15
2462SUPPL2014-10-01
34596SUPPL2014-09-30
12528SUPPL2014-01-22
24897SUPPL2014-01-21
12527SUPPL2013-04-01
2461SUPPL2013-03-29
2460SUPPL2012-10-03
12526SUPPL2012-10-02
34595SUPPL2011-11-21
24895SUPPL2011-11-21
24896SUPPL2011-08-31
12525SUPPL2011-08-30
12524SUPPL2011-08-24
24894SUPPL2011-08-18
24893SUPPL2011-06-17
41328SUPPL2011-02-15
2459SUPPL2010-09-27
12523SUPPL2010-09-23
34593SUPPL2009-06-22
24892SUPPL2009-06-17
24890SUPPL2007-01-08
24891SUPPL2006-09-18
12522SUPPL2006-08-30
2457SUPPL2006-04-25
34592SUPPL2006-04-21
24889SUPPL2005-10-25
12521SUPPL2005-10-24
34591SUPPL2005-04-13
24888SUPPL2005-04-13
12520SUPPL2005-04-13
2456SUPPL2005-04-13
12519SUPPL2005-04-12
2455SUPPL2005-04-12
41326SUPPL2003-11-25
41324SUPPL2003-11-25
20628SUPPL2003-11-25
12517SUPPL2003-10-10
12516SUPPL2003-10-10
12518SUPPL2003-10-09
24887SUPPL2003-09-30
2454SUPPL2003-09-30
2453SUPPL2003-09-30
24886SUPPL2002-11-07
41322SUPPL2002-04-30
41325SUPPL2001-01-28
41327SUPPL2000-01-19
41323SUPPL1999-06-09
20627SUPPL1998-11-24
20625SUPPL1998-11-10
20626SUPPL1998-08-25
20624SUPPL1998-08-24
20623SUPPL1997-11-07