Hyzaar

NDA 20387, held by Organon. Hydrochlorothiazide; Losartan Potassium.

As of Nov 13, 2026, NDA 20387 (Hyzaar), held by Organon, was first approved by FDA on Apr 28, 1995, with 51 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1995
Review: Standard
Supplements approved: 51
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 52 submissions below


Oct 20, 2005	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 5, 2005	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 30, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 28, 1995	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms


Hyzaar12.5MG;50MG · tablet;oral	Hydrochlorothiazide; Losartan Potassium	RxReference drug
Hyzaar25MG;100MG · tablet;oral	Hydrochlorothiazide; Losartan Potassium	RxReference drug
Hyzaar12.5MG;100MG · tablet;oral	Hydrochlorothiazide; Losartan Potassium	RxReference drug

All 52 submissions, including labeling and manufacturing supplements


Jun 20, 2025	Supplement 76Labeling · Standard review	Approved	Letter Label
Mar 17, 2023	Supplement 71Labeling · Standard review	Approved	Letter Label
Aug 20, 2020	Supplement 66Labeling · Standard review	Approved	Label
Aug 20, 2020	Supplement 67Labeling · Standard review	Approved	Label Letter
Nov 7, 2019	Supplement 64Labeling · Standard review	Approved	Label Letter
Oct 12, 2018	Supplement 63Labeling · Standard review	Approved	Letter Label
Dec 11, 2015	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 60Labeling · Standard review	Approved	Letter Label
Jan 17, 2014	Supplement 59Labeling · Standard review	Approved	Label Letter
Mar 27, 2013	Supplement 57Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 56Labeling	Approved	Letter Label
Nov 17, 2011	Supplement 54Labeling	Approved	Letter Label
Aug 26, 2011	Supplement 55Labeling	Approved	Letter Label
Aug 17, 2011	Supplement 52Labeling	Approved	Label Letter
Jun 10, 2011	Supplement 50Labeling	Approved	Letter
Sep 21, 2010	Supplement 48Labeling	Approved	Letter Label
Jun 12, 2009	Supplement 45Labeling · Standard review	Approved	Label Letter
Dec 21, 2006	Supplement 40Labeling · Standard review	Approved	Letter
Aug 29, 2006	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 20, 2006	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 20, 2005	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 12, 2005	Supplement 34Labeling · Standard review	Approved	Letter Label
Apr 12, 2005	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 5, 2005	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 30, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 30, 2003	Supplement 15Labeling · Standard review	Approved	Review Label Letter
Sep 30, 2003	Supplement 13Labeling · Standard review	Approved	Review Label Letter
Jan 8, 2003	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 7, 2002	Supplement 24Labeling · Standard review	Approved	Letter
Oct 23, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 10, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 3, 2001	Supplement 18Labeling · Standard review	Approved	None posted
Aug 24, 2001	Supplement 22Labeling · Standard review	Approved	None posted
Jul 3, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 22, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
May 16, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 23, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 14Labeling · Standard review	Approved	Review
Jan 19, 2000	Supplement 17Labeling · Standard review	Approved	Review
Jun 9, 1999	Supplement 12Labeling · Standard review	Approved	Review
Nov 24, 1998	Supplement 11Labeling · Standard review	Approved	Review
Nov 10, 1998	Supplement 8Manufacturing · Standard review	Approved	Review
Aug 25, 1998	Supplement 10Labeling · Standard review	Approved	Review
Aug 24, 1998	Supplement 6Labeling · Standard review	Approved	Review
Apr 3, 1998	Supplement 9Labeling · Standard review	Approved	None posted
Mar 27, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Supplement 5Labeling · Standard review	Approved	Review
Jul 18, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Dec 1, 1995	Supplement 3Manufacturing · Standard review	Approved	Review
Nov 22, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Nov 6, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 28, 1995	Original applicationNew combination · Standard review	Approved	None posted

Show all 52

Identifiers

Application: NDA 20387
Drugs@FDA: Overview at FDA
Company: Organon

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters