← FDA DRUG APPROVALS

FDA NDA · NDA020387

HYZAAR

losartan potassium and hydrochlorothiazide

Sponsor: ORGANON

APPLICATION
NDA020387
TYPE
NDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYZAAR · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
HYZAAR · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
HYZAAR · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL

Approval history

2025-06-20Labeling · Supplement 76 · standard — Label ↗AP
2023-03-17Labeling · Supplement 71 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 66 · standard — Label ↗AP
2020-08-20Labeling · Supplement 67 · standard — Letter ↗AP
2019-11-07Labeling · Supplement 64 · standard — Letter ↗AP
2018-10-12Labeling · Supplement 63 · standard — Label ↗AP
2015-12-11Labeling · Supplement 47 · standard — Letter ↗AP
2014-09-30Labeling · Supplement 60 · standard — Letter ↗AP
2014-01-17Labeling · Supplement 59 · standard — Label ↗AP
2013-03-27Labeling · Supplement 57 · standard — Label ↗AP
2012-09-28Labeling · Supplement 56 · unknown — Label ↗AP
2011-11-17Labeling · Supplement 54 · unknown — Letter ↗AP
2011-08-26Labeling · Supplement 55 · unknown — Label ↗AP
2011-08-17Labeling · Supplement 52 · unknown — Label ↗AP
2011-06-10Labeling · Supplement 50 · unknown — Letter ↗AP
2010-09-21Labeling · Supplement 48 · unknown — Label ↗AP
2009-06-12Labeling · Supplement 45 · standard — Letter ↗AP
2006-12-21Labeling · Supplement 40 · standard — Letter ↗AP
2006-08-29Labeling · Supplement 41 · standard — Label ↗AP
2006-04-20Labeling · Supplement 38 · standard — Letter ↗AP
2005-10-20Efficacy · Supplement 37 · standard — Review ↗AP
2005-04-12Labeling · Supplement 35 · standard — Letter ↗AP
2005-04-12Labeling · Supplement 34 · standard — Label ↗AP
2005-04-05Efficacy · Supplement 33 · standard — Label ↗AP
2003-09-30Efficacy · Supplement 27 · standard — Label ↗AP
2003-09-30Labeling · Supplement 15 · standard — Review ↗AP
2003-09-30Labeling · Supplement 13 · standard — Review ↗AP
2003-01-08Manufacturing (CMC) · Supplement 26 · standardAP
2002-11-07Labeling · Supplement 24 · standard — Letter ↗AP
2002-10-23Manufacturing (CMC) · Supplement 25 · standardAP
2002-01-10Manufacturing (CMC) · Supplement 23 · standardAP
2001-10-03Labeling · Supplement 18 · standardAP
2001-08-24Labeling · Supplement 22 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 19 · standardAP
2001-06-22Manufacturing (CMC) · Supplement 21 · standardAP
2001-05-16Manufacturing (CMC) · Supplement 20 · standardAP
2000-02-23Manufacturing (CMC) · Supplement 16 · standardAP
2000-01-28Labeling · Supplement 14 · standard — Review ↗AP
2000-01-19Labeling · Supplement 17 · standard — Review ↗AP
1999-06-09Labeling · Supplement 12 · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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