← FDA DRUG APPROVALS

FDA NDA · NDA020758

AVALIDE

irbesartan and hydrochlorothiazide

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA020758
TYPE
NDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

AVALIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVALIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
AVALIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
AVALIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-08-01Labeling · Supplement 87 · standard — Label ↗AP
2021-09-10Labeling · Supplement 80 · standard — Label ↗AP
2021-05-11Labeling · Supplement 81 · standard — Label ↗AP
2020-12-15Labeling · Supplement 76 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 79 · standard — Letter ↗AP
2018-07-20Labeling · Supplement 73 · standard — Letter ↗AP
2017-07-10Labeling · Supplement 72 · standard — Label ↗AP
2016-02-05Labeling · Supplement 70 · standard — Letter ↗AP
2014-05-28Labeling · Supplement 67 · standard — Letter ↗AP
2012-10-26Labeling · Supplement 64 · unknown — Label ↗AP
2012-02-09Labeling · Supplement 60 · unknown — Letter ↗AP
2012-01-18Labeling · Supplement 62 · unknown — Letter ↗AP
2011-06-06Labeling · Supplement 59 · unknown — Letter ↗AP
2011-06-06Labeling · Supplement 58 · unknown — Letter ↗AP
2010-09-07Labeling · Supplement 50 · standard — Letter ↗AP
2007-11-16Efficacy · Supplement 37 · unknown — Label ↗AP
2006-04-21Labeling · Supplement 36 · standard — Label ↗AP
2005-11-21Labeling · Supplement 35 · standard — Letter ↗AP
2005-03-15Manufacturing (CMC) · Supplement 32 · standard — Letter ↗AP
2004-10-29Supplement · Supplement 31 · standard — Review ↗AP
2004-07-21Supplement · Supplement 30 · standard — Review ↗AP
2004-01-02Supplement · Supplement 29 · standard — Review ↗AP
2003-10-10Supplement · Supplement 28 · standard — Review ↗AP
2003-05-01Supplement · Supplement 23 · standard — Review ↗AP
2001-09-26Labeling · Supplement 13 · standardAP
2001-06-07Manufacturing (CMC) · Supplement 21 · standardAP
2001-03-06Manufacturing (CMC) · Supplement 20 · standardAP
2001-02-21Manufacturing (CMC) · Supplement 19 · standardAP
2000-09-20Labeling · Supplement 18 · standardAP
2000-08-23Manufacturing (CMC) · Supplement 12 · standardAP
2000-08-01Manufacturing (CMC) · Supplement 15 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 17 · standardAP
2000-05-09Labeling · Supplement 16 · standard — Review ↗AP
2000-04-28Manufacturing (CMC) · Supplement 14 · standardAP
1999-04-20Labeling · Supplement 11 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 10 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 9 · standardAP
1999-01-21Manufacturing (CMC) · Supplement 8 · standardAP
1998-09-03Manufacturing (CMC) · Supplement 5 · standardAP
1998-08-31Manufacturing (CMC) · Supplement 3 · 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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