Treats hypertension. NDA 20758, held by Sanofi Aventis US. Hydrochlorothiazide; Irbesartan.
As of Nov 13, 2026, NDA 20758 (Avalide), held by Sanofi Aventis US, was first approved by FDA on Sep 30, 1997, with 45 approved supplements and 0 published complete response letters.
AVALIDE (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2007 | Supplement 37Efficacy (new indication or use) | Approved | |
| Sep 30, 1997 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Avalide12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrochlorothiazide; Irbesartan | DiscontinuedReference drug |
| Avalide12.5MG;150MG · tablet;oral | Hydrochlorothiazide; Irbesartan | RxReference drug |
| Avalide12.5MG;300MG · tablet;oral | Hydrochlorothiazide; Irbesartan | RxReference drug |
| Avalide25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrochlorothiazide; Irbesartan | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2025 | Supplement 87Labeling · Standard review | Approved | |
| Sep 10, 2021 | Supplement 80Labeling · Standard review | Approved | |
| May 11, 2021 | Supplement 81Labeling · Standard review | Approved | |
| Dec 15, 2020 | Supplement 76Labeling · Standard review | Approved | |
| Aug 20, 2020 | Supplement 79Labeling · Standard review | Approved | |
| Jul 20, 2018 | Supplement 73Labeling · Standard review | Approved | |
| Jul 10, 2017 | Supplement 72Labeling · Standard review | Approved | |
| Feb 5, 2016 | Supplement 70Labeling · Standard review | Approved | |
| May 28, 2014 | Supplement 67Labeling · Standard review | Approved | |
| Oct 26, 2012 | Supplement 64Labeling | Approved | |
| Feb 9, 2012 | Supplement 60Labeling | Approved | |
| Jan 18, 2012 | Supplement 62Labeling | Approved | |
| Jun 6, 2011 | Supplement 59Labeling | Approved | |
| Jun 6, 2011 | Supplement 58Labeling | Approved | |
| Sep 7, 2010 | Supplement 50Labeling · Standard review | Approved | |
| Nov 16, 2007 | Supplement 37Efficacy (new indication or use) | Approved | |
| Apr 21, 2006 | Supplement 36Labeling · Standard review | Approved | |
| Nov 21, 2005 | Supplement 35Labeling · Standard review | Approved | |
| Mar 15, 2005 | Supplement 32Manufacturing · Standard review | Approved | |
| Oct 29, 2004 | Supplement 31 | Approved | |
| Jul 21, 2004 | Supplement 30 | Approved | |
| Jan 2, 2004 | Supplement 29 | Approved | |
| Oct 10, 2003 | Supplement 28 | Approved | |
| May 1, 2003 | Supplement 23 | Approved | |
| Sep 26, 2001 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 7, 2001 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 6, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 20, 2000 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 23, 2000 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 1, 2000 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 10, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 9, 2000 | Supplement 16Labeling · Standard review | Approved | |
| Apr 28, 2000 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1999 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 16, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1999 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1999 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1998 | Supplement 3Manufacturing · Standard review | Approved | |
| Jul 15, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 14, 1998 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 6, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1997 | Original applicationNew combination · Standard review | Approved |
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
