AVAPRO · ReferencePrescription
IRBESARTAN 300MG · TABLET · ORAL
AVAPRO · ReferenceDiscontinued
IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVAPRO · ReferencePrescription
IRBESARTAN 150MG · TABLET · ORAL
2026-07-24Labeling · Supplement 81 · standardAP
2025-08-01Labeling · Supplement 80 · standard — Label ↗AP 2021-09-10Labeling · Supplement 74 · standard — Label ↗AP 2021-05-11Labeling · Supplement 75 · standard — Label ↗AP 2020-12-15Labeling · Supplement 71 · standard — Letter ↗AP 2018-07-20Labeling · Supplement 69 · standard — Letter ↗AP 2016-02-05Labeling · Supplement 67 · standard — Letter ↗AP 2016-02-05Labeling · Supplement 59 · unknown — Letter ↗AP 2015-01-05Manufacturing (CMC) · Supplement 65 · standardAP
2014-05-28Labeling · Supplement 64 · standard — Letter ↗AP 2013-10-10Manufacturing (CMC) · Supplement 63 · standardAP
2013-02-28Manufacturing (CMC) · Supplement 61 · standardAP
2012-09-12Labeling · Supplement 60 · unknown — Letter ↗AP 2012-01-18Labeling · Supplement 58 · unknown — Label ↗AP 2011-12-08Labeling · Supplement 56 · unknown — Label ↗AP 2011-08-01Labeling · Supplement 55 · unknown — Letter ↗AP 2007-07-31Manufacturing (CMC) · Supplement 44 — Label ↗AP 2006-04-21Labeling · Supplement 38 · standard — Label ↗AP 2006-03-16Labeling · Supplement 39 · standard — Review ↗AP 2005-11-21Labeling · Supplement 37 · standard — Letter ↗AP 2004-10-29Supplement · Supplement 33 · standard — Review ↗AP 2004-07-21Supplement · Supplement 32 · standard — Review ↗AP 2004-05-20Supplement · Supplement 31 · standard — Review ↗AP 2004-01-02Supplement · Supplement 30 · standard — Review ↗AP 2003-10-09Supplement · Supplement 27 · standard — Review ↗AP 2003-09-09Supplement · Supplement 28 · standard — Review ↗AP 2003-05-21Supplement · Supplement 26 · standard — Review ↗AP 2003-05-01Supplement · Supplement 24 · standard — Review ↗AP 2003-03-21Supplement · Supplement 23 · standard — Other ↗AP 2003-03-21Supplement · Supplement 25 · standard — Other ↗AP 2002-09-17Efficacy · Supplement 21 · priority — Review ↗AP 2002-07-19Manufacturing (CMC) · Supplement 22 · standard — Review ↗AP 2001-09-26Labeling · Supplement 11 · standard — Review ↗AP 2001-06-07Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP 2001-05-26Efficacy · Supplement 14 · standard — Review ↗AP 2001-03-06Manufacturing (CMC) · Supplement 19 · standard — Review ↗AP 2001-02-02Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP 2000-09-20Labeling · Supplement 17 · standard — Review ↗AP 2000-08-23Manufacturing (CMC) · Supplement 10 · standardAP
2000-08-01Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP 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.