APPLICATION
ANDA201524
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-27
LATEST ACTION
2025-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
IRBESARTAN 300MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
Approval history
2025-11-28Labeling · Supplement 22 · standardAP
2022-06-10Labeling · Supplement 18 · standardAP
2022-06-10Labeling · Supplement 20 · standardAP
2022-06-10Labeling · Supplement 19 · standardAP
2022-06-10Labeling · Supplement 17 · standardAP
2018-12-13Labeling · Supplement 12 · standardAP
2018-12-13Labeling · Supplement 11 · standardAP
2016-09-27Labeling · Supplement 10 · standardAP
2015-03-12Labeling · Supplement 6 · standardAP
2013-02-27Not Applicable · OriginalTA
2013-02-27Not Applicable · OriginalAP
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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