APPLICATION
ANDA077369
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-30
LATEST ACTION
2026-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
Approval history
2026-03-05Labeling · Supplement 26 · standardAP
2022-01-31Labeling · Supplement 23 · standardAP
2021-06-04Labeling · Supplement 10 · standardAP
2021-06-04Labeling · Supplement 19 · standardAP
2021-06-04Labeling · Supplement 17 · standardAP
2021-06-04Labeling · Supplement 13 · standardAP
2016-09-20Labeling · Supplement 9 · standardAP
2015-03-25Labeling · Supplement 7 · standardAP
2015-03-25Labeling · Supplement 3 · standardAP
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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