APPLICATION
ANDA203072
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-09
LATEST ACTION
2026-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDENone (Tentative Approval)
HYDROCHLOROTHIAZIDE 25MG/300MG, IRBESARTAN · 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 15 · standardAP
2023-02-23Labeling · Supplement 8 · standardAP
2023-02-23Labeling · Supplement 6 · standardAP
2023-02-23Labeling · Supplement 10 · standardAP
2020-06-02Labeling · Supplement 5 · standardAP
2016-09-22Labeling · Supplement 2 · standardAP
2015-04-28Labeling · Supplement 1 · standardAP
2014-05-09UNKNOWN · OriginalTA
2014-05-09UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.