Irbesartan and Hydrochlorothiazide(These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 1997)

Solco Healthcare US, LLC🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2025
Approval ID: 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801
Products: 2 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 1997

Quick Stats

Total Products2

Labelers2

Label Sections38

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.