Approvals/FDA/olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide

Approved

HUMAN PRESCRIPTION DRUG LABEL

3b47a8b467eb3a86

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide

Slate Run Pharmaceuticals, LLC🇺🇸 United States

FDA Page

Effective Date: May 14, 2025
Approval ID: a469adff-25a6-4983-b471-60924d920a86
Products: 5 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE, and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE, and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE, and HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 2010

Quick Stats

Total Products5

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.