Talicia

RedHill Biopharma Ltd🇺🇸 United States

FDA Page

Effective Date: Dec 23, 2025
Approval ID: 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f
Products: 1 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 TALICIA safely and effectively. See full prescribing information for TALICIA. TALICIA (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules, for oral use Initial U.S. Approval: 2019

Quick Stats

Total Products1

Labelers2

Label Sections26

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.