Omeprazole, Sodium bicarbonate

Guardian Drug Company🇺🇸 United States

FDA Page

Effective Date: Nov 8, 2022
Approval ID: e5c6c2cf-fb3b-456a-a0a0-be396d6f8319
Products: 2 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES OMEPRAZOLE AND SODIUM BICARBONATE capsules, for oral use Initial U.S. Approval: 2004

Quick Stats

Total Products2

Labelers2

Label Sections24

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.