Omeprazole(These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES.OMEPRAZOLE delayed-release capsules, for oral useInitial U.S. Approval: 1989)

Sandoz Inc🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2024
Approval ID: 5a09ce48-7139-4fc7-9b6e-439459c8e866
Products: 1 registered
Version: 25

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES.OMEPRAZOLE delayed-release capsules, for oral useInitial U.S. Approval: 1989

Quick Stats

Total Products1

Labelers2

Label Sections36

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.