Omeprazole/Sodium Bicarbonate

Par Pharmaceutical, Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 28, 2020
Approval ID: 297a32ab-c602-4322-b861-7a335684e852
Products: 2 registered
Version: 14

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 FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION. OMEPRAZOLE AND SODIUM BICARBONATE, for oral suspension Initial U.S. Approval: 2004

Quick Stats

Total Products2

Labelers2

Label Sections20

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.