Sitagliptin and metformin hydrochloride

Zydus Pharmaceuticals (USA) Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 12, 2026
Approval ID: 4d812277-21a8-4de3-b728-e3fdd01305b5
Products: 2 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS. SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (sitagliptin and metformin hydrochloride) tablets, for oral useInitial U.S. Approval: 2007

Quick Stats

Total Products2

Labelers1

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.