Synjardy

Boehringer Ingelheim Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 11, 2026
Approval ID: 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66
Products: 4 registered
Version: 18

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SYNJARDY and SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY and SYNJARDY XR. SYNJARDY (empagliflozin and metformin hydrochloride tablets), for oral use SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2015

Quick Stats

Total Products4

Labelers2

Label Sections23

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.