Insulin glargine U-300

Winthrop U.S, a business of sanofi-aventis U.S. LLC🇺🇸 United States

FDA Page

Effective Date: Dec 7, 2023
Approval ID: 99ea856d-9562-443a-9422-1006a3cff2f4
Products: 2 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use INSULIN GLARGINE U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE U-300. INSULIN GLARGINE U-300 (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 2015

Quick Stats

Total Products2

Labelers2

Label Sections21

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.