SEMGLEE

Biocon Biologics Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 3, 2025
Approval ID: 8cf5544f-87d6-468b-f6ae-898b1fdb5d80
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 SEMGLEE safely and effectively. See full prescribing information for SEMGLEE. SEMGLEE (insulin glargine-yfgn) injection, for subcutaneous use Initial U.S. Approval: 2021SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).

Quick Stats

Total Products2

Labelers2

Label Sections32

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.