FOSAMAX

Organon LLC🇺🇸 United States

FDA Page

Effective Date: Nov 24, 2025
Approval ID: 14e931fd-2c5f-4d90-b7db-5980706f4a56
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use FOSAMAX safely and effectively. See full prescribing information for FOSAMAX. FOSAMAX (alendronate sodium) tablets, for oral use FOSAMAX (alendronate sodium) oral solution Initial U.S. Approval: 1995

Quick Stats

Total Products1

Labelers2

Label Sections22

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.