Fluvoxamine Maleate

Apotex Corp🇺🇸 United States

FDA Page

Effective Date: Sep 18, 2025
Approval ID: 6eeb14df-6fcf-a737-5359-5744eb4accea
Products: 3 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 FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994

Quick Stats

Total Products3

Labelers2

Label Sections40

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.