MALARONE

GlaxoSmithKline LLC🇺🇸 United States

FDA Page

Effective Date: Jun 10, 2026
Approval ID: fc22e8d8-3bfb-4f70-a599-dd81262a4887
Products: 2 registered
Version: 31

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use MALARONE safely and effectively. See full prescribing information for MALARONE.MALARONE (atovaquone and proguanil hydrochloride) tabletsMALARONE (atovaquone and proguanil hydrochloride) pediatric tablets Initial U.S. Approval: 2000

Quick Stats

Total Products2

Labelers2

Label Sections34

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.