Hetlioz

Vanda Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 4, 2026
Approval ID: ca4a9b63-708e-49e9-8f9b-010625443b90
Products: 2 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ (tasimelteon) capsules, for oral use HETLIOZ LQ (tasimelteon) oral suspension Initial U.S. Approval: 2014

Quick Stats

Total Products2

Labelers2

Label Sections42

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.