Adzenys XR-ODT

Neos Therapeutics Brands, LLC🇺🇸 United States

FDA Page

Effective Date: May 6, 2026
Approval ID: c1179269-00b5-48ea-972d-31e614e99b7e
Products: 6 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 ADZENYS XR-ODT™ safely and effectively. See full prescribing information for ADZENYS XR-ODT. ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII Initial U.S. Approval: 1960

Quick Stats

Total Products6

Labelers2

Label Sections45

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.