Quillivant

NextWave Pharmaceuticals, Inc🇺🇸 United States

FDA Page

Effective Date: Sep 30, 2025
Approval ID: c2dc2109-44a6-4797-b04e-18761dd9d45a
Products: 4 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use QUILLIVANT XR safely and effectively. See full prescribing information for QUILLIVANT XR. QUILLIVANT XR (methylphenidate hydrochloride) for extended-release oral suspension, CII Initial U.S. Approval: 1955

Quick Stats

Total Products4

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.