QuilliChew ER

NextWave Pharmaceuticals, Inc🇺🇸 United States

FDA Page

Effective Date: Apr 8, 2026
Approval ID: defc1205-8e90-4b1e-b862-05e4c35c7364
Products: 3 registered
Version: 33

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

Quick Stats

Total Products3

Labelers2

Label Sections22

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.