Methylphenidate Hydrochloride

Amneal Pharmaceuticals of New York LLC🇺🇸 United States

FDA Page

Effective Date: May 27, 2026
Approval ID: 10aa0dc0-bd0e-4927-a19a-8722d78ad67d
Products: 6 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 METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955

Quick Stats

Total Products6

Labelers2

Label Sections20

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.