Methylphenidate Hydrochloride (LA)

Mayne Pharma🇺🇸 United States

FDA Page

Effective Date: Aug 24, 2026
Approval ID: e5db854a-1c77-4faf-9e60-daf9c9b6cfa0
Products: 5 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 (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955

Quick Stats

Total Products5

Labelers2

Label Sections24

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.