Focalin

Novartis Pharmaceuticals Corporation🇺🇸 United States

FDA Page

Effective Date: Oct 13, 2023
Approval ID: 1a1da905-42a0-4748-9c39-67eca45deccc
Products: 8 registered
Version: 34

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CIIInitial U.S. Approval: 2005

Quick Stats

Total Products8

Labelers2

Label Sections27

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.