🇺🇸 Focalin XR in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Focalin XR on 26 May 2005

Marketing authorisation

FDA — authorised 26 May 2005

Application: NDA021802
Marketing authorisation holder: SANDOZ
Status: supplemented

Other Psychiatry / Neurology approved in United States

Frequently asked questions

Is Focalin XR approved in United States?

Yes. FDA authorised it on 26 May 2005.

Who is the marketing authorisation holder for Focalin XR in United States?

SANDOZ holds the US marketing authorisation.