🇺🇸 Neoral in United States

FDA authorised Neoral on 14 July 1995

Marketing authorisations

FDA — authorised 14 July 1995

  • Application: NDA050715
  • Marketing authorisation holder: NOVARTIS
  • Status: supplemented

FDA — authorised 14 July 1995

  • Application: NDA050716
  • Marketing authorisation holder: NOVARTIS
  • Status: supplemented

FDA

  • Status: approved

Other Immunology approved in United States

Frequently asked questions

Is Neoral approved in United States?

Yes. FDA authorised it on 14 July 1995; FDA authorised it on 14 July 1995; FDA has authorised it.

Who is the marketing authorisation holder for Neoral in United States?

NOVARTIS holds the US marketing authorisation.