🇺🇸 Cyclosporine (Neoral) in United States

FDA authorised Cyclosporine (Neoral) on 14 July 1995

Marketing authorisations

FDA — authorised 14 July 1995

  • Application: NDA050715
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 14 July 1995

  • Application: NDA050716
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: SOLUTION — ORAL
  • Status: approved

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FDA — authorised 22 May 1997

  • Application: NDA050735
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 22 May 1997

  • Application: NDA050736
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 19 June 1997

  • Application: NDA050737
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 19 June 1997

  • Application: NDA050738
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: NEORAL
  • Indication: CAPSULE — ORAL
  • Status: approved

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Other Immunology approved in United States

Frequently asked questions

Is Cyclosporine (Neoral) approved in United States?

Yes. FDA authorised it on 14 July 1995; FDA authorised it on 14 July 1995; FDA authorised it on 22 May 1997.

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

NOVARTIS holds the US marketing authorisation.