🇺🇸 Zanaflex® in United States

FDA authorised Zanaflex® on 27 November 1996

Marketing authorisations

FDA — authorised 27 November 1996

  • Application: NDA020397
  • Marketing authorisation holder: LEGACY PHARMA USA
  • Local brand name: ZANAFLEX
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 29 August 2002

  • Application: NDA021447
  • Marketing authorisation holder: LEGACY PHARMA USA
  • Local brand name: ZANAFLEX
  • Indication: CAPSULE — ORAL
  • Status: approved

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Other Neurology approved in United States

Frequently asked questions

Is Zanaflex® approved in United States?

Yes. FDA authorised it on 27 November 1996; FDA authorised it on 29 August 2002.

Who is the marketing authorisation holder for Zanaflex® in United States?

LEGACY PHARMA USA holds the US marketing authorisation.