FDA — authorised 27 November 1996
- Marketing authorisation holder: ACORDA
- Status: approved
🇺🇸 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
FDA — authorised 29 August 2002
- Application: NDA021447
- Marketing authorisation holder: LEGACY PHARMA USA
- Local brand name: ZANAFLEX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 November 2012
- Application: ANDA091283
- Marketing authorisation holder: UNICHEM LABS LTD
- Status: approved
FDA — authorised 14 December 2014
- Application: ANDA076416
- Marketing authorisation holder: SUN PHARM INDS INC
- Indication: Labeling
- Status: approved
FDA — authorised 9 March 2018
- Application: ANDA208187
- Marketing authorisation holder: CADILA
- Status: approved
FDA — authorised 27 May 2020
- Application: ANDA213798
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 27 May 2022
- Application: ANDA210267
- Marketing authorisation holder: INGENUS PHARMS LLC
- Indication: Labeling
- Status: approved
Zanaflex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience 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 27 November 1996; FDA authorised it on 29 August 2002.
Who is the marketing authorisation holder for Zanaflex in United States?
ACORDA holds the US marketing authorisation.