FDA — authorised 15 April 2015
- Application: ANDA078401
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Indication: Labeling
- Status: approved
🇺🇸 Lioresal in United States
FDA authorised Lioresal on 15 April 2015
Marketing authorisations
FDA — authorised 28 November 2017
- Application: ANDA209102
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 29 October 2020
- Application: ANDA077241
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
FDA — authorised 25 January 2022
- Application: ANDA215885
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
FDA — authorised 21 November 2025
- Application: ANDA214099
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Manufacturing (CMC)
- Status: approved
Aurobindo Pharma Ltd has been granted marketing authorisation by the FDA for the manufacturing (CMC) of Lioresal. This approval was issued on 21 November 2025, under application number ANDA214099. The approval indicates that Aurobindo Pharma Ltd meets the FDA's standards for manufacturing Lioresal, a medication used to treat muscle spasticity.
Lioresal 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 Lioresal approved in United States?
Yes. FDA authorised it on 15 April 2015; FDA authorised it on 28 November 2017; FDA authorised it on 29 October 2020.
Who is the marketing authorisation holder for Lioresal in United States?
NORTHSTAR HLTHCARE holds the US marketing authorisation.