FDA — authorised 13 August 1962
- Marketing authorisation holder: KING PHARMS
- Status: approved
🇺🇸 Skelaxin in United States
FDA authorised Skelaxin on 13 August 1962
Marketing authorisations
FDA — authorised 31 March 2010
- Application: ANDA040445
- Marketing authorisation holder: SANDOZ
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2013
- Application: ANDA203399
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2015
- Application: NDA022503
- Marketing authorisation holder: PRIMUS PHARMS
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2016
- Application: ANDA204770
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2017
- Application: ANDA203695
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA207466
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2018
- Application: ANDA208774
- Marketing authorisation holder: RISING
- Local brand name: METAXALONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2025
- Application: ANDA040486
- Marketing authorisation holder: MOUNTAIN
- Indication: Labeling
- Status: approved
The FDA approved Skelaxin, a drug product, for labeling indication on May 23, 2025. The marketing authorization holder is Mountain. This approval was granted under the standard expedited pathway.
Skelaxin 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 Skelaxin approved in United States?
Yes. FDA authorised it on 13 August 1962; FDA authorised it on 31 March 2010; FDA authorised it on 21 June 2013.
Who is the marketing authorisation holder for Skelaxin in United States?
KING PHARMS holds the US marketing authorisation.