FDA — authorised 14 July 1978
- Marketing authorisation holder: SEBELA IRELAND LTD
- Status: approved
🇺🇸 Motofen in United States
FDA authorised Motofen on 14 July 1978
Marketing authorisations
FDA — authorised 14 July 1978
- Application: NDA017744
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: MOTOFEN
- Indication: TABLET — ORAL
- Status: approved
Motofen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Motofen approved in United States?
Yes. FDA authorised it on 14 July 1978; FDA authorised it on 14 July 1978.
Who is the marketing authorisation holder for Motofen in United States?
SEBELA IRELAND LTD holds the US marketing authorisation.