FDA — authorised 7 December 2001
- Application: NDA021345
- Marketing authorisation holder: MYLAN IRELAND LTD
- Status: supplemented
🇺🇸 Arixtra in United States
FDA authorised Arixtra on 7 December 2001
Marketing authorisations
FDA
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is Arixtra approved in United States?
Yes. FDA authorised it on 7 December 2001; FDA has authorised it.
Who is the marketing authorisation holder for Arixtra in United States?
MYLAN IRELAND LTD holds the US marketing authorisation.