FDA — authorised 7 December 2001
- Application: NDA021345
- Marketing authorisation holder: MYLAN IRELAND LTD
- Local brand name: ARIXTRA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Fondapariniux in United States
FDA authorised Fondapariniux on 7 December 2001
Marketing authorisations
FDA
- Status: approved
Fondapariniux in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Fondapariniux approved in United States?
Yes. FDA authorised it on 7 December 2001; FDA has authorised it.
Who is the marketing authorisation holder for Fondapariniux in United States?
MYLAN IRELAND LTD holds the US marketing authorisation.