FDA — authorised 21 December 1995
- Marketing authorisation holder: GUERBET
- Status: approved
🇺🇸 Ioxitol in United States
FDA authorised Ioxitol on 21 December 1995
Marketing authorisations
FDA — authorised 21 December 1995
- Application: NDA020316
- Marketing authorisation holder: GUERBET
- Local brand name: OXILAN-300
- Indication: INJECTABLE — INJECTION
- Status: approved
Ioxitol 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 Ioxitol approved in United States?
Yes. FDA authorised it on 21 December 1995; FDA authorised it on 21 December 1995.
Who is the marketing authorisation holder for Ioxitol in United States?
GUERBET holds the US marketing authorisation.