FDA — authorised 26 December 1985
- Application: NDA018956
- Marketing authorisation holder: GE HEALTHCARE
- Status: supplemented
🇺🇸 Omnipaque in United States
FDA authorised Omnipaque on 26 December 1985
Marketing authorisations
FDA — authorised 24 October 1995
- Application: NDA020608
- Marketing authorisation holder: GE HEALTHCARE
- Status: supplemented
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Omnipaque approved in United States?
Yes. FDA authorised it on 26 December 1985; FDA authorised it on 24 October 1995; FDA has authorised it.
Who is the marketing authorisation holder for Omnipaque in United States?
GE HEALTHCARE holds the US marketing authorisation.