FDA — authorised 26 December 1985
- Marketing authorisation holder: GE HEALTHCARE
- Status: approved
🇺🇸 Omnipaque 180 in United States
FDA authorised Omnipaque 180 on 26 December 1985
Marketing authorisations
FDA — authorised 26 December 1985
- Application: NDA018956
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: OMNIPAQUE 180
- Indication: SOLUTION — INJECTION, ORAL, RECTAL
- Status: approved
FDA — authorised 13 November 2025
- Application: ANDA217737
- Marketing authorisation holder: AMNEAL
- Local brand name: IOHEXOL
- Indication: SOLUTION — INJECTION, ORAL, RECTAL
- Status: approved
Omnipaque 180 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Omnipaque 180 approved in United States?
Yes. FDA authorised it on 26 December 1985; FDA authorised it on 26 December 1985; FDA authorised it on 13 November 2025.
Who is the marketing authorisation holder for Omnipaque 180 in United States?
GE HEALTHCARE holds the US marketing authorisation.