FDA — authorised 23 August 1978
- Status: approved
🇺🇸 Amipaque in United States
FDA authorised Amipaque on 23 August 1978
Marketing authorisations
FDA — authorised 23 August 1978
- Application: NDA017982
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: AMIPAQUE
- Indication: INJECTABLE — INJECTION
- Status: approved
Amipaque 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 Amipaque approved in United States?
Yes. FDA authorised it on 23 August 1978; FDA authorised it on 23 August 1978.
Who is the marketing authorisation holder for Amipaque in United States?
Marketing authorisation holder not available in our data.