FDA — authorised 22 March 1996
- Application: NDA020351
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: VISIPAQUE 320
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Low Volume iso-osmolar non-ionic radio contrast medium in United States
FDA authorised Low Volume iso-osmolar non-ionic radio contrast medium on 22 March 1996
Marketing authorisations
FDA — authorised 29 August 1997
- Application: NDA020808
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: VISIPAQUE 320
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Low Volume iso-osmolar non-ionic radio contrast medium in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Low Volume iso-osmolar non-ionic radio contrast medium approved in United States?
Yes. FDA authorised it on 22 March 1996; FDA authorised it on 29 August 1997; FDA has authorised it.
Who is the marketing authorisation holder for Low Volume iso-osmolar non-ionic radio contrast medium in United States?
GE HEALTHCARE holds the US marketing authorisation.