FDA
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Iotrol in United States
Iotrol (IOTROLAN) regulatory status in United States.
Marketing authorisations
FDA
- Application: NDA019580
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: OSMOVIST 190
- Indication: INJECTABLE — INTRATHECAL
- Status: approved
Iotrol 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 Iotrol approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Iotrol in United States?
BAYER HLTHCARE holds the US marketing authorisation.