FDA — authorised 1 February 1979
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Cromosan in United States
FDA authorised Cromosan on 1 February 1979
Marketing authorisations
FDA — authorised 30 August 1991
- Application: NDA017610
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
Cromosan 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 Cromosan approved in United States?
Yes. FDA authorised it on 1 February 1979; FDA authorised it on 30 August 1991.
Who is the marketing authorisation holder for Cromosan in United States?
BAXTER HLTHCARE holds the US marketing authorisation.