FDA — authorised 15 July 1941
- Application: NDA003718
- Marketing authorisation holder: ROCHE
- Local brand name: SYNKAYVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Kappadione in United States
FDA authorised Kappadione on 15 July 1941
Marketing authorisations
FDA
- Marketing authorisation holder: LILLY
- Status: approved
FDA
- Application: NDA005725
- Marketing authorisation holder: LILLY
- Local brand name: KAPPADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
Kappadione 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 Kappadione approved in United States?
Yes. FDA authorised it on 15 July 1941; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Kappadione in United States?
ROCHE holds the US marketing authorisation.