FDA — authorised 17 June 2016
- Application: NDA208010
- Marketing authorisation holder: EIRGEN
- Local brand name: RAYALDEE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Rayaldee in United States
FDA authorised Rayaldee on 17 June 2016
Marketing authorisations
FDA
- Status: approved
Rayaldee 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 Rayaldee approved in United States?
Yes. FDA authorised it on 17 June 2016; FDA has authorised it.
Who is the marketing authorisation holder for Rayaldee in United States?
EIRGEN holds the US marketing authorisation.