FDA — authorised 24 October 1978
- Application: NDA012259
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: ALPHADROL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Etadrol in United States
FDA authorised Etadrol on 24 October 1978
Marketing authorisations
FDA — authorised 7 December 1982
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
Etadrol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Etadrol approved in United States?
Yes. FDA authorised it on 24 October 1978; FDA authorised it on 7 December 1982.
Who is the marketing authorisation holder for Etadrol in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.