FDA — authorised 17 April 1961
- Application: NDA012657
- Marketing authorisation holder: SCHERING
- Local brand name: CELESTONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Celestone in United States
FDA authorised Celestone on 17 April 1961
Marketing authorisations
FDA — authorised 3 March 1965
- Application: NDA014602
- Marketing authorisation holder: ORGANON
- Status: supplemented
FDA — authorised 31 December 1974
- Application: NDA017561
- Marketing authorisation holder: SCHERING
- Local brand name: CELESTONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Celestone 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 Celestone approved in United States?
Yes. FDA authorised it on 17 April 1961; FDA authorised it on 3 March 1965; FDA authorised it on 31 December 1974.
Who is the marketing authorisation holder for Celestone in United States?
SCHERING holds the US marketing authorisation.