FDA — authorised 3 March 1965
- Application: NDA014602
- Marketing authorisation holder: ORGANON
- Local brand name: CELESTONE SOLUSPAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Celestone Soluspan in United States
FDA authorised Celestone Soluspan on 3 March 1965
Marketing authorisations
FDA — authorised 19 April 2016
- Application: ANDA090747
- Marketing authorisation holder: AM REGENT
- Indication: Labeling
- Status: approved
FDA — authorised 17 January 2023
- Application: ANDA077838
- Marketing authorisation holder: HIKMA
- Local brand name: BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Celestone Soluspan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Celestone Soluspan approved in United States?
Yes. FDA authorised it on 3 March 1965; FDA authorised it on 19 April 2016; FDA authorised it on 17 January 2023.
Who is the marketing authorisation holder for Celestone Soluspan in United States?
ORGANON holds the US marketing authorisation.