FDA — authorised 28 September 2009
- Application: ANDA076592
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Labeling
- Status: approved
🇺🇸 Betametasone in United States
FDA authorised Betametasone on 28 September 2009
Marketing authorisations
FDA — authorised 12 December 2014
- Application: ANDA200174
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Not Applicable
- Status: approved
FDA — authorised 8 March 2016
- Application: NDA207589
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Labeling
- Status: approved
FDA — authorised 18 December 2019
- Application: ANDA209106
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 9 June 2020
- Application: ANDA075373
- Marketing authorisation holder: FOUGERA PHARMS
- Indication: Labeling
- Status: approved
Betametasone 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 Betametasone approved in United States?
Yes. FDA authorised it on 28 September 2009; FDA authorised it on 12 December 2014; FDA authorised it on 8 March 2016.
Who is the marketing authorisation holder for Betametasone in United States?
PADAGIS ISRAEL holds the US marketing authorisation.