FDA — authorised 18 March 2002
- Application: ANDA040431
- Marketing authorisation holder: IMPAX LABS
- Status: approved
🇺🇸 Florinef in United States
FDA authorised Florinef on 18 March 2002
Marketing authorisations
FDA — authorised 31 May 2022
- Application: ANDA215279
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 16 October 2024
- Application: ANDA219251
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
Florinef in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Florinef approved in United States?
Yes. FDA authorised it on 18 March 2002; FDA authorised it on 31 May 2022; FDA authorised it on 16 October 2024.
Who is the marketing authorisation holder for Florinef in United States?
IMPAX LABS holds the US marketing authorisation.