FDA — authorised 18 August 1955
- Status: approved
🇺🇸 Florinef in United States
FDA authorised Florinef on 18 August 1955
Marketing authorisations
FDA — authorised 18 March 2002
- Application: ANDA040431
- Marketing authorisation holder: IMPAX LABS
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 January 2003
- Application: ANDA040425
- Marketing authorisation holder: BARR
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2011
- Application: ANDA091302
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA215279
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2022
- Application: ANDA216013
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2024
- Application: ANDA219251
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2026
- Application: ANDA220308
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: FLUDROCORTISONE ACETATE
- Indication: TABLET — ORAL
- 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 Hematology approved in United States
Frequently asked questions
Is Florinef approved in United States?
Yes. FDA authorised it on 18 August 1955; FDA authorised it on 18 March 2002; FDA authorised it on 21 January 2003.
Who is the marketing authorisation holder for Florinef in United States?
Marketing authorisation holder not available in our data.