FDA — authorised 16 April 1964
- Application: NDA050356
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Cortef in United States
FDA authorised Cortef on 16 April 1964
Marketing authorisations
FDA — authorised 30 April 1976
- Application: ANDA080693
- Marketing authorisation holder: FOUGERA PHARMS INC
- Status: approved
FDA — authorised 7 August 1995
- Application: ANDA080692
- Marketing authorisation holder: FOUGERA PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA213724
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 28 May 2025
- Application: NDA218980
- Marketing authorisation holder: ETON
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Cortef, a product of ETON, for a new dosage form on 28 May 2025. This approval was granted under the standard expedited pathway. Cortef is intended for use in a specific indication, as classified under Type 3 - New Dosage Form.
Cortef 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 Cortef approved in United States?
Yes. FDA authorised it on 16 April 1964; FDA authorised it on 30 April 1976; FDA authorised it on 7 August 1995.
Who is the marketing authorisation holder for Cortef in United States?
PH HEALTH holds the US marketing authorisation.