FDA — authorised 13 June 1950
- Application: NDA007110
- Marketing authorisation holder: MERCK
- Local brand name: CORTONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cortone in United States
FDA authorised Cortone on 13 June 1950
Marketing authorisations
FDA — authorised 13 June 1950
- Status: approved
FDA — authorised 4 December 1950
- Application: NDA007750
- Marketing authorisation holder: MERCK
- Local brand name: CORTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 1972
- Application: ANDA080630
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1973
- Application: ANDA083536
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 1973
- Application: ANDA083471
- Marketing authorisation holder: BARR
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1974
- Application: ANDA080694
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Cortone, manufactured by Chartwell Molecular, for its approved indication on 5 June 2024. The application number for this approval is ANDA080694. Cortone was approved through the standard expedited pathway.
FDA — authorised 22 January 1975
- Application: ANDA084246
- Marketing authorisation holder: EVERYLIFE
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 1977
- Application: NDA009458
- Marketing authorisation holder: IMPAX LABS
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 1978
- Application: ANDA085677
- Marketing authorisation holder: WATSON LABS
- Local brand name: CORTISONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 May 1978
- Application: ANDA085884
- Marketing authorisation holder: WATSON LABS
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080493
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CORTISONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
Cortone 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 Cortone approved in United States?
Yes. FDA authorised it on 13 June 1950; FDA authorised it on 13 June 1950; FDA authorised it on 4 December 1950.
Who is the marketing authorisation holder for Cortone in United States?
MERCK holds the US marketing authorisation.