Is Cortisone approved by the US FDA?

Drugs@FDA lists 21 application product lines for Cortisone, including CORTONE (Discontinued); CORTONE (Discontinued); CORTISONE ACETATE (Discontinued); CORTISONE ACETATE (Discontinued); CORTISONE ACETATE (Discontinued).

Active substance

Cortisone

US FDA 21
Health Canada 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CORTONE	25MG/ML; 50MG/ML	injectable · injection	MERCK	Discontinued	13 Jun 1950
CORTONE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	MERCK	Discontinued	4 Dec 1950
CORTISONE ACETATE	25MG; 5MG; 10MG	tablet · oral	PHARMACIA AND UPJOHN	Discontinued	2 Nov 1951
CORTISONE ACETATE	25MG/ML	injectable · injection	PHARMACIA AND UPJOHN	Discontinued	2 Nov 1951
CORTISONE ACETATE	25MG; 5MG	tablet · oral	PANRAY	Discontinued	14 Jan 1952
CORTISONE ACETATE	25MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	3 Jan 1972
CORTISONE ACETATE	25MG	tablet · oral	HIKMA INTL PHARMS	Discontinued	13 Jun 1972
CORTISONE ACETATE	25MG	tablet · oral	WHITEWORTH TOWN PLSN	Discontinued	20 Jun 1973
CORTISONE ACETATE	25MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	9 Jul 1973
CORTISONE ACETATE	25MG	tablet · oral	BARR	Discontinued	31 Aug 1973
CORTISONE ACETATE	25MG	tablet · oral	CHARTWELL MOLECULAR	Discontinued	17 Oct 1974
CORTISONE ACETATE	25MG	tablet · oral	EVERYLIFE	Discontinued	22 Jan 1975
CORTISONE ACETATE	25MG/ML; 50MG/ML	injectable · injection	WATSON LABS	Discontinued	7 Mar 1978
CORTISONE ACETATE	25MG	tablet · oral	WATSON LABS	Discontinued	15 May 1978
CORTISONE ACETATE	25MG	tablet · oral	IMPAX LABS	Discontinued	17 Sep 2001
CORTISONE ACETATE	25MG	tablet · oral	VITARINE	Discontinued
CORTISONE ACETATE	25MG	tablet · oral	PUREPAC PHARM	Discontinued
CORTISONE ACETATE	25MG	tablet · oral	INWOOD LABS	Discontinued
CORTISONE ACETATE	25MG	tablet · oral	ELKINS SINN	Discontinued
CORTISONE ACETATE	25MG/ML; 50MG/ML	injectable · injection	WATSON LABS	Discontinued
CORTISONE ACETATE	25MG	tablet · oral	HEATHER	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CORTISONE ACETATE	00280437	25 MG	TABLET · ORAL	BAUSCH HEALTH, CANADA INC.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.