Is Phenylbutazone approved by the US FDA?

Drugs@FDA lists 12 application product lines for Phenylbutazone, including PHENYLBUTAZONE (Discontinued); PHENYLBUTAZONE (Discontinued); AZOLID (Discontinued); PHENYLBUTAZONE (Discontinued); PHENYLBUTAZONE (Discontinued).

Is Phenylbutazone authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Phenylbutazone, including PHENYLBUTAZONE 100MG TABLETS; PHENYLBUTAZONE 200MG TABLETS.

Active substance

Phenylbutazone

US FDA 12
UK MHRA 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
PHENYLBUTAZONE	100MG	tablet · oral	WATSON LABS	Discontinued	29 Oct 1979
PHENYLBUTAZONE	100MG	tablet · oral	FOSUN PHARMA	Discontinued	10 Jan 1980
AZOLID	100MG	capsule · oral	SANOFI AVENTIS US	Discontinued	13 Oct 1981
PHENYLBUTAZONE	100MG	tablet · oral	WATSON LABS	Discontinued	21 Apr 1982
PHENYLBUTAZONE	100MG	capsule · oral	CHARTWELL RX	Discontinued	16 Jun 1982
PHENYLBUTAZONE	100MG	capsule · oral	WATSON LABS	Discontinued	17 Dec 1982
PHENYLBUTAZONE	100MG	capsule · oral	IVAX PHARMS	Discontinued	24 Jun 1983
PHENYLBUTAZONE	100MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	4 Dec 1985
PHENYLBUTAZONE	100MG	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	4 Dec 1985
BUTAZOLIDIN	100MG	tablet · oral	NOVARTIS	Discontinued	25 Jun 1997
BUTAZOLIDIN	100MG	capsule · oral	NOVARTIS	Discontinued	25 Jun 1997
AZOLID	100MG	tablet · oral	SANOFI AVENTIS US	Discontinued

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
PHENYLBUTAZONE 100MG TABLETS	PL 17736/0080	CHEMIDEX PHARMA LIMITED	POM
PHENYLBUTAZONE 200MG TABLETS	PL 17736/0081	CHEMIDEX PHARMA LIMITED	POM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.