Is Halobetasol + Tazarotene approved by the US FDA?

Drugs@FDA lists 2 application product lines for Halobetasol + Tazarotene, including DUOBRII (Prescription); HALOBETASOL PROPIONATE AND TAZAROTENE (Prescription).

Active substances

Halobetasol + Tazarotene

US FDA 2
Health Canada 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
DUOBRII	0.01%;0.045%	lotion · topical	BAUSCH	Prescription	25 Apr 2019
HALOBETASOL PROPIONATE AND TAZAROTENE	0.01%;0.045%	lotion · topical	SUN PHARMA CANADA	Prescription	2 May 2025

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DUOBRII	02499967	0.01 % / W/W; 0.045 % / W/W	LOTION · TOPICAL	BAUSCH HEALTH, CANADA INC.

Components

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.