Active substance
Halobetasol
- US FDA 18
- Health Canada 3
- US price lines 4
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | PADAGIS ISRAEL | Prescription | 16 Dec 2004 |
| HALOBETASOL PROPIONATE | 0.05% | cream · topical | FOUGERA PHARMS | Prescription | 16 Dec 2004 |
| HALOBETASOL PROPIONATE | 0.05% | cream · topical | PADAGIS ISRAEL | Prescription | 16 Dec 2004 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | COSETTE PHARMS NC | Prescription | 14 Jun 2005 |
| HALOBETASOL PROPIONATE | 0.05% | cream · topical | COSETTE PHARMS NC | Prescription | 24 Apr 2007 |
| ULTRAVATE | 0.05% | lotion · topical | LACER PHARMA | Prescription | 6 Nov 2015 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | ENCUBE | Prescription | 20 Mar 2018 |
| BRYHALI | 0.01% | lotion · topical | BAUSCH | Prescription | 6 Nov 2018 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | QUAGEN | Prescription | 6 Oct 2020 |
| HALOBETASOL PROPIONATE | 0.05% | aerosol, foam · topical | PADAGIS ISRAEL | Prescription | 11 Aug 2023 |
| ULTRAVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ointment · topical | SUN PHARM INDS INC | Discontinued | 17 Dec 1990 |
| ULTRAVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · topical | SUN PHARM INDS INC | Discontinued | 27 Dec 1990 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | FOUGERA PHARMS | Discontinued | 16 Dec 2004 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | SUN PHARMA CANADA | Discontinued | 16 Dec 2004 |
| HALOBETASOL PROPIONATE | 0.05% | cream · topical | SUN PHARMA CANADA | Discontinued | 4 Aug 2005 |
| HALOBETASOL PROPIONATE | 0.05% | ointment · topical | COSETTE PHARMS NC | Discontinued | 7 Sep 2006 |
| LEXETTE | 0.05% | aerosol, foam · topical | MAYNE PHARMA | Discontinued | 24 May 2018 |
| HALOBETASOL PROPIONATE | 0.05% | lotion · topical | PADAGIS ISRAEL | Discontinued | 3 Jun 2020 |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | HALOBETASOL PROP 0.05% CREAM | $0.648 | per GM | 23 Sep 2026 |
| US NADAC | HALOBETASOL PROP 0.05% CREAM | $0.40852 | per GM | 23 Sep 2026 |
| US NADAC | HALOBETASOL PROP 0.05% OINTMNT | $0.84285 | per GM | 23 Sep 2026 |
| US NADAC | HALOBETASOL PROP 0.05% OINTMNT | $0.39724 | per GM | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 18 Aug 2021 LEXETTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Aug 2020 ULTRAVATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Apr 2019 HALOBETASOL PROPIONATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
Combinations containing Halobetasol
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.