What is HALOBETASOL PROPIONATE AND TAZAROTENE used for?

HALOBETASOL PROPIONATE AND TAZAROTENE is an FDA-approved medication. See full prescribing information for approved uses.

Is HALOBETASOL PROPIONATE AND TAZAROTENE FDA approved?

Yes, HALOBETASOL PROPIONATE AND TAZAROTENE is FDA approved (first approved 2025-05-02) and manufactured by SUN PHARMA CANADA.

Who makes HALOBETASOL PROPIONATE AND TAZAROTENE?

HALOBETASOL PROPIONATE AND TAZAROTENE is manufactured by SUN PHARMA CANADA.

Data updated: Nov 8, 2026

HALOBETASOL PROPIONATE AND TAZAROTENE (halobetasol propionate) · SUN PHARMA CANADA

Dermatology Approved 2025-05-02

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2025-05-02
Routes: TOPICAL
Dosage Forms: LOTION

Companies

SUN PHARMA CANADA

Active Ingredient: HALOBETASOL PROPIONATE , TAZAROTENE

HALOBETASOL PROPIONATE AND TAZAROTENE Approval History

2026

Original

New Indication

New Form

Label Update

1 FDA actions from 2025 to 2025

May 2025 ORIGINAL

Update

What HALOBETASOL PROPIONATE AND TAZAROTENE Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

Other (1)

📋

Clinical Trial Registry

1 trials

Trial	Sponsor ID	Phase	Status	Title
NCT03298581	71542610	Ph 2	withdrawn	Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HALOBETASOL PROPIONATE AND TAZAROTENE FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

Track HALOBETASOL PROPIONATE AND TAZAROTENE with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: ANDA217190 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.