Halobetasol Propionate

Treats plaque psoriasis. Sold as Ultravate, Bryhali, Lexette. Every FDA application for this active ingredient: 5 branded and 14 generic.

As of Nov 15, 2026, FDA lists 19 applications for Halobetasol Propionate (sold as Ultravate, Bryhali, Lexette), first approved Dec 17, 1990, with 4 new uses approved and 0 published complete response letters.

First approved: Dec 17, 1990
Applications: 19
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $10.5M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Halobetasol Propionate	Part D	$10.2M	-15%	83,886
Ultravate	Part D	$203K	New	83
Bryhali	Part D	$79K	-21%	123

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 17, 1990	UltravateNDA 19968 · New molecular entity	Sun Pharm Inds Inc	8	Discontinued
Dec 27, 1990	UltravateNDA 19967 · New dosage form	Sun Pharm Inds Inc	13	Discontinued
Dec 16, 2004	Halobetasol PropionateANDA 76872	Padagis Israel	0	Marketed
Dec 16, 2004	Halobetasol PropionateANDA 76903	Fougera Pharms	0	Discontinued
Dec 16, 2004	Halobetasol PropionateANDA 76994	Sun Pharma Canada	0	Discontinued
Dec 16, 2004	Halobetasol PropionateANDA 77001	Fougera Pharms	0	Marketed
Dec 16, 2004	Halobetasol PropionateANDA 77123	Padagis Israel	0	Marketed
Jun 14, 2005	Halobetasol PropionateANDA 77109	Cosette Pharms Nc	0	Marketed
Aug 4, 2005	Halobetasol PropionateANDA 77227	Sun Pharma Canada	0	Discontinued
Sep 7, 2006	Halobetasol PropionateANDA 77721	Cosette Pharms Nc	0	Discontinued
Apr 24, 2007	Halobetasol PropionateANDA 78162	Cosette Pharms Nc	0	Marketed
Nov 6, 2015	UltravateNDA 208183 · New dosage form	Lacer Pharma	1	Marketed
Mar 20, 2018	Halobetasol PropionateANDA 209978	Encube	0	Marketed
May 24, 2018	LexetteNDA 210566 · TYPE 3/4	Mayne Pharma	4	Discontinued
Nov 6, 2018	BryhaliNDA 209355 · New dosage form	Bausch	0	Marketed
Jun 3, 2020	Halobetasol PropionateANDA 211464	Padagis Israel	0	Discontinued
Oct 6, 2020	Halobetasol PropionateANDA 213560	Quagen	0	Marketed
Aug 11, 2023	Halobetasol PropionateANDA 215266	Padagis Israel	0	Marketed
—	Halobetasol PropionateANDA 214285	Perrigo Israel	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA