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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215266

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NDA 215266 describes HALOBETASOL PROPIONATE, which is a drug marketed by Padagis Israel, Cosette, Fougera Pharms, Sun Pharma Canada, Encube, and Quagen, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the HALOBETASOL PROPIONATE profile page.

The generic ingredient in HALOBETASOL PROPIONATE is halobetasol propionate; tazarotene. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the halobetasol propionate; tazarotene profile page.

Summary for 215266

Tradename:	HALOBETASOL PROPIONATE
Applicant:	Padagis Israel
Ingredient:	halobetasol propionate
Patents:	0

Pharmacology for NDA: 215266

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 215266

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOBETASOL PROPIONATE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	215266	ANDA	Mayne Pharma	51862-618	51862-618-50	1 CANISTER in 1 CARTON (51862-618-50) / 50 g in 1 CANISTER
HALOBETASOL PROPIONATE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	215266	ANDA	Mayne Pharma	68308-769	68308-769-50	1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	0.05%
Approval Date:	Aug 11, 2023	TE:	AB	RLD:	No

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