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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077123

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NDA 077123 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 077123

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

Pharmacology for NDA: 077123

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 077123

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077123	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-129	45802-129-32	1 TUBE in 1 CARTON (45802-129-32) / 50 g in 1 TUBE
HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077123	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-129	45802-129-35	1 TUBE in 1 CARTON (45802-129-35) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Dec 16, 2004	TE:	AB	RLD:	No

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