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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078162

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NDA 078162 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 078162

Tradename:	HALOBETASOL PROPIONATE
Applicant:	Cosette
Ingredient:	halobetasol propionate
Patents:	0

Pharmacology for NDA: 078162

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 078162

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	078162	ANDA	Cosette Pharmaceuticals, Inc.	0713-0640	0713-0640-15	15 g in 1 TUBE (0713-0640-15)
HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	078162	ANDA	Cosette Pharmaceuticals, Inc.	0713-0640	0713-0640-86	50 g in 1 TUBE (0713-0640-86)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Apr 24, 2007	TE:	AB	RLD:	No

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