Last Updated: July 27, 2026

Details for New Drug Application (NDA): 209978

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NDA 209978 describes HALOBETASOL PROPIONATE, which is a drug marketed by Padagis Israel, Cosette Pharms Nc, Fougera Pharms, Sun Pharma Canada, Cosette, Encube, and Quagen, and is included in fourteen NDAs. It is available from six 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 209978

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

Pharmacology for NDA: 209978

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 209978

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	209978	ANDA	Encube Ethicals, Inc.	21922-108	21922-108-04	1 TUBE in 1 CARTON (21922-108-04) / 15 g in 1 TUBE
HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	209978	ANDA	Encube Ethicals, Inc.	21922-108	21922-108-14	1 TUBE in 1 CARTON (21922-108-14) / 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Mar 20, 2018	TE:		RLD:	No

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