You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077001

✉ Email this page to a colleague

« Back to Dashboard

NDA 077001 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 077001

Tradename:	HALOBETASOL PROPIONATE
Applicant:	Fougera Pharms
Ingredient:	halobetasol propionate
Patents:	0

Pharmacology for NDA: 077001

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 077001

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077001	ANDA	Bryant Ranch Prepack	63629-8735	63629-8735-1	15 g in 1 TUBE (63629-8735-1)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.