Last Updated: November 9, 2026

Details for New Drug Application (NDA): 074392

« Back to Dashboard

NDA 074392 describes CLOBETASOL PROPIONATE, which is a drug marketed by Alembic, Glenmark Pharms Ltd, Ingenus Pharms Llc, Padagis Israel, Taro, Xiromed, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette Pharms Nc, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin, Pai Holdings Pharm, Rising, Sun Pharma Canada, Teva Pharms Usa, Torrent, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Beach Prods, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms, and Ani Pharms, and is included in eighty-two NDAs. It is available from thirty-six suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There is one drug master file entry for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 074392

Tradename:	CLOBETASOL PROPIONATE
Applicant:	Fougera Pharms Inc
Ingredient:	clobetasol propionate
Patents:	0

Pharmacology for NDA: 074392

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 074392

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 074392

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	074392	ANDA	Proficient Rx LP	82804-083	82804-083-30	30 g in 1 TUBE (82804-083-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Sep 30, 1996	TE:	AB1	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.