You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 211256

✉ Email this page to a colleague

« Back to Dashboard

NDA 211256 describes CLOBETASOL PROPIONATE, which is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin Ltd, Pai Holdings Pharm, Rising, Sun Pharma Canada, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Beach Prods, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, and Ani Pharms, and is included in eighty-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

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

Summary for 211256

Tradename:	CLOBETASOL PROPIONATE
Applicant:	Amneal
Ingredient:	clobetasol propionate
Patents:	0

Pharmacology for NDA: 211256

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 211256

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 211256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211256	ANDA	AvKARE	42291-076	42291-076-15	1 TUBE in 1 CARTON (42291-076-15) / 15 g in 1 TUBE
CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	211256	ANDA	AvKARE	42291-076	42291-076-30	1 TUBE in 1 CARTON (42291-076-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Dec 26, 2018	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.