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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212982

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NDA 212982 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 212982

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

Pharmacology for NDA: 212982

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 212982

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 212982

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	212982	ANDA	Encube Ethicals, Inc.	21922-016	21922-016-04	15 g in 1 TUBE (21922-016-04)
CLOBETASOL PROPIONATE	clobetasol propionate	CREAM;TOPICAL	212982	ANDA	Encube Ethicals, Inc.	21922-016	21922-016-05	30 g in 1 TUBE (21922-016-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Aug 28, 2020	TE:	AB1	RLD:	No

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