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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 075391

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NDA 075391 describes CLOBETASOL PROPIONATE, which is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Xiromed, 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, 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, and Ani Pharms, and is included in eighty-two NDAs. It is available from thirty-nine 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-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 075391

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

Pharmacology for NDA: 075391

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 075391

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 075391

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	SOLUTION;TOPICAL	075391	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0269	0168-0269-50	50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Feb 8, 1999	TE:	AT	RLD:	No

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