Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209974

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NDA 209974 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-eight 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-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 209974

Tradename:	CLOBETASOL PROPIONATE
Applicant:	Pai Holdings Pharm
Ingredient:	clobetasol propionate
Patents:	0

Medical Subject Heading (MeSH) Categories for 209974

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Apr 17, 2018	TE:		RLD:	No

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