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Last Updated: December 14, 2024

Details for New Drug Application (NDA): 209871

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NDA 209871 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, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, Eyenovia, Ani Pharms, and Beach Prods, and is included in eighty-one NDAs. It is available from thirty-seven suppliers. There are two patents protecting this drug. 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 suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 209871

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

Medical Subject Heading (MeSH) Categories for 209871

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SHAMPOO;TOPICAL			Strength	0.05%
Approval Date:	Oct 27, 2017	TE:		RLD:	No

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