Last Updated: June 10, 2026

Details for New Drug Application (NDA): 214895

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NDA 214895 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, 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-eight 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-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 214895

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

Pharmacology for NDA: 214895

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 214895

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 214895

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	SHAMPOO;TOPICAL	214895	ANDA	Amneal Pharmaceuticals NY LLC	69238-1732	69238-1732-8	1 BOTTLE in 1 CARTON (69238-1732-8) / 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	0.05%
Approval Date:	Jun 14, 2021	TE:	AB	RLD:	No

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