Last Updated: September 24, 2026

Details for New Drug Application (NDA): 215990

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NDA 215990 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 215990

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

Pharmacology for NDA: 215990

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 215990

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 215990

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	215990	ANDA	Macleods Pharmaceuticals Limited	33342-506	33342-506-15	1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE
CLOBETASOL PROPIONATE	clobetasol propionate	OINTMENT;TOPICAL	215990	ANDA	Macleods Pharmaceuticals Limited	33342-506	33342-506-30	1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Dec 28, 2023	TE:	AB	RLD:	No

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