Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210998

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NDA 210998 describes DESONIDE, which is a drug marketed by Alembic, Cadila, Cosette Pharms Nc, Glenmark Speclt, Padagis Us, Sun Pharma Canada, Senores Pharms, Encube, Fougera Pharms, Taro, Encube Ethicals, Glenmark Pharms Ltd, Hikma, and Pai Holdings Pharm, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the DESONIDE profile page.

The generic ingredient in DESONIDE is desonide. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

Summary for 210998

Tradename:	DESONIDE
Applicant:	Encube Ethicals
Ingredient:	desonide
Patents:	0

Pharmacology for NDA: 210998

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 210998

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 210998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESONIDE	desonide	OINTMENT;TOPICAL	210998	ANDA	Encube Ethicals, Inc.	21922-004	21922-004-04	1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE
DESONIDE	desonide	OINTMENT;TOPICAL	210998	ANDA	Encube Ethicals, Inc.	21922-004	21922-004-07	1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Jan 30, 2019	TE:	AB	RLD:	No

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