Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214396

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NDA 214396 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 214396

Tradename:	DESONIDE
Applicant:	Alembic
Ingredient:	desonide
Patents:	0

Pharmacology for NDA: 214396

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 214396

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 214396

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESONIDE	desonide	CREAM;TOPICAL	214396	ANDA	Alembic Pharmaceuticals Limited	46708-632	46708-632-15	1 TUBE in 1 CARTON (46708-632-15) / 15 g in 1 TUBE
DESONIDE	desonide	CREAM;TOPICAL	214396	ANDA	Alembic Pharmaceuticals Limited	46708-632	46708-632-60	1 TUBE in 1 CARTON (46708-632-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Dec 8, 2022	TE:	AB	RLD:	No

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