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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075751

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NDA 075751 describes DESONIDE, which is a drug marketed by Alembic, Cadila, Cosette, Glenmark Speclt, Padagis Us, Taro, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the DESONIDE profile page.

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

Summary for 075751

Tradename:	DESONIDE
Applicant:	Fougera Pharms
Ingredient:	desonide
Patents:	0

Pharmacology for NDA: 075751

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 075751

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 075751

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESONIDE	desonide	OINTMENT;TOPICAL	075751	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0309	0168-0309-60	1 TUBE in 1 CARTON (0168-0309-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Mar 12, 2001	TE:	AB	RLD:	No

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