Last Updated: June 9, 2026

Details for New Drug Application (NDA): 077447

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NDA 077447 describes MOMETASONE FUROATE, which is a drug marketed by Chartwell Molecular, Cosette, Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Aurobindo Pharma, and Naspress, and is included in twenty-five NDAs. It is available from sixteen suppliers. Additional details are available on the MOMETASONE FUROATE profile page.

The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for 077447

Tradename:	MOMETASONE FUROATE
Applicant:	Cosette
Ingredient:	mometasone furoate
Patents:	0

Pharmacology for NDA: 077447

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 077447

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 077447

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	077447	ANDA	Cosette Pharmaceuticals, Inc.	0713-0634	0713-0634-15	1 TUBE in 1 CARTON (0713-0634-15) / 15 g in 1 TUBE
MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	077447	ANDA	Cosette Pharmaceuticals, Inc.	0713-0634	0713-0634-37	1 TUBE in 1 CARTON (0713-0634-37) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	May 22, 2006	TE:	AB	RLD:	No

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