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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 076499

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NDA 076499 describes MOMETASONE FUROATE, which is a drug marketed by Chartwell Molecular, Cosette, Fougera Pharms, Glenmark Pharms Inc, 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 fifteen 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-six suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for 076499

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

Pharmacology for NDA: 076499

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 076499

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 076499

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	076499	ANDA	Encube Ethicals, Inc.	21922-072	21922-072-01	1 BOTTLE in 1 BOTTLE (21922-072-01) / 60 mL in 1 BOTTLE
MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	076499	ANDA	Encube Ethicals, Inc.	21922-072	21922-072-21	1 BOTTLE in 1 CARTON (21922-072-21) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.1%
Approval Date:	Nov 21, 2007	TE:	AB	RLD:	No

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