Last Updated: June 9, 2026

Details for New Drug Application (NDA): 076481

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NDA 076481 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 076481

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

Pharmacology for NDA: 076481

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 076481

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 076481

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	076481	ANDA	Encube Ethicals, Inc.	21922-071	21922-071-04	1 TUBE in 1 CARTON (21922-071-04) / 15 g in 1 TUBE
MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	076481	ANDA	Encube Ethicals, Inc.	21922-071	21922-071-06	1 TUBE in 1 CARTON (21922-071-06) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	Nov 14, 2003	TE:	AB	RLD:	No

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