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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 078571

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NDA 078571 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 078571

Tradename:	MOMETASONE FUROATE
Applicant:	Glenmark Pharms Inc
Ingredient:	mometasone furoate
Patents:	0

Pharmacology for NDA: 078571

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 078571

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 078571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	078571	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-225	68462-225-17	15 g in 1 TUBE (68462-225-17)
MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	078571	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-225	68462-225-55	45 g in 1 TUBE (68462-225-55)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	May 28, 2008	TE:		RLD:	No

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