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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 217498

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NDA 217498 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 217498

Tradename:	MOMETASONE FUROATE
Applicant:	Aurobindo Pharma
Ingredient:	mometasone furoate
Patents:	0

Pharmacology for NDA: 217498

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 217498

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 217498

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	217498	ANDA	Aurohealth LLC	58602-522	58602-522-44	1 BOTTLE, SPRAY in 1 CARTON (58602-522-44) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.05MG/SPRAY
Approval Date:	Nov 22, 2024	TE:		RLD:	No

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