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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207989

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NDA 207989 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 207989

Tradename:	MOMETASONE FUROATE
Applicant:	Amneal Pharms
Ingredient:	mometasone furoate
Patents:	0

Pharmacology for NDA: 207989

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 207989

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 207989

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	207989	ANDA	Amneal Pharmaceuticals LLC	65162-891	65162-891-29	1 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.05MG/SPRAY
Approval Date:	Apr 3, 2017	TE:	AB	RLD:	No

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