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Last Updated: March 13, 2026

Details for New Drug Application (NDA): 215878

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NDA 215878 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 215878

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

Pharmacology for NDA: 215878

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 215878

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 215878

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	215878	ANDA	Aurobindo Pharma Limited	59651-402	59651-402-17	1 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.05MG/SPRAY
Approval Date:	Mar 18, 2024	TE:	AB	RLD:	No

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