Last Updated: May 10, 2026

Details for New Drug Application (NDA): 090506

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NDA 090506 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-eight suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for 090506

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

Pharmacology for NDA: 090506

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 090506

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 090506

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	090506	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-385	68462-385-02	1 BOTTLE in 1 CARTON (68462-385-02) / 60 mL in 1 BOTTLE
MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	090506	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-385	68462-385-37	1 BOTTLE in 1 CARTON (68462-385-37) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	LOTION;TOPICAL			Strength	0.1%
Approval Date:	Aug 9, 2010	TE:		RLD:	No

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