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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215883

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NDA 215883 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Deva Holding As, Dr Reddys, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the FORMOTEROL FUMARATE profile page.

The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for 215883

Tradename:	FORMOTEROL FUMARATE
Applicant:	Mankind Pharma
Ingredient:	formoterol fumarate
Patents:	0

Pharmacology for NDA: 215883

Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 215883

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Suppliers and Packaging for NDA: 215883

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215883	ANDA	Major Pharmaceuticals	0904-7454	0904-7454-11	30 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL
FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215883	ANDA	Major Pharmaceuticals	0904-7454	0904-7454-14	60 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.02MG/2ML
Approval Date:	Mar 22, 2023	TE:	AN	RLD:	No

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