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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215078

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NDA 215078 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 215078

Tradename:	FORMOTEROL FUMARATE
Applicant:	Alembic
Ingredient:	formoterol fumarate
Patents:	0

Pharmacology for NDA: 215078

Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 215078

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Suppliers and Packaging for NDA: 215078

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215078	ANDA	Alembic Pharmaceuticals Inc.	62332-655	62332-655-30	30 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL
FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215078	ANDA	Alembic Pharmaceuticals Inc.	62332-655	62332-655-60	60 POUCH in 1 CARTON (62332-655-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.02MG/2ML
Approval Date:	Nov 22, 2021	TE:	AN	RLD:	No

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