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Last Updated: April 15, 2025

Details for New Drug Application (NDA): 218308

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NDA 218308 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for 218308

Tradename:	FORMOTEROL FUMARATE
Applicant:	Deva Holding As
Ingredient:	formoterol fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 218308

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.02MG/2ML
Approval Date:	Feb 11, 2025	TE:	AN	RLD:	No

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