Last Updated: November 13, 2026

Details for New Drug Application (NDA): 215621

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NDA 215621 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 eleven suppliers. Additional details are available on the FORMOTEROL FUMARATE profile page.

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

Summary for 215621

Tradename:	FORMOTEROL FUMARATE
Applicant:	Wilshire Pharms Inc
Ingredient:	formoterol fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 215621

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:	Dec 13, 2022	TE:	AN	RLD:	No

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