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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 216426

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NDA 216426 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in eight 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 are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for 216426

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

Pharmacology for NDA: 216426

Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 216426

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:	Oct 22, 2024	TE:	AN	RLD:	No

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