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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216426


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NDA 216426 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 216426
Tradename:FORMOTEROL FUMARATE
Applicant:Lexenpharm
Ingredient:formoterol fumarate
Patents:0
Pharmacology for NDA: 216426
Mechanism of ActionAdrenergic beta2-Agonists
Medical Subject Heading (MeSH) Categories for 216426
Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Suppliers and Packaging for NDA: 216426
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 216426 ANDA Ingenus Pharmaceuticals, LLC 50742-394 50742-394-30 30 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 216426 ANDA Ingenus Pharmaceuticals, LLC 50742-394 50742-394-60 60 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:Oct 22, 2024TE:ANRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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