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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216486


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NDA 216486 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in seven NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 216486
Tradename:FORMOTEROL FUMARATE
Applicant:Ritedose Corp
Ingredient:formoterol fumarate
Patents:0
Pharmacology for NDA: 216486
Mechanism of ActionAdrenergic beta2-Agonists
Medical Subject Heading (MeSH) Categories for 216486
Suppliers and Packaging for NDA: 216486
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 216486 ANDA Aucta Pharmaceuticals, Inc 73289-0060 73289-0060-1 30 POUCH in 1 CARTON (73289-0060-1) / 2 mL in 1 POUCH (73289-0060-3)
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 216486 ANDA Aucta Pharmaceuticals, Inc 73289-0060 73289-0060-2 60 POUCH in 1 CARTON (73289-0060-2) / 2 mL in 1 POUCH (73289-0060-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:Nov 25, 2022TE:ANRLD:No

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