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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 218304


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NDA 218304 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 218304
Tradename:FORMOTEROL FUMARATE
Applicant:Micro Labs
Ingredient:formoterol fumarate
Patents:0
Pharmacology for NDA: 218304
Mechanism of ActionAdrenergic beta2-Agonists
Medical Subject Heading (MeSH) Categories for 218304
Suppliers and Packaging for NDA: 218304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 218304 ANDA Micro Labs Limited 42571-463 42571-463-62 60 POUCH in 1 CARTON (42571-463-62) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 218304 ANDA Micro Labs Limited 42571-463 42571-463-73 30 POUCH in 1 CARTON (42571-463-73) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:Jun 26, 2024TE:ANRLD:No

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