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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215621


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NDA 215621 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 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 215621
Tradename:FORMOTEROL FUMARATE
Applicant:Wilshire Pharms Inc
Ingredient:formoterol fumarate
Patents:0
Pharmacology for NDA: 215621
Mechanism of ActionAdrenergic beta2-Agonists
Medical Subject Heading (MeSH) Categories for 215621
Suppliers and Packaging for NDA: 215621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 215621 ANDA Rhodes Pharmaceuticals L.P. 42858-094 42858-094-35 30 POUCH in 1 CARTON (42858-094-35) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 215621 ANDA Rhodes Pharmaceuticals L.P. 42858-094 42858-094-62 60 POUCH in 1 CARTON (42858-094-62) / 1 VIAL in 1 POUCH (42858-094-21) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:Dec 13, 2022TE:ANRLD:No

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