Details for New Drug Application (NDA): 215621

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 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 215621

Tradename:	FORMOTEROL FUMARATE
Applicant:	Wilshire Pharms Inc
Ingredient:	formoterol fumarate
Patents:	0

Pharmacology for NDA: 215621

Mechanism of Action

Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 215621

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

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:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.02MG/2ML
Approval Date:	Dec 13, 2022	TE:	AN	RLD:	No

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