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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021592

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NDA 021592 describes FORADIL CERTIHALER, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the FORADIL CERTIHALER profile page.

The generic ingredient in FORADIL CERTIHALER is formoterol fumarate. There are nineteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for 021592

Tradename:	FORADIL CERTIHALER
Applicant:	Novartis
Ingredient:	formoterol fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 021592

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INHALATION			Strength	0.0085MG/INH
Approval Date:	Dec 15, 2006	TE:		RLD:	No

Expired US Patents for NDA 021592

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006	⤷ Get Started Free	⤷ Get Started Free
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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