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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018762

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NDA 018762 describes BRETHAIRE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the BRETHAIRE profile page.

The generic ingredient in BRETHAIRE is terbutaline sulfate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 018762

Tradename:	BRETHAIRE
Applicant:	Novartis
Ingredient:	terbutaline sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018762

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Sympathomimetics
Tocolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.2MG/INH
Approval Date:	Aug 17, 1984	TE:		RLD:	No

Expired US Patents for NDA 018762

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	3,937,838	⤷ Get Started Free
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	4,011,258	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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