Last Updated: September 24, 2026

Details for New Drug Application (NDA): 019548

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NDA 019548 describes TORNALATE, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. Additional details are available on the TORNALATE profile page.

The generic ingredient in TORNALATE is bitolterol mesylate. There is one drug master file entry for this compound. Additional details are available on the bitolterol mesylate profile page.

Summary for 019548

Tradename:	TORNALATE
Applicant:	Sanofi Aventis Us
Ingredient:	bitolterol mesylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	0.2%
Approval Date:	Feb 19, 1992	TE:		RLD:	No

Expired US Patents for NDA 019548

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TORNALATE	bitolterol mesylate	SOLUTION;INHALATION	019548-001	Feb 19, 1992	⤷ Start Trial	⤷ Start Trial
Sanofi Aventis Us	TORNALATE	bitolterol mesylate	SOLUTION;INHALATION	019548-001	Feb 19, 1992	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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