Last Updated: May 3, 2026

Details for New Drug Application (NDA): 012339


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NDA 012339 describes BRONKOSOL, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the BRONKOSOL profile page.

The generic ingredient in BRONKOSOL is isoetharine hydrochloride. There are four drug master file entries for this compound. Additional details are available on the isoetharine hydrochloride profile page.
Summary for 012339
Tradename:BRONKOSOL
Applicant:Sanofi Aventis Us
Ingredient:isoetharine hydrochloride
Patents:0

Profile for product number 007

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL, METERED;INHALATIONStrength0.34MG/INH
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 008

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 009

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength0.25%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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