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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 NDA: 012339

Sanofi Aventis Us
isoetharine mesylate
Therapeutic Class:Respiratory Tract Agents

Summary for product number 007

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

Summary for product number 008

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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.