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Last Updated: January 17, 2020

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Details for New Drug Application (NDA): 019621

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NDA 019621 describes VENTOLIN, which is a drug marketed by Glaxosmithkline and is included in seven NDAs. There are four patents protecting this drug. Additional details are available on the VENTOLIN profile page.

The generic ingredient in VENTOLIN is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 019621
Tradename:VENTOLIN
Applicant:Glaxosmithkline
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 019621
Tradename Dosage Ingredient NDA Submissiondate
VENTOLIN SYRUP;ORAL albuterol sulfate 019621

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 10, 1987TE:RLD:No

Expired US Patents for NDA 019621

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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