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Last Updated: December 14, 2025

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. 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. Forty-eight 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 2MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 10, 1987	TE:		RLD:	No

Expired US Patents for NDA 019621

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

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