Ventolin

NDA 19621, held by Glaxosmithkline. Albuterol Sulfate.

As of Nov 14, 2026, NDA 19621 (Ventolin), held by Glaxosmithkline, was first approved by FDA on Jun 10, 1987, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1987
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 10, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
VentolinEQ 2MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Albuterol Sulfate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 18, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Oct 30, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Jan 26, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
May 2, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Nov 26, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Aug 28, 1992	Supplement 3Labeling · Standard review	Approved	None posted
May 7, 1990	Supplement 2Labeling · Standard review	Approved	None posted
Dec 9, 1987	Supplement 1Labeling · Standard review	Approved	None posted
Jun 10, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19621
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters