Ventolin

NDA 19773, held by Glaxosmithkline. Albuterol Sulfate.

As of Nov 13, 2026, NDA 19773 (Ventolin), held by Glaxosmithkline, was first approved by FDA on Apr 23, 1992, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 23, 1992
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 16, 1997	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 23, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
VentolinEQ 0.083% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation	Albuterol Sulfate	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 18, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Oct 30, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Jun 16, 1997	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 26, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 21, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Jan 13, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Nov 10, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 23, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19773
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