Ventolin Hfa

Prevents bronchospasm. NDA 20983, held by Glaxosmithkline. Albuterol Sulfate.

As of Nov 13, 2026, NDA 20983 (Ventolin Hfa), held by Glaxosmithkline, was first approved by FDA on Apr 19, 2001, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 19, 2001
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Mar 26, 2008	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 19, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ventolin HfaEQ 0.09MG BASE/INH · aerosol, metered;inhalation	Albuterol Sulfate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Aug 18, 2021	Supplement 41Labeling · Standard review	Approved	Letter Label
Dec 16, 2019	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 14, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Jan 12, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 19, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 17, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 21, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 3, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 6, 2012	Supplement 27Labeling	Approved	Label Letter
Aug 27, 2008	Supplement 13	Approved	Pediatric Written Request Pediatric Amendment 1 Pediatric Amendment 2 Pediatric Amendment 3
Mar 26, 2008	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 17, 2006	Supplement 10Manufacturing	Approved	None posted
Apr 19, 2005	Supplement 9Manufacturing · Standard review	Approved	Review Letter Label
Sep 10, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 4, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 25, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 9, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 19, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 20983
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