Prevents bronchospasm. NDA 21457, held by Teva Branded Pharm. Albuterol Sulfate.
As of Nov 14, 2026, NDA 21457 (Proair Hfa), held by Teva Branded Pharm, was first approved by FDA on Oct 29, 2004, with 15 approved supplements and 0 published complete response letters.
Albuterol Sulfate HFA Inhalation Aerosol is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in patients 4 years of age and older. 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
| Sep 16, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Feb 3, 2006 | Supplement 3Efficacy (new indication or use) | Approved | |
| Oct 29, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Proair HfaEQ 0.09MG BASE/INH · aerosol, metered;inhalation | Albuterol Sulfate | RxReference drug |
| Feb 25, 2019 | Supplement 36Labeling · Standard review | Approved | |
| May 20, 2016 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jan 8, 2014 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 23, 2013 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 9, 2013 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 10, 2012 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 7, 2012 | Supplement 26Manufacturing · Standard review | Approved | |
| Dec 10, 2010 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Dec 8, 2010 | Supplement 22Labeling | Approved | |
| Aug 17, 2010 | Supplement 21Labeling · Standard review | Approved | |
| Sep 16, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Feb 3, 2006 | Supplement 3Efficacy (new indication or use) | Approved | |
| Nov 21, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Nov 21, 2005 | Supplement 2Labeling · Standard review | Approved | |
| May 2, 2005 | Supplement 1Manufacturing · Standard review | Approved | |
| Oct 29, 2004 | Original applicationNew dosage form · Standard review | Approved |
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
