Prevents bronchospasm with reversible obstructive airway disease. NDA 20503, held by Kindeva. Albuterol Sulfate.
As of Nov 14, 2026, NDA 20503 (Proventil-Hfa), held by Kindeva, was first approved by FDA on Aug 15, 1996, with 30 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
| Jun 2, 1999 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Proventil-HfaEQ 0.09MG BASE/INH · aerosol, metered;inhalation | Albuterol Sulfate | RxReference drug |
| Sep 22, 2017 | Supplement 54Labeling · Standard review | Approved | |
| Nov 9, 2016 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2016 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2016 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2015 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Feb 25, 2013 | Supplement 47Manufacturing · Standard review | Approved | |
| Jun 5, 2012 | Supplement 46Labeling | Approved | |
| Sep 8, 2009 | Supplement 39Labeling · Standard review | Approved | |
| Jan 29, 2004 | Supplement 22Labeling · Standard review | Approved | |
| Jul 26, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 18, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 17, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 10, 2002 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 5, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 28, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 16, 2000 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 16, 2000 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2000 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 4, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1999 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 2, 1999 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 12, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1997 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 26, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
