NDA 19269, held by Glaxosmithkline. Albuterol Sulfate.
As of Nov 13, 2026, NDA 19269 (Ventolin), held by Glaxosmithkline, was first approved by FDA on Jan 16, 1987, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 1997 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 16, 1987 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| VentolinEQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation | Albuterol Sulfate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 1998 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 30, 1997 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jun 16, 1997 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 26, 1995 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1992 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1992 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 21, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1992 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1989 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1987 | Original applicationNew formulation or manufacturer · 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
