NDA 19383, held by Schering. Albuterol Sulfate.
As of Nov 14, 2026, NDA 19383 (Proventil), held by Schering, was first approved by FDA on Jul 13, 1987, with 10 approved supplements and 0 published complete response letters.
| Sep 18, 1997 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jul 13, 1987 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| ProventilEQ 4MG BASE · tablet, extended release;oral | Albuterol Sulfate | Discontinued |
| Apr 9, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 24, 1999 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1998 | Supplement 10Labeling · Standard review | Approved | |
| Jul 15, 1998 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Dec 12, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1997 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 9, 1996 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 27, 1993 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 5, 1992 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1989 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1987 | 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
