Ventolin Rotacaps

NDA 19489, held by Glaxosmithkline. Albuterol Sulfate.

As of Nov 14, 2026, NDA 19489 (Ventolin Rotacaps), held by Glaxosmithkline, was first approved by FDA on May 4, 1988, with 14 approved supplements and 0 published complete response letters.

First approved: May 4, 1988
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Jul 20, 1993	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 24, 1990	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
May 4, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ventolin RotacapsEQ 0.2MG BASE · capsule;inhalation	Albuterol Sulfate	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jun 30, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 30, 1998	Supplement 18Labeling · Standard review	Approved	None posted
Dec 26, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 26, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 14, 1994	Supplement 12Labeling · Standard review	Approved	None posted
Jan 27, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Aug 18, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 20, 1993	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 15, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 28, 1992	Supplement 7Labeling · Standard review	Approved	None posted
May 21, 1992	Supplement 6Labeling · Standard review	Approved	None posted
Apr 6, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 24, 1990	Supplement 2Labeling · Standard review	Approved	None posted
Sep 24, 1990	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
May 4, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19489
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