Maxair

NDA 19009, held by Bausch. Pirbuterol Acetate.

As of Nov 13, 2026, NDA 19009 (Maxair), held by Bausch, was first approved by FDA on Dec 30, 1986, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1986
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 30, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
MaxairEQ 0.2MG BASE/INH · aerosol, metered;inhalation	Pirbuterol Acetate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 14, 2001	Supplement 6Manufacturing · Standard review	Approved	Label
Apr 17, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 11, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Nov 22, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Aug 19, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 30, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19009
Drugs@FDA: Overview at FDA
Company: Bausch Health

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