Maxair

NDA 20014, held by Bausch. Pirbuterol Acetate.

As of Nov 13, 2026, NDA 20014 (Maxair), held by Bausch, was first approved by FDA on Nov 30, 1992, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1992
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Nov 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 27, 2006	Supplement 22Labeling · Standard review	Approved	Letter
Nov 27, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
May 11, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 29, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
May 26, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
May 26, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 12, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 11, 1998	Supplement 9Labeling · Standard review	Approved	None posted
Jul 24, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Jul 29, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 7, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Feb 25, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 6, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Nov 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20014
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