Albuterol

ANDA 73272, held by Ivax Sub Teva Pharms. Albuterol.

As of Nov 15, 2026, ANDA 73272 (Albuterol), held by Ivax Sub Teva Pharms, was first approved by FDA on Dec 28, 1995, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1995
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 28, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Albuterol0.09MG/INH · aerosol, metered;inhalation	Albuterol	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Apr 18, 2008	Supplement 8Labeling	Approved	None posted
Oct 22, 2001	Supplement 13Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 10Labeling	Approved	None posted
Aug 18, 1998	Supplement 7Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 6Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 5Manufacturing	Approved	None posted
Sep 22, 1997	Supplement 4Manufacturing	Approved	None posted
Jan 16, 1997	Supplement 3Manufacturing	Approved	None posted
Jan 16, 1997	Supplement 2Manufacturing	Approved	None posted
Jul 22, 1996	Supplement 1Labeling	Approved	None posted
Dec 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 73272
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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