Azmacort

NDA 18117, held by Abbvie. Triamcinolone Acetonide.

As of Nov 14, 2026, NDA 18117 (Azmacort), held by Abbvie, was first approved by FDA on Apr 23, 1982, with 30 approved supplements and 0 published complete response letters.

First approved: Apr 23, 1982
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Oct 30, 1996	Supplement 26Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 23, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Azmacort0.1MG/INH · aerosol, metered;inhalation	Triamcinolone Acetonide	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Mar 13, 2008	Supplement 42Labeling · Standard review	Approved	Letter Label
Apr 13, 2007	Supplement 30Labeling · Standard review	Approved	Letter Label
Sep 5, 2006	Supplement 37Manufacturing · Standard review	Approved	Letter
Dec 23, 2003	Supplement 34Labeling · Standard review	Approved	Label Letter
Dec 18, 2003	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 4, 2003	Supplement 32Labeling · Standard review	Approved	Letter Label
Aug 17, 2000	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 8, 1999	Supplement 29Labeling · Standard review	Approved	Review
Jun 12, 1997	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 21, 1996	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 30, 1996	Supplement 26Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 2, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 30, 1992	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 18, 1992	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 12, 1992	Supplement 18Manufacturing · Standard review	Approved	None posted
May 17, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 1, 1990	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 27, 1990	Supplement 21Manufacturing · Standard review	Approved	None posted
May 16, 1990	Supplement 17Manufacturing · Standard review	Approved	None posted
May 15, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 13, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 3, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 23, 1987	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 30, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 26, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 31, 1984	Supplement 5Labeling	Approved	None posted
Mar 13, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 13, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 12, 1984	Supplement 2Labeling	Approved	None posted
Mar 12, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 23, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18117
Drugs@FDA: Overview at FDA
Company: AbbVie

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