Nasacort

NDA 19798, held by Chattem Sanofi. Triamcinolone Acetonide.

As of Nov 14, 2026, NDA 19798 (Nasacort), held by Chattem Sanofi, was first approved by FDA on Jul 11, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 11, 1991
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


May 20, 1996	Supplement 6Efficacy (new indication or use)	Approved	None posted
Jul 11, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nasacort0.055MG/INH · aerosol, metered;nasal	Triamcinolone Acetonide	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 17, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 12, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 21, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 2, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
May 20, 1996	Supplement 6Efficacy (new indication or use)	Approved	None posted
May 6, 1994	Supplement 2Labeling	Approved	None posted
Nov 30, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 11, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19798
Drugs@FDA: Overview at FDA
Company: Chattem Sanofi

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