Triamcinolone Acetonide

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 85692, held by Fougera Pharms. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 85692 (Triamcinolone Acetonide), held by Fougera Pharms, was first approved by FDA on Mar 9, 1978, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1978
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 9, 1978	Original application	Approved	None posted

Products

3 strengths and forms


Triamcinolone Acetonide0.025% · cream;topical	Triamcinolone Acetonide	RxReference drug
Triamcinolone Acetonide0.5% · cream;topical	Triamcinolone Acetonide	RxReference drug
Triamcinolone Acetonide0.1% · cream;topical	Triamcinolone Acetonide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Aug 12, 1997	Supplement 52Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 51Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 49Manufacturing	Approved	None posted
May 9, 1995	Supplement 50Manufacturing	Approved	None posted
Aug 24, 1993	Supplement 48Manufacturing	Approved	None posted
May 20, 1988	Supplement 44Manufacturing	Approved	None posted
Mar 3, 1988	Supplement 42Manufacturing	Approved	None posted
Dec 2, 1986	Supplement 40Manufacturing	Approved	None posted
Jul 26, 1984	Supplement 39Manufacturing	Approved	None posted
Sep 14, 1983	Supplement 38Manufacturing	Approved	None posted
May 26, 1983	Supplement 36Manufacturing	Approved	None posted
May 26, 1983	Supplement 37Manufacturing	Approved	None posted
Mar 9, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85692
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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