Triamcinolone Acetonide

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 85691, held by Fougera Pharms. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 85691 (Triamcinolone Acetonide), held by Fougera Pharms, was first approved by FDA on Mar 9, 1978, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1978
Supplements approved: 16
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 17 submissions below

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

Products

3 strengths and forms


Triamcinolone Acetonide0.025% · ointment;topical	Triamcinolone Acetonide	Rx
Triamcinolone Acetonide0.5% · ointment;topical	Triamcinolone Acetonide	Rx
Triamcinolone Acetonide0.1% · ointment;topical	Triamcinolone Acetonide	Rx

All 17 submissions, including labeling and manufacturing supplements


Aug 23, 2004	Supplement 35Labeling	Approved	None posted
Mar 7, 1996	Supplement 33Manufacturing	Approved	None posted
Dec 30, 1994	Supplement 32Manufacturing	Approved	None posted
May 20, 1988	Supplement 31Manufacturing	Approved	None posted
May 20, 1988	Supplement 27Manufacturing	Approved	None posted
Mar 25, 1988	Supplement 30Labeling	Approved	None posted
Jul 31, 1987	Supplement 29Manufacturing	Approved	None posted
Sep 25, 1986	Supplement 26Manufacturing	Approved	None posted
May 4, 1983	Supplement 25Manufacturing	Approved	None posted
May 4, 1983	Supplement 24Manufacturing	Approved	None posted
Oct 28, 1982	Supplement 23Manufacturing	Approved	None posted
Jul 27, 1982	Supplement 19Manufacturing	Approved	None posted
Jul 27, 1982	Supplement 17Manufacturing	Approved	None posted
Jul 27, 1982	Supplement 16Manufacturing	Approved	None posted
Jul 27, 1982	Supplement 11Manufacturing	Approved	None posted
Jul 27, 1982	Supplement 10Manufacturing	Approved	None posted
Mar 9, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85691
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