Triamcinolone Acetonide

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 40037, held by Sun Pharma Canada. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 40037 (Triamcinolone Acetonide), held by Sun Pharma Canada, was first approved by FDA on Sep 30, 1994, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1994
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Triamcinolone Acetonide Ointment is 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 8 submissions below

Date	Submission	Status	Documents
Sep 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide0.1% · ointment;topical	Triamcinolone Acetonide	Rx

All 8 submissions, including labeling and manufacturing supplements


Oct 26, 2016	Supplement 16Manufacturing	Approved	None posted
Jun 30, 1998	Supplement 7Manufacturing	Approved	None posted
Nov 28, 1997	Supplement 6Manufacturing	Approved	None posted
Nov 28, 1997	Supplement 5Manufacturing	Approved	None posted
Nov 28, 1997	Supplement 4Manufacturing	Approved	None posted
Sep 17, 1996	Supplement 2Manufacturing	Approved	None posted
Dec 15, 1995	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 40037
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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