Triamcinolone Acetonide

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 40671, held by Micro Labs. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 40671 (Triamcinolone Acetonide), held by Micro Labs, was first approved by FDA on Jun 9, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2006
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Triamcinolone acetonide cream, USP 0.1% 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 3 submissions below

Date	Submission	Status	Documents
Jun 9, 2006	Original application	Approved	None posted

Products

2 strengths and forms


Triamcinolone Acetonide0.025% · cream;topical	Triamcinolone Acetonide	Rx
Triamcinolone Acetonide0.1% · cream;topical	Triamcinolone Acetonide	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 8, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Jul 26, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jun 9, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 40671
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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