Aristocort, Aristocort A

ANDA 83017, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 83017 (Aristocort, Aristocort A), held by Astellas, was first approved by FDA on Jul 26, 1972, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1972
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 26, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Aristocort0.025% · cream;topical	Triamcinolone Acetonide	Discontinued
Aristocort A0.025% · cream;topical	Triamcinolone Acetonide	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 29, 1992	Supplement 39Manufacturing	Approved	None posted
Apr 16, 1987	Supplement 36Manufacturing	Approved	None posted
Apr 16, 1987	Supplement 37Manufacturing	Approved	None posted
Feb 2, 1984	Supplement 33Manufacturing	Approved	None posted
Jul 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 83017
Drugs@FDA: Overview at FDA
Company: Astellas Pharma

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