Aristocort, Aristocort A

ANDA 83015, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 83015 (Aristocort, Aristocort A), held by Astellas, was first approved by FDA on Jul 26, 1972, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1972
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

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

Products

2 strengths and forms


Aristocort0.5% · cream;topical	Triamcinolone Acetonide	DiscontinuedReference drug
Aristocort A0.5% · cream;topical	Triamcinolone Acetonide	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Oct 8, 1998	Supplement 46Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 47Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 48Manufacturing	Approved	None posted
Jul 17, 1997	Supplement 45Manufacturing	Approved	None posted
Apr 14, 1995	Supplement 43Manufacturing	Approved	None posted
Jun 29, 1992	Supplement 42Manufacturing	Approved	None posted
Apr 16, 1987	Supplement 39Manufacturing	Approved	None posted
Apr 16, 1987	Supplement 40Manufacturing	Approved	None posted
Dec 28, 1983	Supplement 36Manufacturing	Approved	None posted
Jul 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 83015
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