Aristocort, Aristocort A

ANDA 83016, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 83016 (Aristocort, Aristocort A), held by Astellas, was first approved by FDA on Jul 24, 1972, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1972
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 24, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Aristocort0.1% · cream;topical	Triamcinolone Acetonide	Discontinued
Aristocort A0.1% · cream;topical	Triamcinolone Acetonide	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Oct 8, 1998	Supplement 50Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 49Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 48Manufacturing	Approved	None posted
Jul 17, 1997	Supplement 47Manufacturing	Approved	None posted
Apr 14, 1995	Supplement 45Manufacturing	Approved	None posted
Jun 29, 1992	Supplement 41Manufacturing	Approved	None posted
Nov 9, 1989	Supplement 44Labeling	Approved	None posted
Oct 6, 1989	Supplement 43Manufacturing	Approved	None posted
Oct 6, 1989	Supplement 42Manufacturing	Approved	None posted
Feb 2, 1984	Supplement 37Manufacturing	Approved	None posted
Jul 24, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 83016
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