Aristocort A

ANDA 88819, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 88819 (Aristocort A), held by Astellas, was first approved by FDA on Sep 29, 2006, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2006
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
Sep 29, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aristocort A0.1% · cream;topical	Triamcinolone Acetonide	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 29, 2006	Original application	Approved	None posted
May 6, 1998	Supplement 8Manufacturing	Approved	None posted
May 6, 1998	Supplement 9Manufacturing	Approved	None posted
May 6, 1998	Supplement 10Manufacturing	Approved	None posted
May 6, 1998	Supplement 11Manufacturing	Approved	None posted
Jul 17, 1997	Supplement 7Manufacturing	Approved	None posted
Apr 14, 1995	Supplement 6Manufacturing	Approved	None posted
Oct 6, 1989	Supplement 5Manufacturing	Approved	None posted
Mar 9, 1987	Supplement 1Manufacturing	Approved	None posted
Mar 9, 1987	Supplement 2Manufacturing	Approved	None posted

Identifiers

Application: ANDA 88819
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