Aristocort A, Aristocort

ANDA 80750, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 80750 (Aristocort A, Aristocort), held by Astellas, was first approved by FDA on Apr 26, 1972, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1972
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

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

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Jul 16, 1997	Supplement 39Manufacturing	Approved	None posted
Apr 14, 1995	Supplement 38Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 34Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 35Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 36Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 37Labeling	Approved	None posted
Dec 30, 1983	Supplement 32Manufacturing	Approved	None posted
Mar 25, 1982	Supplement 25Manufacturing	Approved	None posted
Mar 25, 1982	Supplement 26Manufacturing	Approved	None posted
Mar 25, 1982	Supplement 28Manufacturing	Approved	None posted
Mar 25, 1982	Supplement 29Manufacturing	Approved	None posted
Apr 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80750
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