Aristocort, Aristocort A

ANDA 80745, held by Astellas. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 80745 (Aristocort, Aristocort A), held by Astellas, was first approved by FDA on Apr 28, 1972, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 28, 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
Apr 28, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Aristocort0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Triamcinolone Acetonide	DiscontinuedReference drug
Aristocort A0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Triamcinolone Acetonide	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Oct 13, 1989	Supplement 24Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 25Labeling	Approved	None posted
Oct 13, 1989	Supplement 26Manufacturing	Approved	None posted
Dec 28, 1983	Supplement 22Manufacturing	Approved	None posted
Apr 28, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80745
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