Aristocort

NDA 12802, held by Fosun Pharma. Triamcinolone Diacetate.

As of Nov 14, 2026, NDA 12802 (Aristocort), held by Fosun Pharma, was first approved by FDA on Sep 5, 1961, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 5, 1961
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 5, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aristocort40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Triamcinolone Diacetate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 34Labeling · Standard review	Approved	Letter Label
Sep 4, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 14, 2010	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 17, 2003	Supplement 16Labeling	Approved	Letter
Jan 17, 2003	Supplement 14Labeling	Approved	Letter
Aug 29, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 25, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 9, 1995	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 4, 1994	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 7, 1993	Supplement 24Labeling	Approved	None posted
Nov 5, 1992	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 6, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 22, 1992	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 6, 1992	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 12, 1989	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 3, 1980	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 5, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12802
Drugs@FDA: Overview at FDA
Company: Fosun 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