Aristospan

NDA 16466, held by Ethypharm. Triamcinolone Hexacetonide.

As of Nov 13, 2026, NDA 16466 (Aristospan), held by Ethypharm, was first approved by FDA on Jul 29, 1969, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1969
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 29, 1969	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

2 strengths and forms


Aristospan5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Triamcinolone Hexacetonide	DiscontinuedReference drug
Aristospan20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Triamcinolone Hexacetonide	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 4, 2014	Supplement 45Manufacturing · Standard review	Approved	Review
Jul 3, 2014	Supplement 46Labeling · Standard review	Approved	Letter Label
Jun 3, 2009	Supplement 41Labeling · Standard review	Approved	Letter Label
Jun 3, 2009	Supplement 40Labeling · Standard review	Approved	Letter Label
Mar 1, 2007	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 1, 2006	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 12, 2002	Supplement 32Manufacturing · Standard review	Approved	Review
Oct 25, 1999	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 18, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 8, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 4, 1994	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 7, 1993	Supplement 26Labeling	Approved	None posted
Jan 6, 1992	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 26, 1991	Supplement 23Manufacturing · Standard review	Approved	None posted
May 30, 1990	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 12, 1985	Supplement 17Labeling	Approved	None posted
Oct 7, 1980	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 18, 1979	Supplement 11Labeling	Approved	None posted
Apr 18, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 13, 1979	Supplement 12Labeling	Approved	None posted
Aug 4, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 29, 1969	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16466
Drugs@FDA: Overview at FDA
Company: Ethypharm

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