Triamcinolone Acetonide

ANDA 90164, held by Sandoz. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 90164 (Triamcinolone Acetonide), held by Sandoz, was first approved by FDA on Jun 1, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2009
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
Jun 1, 2009	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide40MG/ML · injectable;injection	Triamcinolone Acetonide	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 8, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 13, 2012	Supplement 6Labeling · Standard review	Approved	None posted
Mar 18, 2011	Supplement 3Labeling	Approved	None posted
Jun 1, 2009	Original application	Approved	Review Letter

Identifiers

Application: ANDA 90164
Drugs@FDA: Overview at FDA
Company: Sandoz

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