Triamcinolone Acetonide

NDA 11601, held by Pharmobedient. Triamcinolone Acetonide.

As of Nov 13, 2026, NDA 11601 (Triamcinolone Acetonide), held by Pharmobedient, was first approved by FDA on Oct 23, 1958, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1958
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Oct 23, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Triamcinolone Acetonide	DiscontinuedReference drug
Triamcinolone Acetonide0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Triamcinolone Acetonide	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 22, 2016	Supplement 43Manufacturing · Standard review	Approved	None posted
Mar 15, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Jun 4, 1987	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 15, 1986	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 8, 1984	Supplement 38Manufacturing · Standard review	Approved	None posted
Dec 13, 1982	Supplement 36Labeling	Approved	Label
Mar 18, 1982	Supplement 37Manufacturing · Standard review	Approved	None posted
Mar 24, 1980	Supplement 35Labeling	Approved	None posted
Apr 17, 1979	Supplement 34Labeling	Approved	None posted
Feb 5, 1979	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 13, 1978	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 5, 1978	Supplement 31Labeling	Approved	None posted
Oct 11, 1977	Supplement 29Manufacturing · Standard review	Approved	None posted
Oct 11, 1977	Supplement 28Manufacturing · Standard review	Approved	None posted
May 27, 1977	Supplement 26Manufacturing · Standard review	Approved	None posted
May 23, 1977	Supplement 27Labeling	Approved	None posted
Jan 31, 1977	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 8, 1976	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 28, 1976	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 6, 1975	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 6, 1975	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 13, 1974	Supplement 18Labeling	Approved	None posted
Jul 18, 1974	Supplement 17	Approved	None posted
Oct 23, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11601
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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