Triamcinolone Acetonide

ANDA 88450, held by Pharmobedient. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 88450 (Triamcinolone Acetonide), held by Pharmobedient, was first approved by FDA on Apr 1, 1985, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 1, 1985
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 1, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triamcinolone Acetonide0.025% · lotion;topical	Triamcinolone Acetonide	Rx

All 9 submissions, including labeling and manufacturing supplements


Nov 10, 2014	Supplement 13Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 9Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 10Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 11Labeling	Approved	None posted
Dec 27, 1993	Supplement 8Labeling	Approved	None posted
Feb 21, 1992	Supplement 7Labeling	Approved	None posted
May 11, 1989	Supplement 6Labeling	Approved	None posted
May 29, 1986	Supplement 2Manufacturing	Approved	None posted
Apr 1, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88450
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