Flutex

ANDA 87376, held by Ivax Pharms. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 87376 (Flutex), held by Ivax Pharms, was first approved by FDA on Nov 1, 1988, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 1, 1988
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 1, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Flutex0.5% · ointment;topical	Triamcinolone Acetonide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 27, 1992	Supplement 1Labeling	Approved	None posted
Nov 1, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 87376
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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