Flutex

ANDA 85539, held by Ivax Pharms. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 85539 (Flutex), held by Ivax Pharms, was first approved by FDA on Jun 23, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 23, 1978
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
Jun 23, 1978	Original application	Approved	None posted

Products

3 strengths and forms


Flutex0.025% · cream;topical	Triamcinolone Acetonide	Discontinued
Flutex0.1% · cream;topical	Triamcinolone Acetonide	Discontinued
Flutex0.5% · cream;topical	Triamcinolone Acetonide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 11, 1990	Supplement 8Labeling	Approved	None posted
Jun 23, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85539
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