Desoximetasone

ANDA 78369, held by Fougera Pharms. Desoximetasone.

As of Nov 15, 2026, ANDA 78369 (Desoximetasone), held by Fougera Pharms, was first approved by FDA on Jun 29, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2010
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 29, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desoximetasone0.25% · cream;topical	Desoximetasone	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 14, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 13, 2014	Supplement 1Manufacturing	Approved	None posted
Jun 29, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78369
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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