Diflorasone Diacetate

ANDA 75374, held by Avondale Pharms. Diflorasone Diacetate.

As of Nov 15, 2026, ANDA 75374 (Diflorasone Diacetate), held by Avondale Pharms, was first approved by FDA on Apr 27, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 27, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 27, 1999	Original application	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diflorasone Diacetate0.05% · ointment;topical	Diflorasone Diacetate	Rx

All 6 submissions, including labeling and manufacturing supplements


Nov 14, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Apr 12, 2005	Supplement 5Labeling	Approved	None posted
Oct 2, 2003	Supplement 4Labeling	Approved	None posted
Aug 19, 2003	Supplement 1Labeling	Approved	None posted
Apr 27, 1999	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 75374
Drugs@FDA: Overview at FDA
Company: Avondale 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