Diflorasone Diacetate

ANDA 75187, held by Avondale Pharms. Diflorasone Diacetate.

As of Nov 15, 2026, ANDA 75187 (Diflorasone Diacetate), held by Avondale Pharms, was first approved by FDA on Mar 30, 1998, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1998
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 30, 1998	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diflorasone Diacetate0.05% · cream;topical	Diflorasone Diacetate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 12, 2005	Supplement 7Labeling	Approved	None posted
Oct 2, 2003	Supplement 3Labeling	Approved	None posted
Aug 19, 2003	Supplement 1Labeling	Approved	None posted
Mar 30, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 75187
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