Diflorasone Diacetate

ANDA 76263, held by Ani Pharms. Diflorasone Diacetate.

As of Nov 15, 2026, ANDA 76263 (Diflorasone Diacetate), held by Ani Pharms, was first approved by FDA on Dec 20, 2002, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2002
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
Dec 20, 2002	Original application	Approved	None posted

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


Nov 9, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Nov 9, 2020	Supplement 10Labeling · Standard review	Approved	None posted
May 19, 2005	Supplement 3Labeling	Approved	None posted
Dec 20, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76263
Drugs@FDA: Overview at FDA
Company: ANI 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