Diflunisal

ANDA 74604, held by Ani Pharms. Diflunisal.

As of Nov 15, 2026, ANDA 74604 (Diflunisal), held by Ani Pharms, was first approved by FDA on Jun 10, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1996
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
Jun 10, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diflunisal500MG · tablet;oral	Diflunisal	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Apr 26, 2001	Supplement 1Manufacturing	Approved	None posted
Jun 10, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74604
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