Diflunisal

ANDA 202845, held by Heritage Pharma. Diflunisal.

As of Nov 15, 2026, ANDA 202845 (Diflunisal), held by Heritage Pharma, was first approved by FDA on Mar 8, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2012
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 8, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Diflunisal500MG · tablet;oral	Diflunisal	Rx
Diflunisal250MG · tablet;oral	Diflunisal	Rx
Diflunisal375MG · tablet;oral	Diflunisal	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Aug 16, 2024	Supplement 19Manufacturing	Approved	None posted
Apr 28, 2021	Supplement 7Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Mar 8, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202845
Drugs@FDA: Overview at FDA
Company: Heritage 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