Diflunisal

ANDA 73679, held by Teva. Diflunisal.

As of Nov 15, 2026, ANDA 73679 (Diflunisal), held by Teva, was first approved by FDA on Jul 31, 1992, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1992
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 31, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diflunisal250MG · tablet;oral	Diflunisal	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Dec 2, 1999	Supplement 14Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 15Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 7Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 8Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 6Manufacturing	Approved	None posted
Aug 23, 1995	Supplement 4Manufacturing	Approved	None posted
May 4, 1995	Supplement 2Labeling	Approved	None posted
May 4, 1995	Supplement 5Labeling	Approved	None posted
Oct 21, 1994	Supplement 3Manufacturing	Approved	None posted
Aug 18, 1992	Supplement 1Labeling	Approved	None posted
Jul 31, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73679
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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