Diflunisal

ANDA 73563, held by Dastech Intl. Diflunisal.

As of Nov 15, 2026, ANDA 73563 (Diflunisal), held by Dastech Intl, was first approved by FDA on Nov 27, 1992, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1992
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
Nov 27, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diflunisal500MG · tablet;oral	Diflunisal	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 25, 1998	Supplement 3Labeling	Approved	None posted
Apr 22, 1997	Supplement 2Labeling	Approved	None posted
Aug 28, 1996	Supplement 1Manufacturing	Approved	None posted
Nov 27, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73563
Drugs@FDA: Overview at FDA
Company: Dastech International

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