Flurbiprofen

As of Nov 13, 2026, ANDA 74405 (Flurbiprofen), held by Teva, was first approved by FDA on May 24, 1995, with 4 approved supplements and 0 published complete response letters.

First approved: May 24, 1995
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 24, 1995	Original application	Approved	None posted

Products

2 strengths and forms


Flurbiprofen100MG · tablet;oral	Flurbiprofen	Discontinued
Flurbiprofen50MG · tablet;oral	Flurbiprofen	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 29, 1999	Supplement 4Manufacturing	Approved	None posted
Jun 25, 1998	Supplement 1Manufacturing	Approved	None posted
Jun 25, 1998	Supplement 2Manufacturing	Approved	None posted
Jun 25, 1998	Supplement 3Manufacturing	Approved	None posted
May 24, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74405
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