Flurbiprofen

ANDA 74411, held by Ivax Sub Teva Pharms. Flurbiprofen.

As of Nov 13, 2026, ANDA 74411 (Flurbiprofen), held by Ivax Sub Teva Pharms, was first approved by FDA on May 31, 1995, with 11 approved supplements and 0 published complete response letters.

First approved: May 31, 1995
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 31, 1995	Original application	Approved	None posted

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 11Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 9Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 10Manufacturing	Approved	None posted
Dec 20, 2000	Supplement 5Manufacturing	Approved	None posted
Dec 20, 2000	Supplement 6Manufacturing	Approved	None posted
Dec 20, 2000	Supplement 7Manufacturing	Approved	None posted
Dec 20, 2000	Supplement 8Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 4Manufacturing	Approved	None posted
Nov 23, 1999	Supplement 3Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 2Manufacturing	Approved	None posted
May 30, 1997	Supplement 1Manufacturing	Approved	None posted
May 31, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74411
Drugs@FDA: Overview at FDA
Company: IVAX 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