Flurbiprofen

ANDA 74448, held by Rising. Flurbiprofen.

As of Nov 13, 2026, ANDA 74448 (Flurbiprofen), held by Rising, was first approved by FDA on Jul 28, 1995, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1995
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 28, 1995	Original application	Approved	None posted

Products

2 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Jul 11, 2002	Supplement 8Manufacturing	Approved	None posted
Apr 19, 2002	Supplement 7Manufacturing	Approved	None posted
Mar 25, 2002	Supplement 9Manufacturing	Approved	None posted
Jul 27, 2001	Supplement 6Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 5Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 4Manufacturing	Approved	None posted
Nov 20, 2000	Supplement 2Manufacturing	Approved	None posted
May 13, 1999	Supplement 3Labeling	Approved	None posted
May 13, 1999	Supplement 1Manufacturing	Approved	None posted
Jul 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74448
Drugs@FDA: Overview at FDA
Company: Rising 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