Flurbiprofen

ANDA 74647, held by Pliva. Flurbiprofen.

As of Nov 13, 2026, ANDA 74647 (Flurbiprofen), held by Pliva, was first approved by FDA on Apr 1, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 1, 1997
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 1, 1997	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jul 7, 2000	Supplement 1Manufacturing	Approved	None posted
Apr 1, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74647
Drugs@FDA: Overview at FDA
Company: PLIVA

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