Flurbiprofen

ANDA 74358, held by Natco Pharma. Flurbiprofen.

As of Nov 13, 2026, ANDA 74358 (Flurbiprofen), held by Natco Pharma, was first approved by FDA on Jun 20, 1994, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 20, 1994
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
Jun 20, 1994	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


Nov 21, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Apr 17, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Apr 17, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Jan 10, 2008	Supplement 8Labeling	Approved	None posted
May 19, 2006	Supplement 5Labeling	Approved	None posted
Jul 31, 2003	Supplement 3Labeling	Approved	None posted
Jun 29, 1998	Supplement 2Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 1Manufacturing	Approved	None posted
Jun 20, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74358
Drugs@FDA: Overview at FDA
Company: Natco Pharma

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