Flurbiprofen

ANDA 75058, held by Sun Pharm Inds Inc. Flurbiprofen.

As of Nov 13, 2026, ANDA 75058 (Flurbiprofen), held by Sun Pharm Inds Inc, was first approved by FDA on Apr 27, 2001, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2001
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 27, 2001	Original application	Approved	Letter

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Apr 30, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Apr 20, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Aug 9, 2007	Supplement 7Labeling	Approved	None posted
Jun 19, 2007	Supplement 6Labeling	Approved	None posted
Jun 15, 2006	Supplement 3Labeling	Approved	None posted
Apr 27, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75058
Drugs@FDA: Overview at FDA
Company: Sun 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