Ketoprofen

ANDA 73516, held by Teva. Ketoprofen.

As of Nov 15, 2026, ANDA 73516 (Ketoprofen), held by Teva, was first approved by FDA on Dec 22, 1992, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1992
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 22, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketoprofen50MG · capsule;oral	Ketoprofen	Rx

All 20 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 30Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Nov 29, 2006	Supplement 23Labeling	Approved	None posted
Mar 8, 2006	Supplement 21Labeling	Approved	None posted
Oct 24, 2001	Supplement 16Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 15Manufacturing	Approved	None posted
Jan 14, 2000	Supplement 14Manufacturing	Approved	None posted
Mar 26, 1999	Supplement 13Manufacturing	Approved	None posted
Jul 14, 1998	Supplement 12Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 9Labeling	Approved	None posted
Dec 10, 1997	Supplement 11Manufacturing	Approved	None posted
May 13, 1997	Supplement 10Manufacturing	Approved	None posted
Mar 14, 1997	Supplement 8Manufacturing	Approved	None posted
Mar 14, 1997	Supplement 7Manufacturing	Approved	None posted
Jul 31, 1995	Supplement 5Manufacturing	Approved	None posted
Feb 16, 1995	Supplement 3Manufacturing	Approved	None posted
Sep 6, 1994	Supplement 2Manufacturing	Approved	None posted
Jul 15, 1994	Supplement 1Manufacturing	Approved	None posted
Dec 22, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73516
Drugs@FDA: Overview at FDA
Company: Teva 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