Ketoprofen

Manages rheumatoid arthritis and osteoarthritis. ANDA 74014, held by Misemer. Ketoprofen.

As of Nov 15, 2026, ANDA 74014 (Ketoprofen), held by Misemer, was first approved by FDA on Jan 29, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1993
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ORUDIS capsules USP and other treatment options before deciding to use ORUDIS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). ORUDIS is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ORUDIS is indicated for the management of pain. ORUDIS indicated for treatment of primary dysmenorrhea.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 29, 1993	Original application	Approved	None posted

Products

3 strengths and forms


Ketoprofen25MG · capsule;oral	Ketoprofen	Rx
Ketoprofen50MG · capsule;oral	Ketoprofen	Rx
Ketoprofen75MG · capsule;oral	Ketoprofen	Rx

All 11 submissions, including labeling and manufacturing supplements


Nov 22, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Sep 25, 2017	Supplement 8Manufacturing	Approved	None posted
May 9, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jan 14, 1998	Supplement 5Labeling	Approved	None posted
Jan 7, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 28, 1995	Supplement 3Manufacturing	Approved	None posted
Mar 28, 1995	Supplement 4Manufacturing	Approved	None posted
Aug 19, 1994	Supplement 1Manufacturing	Approved	None posted
Aug 19, 1994	Supplement 2Labeling	Approved	None posted
Jan 29, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74014
Drugs@FDA: Overview at FDA
Company: MISEMER

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