Ketoprofen

As of Nov 15, 2026, ANDA 74035 (Ketoprofen), held by Rising, was first approved by FDA on Dec 31, 1996, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1996
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
Dec 31, 1996	Original application	Approved	None posted

Products

2 strengths and forms


Ketoprofen50MG · capsule;oral	Ketoprofen	Discontinued
Ketoprofen75MG · capsule;oral	Ketoprofen	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 15Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Jan 8, 2008	Supplement 9Labeling	Approved	None posted
Jul 3, 2006	Supplement 6Labeling	Approved	None posted
Jun 26, 2002	Supplement 4Manufacturing	Approved	None posted
Feb 20, 1998	Supplement 3Labeling	Approved	None posted
Feb 5, 1998	Supplement 2Manufacturing	Approved	None posted
Jul 22, 1997	Supplement 1Labeling	Approved	None posted
Dec 31, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74035
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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