Ketoprofen

ANDA 75270, held by Actavis Labs Fl Inc. Ketoprofen.

As of Nov 15, 2026, ANDA 75270 (Ketoprofen), held by Actavis Labs Fl Inc, was first approved by FDA on Mar 24, 1999, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 24, 1999
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
Mar 24, 1999	Original application	Approved	Letter

Products

3 strengths and forms


Ketoprofen200MG · capsule, extended release;oral	Ketoprofen	Discontinued
Ketoprofen100MG · capsule, extended release;oral	Ketoprofen	Discontinued
Ketoprofen150MG · capsule, extended release;oral	Ketoprofen	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 14Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Feb 21, 2008	Supplement 10Labeling	Approved	None posted
Sep 22, 2006	Supplement 8Labeling	Approved	None posted
Jul 3, 2006	Supplement 7Labeling	Approved	None posted
Dec 24, 2002	Supplement 3Manufacturing	Approved	None posted
Sep 20, 2002	Supplement 2Manufacturing	Approved	None posted
Feb 4, 2000	Supplement 1Manufacturing	Approved	None posted
Mar 24, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75270
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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