Ketoprofen

ANDA 74879, held by Alkermes Gainesville. Ketoprofen.

As of Nov 15, 2026, ANDA 74879 (Ketoprofen), held by Alkermes Gainesville, was first approved by FDA on Dec 10, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1997
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 10, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketoprofen200MG · capsule, extended release;oral	Ketoprofen	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 18, 2002	Supplement 7Manufacturing	Approved	None posted
Sep 25, 2000	Supplement 3Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 2Manufacturing	Approved	None posted
Sep 8, 1998	Supplement 1Manufacturing	Approved	None posted
Dec 10, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74879
Drugs@FDA: Overview at FDA
Company: Alkermes Gainesville

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