Manages rheumatoid arthritis and osteoarthritis. ANDA 75679, held by Mylan. Ketoprofen.
As of Nov 15, 2026, ANDA 75679 (Ketoprofen), held by Mylan, was first approved by FDA on Feb 20, 2002, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketoprofen extended-release capsules before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 20, 2002 | Original application | Approved |
| Ketoprofen200MG · capsule, extended release;oral | Ketoprofen | Rx |
| Ketoprofen150MG · capsule, extended release;oral | Ketoprofen | Discontinued |
| Ketoprofen100MG · capsule, extended release;oral | Ketoprofen | Discontinued |
| Nov 21, 2024 | Supplement 19Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 8, 2008 | Supplement 4Labeling | Approved | None posted |
| Jul 3, 2006 | Supplement 2Labeling | Approved | None posted |
| Feb 20, 2002 | Original application | Approved |
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
