Oxaprozin

Relieves osteoarthritis. ANDA 208633, held by Amneal Pharms Co. Oxaprozin.

As of Nov 13, 2026, ANDA 208633 (Oxaprozin), held by Amneal Pharms Co, was first approved by FDA on May 4, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: May 4, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA). Relief of signs and symptoms of Rheumatoid Arthritis (RA). Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 4, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 7, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Oct 7, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Oct 7, 2022	Supplement 10Labeling · Standard review	Approved	None posted
May 4, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208633
Drugs@FDA: Overview at FDA
Company: Amneal 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