Oxaprozin

Relieves osteoarthritis. ANDA 75855, held by Dr Reddys Labs Ltd. Oxaprozin.

As of Nov 13, 2026, ANDA 75855 (Oxaprozin), held by Dr Reddys Labs Ltd, was first approved by FDA on Jan 31, 2001, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2001
Supplements approved: 6
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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jan 31, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Rx

All 7 submissions, including labeling and manufacturing supplements


Feb 18, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Aug 17, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Aug 17, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Sep 11, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Sep 11, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Mar 31, 2006	Supplement 5Labeling	Approved	None posted
Jan 31, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75855
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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