Oxaprozin

ANDA 75848, held by Watson Labs. Oxaprozin.

As of Nov 13, 2026, ANDA 75848 (Oxaprozin), held by Watson Labs, was first approved by FDA on Feb 9, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 9, 2001
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
Feb 9, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 22, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jul 19, 2004	Supplement 4Labeling	Approved	None posted
Nov 7, 2002	Supplement 2Manufacturing	Approved	None posted
Jun 7, 2002	Supplement 1Manufacturing	Approved	None posted
Feb 9, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75848
Drugs@FDA: Overview at FDA
Company: Watson 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