Oxaprozin

ANDA 75843, held by Actavis Elizabeth. Oxaprozin.

As of Nov 13, 2026, ANDA 75843 (Oxaprozin), held by Actavis Elizabeth, was first approved by FDA on Oct 3, 2001, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2001
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 3, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 18, 2003	Supplement 3Labeling	Approved	None posted
Mar 13, 2002	Supplement 1Manufacturing	Approved	None posted
Oct 3, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75843
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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