Oxaprozin

ANDA 75844, held by Sun Pharm Inds Inc. Oxaprozin.

As of Nov 13, 2026, ANDA 75844 (Oxaprozin), held by Sun Pharm Inds Inc, was first approved by FDA on Jan 3, 2002, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2002
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 3, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Aug 9, 2007	Supplement 11Labeling	Approved	None posted
Jun 19, 2007	Supplement 10Labeling	Approved	None posted
Jun 8, 2006	Supplement 9Labeling	Approved	None posted
Feb 7, 2006	Supplement 8Labeling	Approved	None posted
Mar 21, 2003	Supplement 6Labeling	Approved	None posted
Jun 12, 2002	Supplement 1Manufacturing	Approved	None posted
Jan 3, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75844
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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