Oxycodone And Acetaminophen

ANDA 40289, held by Duramed Pharms Barr. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40289 (Oxycodone And Acetaminophen), held by Duramed Pharms Barr, was first approved by FDA on Mar 16, 1999, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 16, 1999
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
Mar 16, 1999	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Acetaminophen500MG;5MG · capsule;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Apr 12, 2002	Supplement 6Manufacturing	Approved	None posted
Apr 12, 2002	Supplement 5Manufacturing	Approved	None posted
Apr 12, 2002	Supplement 4Manufacturing	Approved	None posted
Apr 12, 2002	Supplement 3Manufacturing	Approved	None posted
Aug 31, 2001	Supplement 2Manufacturing	Approved	None posted
May 20, 1999	Supplement 1Manufacturing	Approved	None posted
Mar 16, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 40289
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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