Oxycodone And Acetaminophen

ANDA 40272, held by Duramed Pharms Barr. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40272 (Oxycodone And Acetaminophen), held by Duramed Pharms Barr, was first approved by FDA on Jun 30, 1998, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1998
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 30, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 13, 2002	Supplement 2Manufacturing	Approved	None posted
Aug 13, 2002	Supplement 3Manufacturing	Approved	None posted
Jun 29, 1999	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 40272
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