Oxycodone And Acetaminophen

ANDA 87406, held by Barr. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 87406 (Oxycodone And Acetaminophen), held by Barr, was first approved by FDA on Nov 2, 1981, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 2, 1981
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Nov 2, 1981	Original application	Approved	None posted

Products

1 strengths and forms

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

All 24 submissions, including labeling and manufacturing supplements


Dec 21, 1999	Supplement 37Manufacturing	Approved	None posted
May 20, 1999	Supplement 36Manufacturing	Approved	None posted
Apr 7, 1999	Supplement 35Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 34Manufacturing	Approved	None posted
Jun 26, 1997	Supplement 33Labeling	Approved	None posted
Jun 26, 1997	Supplement 32Manufacturing	Approved	None posted
Jun 26, 1997	Supplement 31Manufacturing	Approved	None posted
Jun 26, 1997	Supplement 30Manufacturing	Approved	None posted
Jun 26, 1997	Supplement 29Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 28Manufacturing	Approved	None posted
Jan 24, 1994	Supplement 27Labeling	Approved	None posted
Apr 29, 1992	Supplement 23Manufacturing	Approved	None posted
Apr 29, 1992	Supplement 22Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 26Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 24Manufacturing	Approved	None posted
Apr 22, 1991	Supplement 21Manufacturing	Approved	None posted
May 17, 1989	Supplement 20Labeling	Approved	None posted
May 13, 1988	Supplement 19Manufacturing	Approved	None posted
Mar 30, 1987	Supplement 12Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 8Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 7Manufacturing	Approved	None posted
Dec 31, 1984	Supplement 4Manufacturing	Approved	None posted
Jul 29, 1983	Supplement 3Manufacturing	Approved	None posted
Nov 2, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87406
Drugs@FDA: Overview at FDA
Company: Barr 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