Oxycodone And Acetaminophen

ANDA 40106, held by Vintage Pharms. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40106 (Oxycodone And Acetaminophen), held by Vintage Pharms, was first approved by FDA on Jul 30, 1996, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1996
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
Jul 30, 1996	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Sep 17, 1997	Supplement 1Manufacturing	Approved	None posted
Sep 17, 1997	Supplement 2Manufacturing	Approved	None posted
Jul 30, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 40106
Drugs@FDA: Overview at FDA
Company: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

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