Percocet

ANDA 40341, held by Vintage Pharms LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40341 (Percocet), held by Vintage Pharms LLC, was first approved by FDA on Jul 26, 1999, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1999
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 26, 1999	Original application	Approved	Letter Review

Products

2 strengths and forms


Percocet500MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
Percocet650MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Nov 30, 2006	Supplement 13Labeling	Approved	Label
Jul 31, 2002	Supplement 9Manufacturing	Approved	None posted
Nov 21, 2001	Supplement 8Manufacturing	Approved	None posted
Oct 18, 2001	Supplement 7Manufacturing	Approved	None posted
May 18, 2000	Supplement 1Manufacturing	Approved	None posted
May 18, 2000	Supplement 2Manufacturing	Approved	None posted
May 18, 2000	Supplement 5Manufacturing	Approved	None posted
May 18, 2000	Supplement 6Manufacturing	Approved	None posted
Jan 11, 2000	Supplement 4Labeling	Approved	None posted
Nov 2, 1999	Supplement 3Labeling	Approved	None posted
Jul 26, 1999	Original application	Approved	Letter Review

Identifiers

Application: ANDA 40341
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