Percocet

ANDA 85106, held by Ozantri. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 85106 (Percocet), held by Ozantri, was first approved by FDA on Aug 31, 1976, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 31, 1976
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
Aug 31, 1976	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Percocet325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 35REMS	Approved	None posted
Dec 29, 2025	Supplement 34Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 33REMS	Approved	None posted
Apr 3, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 28Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 27REMS · Standard review	Approved	None posted
Dec 16, 2016	Supplement 26Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 25Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 23Labeling · Standard review	Approved	None posted
Jun 29, 2011	Supplement 22Labeling	Approved	None posted
May 16, 1994	Supplement 20Manufacturing	Approved	None posted
Apr 30, 1992	Supplement 19Manufacturing	Approved	None posted
Apr 30, 1992	Supplement 18Manufacturing	Approved	None posted
Apr 30, 1992	Supplement 17Manufacturing	Approved	None posted
Apr 30, 1992	Supplement 16Labeling	Approved	None posted
Apr 30, 1992	Supplement 15Labeling	Approved	None posted
Mar 10, 1988	Supplement 14Manufacturing	Approved	None posted
Mar 10, 1988	Supplement 13Manufacturing	Approved	None posted
Mar 3, 1988	Supplement 11Manufacturing	Approved	None posted
Aug 31, 1976	Original application	Approved	REMS

Identifiers

Application: ANDA 85106
Drugs@FDA: Overview at FDA
Company: Ozantri

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