Percocet

Manages pain severe enough to require an opioid analgesic. ANDA 40330, held by Ozantri. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40330 (Percocet), held by Ozantri, was first approved by FDA on Jun 25, 1999, with 25 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1999
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve ENDOCET for use in patients for whom alternative treatment options (e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Jun 25, 1999	Original application	Approved	REMS Letter Review

Products

4 strengths and forms


Percocet325MG;2.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Percocet325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Percocet325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Percocet325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 26 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 65REMS	Approved	None posted
Dec 22, 2025	Supplement 63Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 62REMS	Approved	None posted
Apr 3, 2024	Supplement 61Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 58Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 59Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 57Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 55Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 52Labeling · Standard review	Approved	Label Medication Guide
Sep 18, 2018	Supplement 50REMS · Standard review	Approved	None posted
Dec 16, 2016	Supplement 43Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 44Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 45Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 35Labeling · Standard review	Approved	None posted
Apr 10, 2012	Supplement 31Labeling	Approved	None posted
Jun 28, 2011	Supplement 26Labeling	Approved	None posted
Nov 30, 2006	Supplement 15Labeling	Approved	Label
Mar 16, 2004	Supplement 14Labeling	Approved	None posted
Jul 31, 2002	Supplement 7Manufacturing	Approved	None posted
Oct 18, 2001	Supplement 6Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 1Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 3Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 4Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 5Manufacturing	Approved	None posted
Nov 2, 1999	Supplement 2Labeling	Approved	None posted
Jun 25, 1999	Original application	Approved	REMS Letter Review

Identifiers

Application: ANDA 40330
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