Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 40777, held by Amneal Pharms. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40777 (Oxycodone And Acetaminophen), held by Amneal Pharms, was first approved by FDA on Nov 27, 2007, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 27, 2007
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets are 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Nov 27, 2007	Original application	Approved	REMS

Products

1 strengths and forms

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

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 33REMS	Approved	None posted
Dec 29, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 30REMS	Approved	None posted
Aug 22, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Feb 23, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Feb 23, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Feb 21, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 13Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 14REMS	Approved	None posted
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Jun 29, 2011	Supplement 6Labeling	Approved	None posted
Nov 27, 2007	Original application	Approved	REMS

Identifiers

Application: ANDA 40777
Drugs@FDA: Overview at FDA
Company: Amneal 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