Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 40608, held by Pharmobedient. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40608 (Oxycodone And Acetaminophen), held by Pharmobedient, was first approved by FDA on Dec 30, 2005, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2005
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 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
Dec 30, 2005	Original application	Approved	REMS

Products

4 strengths and forms


Oxycodone And Acetaminophen300MG;2.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen300MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen300MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen300MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 24REMS	Approved	None posted
Dec 22, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 22REMS	Approved	None posted
Mar 12, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 13REMS	Approved	None posted
Aug 24, 2018	Supplement 12Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Jul 1, 2011	Supplement 7Labeling	Approved	None posted
Sep 25, 2007	Supplement 1Labeling	Approved	None posted
Dec 30, 2005	Original application	Approved	REMS

Identifiers

Application: ANDA 40608
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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