Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 203864, held by Epic Pharma LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 203864 (Oxycodone And Acetaminophen), held by Epic Pharma LLC, was first approved by FDA on Jul 2, 2018, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 2, 2018
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Jul 2, 2018	Original application	Approved	None posted

Products

3 strengths and forms


Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Dec 23, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Sep 19, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Feb 28, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Feb 26, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Sep 27, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Jul 2, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 203864
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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