Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 207510, held by Wes Pharma Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 207510 (Oxycodone And Acetaminophen), held by Wes Pharma Inc, was first approved by FDA on Mar 21, 2018, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 21, 2018
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, 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, 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 13 submissions below

Date	Submission	Status	Documents
Mar 21, 2018	Original application	Approved	REMS

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 13 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 15REMS	Approved	None posted
Dec 29, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 13REMS	Approved	None posted
Mar 13, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Mar 13, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Mar 21, 2018	Original application	Approved	REMS

Identifiers

Application: ANDA 207510
Drugs@FDA: Overview at FDA
Company: WES Pharma Inc

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