Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 207419, held by Ascent Pharms Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 207419 (Oxycodone And Acetaminophen), held by Ascent Pharms Inc, was first approved by FDA on Mar 22, 2017, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2017
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 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, and misuse, with opioids, which can occur at any dosage or duration, reserve Oxycodone and Acetaminophen Tablets 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 13 submissions below

Date	Submission	Status	Documents
Mar 22, 2017	Original application	Approved	REMS

Products

4 strengths and forms


Oxycodone And Acetaminophen325MG;2.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
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 21REMS	Approved	None posted
Dec 22, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 14REMS	Approved	None posted
Aug 22, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Aug 22, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Oct 29, 2018	Supplement 3Manufacturing	Approved	None posted
Sep 20, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 2REMS	Approved	None posted
Mar 22, 2017	Original application	Approved	REMS

Identifiers

Application: ANDA 207419
Drugs@FDA: Overview at FDA
Company: Ascent Pharmaceuticals, 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