Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 204407, held by Novel Labs Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 204407 (Oxycodone And Acetaminophen), held by Novel Labs Inc, was first approved by FDA on Feb 24, 2017, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2017
Supplements approved: 10
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, 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 11 submissions below

Date	Submission	Status	Documents
Feb 24, 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 11 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 16REMS	Approved	None posted
Jan 12, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 13REMS	Approved	None posted
Mar 19, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Mar 15, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Mar 14, 2024	Supplement 9Labeling · 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 20, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 2REMS	Approved	None posted
Feb 24, 2017	Original application	Approved	REMS

Identifiers

Application: ANDA 204407
Drugs@FDA: Overview at FDA
Company: Novel Laboratories

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