Oxycodone And Acetaminophen

ANDA 210644, held by Abhai LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 210644 (Oxycodone And Acetaminophen), held by Abhai LLC, was first approved by FDA on Feb 9, 2018, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 9, 2018
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 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 hydrochloride, 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 10 submissions below

Date	Submission	Status	Documents
Feb 9, 2018	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 10 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 21REMS	Approved	None posted
Dec 22, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 15REMS	Approved	None posted
Mar 27, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Mar 5, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Feb 9, 2018	Original application	Approved	REMS

Identifiers

Application: ANDA 210644
Drugs@FDA: Overview at FDA
Company: ABHAI LLC

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