Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 211499, held by Abhai LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 211499 (Oxycodone And Acetaminophen), held by Abhai LLC, was first approved by FDA on Dec 31, 2018, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2018
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxycodone Hydrochloride and Acetaminophen Oral Solution 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 hydrochloride and acetaminophen oral solution 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
Dec 31, 2018	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Acetaminophen325MG/5ML;5MG/5ML · solution;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 16REMS	Approved	None posted
Dec 22, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 10REMS	Approved	None posted
Mar 27, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Mar 5, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 31, 2018	Original application	Approved	REMS

Identifiers

Application: ANDA 211499
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