Oxycodone And Acetaminophen

Relieves moderate to moderately severe pain. ANDA 202677, held by Alvogen. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 202677 (Oxycodone And Acetaminophen), held by Alvogen, was first approved by FDA on Jul 26, 2012, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 26, 2012
Supplements approved: 13
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 relief of moderate to moderately severe pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jul 26, 2012	Original application	Approved	REMS

Products

3 strengths and forms


Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 14 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 22REMS	Approved	None posted
Dec 23, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 19REMS	Approved	None posted
Mar 13, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Mar 5, 2021	Supplement 16Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 10REMS	Approved	None posted
Dec 16, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Mar 8, 2016	Supplement 5Manufacturing	Approved	None posted
Oct 18, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Jul 26, 2012	Original application	Approved	REMS

Identifiers

Application: ANDA 202677
Drugs@FDA: Overview at FDA
Company: Alvogen

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