Oxycodone And Acetaminophen

Relieves moderate to moderately severe pain. ANDA 40778, held by Amneal Pharms Ny. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40778 (Oxycodone And Acetaminophen), held by Amneal Pharms Ny, was first approved by FDA on Nov 27, 2007, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 27, 2007
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP are 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 16 submissions below

Date	Submission	Status	Documents
Nov 27, 2007	Original application	Approved	REMS

Products

2 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 35REMS	Approved	None posted
Oct 31, 2024	Supplement 32REMS	Approved	None posted
Mar 13, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 25Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 15Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 16REMS	Approved	None posted
Dec 16, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Dec 15, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Jun 29, 2011	Supplement 6Labeling	Approved	None posted
Nov 27, 2007	Original application	Approved	REMS

Identifiers

Application: ANDA 40778
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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