Oxycodone And Acetaminophen

Manages pain severe enough to require an opioid analgesic. ANDA 40545, held by Specgx LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40545 (Oxycodone And Acetaminophen), held by Specgx LLC, was first approved by FDA on Jun 30, 2004, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2004
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxycodone and acetaminophen tablets are 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 ( see WARNINGS ), reserve opioid analgesics, including oxycodone and acetaminophen tablets, 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 17 submissions below

Date	Submission	Status	Documents
Jun 30, 2004	Original application	Approved	REMS

Products

2 strengths and forms


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

All 17 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 31REMS	Approved	None posted
Dec 29, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 28REMS	Approved	None posted
Mar 4, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 21Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 16Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 15REMS	Approved	None posted
Dec 16, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Jun 28, 2011	Supplement 7Labeling	Approved	None posted
Jan 26, 2008	Supplement 4Manufacturing	Approved	None posted
Jul 23, 2007	Supplement 3Labeling	Approved	None posted
Oct 25, 2004	Supplement 2Labeling	Approved	None posted
Jun 30, 2004	Original application	Approved	REMS

Identifiers

Application: ANDA 40545
Drugs@FDA: Overview at FDA
Company: SpecGx

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