Oxycet

Relieves moderate to moderately severe pain. ANDA 87463, held by Specgx LLC. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 87463 (Oxycet), held by Specgx LLC, was first approved by FDA on Dec 7, 1983, with 33 approved supplements and 0 published complete response letters.

First approved: Dec 7, 1983
Supplements approved: 33
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 34 submissions below

Date	Submission	Status	Documents
Dec 7, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycet325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 34 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 60REMS	Approved	None posted
Dec 29, 2025	Supplement 59Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 57REMS	Approved	None posted
Mar 4, 2024	Supplement 56Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 55Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 54Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 49Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 45Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 43Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 42REMS	Approved	None posted
Dec 16, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 38Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 36Labeling · Standard review	Approved	None posted
Jun 28, 2011	Supplement 34Labeling	Approved	None posted
Jul 23, 2007	Supplement 30Labeling	Approved	None posted
Oct 25, 2004	Supplement 29Labeling	Approved	None posted
Jan 9, 2003	Supplement 24Labeling	Approved	None posted
Mar 11, 1999	Supplement 20Labeling	Approved	None posted
Mar 11, 1999	Supplement 19Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 18Labeling	Approved	None posted
Dec 17, 1997	Supplement 17Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 16Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 15Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 14Manufacturing	Approved	None posted
Dec 17, 1997	Supplement 13Manufacturing	Approved	None posted
Jun 19, 1992	Supplement 12Labeling	Approved	None posted
Dec 16, 1991	Supplement 11Labeling	Approved	None posted
Feb 18, 1988	Supplement 8Manufacturing	Approved	None posted
May 20, 1986	Supplement 9Manufacturing	Approved	None posted
Feb 13, 1986	Supplement 7Manufacturing	Approved	None posted
Aug 10, 1984	Supplement 3Manufacturing	Approved	None posted
Aug 10, 1984	Supplement 2Manufacturing	Approved	None posted
Mar 29, 1984	Supplement 1Manufacturing	Approved	None posted
Dec 7, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87463
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