Roxicet

ANDA 87003, held by Hikma. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 87003 (Roxicet), held by Hikma, was first approved by FDA on Feb 25, 1980, with 32 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1980
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Feb 25, 1980	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Roxicet325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 52REMS	Approved	None posted
Dec 22, 2025	Supplement 50Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 48REMS	Approved	None posted
Mar 7, 2024	Supplement 47Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 46Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 45Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 43Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 42Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 41REMS	Approved	None posted
Dec 16, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 38Labeling · Standard review	Approved	None posted
Aug 12, 2014	Supplement 36Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 35Labeling · Standard review	Approved	None posted
Jun 28, 2011	Supplement 34Labeling	Approved	None posted
Aug 29, 2007	Supplement 27Labeling	Approved	None posted
Jun 5, 2001	Supplement 20Labeling	Approved	None posted
Mar 22, 1999	Supplement 19Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 18Manufacturing	Approved	None posted
Jun 19, 1995	Supplement 17Manufacturing	Approved	None posted
Sep 15, 1994	Supplement 14Manufacturing	Approved	None posted
Sep 23, 1993	Supplement 16Labeling	Approved	None posted
May 13, 1993	Supplement 15Labeling	Approved	None posted
May 29, 1991	Supplement 13Labeling	Approved	None posted
Feb 1, 1991	Supplement 8Manufacturing	Approved	None posted
Feb 1, 1991	Supplement 7Labeling	Approved	None posted
Feb 1, 1991	Supplement 6Manufacturing	Approved	None posted
Aug 29, 1989	Supplement 9Labeling	Approved	None posted
Oct 21, 1988	Supplement 12Manufacturing	Approved	None posted
Oct 21, 1988	Supplement 11Manufacturing	Approved	None posted
Oct 21, 1988	Supplement 10Manufacturing	Approved	None posted
Sep 1, 1982	Supplement 1Manufacturing	Approved	None posted
Mar 29, 1982	Supplement 2Manufacturing	Approved	None posted
Feb 25, 1980	Original application	Approved	REMS

Identifiers

Application: ANDA 87003
Drugs@FDA: Overview at FDA
Company: Hikma

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