Roxicet

ANDA 89351, held by Hikma. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 89351 (Roxicet), held by Hikma, was first approved by FDA on Dec 3, 1986, with 31 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1986
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Dec 3, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Roxicet325MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 32 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 41REMS	Approved	None posted
Dec 22, 2025	Supplement 39Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 37REMS	Approved	None posted
Mar 14, 2024	Supplement 36Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 35Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 33Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 31Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 30Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 29REMS	Approved	None posted
Dec 16, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 26Labeling · Standard review	Approved	None posted
Jun 28, 2011	Supplement 25Labeling	Approved	None posted
Aug 29, 2007	Supplement 23Labeling	Approved	None posted
May 15, 2002	Supplement 18Manufacturing	Approved	None posted
Jun 1, 2001	Supplement 17Labeling	Approved	None posted
Dec 18, 2000	Supplement 16Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 15Manufacturing	Approved	None posted
Feb 16, 1999	Supplement 13Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 14Manufacturing	Approved	None posted
Nov 12, 1997	Supplement 11Manufacturing	Approved	None posted
Nov 12, 1997	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Sep 22, 1995	Supplement 8Manufacturing	Approved	None posted
Feb 16, 1994	Supplement 7Labeling	Approved	None posted
May 29, 1991	Supplement 6Labeling	Approved	None posted
Feb 15, 1989	Supplement 40Labeling	Approved	None posted
Feb 15, 1989	Supplement 5Labeling	Approved	None posted
Feb 15, 1989	Supplement 2Labeling	Approved	None posted
Jul 1, 1988	Supplement 4Manufacturing	Approved	None posted
Jul 1, 1988	Supplement 3Manufacturing	Approved	None posted
Dec 3, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89351
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