Xartemis Xr

NDA 204031, held by Mallinckrodt Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 13, 2026, NDA 204031 (Xartemis Xr), held by Mallinckrodt Inc, was first approved by FDA on Mar 11, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 11, 2014
Review: Priority
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 11, 2014	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xartemis Xr325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Acetaminophen; Oxycodone Hydrochloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Sep 18, 2018	Supplement 4REMS	Approved	Letter Label Medication Guide
Sep 18, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 16, 2016	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 12, 2015	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 26, 2015	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 11, 2014	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 204031
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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