Roxilox

ANDA 40061, held by Roxane. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40061 (Roxilox), held by Roxane, was first approved by FDA on Jul 3, 1995, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1995
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 3, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Roxilox500MG;5MG · capsule;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 14, 2001	Supplement 8Labeling	Approved	None posted
Apr 26, 2001	Supplement 6Manufacturing	Approved	None posted
Apr 26, 2001	Supplement 7Manufacturing	Approved	None posted
Apr 22, 1999	Supplement 4Manufacturing	Approved	None posted
Mar 19, 1999	Supplement 2Manufacturing	Approved	None posted
Mar 19, 1999	Supplement 3Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 1Manufacturing	Approved	None posted
Jul 3, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 40061
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

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