Tylox

ANDA 88790, held by Janssen Pharms. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 88790 (Tylox), held by Janssen Pharms, was first approved by FDA on Dec 12, 1984, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1984
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 12, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tylox500MG;5MG · capsule;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jul 31, 2002	Supplement 14Manufacturing	Approved	None posted
Jul 31, 2002	Supplement 15Manufacturing	Approved	None posted
Nov 30, 2001	Supplement 16Manufacturing	Approved	None posted
Jan 24, 2001	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1998	Supplement 11Manufacturing	Approved	None posted
Jan 6, 1997	Supplement 10Manufacturing	Approved	None posted
Mar 25, 1996	Supplement 9Manufacturing	Approved	None posted
May 30, 1991	Supplement 8Labeling	Approved	None posted
Dec 12, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88790
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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