Combunox

NDA 21378, held by Forest Labs. Ibuprofen; Oxycodone Hydrochloride.

As of Nov 15, 2026, NDA 21378 (Combunox), held by Forest Labs, was first approved by FDA on Nov 26, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2004
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 26, 2004	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Combunox400MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ibuprofen; Oxycodone Hydrochloride	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Sep 2, 2010	Supplement 6Labeling · Standard review	Approved	Label
Jun 20, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Mar 2, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 26, 2004	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21378
Drugs@FDA: Overview at FDA
Company: Forest 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