Duexis

NDA 22519, held by Horizon. Famotidine; Ibuprofen.

As of Nov 14, 2026, NDA 22519 (Duexis), held by Horizon, was first approved by FDA on Apr 23, 2011, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 23, 2011
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 23, 2011	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Duexis26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Famotidine; Ibuprofen	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 14Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 22, 2019	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 7, 2017	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 8, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
May 9, 2016	Supplement 9Labeling	Approved	Label Letter
Mar 4, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 31, 2013	Supplement 6Labeling	Approved	None posted
Aug 28, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 13, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 18, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 23, 2011	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22519
Drugs@FDA: Overview at FDA
Company: Horizon Therapeutics

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