Vimovo

NDA 22511, held by Horizon. Esomeprazole Magnesium; Naproxen.

As of Nov 15, 2026, NDA 22511 (Vimovo), held by Horizon, was first approved by FDA on Apr 30, 2010, with 26 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2010
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Jul 6, 2017	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 30, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


VimovoEQ 20MG BASE;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, delayed release;oral	Esomeprazole Magnesium; Naproxen	DiscontinuedReference drug
VimovoEQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, delayed release;oral	Esomeprazole Magnesium; Naproxen	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 30Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 18, 2023	Supplement 29Labeling · Standard review	Approved	Label Letter
Mar 4, 2022	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 28, 2021	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 22, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 6, 2017	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 19, 2015	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 25, 2015	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 17Labeling	Approved	Label Letter
Aug 27, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
May 14, 2014	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 27, 2014	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 20, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 25, 2014	Supplement 12Labeling	Approved	Label Letter
Jun 12, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 9, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 20, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
Nov 18, 2011	Supplement 1Labeling	Approved	Label Letter
Jun 21, 2011	Supplement 3Labeling	Approved	Letter Label
Jun 21, 2011	Supplement 2Labeling	Approved	Letter Label
May 20, 2011	Supplement 4Labeling	Approved	Label Letter
Apr 30, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22511
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