Nexium

Treats heartburn and other symptoms associated GERD. NDA 21153, held by Astrazeneca. Esomeprazole Magnesium.

As of Nov 14, 2026, NDA 21153 (Nexium), held by Astrazeneca, was first approved by FDA on Feb 20, 2001, with 41 approved supplements and 0 published complete response letters.

First approved: Feb 20, 2001
Review: Priority
Supplements approved: 41
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the:

Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.
Maintenance of healing of EE in adults.
Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.
Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below


Oct 11, 2006	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
Apr 28, 2006	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 24, 2004	Supplement 19Efficacy (new indication or use)	Approved	Label Letter
Feb 20, 2001	Original applicationNew active ingredient · Priority review	Approved	Letter Label Review Pediatric Written Request

Products

2 strengths and forms


NexiumEQ 20MG BASE · capsule, delayed rel pellets;oral	Esomeprazole Magnesium	RxReference drug
NexiumEQ 40MG BASE · capsule, delayed rel pellets;oral	Esomeprazole Magnesium	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 60Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 59Labeling · Standard review	Approved	Label Letter
Aug 25, 2021	Supplement 56Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 57Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 53Labeling · Standard review	Approved	Letter Label
Dec 20, 2016	Supplement 51Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 52Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 50Labeling	Approved	Label Letter
Mar 27, 2014	Supplement 46Labeling · Standard review	Approved	Label Letter
Feb 25, 2014	Supplement 49Labeling	Approved	Label Letter
Feb 14, 2014	Supplement 48Manufacturing	Approved	Review
Oct 4, 2013	Supplement 47Manufacturing	Approved	Review
Jun 17, 2013	Supplement 45Manufacturing	Approved	Review
Nov 28, 2012	Supplement 44Labeling · Standard review	Approved	Label Letter
Oct 9, 2012	Supplement 42Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 43Labeling · Standard review	Approved	Letter Label
Jan 20, 2012	Supplement 40Labeling · Standard review	Approved	Label Letter
Jun 30, 2011	Supplement 38Labeling	Approved	Label Letter
Jun 21, 2011	Supplement 35Labeling	Approved	Label Letter
Sep 3, 2010	Supplement 36Labeling	Approved	Label Letter
Mar 4, 2010	Supplement 34Labeling	Approved	Letter Label
Oct 9, 2009	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 15, 2009	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 11, 2008	Supplement 29Labeling · Standard review	Approved	Letter
Apr 27, 2007	Supplement 28Labeling	Approved	Label
Apr 27, 2007	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 11, 2006	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
Sep 26, 2006	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 15, 2006	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 28, 2006	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 16, 2006	Supplement 21Labeling · Standard review	Approved	Letter Label
Jun 6, 2005	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 24, 2004	Supplement 19Efficacy (new indication or use)	Approved	Label Letter
Apr 23, 2004	Supplement 15Labeling · Standard review	Approved	Review Label Letter
Jan 9, 2004	Supplement 8Labeling · Standard review	Approved	Review Label Letter
Feb 27, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Oct 1, 2002	Supplement 6Manufacturing	Approved	None posted
Sep 20, 2002	Supplement 5Labeling · Standard review	Approved	Review Letter
Mar 14, 2002	Supplement 3Manufacturing	Approved	None posted
May 16, 2001	Supplement 2Manufacturing	Approved	None posted
May 16, 2001	Supplement 1Manufacturing	Approved	None posted
Feb 20, 2001	Original applicationNew active ingredient · Priority review	Approved	Letter Label Review Pediatric Written Request

Identifiers

Application: NDA 21153
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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