Nexium

Treats heartburn and other symptoms associated GERD. NDA 21957, held by Astrazeneca. Esomeprazole Magnesium.

As of Nov 15, 2026, NDA 21957 (Nexium), held by Astrazeneca, was first approved by FDA on Oct 20, 2006, with 22 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2006
Review: Standard
Supplements approved: 22
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 23 submissions below


Dec 15, 2011	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 18, 2009	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Oct 20, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

4 strengths and forms


NexiumEQ 20MG BASE/PACKET · for suspension, delayed release;oral	Esomeprazole Magnesium	RxReference drug
NexiumEQ 40MG BASE/PACKET · for suspension, delayed release;oral	Esomeprazole Magnesium	RxReference drug
NexiumEQ 2.5MG BASE/PACKET · for suspension, delayed release;oral	Esomeprazole Magnesium	RxReference drug
NexiumEQ 5MG BASE/PACKET · for suspension, delayed release;oral	Esomeprazole Magnesium	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 27Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Aug 25, 2021	Supplement 23Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 20, 2016	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 17Labeling	Approved	Label Letter
Mar 27, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Feb 25, 2014	Supplement 16Labeling	Approved	Label Letter
Nov 28, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 9, 2012	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 20, 2012	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 15, 2011	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 30, 2011	Supplement 10Labeling	Approved	Label Letter
Jun 21, 2011	Supplement 8Labeling	Approved	Label Letter
Sep 3, 2010	Supplement 9Labeling	Approved	Label Letter
Mar 4, 2010	Supplement 7Labeling	Approved	Letter Label
Jun 18, 2009	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 15, 2009	Supplement 3Labeling · Standard review	Approved	Letter Label
Jan 11, 2008	Supplement 1Labeling · Standard review	Approved	Letter
Oct 20, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21957
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