← FDA DRUG APPROVALS

FDA NDA · NDA021957

NEXIUM

esomeprazole magnesium

Sponsor: ASTRAZENECA

APPLICATION
NDA021957
TYPE
NDA
ORIGINAL APPROVAL
2006-10-20
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 27 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 26 · standard — Letter ↗AP
2021-08-25Labeling · Supplement 23 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 24 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 20 · standard — Label ↗AP
2016-12-20Labeling · Supplement 18 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 19 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 17 · 901 required — Label ↗AP
2014-03-27Labeling · Supplement 15 · standard — Label ↗AP
2014-02-25Labeling · Supplement 16 · 901 required — Letter ↗AP
2012-11-28Labeling · Supplement 14 · standard — Letter ↗AP
2012-10-09Labeling · Supplement 12 · standard — Label ↗AP
2012-09-28Labeling · Supplement 13 · standard — Label ↗AP
2012-01-20Labeling · Supplement 11 · standard — Label ↗AP
2011-12-15Efficacy · Supplement 4 · priority — Label ↗AP
2011-06-30Labeling · Supplement 10 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 8 · unknown — Label ↗AP
2010-09-03Labeling · Supplement 9 · unknown — Label ↗AP
2010-03-04Labeling · Supplement 7 · unknown — Label ↗AP
2009-06-18Efficacy · Supplement 5 · priority — Label ↗AP
2009-01-15Labeling · Supplement 3 · standard — Letter ↗AP
2008-01-11Labeling · Supplement 1 · standard — Letter ↗AP
2006-10-20Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →