← FDA DRUG APPROVALS

FDA NDA · NDA022101

NEXIUM

esomeprazole magnesium

Sponsor: ASTRAZENECA

APPLICATION
NDA022101
TYPE
NDA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 24 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 23 · standard — Letter ↗AP
2021-08-25Labeling · Supplement 20 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 21 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 17 · standard — Label ↗AP
2016-12-20Labeling · Supplement 15 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 16 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 14 · 901 required — Label ↗AP
2014-03-27Labeling · Supplement 12 · standard — Letter ↗AP
2014-02-25Labeling · Supplement 13 · 901 required — Label ↗AP
2012-11-28Labeling · Supplement 11 · standard — Label ↗AP
2012-10-09Labeling · Supplement 9 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 10 · standard — Letter ↗AP
2012-01-20Labeling · Supplement 8 · standard — Label ↗AP
2011-06-30Labeling · Supplement 7 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 5 · unknown — Label ↗AP
2010-09-03Labeling · Supplement 6 · unknown — Label ↗AP
2010-03-04Labeling · Supplement 4 · unknown — Label ↗AP
2009-10-09Labeling · Supplement 3 · standard — Label ↗AP
2009-01-15Labeling · Supplement 1 · standard — Label ↗AP
2008-02-27Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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