← FDA DRUG APPROVALS

FDA NDA · NDA204655

NEXIUM 24HR

esomeprazole magnesium

Sponsor: ASTRAZENECA LP

APPLICATION
NDA204655
TYPE
NDA
ORIGINAL APPROVAL
2014-03-28
LATEST ACTION
2022-09-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

NEXIUM 24HR · ReferenceOver-the-counter
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2022-09-06Labeling · Supplement 18 · standard — Letter ↗AP
2020-12-04Labeling · Supplement 14 · standard — Letter ↗AP
2019-04-04Labeling · Supplement 11 · standard — Label ↗AP
2018-01-24Labeling · Supplement 9 · standard — Letter ↗AP
2017-02-03Labeling · Supplement 7 · standard — Label ↗AP
2017-01-09Labeling · Supplement 6 · standard — Letter ↗AP
2016-06-17Manufacturing (CMC) · Supplement 4 · standardAP
2015-06-23Manufacturing (CMC) · Supplement 3 · standardAP
2015-06-02Labeling · Supplement 2 · standard — Label ↗AP
2014-10-03Labeling · Supplement 1 · standard — Label ↗AP
2014-03-28Type 8 - Partial Rx to OTC Switch · Original · standard — Label ↗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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