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FDA NDA · NDA021689

NEXIUM IV

Sponsor: ASTRAZENECA

APPLICATION
NDA021689
TYPE
NDA
ORIGINAL APPROVAL
2005-03-31
LATEST ACTION
2023-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NEXIUM IV · ReferenceDiscontinued
ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
NEXIUM IV · ReferenceDiscontinued
ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2023-07-18Labeling · Supplement 38 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 37 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 35 · standard — Letter ↗AP
2019-09-30Labeling · Supplement 34 · standard — Letter ↗AP
2018-08-10Labeling · Supplement 33 · standard — Letter ↗AP
2016-12-19Labeling · Supplement 31 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 32 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 30 · 901 required — Label ↗AP
2014-10-20Manufacturing (CMC) · Supplement 29 · standardAP
2014-03-27Labeling · Supplement 27 · standard — Letter ↗AP
2014-03-04Efficacy · Supplement 14 · priority — Review ↗AP
2014-02-25Labeling · Supplement 28 · 901 required — Letter ↗AP
2012-10-09Labeling · Supplement 25 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 26 · standard — Label ↗AP
2012-01-20Labeling · Supplement 22 · standard — Label ↗AP
2011-06-30Labeling · Supplement 20 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 16 · unknown — Label ↗AP
2011-04-29Efficacy · Supplement 17 · standard — Letter ↗AP
2010-09-03Labeling · Supplement 18 · unknown — Label ↗AP
2010-03-04Labeling · Supplement 15 · unknown — Label ↗AP
2009-01-15Labeling · Supplement 13 · standard — Letter ↗AP
2009-01-15Labeling · Supplement 12 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 8 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 11 · standard — Label ↗AP
2006-09-26Labeling · Supplement 7 · standard — Label ↗AP
2006-09-15Labeling · Supplement 6 · standard — Letter ↗AP
2006-02-16Labeling · Supplement 3 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 2 · standard — Letter ↗AP
2005-03-31Type 3 - New Dosage Form · 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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