← FDA DRUG APPROVALS

FDA NDA · NDA021153

NEXIUM

esomeprazole magnesium

Sponsor: ASTRAZENECA

APPLICATION
NDA021153
TYPE
NDA
ORIGINAL APPROVAL
2001-02-20
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription

Products

NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
NEXIUM · ReferencePrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2023-07-18Labeling · Supplement 60 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 59 · standard — Letter ↗AP
2021-08-25Labeling · Supplement 56 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 57 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 53 · standard — Label ↗AP
2016-12-20Labeling · Supplement 51 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 52 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 50 · 901 required — Letter ↗AP
2014-03-27Labeling · Supplement 46 · standard — Label ↗AP
2014-02-25Labeling · Supplement 49 · 901 required — Label ↗AP
2014-02-14Manufacturing (CMC) · Supplement 48 — Review ↗AP
2013-10-04Manufacturing (CMC) · Supplement 47 — Review ↗AP
2013-06-17Manufacturing (CMC) · Supplement 45 — Review ↗AP
2012-11-28Labeling · Supplement 44 · standard — Label ↗AP
2012-10-09Labeling · Supplement 42 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 43 · standard — Letter ↗AP
2012-01-20Labeling · Supplement 40 · standard — Label ↗AP
2011-06-30Labeling · Supplement 38 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 35 · unknown — Letter ↗AP
2010-09-03Labeling · Supplement 36 · unknown — Letter ↗AP
2010-03-04Labeling · Supplement 34 · unknown — Letter ↗AP
2009-10-09Labeling · Supplement 33 · standard — Label ↗AP
2009-01-15Labeling · Supplement 31 · standard — Label ↗AP
2008-01-11Labeling · Supplement 29 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 28 — Label ↗AP
2007-04-27Labeling · Supplement 27 · standard — Letter ↗AP
2006-10-11Efficacy · Supplement 23 · unknown — Letter ↗AP
2006-09-26Labeling · Supplement 25 · standard — Label ↗AP
2006-09-15Labeling · Supplement 24 · standard — Letter ↗AP
2006-04-28Efficacy · Supplement 22 · priority — Label ↗AP
2006-02-16Labeling · Supplement 21 · standard — Label ↗AP
2005-06-06Labeling · Supplement 20 · standard — Letter ↗AP
2004-11-24Efficacy · Supplement 19 · unknown — Letter ↗AP
2004-04-23Labeling · Supplement 15 · standard — Review ↗AP
2004-01-09Labeling · Supplement 8 · standard — Label ↗AP
2003-02-27Labeling · Supplement 4 · standard — Letter ↗AP
2002-10-01Manufacturing (CMC) · Supplement 6AP
2002-09-20Labeling · Supplement 5 · standard — Review ↗AP
2002-03-14Manufacturing (CMC) · Supplement 3AP
2001-05-16Manufacturing (CMC) · Supplement 2AP
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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