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FDA NDA · NDA022056

PRILOSEC

omeprazole magnesium

Sponsor: AZURITY

APPLICATION
NDA022056
TYPE
NDA
ORIGINAL APPROVAL
2008-03-20
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PRILOSEC · ReferencePrescription
OMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
PRILOSEC · ReferencePrescription
OMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 26 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 25 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 23 · standard — Letter ↗AP
2018-08-21Labeling · Supplement 21 · standard — Label ↗AP
2018-06-07Labeling · Supplement 22 · standard — Label ↗AP
2016-12-19Labeling · Supplement 19 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 20 · standard — Letter ↗AP
2016-02-03Efficacy · Supplement 18 · standard — Label ↗AP
2014-12-19Labeling · Supplement 17 · 901 required — Label ↗AP
2014-03-27Labeling · Supplement 14 · standard — Label ↗AP
2014-02-25Labeling · Supplement 15 · 901 required — Label ↗AP
2013-05-15Labeling · Supplement 13 · standard — Letter ↗AP
2012-10-09Labeling · Supplement 11 · standard — Label ↗AP
2012-09-28Labeling · Supplement 12 · standard — Letter ↗AP
2012-01-20Labeling · Supplement 10 · unknown — Label ↗AP
2011-06-30Labeling · Supplement 7 · unknown — Label ↗AP
2011-05-20Labeling · Supplement 9 · 901 required — Label ↗AP
2011-01-20Labeling · Supplement 8 · unknown — Label ↗AP
2010-09-03Labeling · Supplement 5 · unknown — Letter ↗AP
2010-03-03Labeling · Supplement 3 · unknown — Label ↗AP
2008-12-01Labeling · Supplement 1 · standard — Letter ↗AP
2008-03-20Type 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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