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FDA NDA · NDA021229

PRILOSEC OTC

omeprazole magnesium

Sponsor: ASTRAZENECA

APPLICATION
NDA021229
TYPE
NDA
ORIGINAL APPROVAL
2003-06-20
LATEST ACTION
2022-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

PRILOSEC OTC · ReferenceOver-the-counter
OMEPRAZOLE MAGNESIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2022-10-04Labeling · Supplement 35 · standard — Letter ↗AP
2020-01-30Labeling · Supplement 34 · standard — Letter ↗AP
2019-04-04Labeling · Supplement 33 · standard — Label ↗AP
2018-06-12Labeling · Supplement 32 · standard — Letter ↗AP
2018-04-03Labeling · Supplement 31 · standard — Letter ↗AP
2016-10-12Labeling · Supplement 29 · standard — Letter ↗AP
2015-06-22Labeling · Supplement 26 · standard — Letter ↗AP
2014-05-15Manufacturing (CMC) · Supplement 27 · standardAP
2013-09-06Labeling · Supplement 25 · standard — Label ↗AP
2012-09-13Labeling · Supplement 24 · standard — Letter ↗AP
2011-08-29Labeling · Supplement 23 · unknown — Letter ↗AP
2011-07-22Labeling · Supplement 21 · unknown — Letter ↗AP
2011-06-20Labeling · Supplement 20 · unknown — Letter ↗AP
2011-06-16Manufacturing (CMC) · Supplement 22 · standardAP
2011-02-25Labeling · Supplement 19 · standard — Letter ↗AP
2010-12-20Labeling · Supplement 17 · standard — Letter ↗AP
2010-07-06Labeling · Supplement 14 · unknown — Letter ↗AP
2009-09-09Labeling · Supplement 13 · standard — Letter ↗AP
2008-06-18Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2008-02-29Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2008-01-18Labeling · Supplement 8 · standard — Letter ↗AP
2007-03-19Labeling · Supplement 6 · standard — Label ↗AP
2006-10-02Labeling · Supplement 5 · standard — Label ↗AP
2004-12-20Labeling · Supplement 2 · standard — Letter ↗AP
2003-06-20Type 2 - New Active Ingredient and Type 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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