← FDA DRUG APPROVALS

FDA NDA · NDA021849

OMEPRAZOLE AND SODIUM BICARBONATE

omeprazole, sodium bicarbonate

Sponsor: SALIX

APPLICATION
NDA021849
TYPE
NDA
ORIGINAL APPROVAL
2006-02-27
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZEGERID · ReferenceDiscontinued
OMEPRAZOLE 40MG, SODIUM BICARBONATE 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZEGERID · ReferenceDiscontinued
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2023-07-18Labeling · Supplement 20 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 19 · standard — Letter ↗AP
2021-03-16Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2020-11-27Labeling · Supplement 16 · standard — Letter ↗AP
2019-09-24Labeling · Supplement 15 · standard — Label ↗AP
2018-06-07Labeling · Supplement 14 · standard — Label ↗AP
2016-10-24Labeling · Supplement 12 · standard — Letter ↗AP
2016-06-01Manufacturing (CMC) · Supplement 11 · standardAP
2014-12-19Labeling · Supplement 10 · 901 required — Letter ↗AP
2014-02-25Labeling · Supplement 9 · 901 required — Label ↗AP
2012-11-09Labeling · Supplement 7 · standard — Letter ↗AP
2012-04-19Labeling · Supplement 8 · standard — Label ↗AP
2011-12-07Labeling · Supplement 6 · unknown — Label ↗AP
2011-05-20Labeling · Supplement 5 · unknown — Label ↗AP
2010-09-03Labeling · Supplement 4 · 901 required — Letter ↗AP
2010-01-20Labeling · Supplement 3 · standard — Letter ↗AP
2007-12-21Manufacturing (CMC) · Supplement 2 — Review ↗AP
2006-02-27Type 4 - New Combination · 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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