← FDA DRUG APPROVALS

FDA NDA · NDA021636

OMEPRAZOLE AND SODIUM BICARBONATE

omeprazole, sodium bicarbonate

Sponsor: SALIX

APPLICATION
NDA021636
TYPE
NDA
ORIGINAL APPROVAL
2004-06-15
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

ZEGERID · ReferenceDiscontinued
OMEPRAZOLE 20MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
ZEGERID · ReferenceDiscontinued
OMEPRAZOLE 40MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

2023-07-18Labeling · Supplement 25 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 24 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 22 · standard — Letter ↗AP
2019-09-24Labeling · Supplement 20 · standard — Label ↗AP
2018-06-07Labeling · Supplement 19 · standard — Label ↗AP
2016-10-24Labeling · Supplement 17 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 16 · 901 required — Letter ↗AP
2014-02-25Labeling · Supplement 15 · 901 required — Label ↗AP
2013-12-20Manufacturing (CMC) · Supplement 14 · standardAP
2012-11-09Labeling · Supplement 12 · standard — Letter ↗AP
2012-04-19Labeling · Supplement 13 · standard — Letter ↗AP
2011-12-07Labeling · Supplement 11 · unknown — Letter ↗AP
2011-05-20Labeling · Supplement 10 · unknown — Letter ↗AP
2010-09-03Labeling · Supplement 9 · 901 required — Label ↗AP
2010-01-20Labeling · Supplement 8 · standard — Letter ↗AP
2004-06-15Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →