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FDA NDA · NDA021706

ZEGERID

Sponsor: SANTARUS

APPLICATION
NDA021706
TYPE
NDA
ORIGINAL APPROVAL
2004-12-21
LATEST ACTION
2004-12-21
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

ZEGERID · ReferenceDiscontinued
OMEPRAZOLE 40MG/PACKET, SODIUM BICARBONATE 1.68GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2004-12-21Type 6 - New Indication (no longer used) · 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.

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