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FDA NDA · NDA021850

ZEGERID

Sponsor: SANTARUS

APPLICATION
NDA021850
TYPE
NDA
ORIGINAL APPROVAL
2006-03-24
LATEST ACTION
2010-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

ZEGERIDDiscontinued
MAGNESIUM HYDROXIDE 700MG, OMEPRAZOLE 20MG, SODIUM BICARBONATE 600MG · TABLET, CHEWABLE · ORAL
ZEGERIDDiscontinued
MAGNESIUM HYDROXIDE 700MG, OMEPRAZOLE 40MG, SODIUM BICARBONATE 600MG · TABLET, CHEWABLE · ORAL

Approval history

2010-09-03Labeling · Supplement 3 · standard — Label ↗AP
2010-01-20Labeling · Supplement 2 · standard — Label ↗AP
2006-03-24Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗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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