← FDA DRUG APPROVALS

FDA NDA · NDA022456

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Sponsor: SANTARUS

APPLICATION
NDA022456
TYPE
NDA
ORIGINAL APPROVAL
2009-12-04
LATEST ACTION
2012-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATEDiscontinued
MAGNESIUM HYDROXIDE 343MG, OMEPRAZOLE 40MG, SODIUM BICARBONATE 750MG · TABLET · ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATEDiscontinued
MAGNESIUM HYDROXIDE 343MG, OMEPRAZOLE 20MG, SODIUM BICARBONATE 750MG · TABLET · ORAL

Approval history

2012-12-11Labeling · Supplement 5 · standard — Label ↗AP
2012-05-23Labeling · Supplement 6 · standard — Label ↗AP
2011-12-07Labeling · Supplement 4 · standard — Label ↗AP
2011-05-20Labeling · Supplement 3 · standard — Letter ↗AP
2010-09-03Labeling · Supplement 2 · standard — Label ↗AP
2009-12-04Type 3 - New Dosage Form · Original · standard — Label ↗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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