Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate

NDA 22456, held by Santarus. Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate.

As of Nov 14, 2026, NDA 22456 (Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate), held by Santarus, was first approved by FDA on Dec 4, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2009
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 4, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate343MG;20MG;750MG · tablet;oral	Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate	Discontinued
Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate343MG;40MG;750MG · tablet;oral	Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 11, 2012	Supplement 5Labeling · Standard review	Approved	Letter Label
May 23, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
Dec 7, 2011	Supplement 4Labeling · Standard review	Approved	Label Letter
May 20, 2011	Supplement 3Labeling · Standard review	Approved	Letter
Sep 3, 2010	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 4, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22456
Drugs@FDA: Overview at FDA
Company: Santarus

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters