Last Updated: November 8, 2026

Details for New Drug Application (NDA): 022456

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NDA 022456 describes MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Santarus and is included in one NDA. Additional details are available on the MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE is magnesium hydroxide; omeprazole; sodium bicarbonate. There is one drug master file entry for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for 022456

Tradename:	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:	Santarus
Ingredient:	magnesium hydroxide; omeprazole; sodium bicarbonate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	343MG;20MG;750MG
Approval Date:	Dec 4, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	343MG;40MG;750MG
Approval Date:	Dec 4, 2009	TE:		RLD:	No

Expired US Patents for NDA 022456

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	7,399,772	⤷ Start Trial
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	7,399,772	⤷ Start Trial
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	6,489,346	⤷ Start Trial
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	6,489,346	⤷ Start Trial
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	6,699,885	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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