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Last Updated: December 11, 2025

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 are one hundred and forty-six drug master file entries 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	022456-002	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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