Details for New Drug Application (NDA): 021849

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NDA 021849 describes ZEGERID, which is a drug marketed by Salix, Santarus, and Riley Consumer, and is included in five NDAs. It is available from three suppliers. Additional details are available on the ZEGERID profile page.

The generic ingredient in ZEGERID 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 021849

Tradename:	ZEGERID
Applicant:	Salix
Ingredient:	omeprazole; sodium bicarbonate
Patents:	0

Pharmacology for NDA: 021849

Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 021849

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA	Santarus, Inc..	68012-102	68012-102-30	30 CAPSULE in 1 BOTTLE (68012-102-30)
ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA	Santarus, Inc..	68012-104	68012-104-05	5 CAPSULE in 1 BOTTLE (68012-104-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG;1.1GM
Approval Date:	Feb 27, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	40MG;1.1GM
Approval Date:	Feb 27, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021849

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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