Details for New Drug Application (NDA): 021636

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NDA 021636 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 021636

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

Pharmacology for NDA: 021636

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

Suppliers and Packaging for NDA: 021636

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636	NDA	Santarus, Inc..	68012-052	68012-052-30	30 PACKET in 1 CARTON (68012-052-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET
ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636	NDA	Santarus, Inc..	68012-054	68012-054-03	3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	20MG/PACKET;1.68GM/PACKET
Approval Date:	Jun 15, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/PACKET;1.68GM/PACKET
Approval Date:	Dec 21, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021636

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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