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Last Updated: December 13, 2019

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Details for New Drug Application (NDA): 021849

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NDA 021849 describes ZEGERID, which is a drug marketed by Salix, Santarus, and Bayer Healthcare Llc, 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
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 AUTHORIZED GENERIC Prasco Laboratories 66993-412 66993-412-30 30 CAPSULE in 1 BOTTLE (66993-412-30)
ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-413 66993-413-30 30 CAPSULE in 1 BOTTLE (66993-413-30)
Paragraph IV (Patent) Challenges for 021849
Tradename Dosage Ingredient NDA Submissiondate
ZEGERID CAPSULE;ORAL omeprazole; sodium bicarbonate 021849 2007-04-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:Yes

Expired US Patents for NDA 021849

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

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