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Last Updated: December 11, 2019

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Details for New Drug Application (NDA): 021636

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NDA 021636 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 021636
Tradename:ZEGERID
Applicant:Salix
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Pharmacology for NDA: 021636
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
Paragraph IV (Patent) Challenges for 021636
Tradename Dosage Ingredient NDA Submissiondate
ZEGERID FOR SUSPENSION;ORAL omeprazole; sodium bicarbonate 021636 2007-11-13
ZEGERID FOR SUSPENSION;ORAL omeprazole; sodium bicarbonate 021636 2007-08-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Jun 15, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/PACKET;1.68GM/PACKET
Approval Date:Dec 21, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021636

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

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