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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022281

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NDA 022281 describes ZEGERID OTC, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ZEGERID OTC profile page.

The generic ingredient in ZEGERID OTC is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 022281
Tradename:ZEGERID OTC
Applicant:Bayer Healthcare Llc
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Suppliers and Packaging for NDA: 022281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281 NDA Bayer HealthCare LLC 11523-7265 11523-7265-1 1 BOTTLE in 1 CARTON (11523-7265-1) > 14 CAPSULE in 1 BOTTLE
ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281 NDA Bayer HealthCare LLC 11523-7265 11523-7265-3 3 BOTTLE in 1 CARTON (11523-7265-3) > 14 CAPSULE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022281
Tradename Dosage Ingredient NDA Submissiondate
ZEGERID OTC CAPSULE;ORAL omeprazole; sodium bicarbonate 022281 2010-04-20

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Dec 1, 2009TE:RLD:Yes

Expired US Patents for NDA 022281

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009   Start Trial   Start Trial
Bayer Healthcare Llc ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009   Start Trial   Start Trial
Bayer Healthcare Llc ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009   Start Trial   Start Trial
Bayer Healthcare Llc ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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