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Details for New Drug Application (NDA): 022283

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NDA 022283 describes ZEGERID OTC, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. 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 eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for NDA: 022283

Tradename:
ZEGERID OTC
Applicant:
Bayer Healthcare Llc
Ingredient:
omeprazole; sodium bicarbonate
Patents:3
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Jun 17, 2013TE:RLD:Yes
Patent:6,780,882Patent Expiration:Jul 15, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:5,840,737Patent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING FREQUENT HEARTBURN
Patent:7,399,772Patent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING FREQUENT HEARTBURN

Expired Orange Book Patents for NDA: 022283

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 20135,840,737► subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 20137,399,772► subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 20136,780,882► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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