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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 Santarus Inc, Santarus, and Bayer Healthcare Llc, and is included in five NDAs. It is available from four suppliers. There are seven patents protecting this drug and four Paragraph IV challenges. 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 twenty-eight drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for NDA: 021849

Tradename:
ZEGERID
Applicant:
Santarus Inc
Ingredient:
omeprazole; sodium bicarbonate
Patents:1
Formulation / Manufacturing:see details

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 Physicians Total Care, Inc. 54868-5611 54868-5611-0 30 CAPSULE in 1 BOTTLE (54868-5611-0)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:No
Patent:7,399,772Patent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:Yes
Patent:7,399,772Patent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
Patent:7,399,772Patent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER

Expired Orange Book Patents for NDA: 021849

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 20066,489,346► subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 20066,489,346► subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 20066,699,885► 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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