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Details for New Drug Application (NDA): 021850

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NDA 021850 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: 021850

Tradename:
ZEGERID
Applicant:
Santarus
Ingredient:
magnesium hydroxide; omeprazole; sodium bicarbonate
Patents:4
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength700MG;20MG;600MG
Approval Date:Mar 24, 2006TE:RLD:No
Patent:6,489,346Patent Expiration:Jul 16, 2016Product Flag?YSubstance Flag?YDelist 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
Patent:6,645,988Patent Expiration:Jul 16, 2016Product Flag?YSubstance Flag?YDelist 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
Patent:6,699,885Patent Expiration:Jul 16, 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

Expired Orange Book Patents for NDA: 021850

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 20066,489,346► subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 20066,489,346► subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 20067,399,772► 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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