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Details for New Drug Application (NDA): 022456

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NDA 022456 describes MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Santarus and is included in one NDA. There are four patents protecting this drug. Additional details are available on the MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE 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: 022456

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength343MG;20MG;750MG
Approval Date:Dec 4, 2009TE:RLD:No
Patent:6,645,988Patent Expiration:Jul 16, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,489,346Patent Expiration:Jul 16, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER
Patent:6,699,885Patent Expiration:Jul 16, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER

Expired Orange Book Patents for NDA: 022456



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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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