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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo

Generated: February 18, 2018

DrugPatentWatch Database Preview

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. 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 thirty-seven drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.
Summary for 021849
Applicant:Santarus Inc
Ingredient:omeprazole; sodium bicarbonate
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 E 54868-5611-0
ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-412 N 66993-412-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Feb 27, 2006TE:ABRLD:Yes

Expired US Patents for NDA 021849

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Harvard Business School

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