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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Federal Trade Commission
AstraZeneca
Harvard Business School
Deloitte
Cipla
Accenture
Queensland Health

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204922

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NDA 204922 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, and Zydus Pharms Usa Inc, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 204922
Tradename:OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:Aurolife Pharma Llc
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922 ANDA Aurolife Pharma, LLC 13107-115 N 13107-115-05
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922 ANDA Aurolife Pharma, LLC 13107-115 N 13107-115-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Aug 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Aug 19, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
Daiichi Sankyo
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Colorcon
QuintilesIMS
Queensland Health
Fuji
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