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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
UBS
Cantor Fitzgerald
Novartis
Accenture
US Army
Moodys
Harvard Business School
Johnson and Johnson

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204228

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NDA 204228 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, and Sciegen Pharms Inc, and is included in eleven 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 204228
Tradename:OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:Ajanta Pharma Ltd
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204228
Suppliers and Packaging for NDA: 204228
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204228 ANDA Northstar Rx LLC 16714-508 N 16714-508-01
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204228 ANDA Northstar Rx LLC 16714-509 N 16714-509-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Jul 15, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Jul 15, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Argus Health
Fuji
McKesson
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Healthtrust
Teva
Moodys
Merck

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