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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Moodys
US Department of Justice
McKesson
Harvard Business School
Johnson and Johnson
Citi
Dow
Federal Trade Commission

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078964

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NDA 078964 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Lannett Co Inc, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in ten NDAs. It is available from twenty-two suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 078964
Tradename:RABEPRAZOLE SODIUM
Applicant:Lupin Ltd
Ingredient:rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078964
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 078964
Suppliers and Packaging for NDA: 078964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 N 63187-788-30
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 N 63187-788-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Nov 8, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Cipla
Citi
Accenture
Queensland Health
Baxter
Merck
Mallinckrodt

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