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Harvard Business School
Farmers Insurance
US Army
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Daiichi Sankyo
Dow
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204179

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NDA 204179 describes RABEPRAZOLE SODIUM, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Kremers Urban Pharms, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nine NDAs. It is available from twenty-one 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-six suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 204179
Tradename:RABEPRAZOLE SODIUM
Applicant:Amneal Pharms
Ingredient:rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204179
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 204179
Suppliers and Packaging for NDA: 204179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204179 ANDA Unit Dose Services 50436-0724 N 50436-0724-1
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204179 ANDA Amneal Pharmaceuticals LLC 65162-724 N 65162-724-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Jul 31, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Cipla
Deloitte
Federal Trade Commission
Fish and Richardson
Harvard Business School
Argus Health
Cantor Fitzgerald

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