BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Daiichi Sankyo
US Army

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090678

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NDA 090678 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 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 090678
Applicant:Kremers Urban Pharms
Ingredient:rabeprazole sodium
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090678
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 090678
Suppliers and Packaging for NDA: 090678
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 090678 ANDA AvKARE, Inc. 42291-722 N 42291-722-10
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 090678 ANDA Unit Dose Services 50436-0302 N 50436-0302-1

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:

US Army
Fish and Richardson
Farmers Insurance
Express Scripts
Chinese Patent Office

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