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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204237

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NDA 204237 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-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 204237
Tradename:RABEPRAZOLE SODIUM
Applicant:Breckenridge Pharm
Ingredient:rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204237
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 204237
Suppliers and Packaging for NDA: 204237
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204237 ANDA Breckenridge Pharmaceutical, Inc. 51991-683 N 51991-683-05
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204237 ANDA Breckenridge Pharmaceutical, Inc. 51991-683 N 51991-683-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Nov 18, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Fuji
Julphar
Deloitte
Farmers Insurance
McKesson
Daiichi Sankyo
AstraZeneca

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