BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Federal Trade Commission
Daiichi Sankyo

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202376

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NDA 202376 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-five suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 202376
Applicant:Torrent Pharms Ltd
Ingredient:rabeprazole sodium
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202376
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 202376
Suppliers and Packaging for NDA: 202376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 202376 ANDA Major Pharmaceuticals 0904-6375 E 0904-6375-61
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 202376 ANDA Torrent Pharmaceuticals Limited 13668-107 N 13668-107-90

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:

Chinese Patent Office
US Department of Justice

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