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Serving leading biopharmaceutical companies globally:

Deloitte
Queensland Health
McKinsey
US Army
Moodys
Harvard Business School
Medtronic
Merck
Citi
AstraZeneca

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076885

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NDA 076885 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 076885
Tradename:RABEPRAZOLE SODIUM
Applicant:Mylan Pharms Inc
Ingredient:rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076885
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 076885
Suppliers and Packaging for NDA: 076885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076885 ANDA Mylan Pharmaceuticals Inc. 0378-6709 0378-6709-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6709-05)
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076885 ANDA Mylan Pharmaceuticals Inc. 0378-6709 0378-6709-93 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6709-93)

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 leading biopharmaceutical companies globally:

Fish and Richardson
Moodys
AstraZeneca
Queensland Health
US Army
Cerilliant
Deloitte
QuintilesIMS
US Department of Justice

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