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Generated: June 23, 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 Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Lannett Co Inc, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in ten NDAs. It is available from twenty-two 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-seven 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 N 0378-6709-05
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076885 ANDA Mylan Pharmaceuticals Inc. 0378-6709 N 0378-6709-77

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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