BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Army
Harvard Business School
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US Department of Justice

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078964

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NDA 078964 describes RABEPRAZOLE SODIUM, which is a drug marketed by Teva Pharms Usa, Dr Reddys Labs Ltd, Breckenridge Pharm, Aurobindo Pharma Ltd, Lupin Ltd, Torrent Pharms Ltd, Kremers Urban Pharms, Amneal Pharms, and Mylan Pharms Inc, and is included in nine NDAs. It is available from seventeen suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are twenty-nine 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 NDA: 078964

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078964

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 078964

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 63187-788-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-788-30)
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 63187-788-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-788-60)

Summary 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 500+ biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Harvard Business School
US Department of Justice
Daiichi Sankyo

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