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Serving leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
Fish and Richardson
Merck
Deloitte
Express Scripts
UBS
Colorcon
US Army
Queensland Health

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090678

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NDA 090678 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 eighteen 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-five suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for 090678

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090678

Mechanism of ActionProton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for 090678

Suppliers and Packaging for NDA: 090678

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 090678 ANDA AvKARE, Inc. 42291-722 42291-722-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-722-10)
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 090678 ANDA Unit Dose Services 50436-0302 50436-0302-1 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-0302-1)

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 leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Accenture
US Army
Boehringer Ingelheim
Novartis
Johnson and Johnson
QuintilesIMS
Queensland Health
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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