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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
McKesson
Chinese Patent Office
US Department of Justice
Dow
Citi
Chubb
Cipla
Novartis

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021511

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NDA 021511 describes COPEGUS, which is a drug marketed by Roche and is included in one NDA. It is available from one supplier. Additional details are available on the COPEGUS profile page.

The generic ingredient in COPEGUS is ribavirin. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 021511
Tradename:COPEGUS
Applicant:Roche
Ingredient:ribavirin
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 021511
Ingredient-typeNucleoside Analog
Medical Subject Heading (MeSH) Categories for 021511
Suppliers and Packaging for NDA: 021511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COPEGUS ribavirin TABLET;ORAL 021511 NDA Genentech, Inc. 0004-0086 0004-0086-94 168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 3, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Jun 21, 2005TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Citi
Covington
Deloitte
UBS
US Army
Merck
Daiichi Sankyo

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