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AstraZeneca
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Generated: May 22, 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. 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. Fourteen 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
Medical Subject Heading (MeSH) Categories for 021511

Profile for product number 001

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

Profile for product number 002

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

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