PegIntron Rebetol Combopack Redipen Single-dose Delivery System and Rebetol Ribavirin

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Brand NamePegIntron Rebetol Combopack Redipen Single-dose Delivery System and Rebetol Ribavirin
Generic Namepeginterferon alfa-2b,
Marketed bySchering-Plough Corp.
NDA/BLA HolderSchering
NDA/BLA NumberBLA 125196/0
NDA/BLA Approval Date6/13/2008
StatusApproved
Review ClassificationNot Applicable
REMS Approval Date6/13/2008
Class REMSNo
REMS Source Document
Boxed Warning?
Boxed Warning
Indication
Route of Administration
Mechanism of Action
Risks
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Deemed/Approved
Approval Letters

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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