(contact us for more information on Rebetol)
Brand NameRebetol
Generic Nameribivarin
Marketed bySchering Plough
NDA/BLA HolderSchering Plough
NDA/BLA NumberNDA 20-903/S-042, S-043, S-044, S-045, NDA 21-546/S-001
NDA/BLA Approval Date6/3/1998, 7/29/2003
Review ClassificationPriority
REMS Approval Date11/6/2009
Class REMSNo
REMS Source Document
Boxed Warning?
Boxed Warning
Route of Administration
Mechanism of Action
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
Approval Letters


REMS Document: from FDA Approved REMS

Approval Letters: from FDA Medication Guide Website

Approved Labeling: from FDA Medication Guide Website

Medication Guide: from FDA Medication Guide Website

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