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Brand NameSotret
Generic Nameisotretinoin
Marketed byRanbaxy Pharmaceuticals Inc.
NDA/BLA HolderHoffman LaRoche
NDA/BLA NumberANDA 76-041, ANDA 76-503
NDA/BLA Approval Date12/24/2002, 6/20/2003
Review ClassificationNot Available
REMS Approval Date3/25/2009
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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