Treximet Tablets

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Brand NameTreximet Tablets
Generic Namesumatriptan succinate and naproxen sodium
Marketed byGlaxoSmithKline PLC
NDA/BLA HolderGlaxoSmithKline
NDA/BLA NumberNDA 21-926
NDA/BLA Approval Date4/15/2008
Review ClassificationStandard
REMS Approval Date4/15/2008
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
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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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