Edluar Sublingual Tablets

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Brand NameEdluar Sublingual Tablets
Generic Namezolpidem tartrate
Marketed byOrexo AB
NDA/BLA HolderOrexo AB
NDA/BLA NumberNDA 21-997
NDA/BLA Approval Date3/13/2009
Review ClassificationNot Applicable
REMS Approval Date3/13/2009
Class REMSNo
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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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