Morphine Sulfate Oral Solution

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Brand NameMorphine Sulfate Oral Solution
Generic Namemorphine sulfate
Marketed byRoxane
NDA/BLA HolderRoxane
NDA/BLA NumberNDA 22-195/S-002
NDA/BLA Approval Date3/17/2008
Review ClassificationStandard
REMS Approval Date1/25/2010
Class REMSNo
REMS Source Document
Boxed Warning?
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Medication Guide
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Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
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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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