Drug Approval Package: Zejula (niraparib)

Company:  TESARO, Inc.
Application No.:  208447Orig1s000
Approval Date: March 27, 2017

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
• Officer/Employee List (PDF)
• Chemistry Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

 

Date created: April 21, 2017

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