Drug Approval Package: Xarelto (Rivaroxaban) NDA 202439

Company: Janssen Pharmaceuticals
Application No.: 202439
Approval Date: 11/04/2011

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Environmental Assessment (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review (PDF)
• Risk Evaluation and Mitigation Strategy (PDF)
• Statistical Review (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)
• Rocket AF Reanalysis (PDF)

 

Date created: April 2, 2012
Updated: October 5, 2016

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