Drug Approval Package: ERLEADA (apalutamide)

This review package includes Clinical Study Reports as part of a pilot project. The Clinical Study Report section provides information for pivotal clinical trials, not for all studies in the application. More information

Company: Janssen Biotech
Application Number: 210951 Orig 1
Approval Date: 02/14/2018

Drugs@FDA information available about ERLEADA

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FDA Approval Letter and Labeling

Approval Letter(s) (PDF)
Printed Labeling (PDF)

FDA Application Review Files

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)

Sponsor Clinical Study Reports ARN-509-003 SPARTAN NCT # 01946204

Date created: March 19, 2018

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