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Drug Approval Package: Balversa (erdafinitib)

Company: Janssen Biotech, Inc.
Application Number: 212018
Approval Date: 04/12/2019

Drugs@FDA information available about Balversa

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

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

FDA Application Review Files

Officer/Employee List (PDF)
Multi-Discipline Review (PDF)
Chemistry Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: May 9, 2019

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.

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