Drug Approval Package: Balversa (erdafinitib)
Company: Janssen Biotech, Inc.
Application Number: 212018
Approval Date: 04/12/2019
Application Number: 212018
Approval Date: 04/12/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
Date created: May 9, 2019
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