Drug Approval Package: TAVALISSE (fostamatinib disodium hexahydrate)
Company: Rigel Pharmaceuticals, Inc.
Application Number: 209299
Approval Date: 04/17/2018
Application Number: 209299
Approval Date: 04/17/2018
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
Date created: May 15, 2018
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®.