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Drug Approval Package: VAFSEO

Company: Akebia Therapeutics, Inc.
Application Number: 215192
Approval Date: 3/24/2024

Drugs@FDA information available about VAFSEO

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

Product Quality Review(s) (PDF)
Integrated Review (PDF)
Other Action Letters (PDF)
Proprietary Name Review(s) (PDF)
Officer/Employee List (PDF)
Other Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Administrative and Correspondence Documents (PDF)

Date created: April 23, 2024

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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