Drug Approval Package: Kanjinti

Company: Amgen, Inc.
Application Number: 761073
Approval Date: 06/13/2019

Drugs@FDA information available about Kanjinti

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Other Action Letters (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Clinical Review(s) (PDF)
• Product Quality Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)

Date created: July 18, 2019

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