Drug Approval Package: XOFLUZA
Company: Genentech, Incorporated
Application Number: 214410
Approval Date: 8/11/2022
Application Number: 214410
Approval Date: 8/11/2022
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
- Integrated Review (PDF)
- Cross Discipline Team Leader Review (PDF)
- Clinical Microbiology/Virology Review(s) (PDF)
- Other Action Letters (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: October 03, 2022
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