Drug Approval Package: POLIVY
Company: Genentech, Inc.
Application Number: 761121
Approval Date: 06/10/2019
Application Number: 761121
Approval Date: 06/10/2019
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
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: July 2, 2019
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