Drug Approval Package: POLIVY
Company: Genentech, Inc.
Application Number: 761121
Approval Date: 4/19/2023
Application Number: 761121
Approval Date: 4/19/2023
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)
- Multi-Discipline Review (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: March 04, 2024
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