Drug Approval Package: PONVORY

Company: Janssen Pharmaceuticals, Inc.
Application Number: 213498
Approval Date: 3/18/2021

Drugs@FDA information available about PONVORY

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)
• Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
• Clinical Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Statistical Review(s) (PDF)
• Summary Review (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: April 16, 2021

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