Company: Regeneron Pharmaceuticals, Inc.
Application Number: 761181
Approval Date: 3/11/2021
Application Number: 761181
Approval Date: 3/11/2021
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)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Statistical Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: March 11, 2021
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