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Drug Approval Package: EXXUA

Company: Fabre-Kramer Pharmaceuticals, Inc.
Application Number: 021164
Approval Date: 11/22/2023

Drugs@FDA information available about EXXUA

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)
Cross Discipline Team Leader Review (PDF)
Office Director Memo (PDF)
Other Action Letters (PDF)
Multi-Discipline Review (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: November 28, 2023

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.

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