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Drug Approval Package: TEMBEXA

Company: Chimerix, Inc.
Application Number: 214460Orig1s000, 214461Orig1s000
Approval Date: 6/4/2021

Drugs@FDA information available about TEMBEXA
Drugs@FDA information available about TEMBEXA

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)
Clinical Microbiology/Virology 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: January 03, 2022

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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