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Drug Approval Package: PIFELTRO (doravirine)

Company: Merck Sharp & Dohme Corp.
Application Number: 210806 & 210807
Approval Date: 08/30/2018

Drugs@FDA information available about PIFELTRO

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

Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
Officer/Employee List (PDF)
Chemistry Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: October 9, 2018

Updated: April 25, 2019

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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