Drug Approval Package: TRIUMEQ PD

Company: VIIV Healthcare Company
Application Number: 215413
Approval Date: 3/30/2022

Drugs@FDA information available about TRIUMEQ PD

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)
• Clinical Microbiology/Virology Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: May 12, 2021

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