Drug Approval Package: TEMIXYS (lamivudine and tenofovir disoproxil fumarate)

Company: ELC Group s.r.o., U.S. Agent for Celltrion Inc.
Application Number: 211284
Approval Date: 11/16/2018

Drugs@FDA information available about TEMIXYS

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)

Date created: December 17, 2018

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