Drug Approval Package: RETEVMO

Company: Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company.
Application Number: 213246
Approval Date: 05/08/2020

Drugs@FDA information available about RETEVMO

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)
• Multi-Discipline Review (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: August 07, 2020

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