Drug Approval Package: JAYPIRCA

Company: Loxo Oncology, Inc.
Application Number: 216059
Approval Date: 1/27/2023

Drugs@FDA information available about JAYPIRCA

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: February 24, 2023

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