Drug Approval Package: PEDMARK

Company: Fennec Pharmaceuticals, Inc.
Application Number: 212937
Approval Date: 9/20/2022

Drugs@FDA information available about PEDMARK

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)
• Administrative and Correspondence Documents (PDF)

Date created: May 31, 2023

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®.