Drug Approval Package: PHEBURANE

Company: Medunik Canada Inc.
Application Number: 216513
Approval Date: 6/17/2022

Drugs@FDA information available about PHEBURANE

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)

Date created: March 14, 2023

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