Drug Approval Package: BORTEZOMIB

Company: Dr. Reddy’s Laboratory Limited
Application Number: 206927
Approval Date: 10/04/2019

Drugs@FDA information available about BORTEZOMIB

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)
• Clinical Review(s) (PDF)
• Other Action Letters (PDF)
• Non-Clinical Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Summary Review (PDF)

Date created: February 21, 2020

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