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Drug Approval Package: TRUXIMA (rituximab-abbs)

Company: CELLTRION, Inc.
Application Number: 761088
Approval Date: 11/28/2018

Drugs@FDA information available about TRUXIMA

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

Other Action Letters (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Office Director Memo (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)

Date created: February 25, 2019

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®.

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