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Drug Approval Package: TROGARZO injection (ibalizumab-uiyk)

Company: TaiMed Biologics USA Corp
Application Number: 761065Orig1s000
Approval Date: March 6, 2018

Drugs@FDA information available about TROGARZO

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

Summary Review (PDF)
Officer/Employee List (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Statistical Review (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: March 30, 2018

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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