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Drug Approval Package: KLOXXADOTM

Company: Hikma Pharmaceuticals USA, Inc.
Application Number: 212045
Approval Date: 4/29/2021

Drugs@FDA information available about KLOXXADOTM

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 Pharmacology and Biopharmaceutics Review(s) (PDF)
Clinical Review(s) (PDF)
Other Action Letters (PDF)
Non-Clinical Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Officer/Employee List (PDF)
Other Review(s) (PDF)
Summary Review (PDF)

Date created: October 05, 2021

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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