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Drug Approval Package: NALOXONE HYDROCHLORIDE

Company: Kaleo, Inc.
Application Number: 215457
Approval Date: 2/28/2022

Drugs@FDA information available about NALOXONE HYDROCHLORIDE

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)
Non-Clinical Review(s) (PDF)
Officer/Employee List (PDF)
Other Review(s) (PDF)
Summary Review (PDF)
Administrative and Correspondence Documents (PDF)

Date created: April 18, 2022

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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