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Drug Approval Package: Evekeo ODT

Company: Arbor Pharmaceuticals, LLC
Application Number: 209905
Approval Date: 01/30/2019

Drugs@FDA information available about Hydrocodone

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

Approval Letter (PDF)
Printed Labeling (PDF)

FDA Application Review Files

Product Quality Review(s) (PDF)
Clinical Pharmacology and Biopharmceutics Review(s) (PDF)
Clinical Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Officer/Employee List (PDF)
Other Review(s) (PDF)
Non-Clinical Review(s) (PDF)
Statistical Review (PDF)
Summary Review (PDF)

Date created: February 7, 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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