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Drug Approval Package: Mydayis (mixed salts of a single-entity amphetamine product)

Company: Shire Development, LLC.
Application Number: 022063
Approval Date: 06/20/2017

Drugs@FDA information available about Mydayis

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)
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)
Administrative Document(s) & Correspondence (PDF)

Date created: June 06, 2018

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

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