Drug Approval Package: Mydayis (mixed salts of a single-entity amphetamine product)
Company: Shire Development, LLC.
Application Number: 022063
Approval Date: 06/20/2017
Application Number: 022063
Approval Date: 06/20/2017
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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
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