Drug Approval Package: WAKIX
Company: Harmony Biosciences, LLC
Application Number: 211150
Approval Date: 10/13/2020
Application Number: 211150
Approval Date: 10/13/2020
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Clinical Review(s) (PDF)
- Other Action Letters (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Statistical Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: June 11, 2021
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