Drug Approval Package: Procysbi

Company: Horizon Pharma USA, Inc.
Application Number: 213491
Approval Date: 02/14/2020

Drugs@FDA information available about Procysbi

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Summary Review (PDF)
• Officer/Employee List (PDF)
• Chemistry Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)

Date created: May 29, 2019

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