Drug Approval Package: QUVIVIQ

Company: Idorsia Pharmaceuticals Ltd.
Application Number: 214985
Approval Date: 1/7/2022

Drugs@FDA information available about QUVIVIQ

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Integrated Review (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: February 14, 2022

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