Drug Approval Package: HETLIOZ LQ

Company: Vanda Pharmaceuticals Inc.
Application Number: 214517
Approval Date: 12/01/2020

Drugs@FDA information available about HETLIOZ LQ

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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)
• Multi-Discipline Review (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: July 19, 2021

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