Drug Approval Package: VYVGART HYTRULO
Company: Argenx BV
Application Number: 761304
Approval Date: 6/20/2023
Application Number: 761304
Approval Date: 6/20/2023
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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)
Date created: March 18, 2024
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