Drug Approval Package: FLUORODOPA F18

Company: The Feinstein Institutes for Medical Research
Application Number: 200655
Approval Date: 10/10/2019

Drugs@FDA information available about FLUORODOPA F18

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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)
• Other Action Letters (PDF)
• Multi-Discipline Review (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: November 20, 2019

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