Drug Approval Package: OXERVATE (cenegermin-bkbj)

Company: Dompé farmaceutici S.p.A.
Application Number: 761094
Approval Date: 08/22/2018

Drugs@FDA information available about OXERVATE

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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)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: September 20, 2018

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