Drug Approval Package: Bendamustine Hydrochloride

Company: Eagle Pharmaceuticals, Inc.
Application Number: 205580
Approval Date: 05/15/2018

Drugs@FDA information available about Bendamustine Hydrochloride

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Summary Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created:March 25, 2019

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