Bivalirudin in 0.9% Sodium Chloride, 250 mg/50 mL and 500 mg/100 mL Injection

Company:  Celerity Pharmaceuticals, LLC
Application No.:  208374
Approval Date: 12/21/2017

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

 

Date created: February 20, 2018

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