Drug Approval Package

Argatroban Injection, 100mg/mL
Company: Hikma Pharmaceuticals Co. Ltd
Application No.: 203049
Approval Date: 01/05/2012

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Environmental Assessment (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Microbiology Review (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: May 31, 2013

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