Drug Approval Package

Accretropin (somatropin [rDNA origin]) Injection, 5 mg/ml
Company: Cangene Corporation
Application No.: 021538
Approval Date: 1/23/2008

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: February 24, 2010

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