Drug Approval Package

Testosterone Gel
Company:  Perrigo Israel Pharmaceuticals Ltd.
Application No.:  203098
Approval Date: 01/31/2013

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• Approval Letter(s) (PDF)
• Other Action Letters (PDF)
• Printed Labeling (PDF)
• 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)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: June 27, 2013

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