Drug Approval Package

Jalyn (dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg)
Company: GlaxoSmithKline LLC
Application No.: 022460
Approval Date: 06/14/2010

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader 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 3, 2011

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