Drug Approval Package

Valtropin (somatropin [rDNA origin] 5 mg for Injection, USP)
Company:  LG Life Sciences, Ltd.
Application No.:  021905
Approval Date: 4/19/2007

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• Approval Letter(s) (PDF)
• Approvable Letter (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (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)
• Administrative Document(s) & Correspondence
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: May 27, 2009

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