Drug Approval Package

Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40 mg and 80 mg
Company: Synthon Pharmaceuticals, Inc.
NDA: 021961
Approval Date: 10/9/2007

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)
  
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
  • Part 4 (PDF)

Date created: February 2, 2009

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