Drug Approval Package

Patanase (Olopatadine Hydrochloride) Nasal Spray
Company:  Alcon Research, Ltd.
Application No.:  021861
Approval Date: 4/15/2008

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Office Director Memo (PDF
• Other Action Letters (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
  • Part 4 (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: March 18, 2010

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