Drug Approval Package

 Seroquel/Quetiapine Fumarate
Company: Zeneca Pharmaceuticals
Application # 20639
Approval Date: 9/26/1997

• Approval Letter [308 KB]
• Medical Review(s)
  • Part 1 [3 MB]
  • Part 2 [4.2 MB]
  • Part 3 [4.2 MB]
• Chemistry Review(s)/EA(Fonsi) [1.2 MB]
• Pharmacology Review(s)
  • Part 1 [3.3 MB]
  • Part 2 [4.2 MB]
  • Part 3 [4.9]
• Statistical Review(s) [2.3 MB] Statistical Review Part 2
• Administrative Documents [699 KB]

Date created: July 17, 2007

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