Drug Approval Package

Temodar (Temozolomide) Capsules
Company:  Schering Corporation
Application No.:  021029
Approval Date: 8/11/1999

• Approval Letter(s) & Final Printed Labeling (PDF) (2.5 MB)

• Medical Review(s)
  Part 1 (PDF) (2.5 MB)
  Part 2 (PDF) (2.8 MB)
  Part 3 (PDF) (2.6 MB)
  Part 4 (PDF) (2.7 MB)

• Chemistry Review(s) (PDF) (453 KB)

• Pharmacology Review(s)
  Part 1 (PDF) (3 MB)
  Part 2 (PDF) (3 MB)

• Statistical Review(s) & Microbiology Review(s) (PDF) (793 KB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.2 MB)

• Administrative Document(s)/Correspondence (PDF) (3 MB)

Date created: March 30, 2001

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