Drug Approval Package

Rapamune (Sirolimus) Oral Solution
Company:  Wyeth-Ayerst Research
Application No.:  021083
Approval Date: 19/15/1999

• Approval Letter(s) (PDF) (523 KB)

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

• Chemistry Review(s) & Environmental Assessment (PDF) (501 KB)

• Pharmacology Review(s)
  Part 1 (PDF) (1.9 MB)
  Part 2 (PDF) (2.9 MB)
  Part 3 (PDF) (2.1 MB)
  Part 4 (PDF) (2.4 MB)

• Statistical Review(s) (PDF) (3 MB)

• Microbiology Review(s)
  Part 1 (PDF) (2 MB)
  Part 2 (PDF) (2.7 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.4 MB)
  Part 2 (PDF) (2.7 MB)
  Part 3 (PDF) (2.4 MB)
  Part 4 (PDF) (2.8 MB)

Date created: March 30, 2001

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