Drug Approval Package

Avita Gel (Tretinoin Gel)
Company:  Penederm Inc.
Application No.:  20-400
Approval Date: 1/29/1998

• Approval Letter & Tenative Approval Letter (PDF) (152 MB)

• Medical Review(s)
  Part 1 (PDF) (1.7 MB)
  Part 2 (PDF) (2.4 MB)

• Chemistry Review(s) (PDF) (732 KB)

• Environmental Assessment (PDF) (828 KB)

• Pharmacology Review(s) (PDF) (2.1 MB)

• Statistical Review(s) & Microbiology Review(s) (PDF) (2.9 MB)

• Bioequivalence Review(s) (PDF) (1.5 MB)

• Administrative Document(s) (PDF) (892 KB)

• Correspondence (PDF) (2.3 MB)

Date created: March 08, 2001; last update: July 5, 2005

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