Drug Approval Package

Actiq (oral transmucosal fentanyl citrate)
Company:  Anesta Corporation
Application No.:  02747
Approval Date: 11/4/1998

• Approval Letter(s) (PDF) (559 KB)

• Medical Review(s)
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (2.2 MB)
  Part 3 (PDF) (2.9 MB)
  Part 4 (PDF) (2.9 MB)

• Chemistry Review(s) (PDF) (1.6 MB)

• Environmental Assessment (PDF) (1.4 MB)

• Pharmacology Review(s) (PDF) (3 MB)

• Statistical Review(s)
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (2.5 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.8 MB)

• Administrative Document(s) (PDF) (2 MB)

• Correspondence (PDF) (1.6 MB)

Date created: September 10, 2001

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.