Drug Approval Package

Aciphex Delayed Release (Rabeprazole Sodium) Tablets
Company:  Eisai Inc.
Application No.:  020973
Approval Date: 8/19/1999

• Approval Letter(s) (PDF) (944 KB)

• Medical Review(s)

  Part 1 (PDF) (3 MB)	Part 7 (PDF) (2.8 MB)	Part 13 (PDF) (2.7 MB)
  Part 2 (PDF) (3 MB)	Part 8 (PDF) (3 MB)	Part 14 (PDF) (2.8 MB)
  Part 3 (PDF) (3 MB)	Part 9 (PDF) (3 MB)	Part 15 (PDF) (2.6 MB)
  Part 4 (PDF) (2.9 MB)	Part 10 (PDF) (3 MB)	Part 16 (PDF) (2.6 MB)
  Part 5 (PDF) (2.9 MB)	Part 11 (PDF) (3 MB)	Part 17 (PDF) (2.9 MB)
  Part 6 (PDF) (3 MB)	Part 12 (PDF) (3 MB)

• Chemistry Review(s) (PDF) (1.3 MB)

• Pharmacology Review(s)

  Part 1 (PDF) (3 MB)	Part 6 (PDF) (2.8 MB)	Part 11 (PDF) (2.7 MB)
  Part 2 (PDF) (3 MB)	Part 7 (PDF) (3 MB)	Part 12 (PDF) (2.4 MB)
  Part 3 (PDF) (3 MB)	Part 8 (PDF) (2.7 MB)	Part 13 (PDF) (2.5 MB)
  Part 4 (PDF) (3 MB)	Part 9 (PDF) (2.7 MB)
  Part 5 (PDF) (3 MB)	Part 10 (PDF) (2.7 MB)

• Statistical Review(s)
  Part 1 (PDF) (3 MB)
  Part 2 (PDF) (3 MB)
  Part 3 (PDF) (2.6 MB)
  Part 4 (PDF) (2.7 MB)
  Part 5 (PDF) (2.7 MB)
  Part 6 (PDF) (2.2 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)

  Part 1 (PDF) (3 MB)	Part 6 (PDF) (2.8 MB)	Part 11 (PDF) (3 MB)
  Part 2 (PDF) (3 MB)	Part 7 (PDF) (2.8 MB)	Part 12 (PDF) (3 MB)
  Part 3 (PDF) (3 MB)	Part 8 (PDF) (2.7 MB)	Part 13 (PDF) (2.8 MB)
  Part 4 (PDF) (2.6 MB)	Part 9 (PDF) (2.8 MB)	Part 14 (PDF) (2.9 MB)
  Part 5 (PDF) (2.5 MB)	Part 10 (PDF) (2.9 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.9 MB)
  Part 2 (PDF) (2.6 MB)
  Part 3 (PDF) (2.1 MB)
  Part 4 (PDF) (2.5 MB)
  Part 5 (PDF) (2.4 MB)

Date created: March 30, 2001

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