Drug Approval Package
Aciphex
Delayed Release (Rabeprazole Sodium) Tablets
Company: Eisai Inc.
Application No.: 020973
Approval Date: 8/19/1999
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Approval Letter(s) (PDF) (944 KB)
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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)
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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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