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Approval Letter (477 KB)
Medical Review(s) Part 1 (2.7 MB) Part 2 (2.8 MB) Part 3 (2.2 MB) Part 4 (2.5 MB) Part 5 (2.9 MB) Part 6 (2.7 MB) Part 7 (2.9 MB) Part 8 (2.8 MB) Part 9 (2.6 MB) Part 10 (2.7 MB) Part 11 (2.9 MB) Part 12 (2.7 MB) Part 13 (2.3 MB)
Chemistry Review(s) (376 KB)
Environmental Assessment (801 KB)
Pharmacology Review(s) Part 1 (2.3 MB) Part 2 (2.8 MB) Part 3 (2.4 MB) Part 4 (2.1 MB) Part 5 (2.6 MB) Part 6 (2.8 MB) Part 7 (2.8 MB)
Statistical Review(s) Part 1 (2.3 MB) Part 2 (2.7 MB) Part 3 (2.9 MB)
Clinical Pharmacology Biopharmaceutics Review(s) Part 1 (2.1 MB) Part 2 (2.2 MB) Part 3 (1.9 MB)
Administrative Document(s) (945 KB)
Correspondence Part 1 (1.9 MB) Part 2 (2 MB) Part 3 (2.1 MB)
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Date created: March 30, 2001; last update: July 5, 2005
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