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Approval Letter (717 KB)
Medical Review(s) Part 1 (2.6 MB) Part 2 (2.8 MB)
Chemistry Review(s) (2.1 MB)
Pharmacology Review(s) Part 1 (2.7 MB) Part 2 (2.5 MB)
Statistical Review(s) (2.1 MB)
Microbiology Review(s) (858 KB)
Clinical Pharmacology Biopharmaceutics Review(s) (2.2 MB)
Administrative Document(s) Part 1 (2.2 MB) Part 2 (2.4 MB) Part 3 (2.4 MB)
Correspondence Part 1 (2 MB) Part 2 (2.2 MB) Part 3 (2.5 MB)
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Date created: March 30, 2001; last update: July 5, 2005
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