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Approval Letter(s) (559 KB)
Medical Review(s) Part 1 (2.6 MB) Part 2 (2.2 MB) Part 3 (2.9 MB) Part 4 (2.9 MB)
Chemistry Review(s) (1.6 MB)
Environmental Assessment (1.4 MB)
Pharmacology Review(s) (3 MB)
Statistical Review(s) Part 1 (2.6 MB) Part 2 (2.5 MB)
Clinical Pharmacology Biopharmaceutics Review(s) (2.8 MB)
Administrative Document(s) (2 MB)
Correspondence (1.6 MB)
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Date created: September 10, 2001
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FDA/Center for Drug Evaluation and Research
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