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Approval Letter(s) (270 KB)
Final Printed Labeling (1.9 MB)
Medical Review(s)
Part 1 (1.7 MB)
Chemistry Review(s) & Environmental Assessment (1.9 MB)
Pharmacology Review(s) Part 1 (2.3 MB) Part 2 (2.9 MB) Part 3 (3 MB) Part 4 (2.4 MB)
Statistical Review(s) (707 KB)
Clinical Pharmacology Biopharmaceutics Review(s)
Administrative Document(s)/Correspondence Part 1 (2.7 MB) Part 2 (2.7 MB) Part 3 (2.8 MB) Part 4 (2.6 MB) Part 5 (2.5 MB)
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Date created: September 10, 2001
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