Approval Letter (PDF)
Final Printed Labeling (PDF)
Medical Review (PDF)
Part 1, Part 2, and Part 3
Chemistry Review (PDF)
Environmental Assessment (PDF)
Pharmacology Review (PDF)
Part 1, Part 2, Part 3, and Part 4
Statistical Review(s) (PDF)
Microbiology Review (PDF)
Clinical Pharmacology Biopharmaceutics Review
Part 1 and Part 2 (PDF)
Administrative Document(s)/Correspondence (PDF)
Part 1 and Part 2
Date created: April 22, 2003
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