Drug Approval Package
Rezulin
(Troglitazone) Tablets
Company: Parke-Davis Pharmaceutical Research
Application No.: 020720/S12, S14
Approval Date: 9/16/1999
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Approval Letter(s) (PDF) (610 KB)
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Final Printed Labeling (PDF) (2.6 MB)
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Medical Review(s)
Part 1 (PDF) (1.7 MB)
Part 2 (PDF) (2.1 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (385 KB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (1.9 MB)
Part 2 (PDF) (2 MB)
Date created: March 30, 2001
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