Drug Approval Package
Evista
(Raloxifene Hydrochloride) Tablets
Company: Eli Lilly & Co.
Application No.: 020815/S003
Approval Date: 9/30/1999
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Approval Letter(s) (PDF) (591 KB)
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Final Printed Labeling
Part 1 (PDF) (2.1 MB)
Part 2 (PDF) (2.2 MB) -
Medical Review(s)
Part 1 (PDF) (2.8 MB)
Part 2 (PDF) (2.7 MB)
Part 3 (PDF) (2.9 MB)
Part 4 (PDF) (2.7 MB)
Part 5 (PDF) (2.7 MB)
Part 6 (PDF) (2.4 MB) -
Statistical Review(s) (PDF) (1.5 MB)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (2.9 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (3 MB)
Part 4 (PDF) (2.8 MB) -
Administrative Document(s)/Correspondence
Part 1 (PDF) (2.6 MB)
Part 2 (PDF) (2.6 MB)
Part 3 (PDF) (2.4 MB)
Part 4 (PDF) (2.7 MB)
Date created: June 20, 2001
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