Drug Approval Package
Hycamtin
(topotecan hydrochloride) Injection
Company: SmithKline Beecham Pharmaceuticals
Application No.: 20-671/S-004
Approval Date: 10/30/1998
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Approval Letter(s) (PDF) (733 KB)
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Medical Review(s)
Part 1 (PDF) (2.6 MB)
Part 2 (PDF) (2.1 MB)
Part 3 (PDF) (2.3 MB) -
Chemistry Review(s) (PDF) (463 KB)
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Statistical Review(s) (PDF) (2.9 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (891 KB)
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Administrative Document(s)/Correspondence (PDF) (3 MB)
Date created: September 10, 2001
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