Drug Approval Package
Valstar (Valrubicin) Sterile Solution
Company: Anthra Pharmaceuticals, Inc.
Application No.: 20-892
Approval Date: 9/25/1998
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Approval Letter (PDF) (143 KB)
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Medical Review(s)
Part 1 (PDF) (1.7 MB)
Part 2 (PDF) (2.7 MB)
Part 3 (PDF) (2.5 MB)
Part 4 (PDF) (2 MB) -
Chemistry Review(s) (PDF) (403 KB)
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Pharmacology Review(s)
Part 1 (PDF) (1.4 MB)
Part 2 (PDF) (1.6 MB) -
Statistical Review(s) & Microbiology Review(s) (PDF) (1 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.1 MB)
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Administrative Document(s)/Correspondence (PDF) (783 KB)
Date created: March 30, 2001; last update: July 5, 2005
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