Drug Approval Package
Uvadex (methoxsalen) Sterile Solution
Company: Therakos, Inc.
Application No.: 20-969
Approval Date: 2/25/1999
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Approval Letter & Final Printed Labeling (PDF) (2.5 MB)
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Medical Review(s)
Part 1 (PDF) (2.2 MB)
Part 2 (PDF) (2.6 MB)
Part 3 (PDF) (1.9 MB) -
Chemistry Review(s) & Environmental Assessment (PDF) (2.4 MB)
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Pharmacology Review(s)
Part 1 (PDF) (2.6 MB)
Part 2 (PDF) (2.9 MB)
Part 3 (PDF) (2.9 MB) -
Statistical Review(s) & Microbiology Review(s) (PDF) (1.7 MB)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (2.9 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (2.8 MB) -
Administrative Document(s)
Part 1 (PDF) (1.7 MB)
Part 2 (PDF) (1.6 MB) -
Correspondence (PDF) (482 KB)
Date created: March 30, 2001; last update: July 5, 2005
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