Drug Approval Package
Xyrem (Sodium Oxybate) Oral Solution
Company: Orphan Medical
Application No.: 21-196
Approval Date: 7/17/2002
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Approval Letter(s) (PDF)
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Medical Review(s)
Part 1 (PDF) Part 6 (PDF) Part 11 (PDF) Part 2 (PDF) Part 7 (PDF) Part 12 (PDF) Part 3 (PDF) Part 8 (PDF) Part 13 (PDF) Part 4 (PDF) Part 9 (PDF) Part 14 (PDF) Part 5 (PDF) Part 10 (PDF) Part 15 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Pharmacolgy Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: October 23, 2002
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