Drug Approval Package
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Paxil
CR (Paroxetine Hydrochloride)
Company: Smith Kline Beecham
Application No.: 020936
Approval Date: 2/16/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF) Part 2 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: August 09, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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