Drug Approval Package
Precedex
(Dexmedetomidine Hydrochloride)
Company: Abbott Laboratories
Application No.: 21-038
Approval Date: 12/17/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Part 4 (PDF) -
Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: July 26, 2001
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