Drug Approval Package
Plenaxis (abarelix)
Injectable Suspension
Company: Praecis
Pharmaceuticals
Application No.: 021320
Approval Date: 11/25/2003
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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)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF)
Part 8 (PDF)
Part 9 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Statistical Review(s) (PDF)
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Administrative Document(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Correspondence (PDF)
Date created: March 082004
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