Drug Approval Package
Vioxx (rofecoxib) Tablets & Suspension
Company: Merck & Co., Inc.
Application No.: 21-042/S-007, S-008, S-010, S-012, S-013, S-014
& 21-052/S-004, S-005, S-006, S-007, S-008, S-009
Approval Date: 4/11/2002
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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) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Correspondence
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)
Date created: July 25, 2002
Note: Documents in PDF format require the Adobe Acrobat Reader®.







