Drug Approval Package
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Vioxx
(Rofecoxib) Tablets
Company: Merck Research Laboratories
Application No.: 021042 & 021052
Approval Date: 5/20/1999
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Approval Letter(s) (PDF) (1 MB)
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Final Printed Labeling (PDF) (3 MB)
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Medical Review(s)
Part 1 (PDF) (2.4 MB) Part 15 (PDF) (3 MB) Part 29 (PDF) (2.3 MB) Part 2 (PDF) (3 MB) Part 16 (PDF) (3 MB) Part 30 (PDF) (2.1 MB) Part 3 (PDF) (3 MB) Part 17 (PDF) (3 MB) Part 31 (PDF) (3 MB) Part 4 (PDF) (3 MB) Part 18 (PDF) (3 MB) Part 32 (PDF) (3 MB) Part 5 (PDF) (3 MB) Part 19 (PDF) (3 MB) Part 33 (PDF) (3 MB) Part 6 (PDF) (2.7 MB) Part 20 (PDF) (3 MB) Part 34 (PDF) (3 MB) Part 7 (PDF) (3 MB) Part 21 (PDF) (2.9 MB) Part 35 (PDF) (3 MB) Part 8 (PDF) (3 MB) Part 22 (PDF) (2.4 MB) Part 36 (PDF) (3 MB) Part 9 (PDF) (2.7 MB) Part 23 (PDF) (2.8 MB) Part 37 (PDF) (3 MB) Part 10 (PDF) (3 MB) Part 24 (PDF) (3 MB) Part 38 (PDF) (2.7 MB) Part 11 (PDF) (2.9 MB) Part 25 (PDF) (2.8 MB) Part 39 (PDF) (3 MB) Part 12 (PDF) (2.9 MB) Part 26 (PDF) (3 MB) Part 40 (PDF) (2.9 MB) Part 13 (PDF) (3 MB) Part 27 (PDF) (2.9 MB) Part 41 (PDF) (3 MB) Part 14 (PDF) (3 MB) Part 28 (PDF) (3 MB) -
Pharmacology Review(s)
Part 1 (PDF) (3 MB) Part 6 (PDF) (2.9 MB) Part 11 (PDF) (3 MB) Part 2 (PDF) (3 MB) Part 7 (PDF) (2.5 MB) Part 12 (PDF) (2.8 MB) Part 3 (PDF) (1.7 MB) Part 8 (PDF) (2.8 MB) Part 13 (PDF) (2.8 MB) Part 4 (PDF) (2.9 MB) Part 9 (PDF) (2.7 MB) Part 14 (PDF) (2.3 MB) Part 5 (PDF) (3 MB) Part 10 (PDF) (2.8 MB) Part 15 (PDF) (2.3 MB) -
Statistical Review(s)
Part 1 (PDF) (2.6 MB) Part 5 (PDF) (2.5 MB) Part 9 (PDF) (2.5 MB) Part 2 (PDF) (2.7 MB) Part 6 (PDF) (2.3 MB) Part 10 (PDF) (2.4 MB) Part 3 (PDF) (2.5 MB) Part 7 (PDF) (2.9 MB) Part 4 (PDF) (2.4 MB) Part 8 (PDF) (2.4 MB) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) (2.8 MB) Part 5 (PDF) (2.9 MB) Part 9 (PDF) (2.6 MB) Part 2 (PDF) (3 MB) Part 6 (PDF) (2.7 MB) Part 10 (PDF) (3 MB) Part 3 (PDF) (2.8 MB) Part 7 (PDF) (3 MB) Part 11 (PDF) (2.8 MB) Part 4 (PDF) (3 MB) Part 8 (PDF) (2.5 MB) -
Administrative Document(s)/Correspondence
Part 1 (PDF) (2.5 MB) Part 6 (PDF) (2.5 MB) Part 11 (PDF) (2.8 MB) Part 2 (PDF) (2.6 MB) Part 7 (PDF) (2.2 MB) Part 12 (PDF) (2.8 MB) Part 3 (PDF) (2.8 MB) Part 8 (PDF) (2.7 MB) Part 13 (PDF) (2.7 MB) Part 4 (PDF) (2.6 MB) Part 9 (PDF) (2.6 MB) Part 14 (PDF) (2.6 MB) Part 5 (PDF) (2.8 MB) Part 10 (PDF) (3 MB)
Date created: January 18, 2006
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