Drug Approval Package
Reyataz (atazanavir)
Capsules
Company: Bristol-Myers Squibb
Application No.: 021567
Approval Date: 6/20/2003
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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) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Correspondence (PDF)
Date created: September 9, 2003; Updated January 12, 2012
Note: Documents in PDF format require the Adobe Acrobat Reader®.