Drug Approval Package
Rocaltrol (Calcitriol) Oral Solution & Capsules
Company: Hoffman Laroche
Application No.: 021-068 & 18044/S025
Approval Date: 11/20/1998
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Approval Letter & Final Printed Labeling (PDF) (1.6 MB)
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Medical Review(s)
Part 1 (PDF) (2.8 MB)
Part 2 (PDF) (2.8 MB) -
Chemistry Review(s) (PDF) (146 KB)
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Pharmacology Review(s)
Part 1 (PDF) (1.8 MB)
Part 2 (PDF) (2.3 MB) -
Statistical Review(s) (PDF) (591 KB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.2 MB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (1.6 MB)
Part 2 (PDF) (2 MB)
Date created: March 30, 2001; last update: July 1, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.