Drug Approval Package
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Orfadin
(Nitisinone) Capsules
Company: R&R Registrations U.S. Agent for Swedish Orphan, AB
Application No.: 21-232
Approval Date: 1/18/2002
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
Date created: January 18, 2006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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