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Drug Approval Package: ORFADIN (nitisinone)

Company: Swedish Orphan Biovitrum AB
Application No.: 206356Orig1
Approval Date: April 22, 2016

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Cross Discipline Team Leader Review (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: December 30, 2016

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