Drug Approval Package

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Drug Approval Package

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Tirosint (levothyroxine sodium capsules)
Company: Institut Biochimique SA (IBSA)
NDA: 22121
Approval Date: 08/01/2007

Approval Letter(s) (PDF)
Approvable Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Administrative Document(s) and Correspondence (PDF)

Date created: Sepember 5, 2008

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