Drug Approval Package

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Drug Approval Package

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Fenofibrate Tablets, 40 mg, 120 mg
Company: LifeCycle Pharma A/S
NDA: 022118
Approval Date: 8/10/2007

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

Date created: October 30, 2008

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