Drug Approval Package

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Drug Approval Package

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Trilipix (fenofibric acid) Delayed Release Capsules, 45 mg, 135 mg
Company: Abbott Laboratories
Application No.: 022224
Approval Date: 12/15/2008

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

Approval Letter(s) (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Printed Labeling (PDF)
Medical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)
- Part 7 (PDF)
- Part 8 (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
Statistical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Clinical Pharmacology Biopharmaceutics Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Administrative Document(s) & Correspondence
- Part 1 (PDF)
- Part 2 (PDF)

Date created: May 28, 2009

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