Drug Approval Package
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DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable
Suspension
Company: Lantheus Medical Imaging
Application No.: 021064s011
Approval Date: 10/24/2011
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Other Action Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: August 14, 2012
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Note: Documents in PDF format require the Adobe Acrobat Reader®.
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