Drug Approval Package
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Lovenox (enoxaparin sodium) Injection
Company: Sanofi-Aventis U.S. Inc.
NDA: 022138 and 020164/s75
Approval Date: 5/16/2007
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Medical Review(s)
- Chemistry Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s)
- Other Review(s) (PDF)
- Division Director Memo (PDF)
Date created: March 24, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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