Drug Approval Package
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Plan B (0.75mg levonorgestrel)
Company: Duramed Research
Application No.: 21045/S011
Approval Date: 8/24/2006
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created August 29, 2006
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