Drug Approval Package

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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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