Drug Approval Package
Levlite (Levonorgestrel) Tablets
Company: Berlex Laboratories
Application No.: 20860
Approval Date: 7/13/1998
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Approval Letter (PDF) (179 KB)
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Medical Review(s), Chemistry Review(s) and Pharmacology Review(s) (PDF) (1.9 MB)
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Statistical Reviews(s) and Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.2 MB)
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Administrative Documents(s) and Correspondence (PDF) (3 MB)
Date created: March 30, 2001; last update: July 5, 2005
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