Drug Approval Package

 Prezista (Darumavir) Tablets
Company: Tibotec, Inc.
Application No.:  021976
Approval Date: 06/23/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 062006

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