Drug Approval Package

 Atripla (Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate) Tablets
Company: Gilead Sciences
Application No.:  021937
Approval Date: 07/12/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 132006

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