Drug Approval Package

 Sprycel (Dasatinib) Tablets
Company: Bristol-Myers Squibb Co.
Application No.:  021986 & 022072
Approval Date: 06/28/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 062006

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