Drug Approval Package

 Videx (Didanosine) Chewable/Dispersible Tablets, Buffered Powder for Oral Solution and Pediatric Power for Oral Solution
Company:  Bristol-Myers Squibb Co.
Application No.:  020154s029 & s030, 20155s021 & 20156s022
Approval Date: 10/28/1999

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s) (PDF)

• Statistical Review(s) (PDF)    

• Microbiology Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)  

Date created: August 4,2004

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