Drug Approval Package

CellCept (Mycophenolate Mofetil) Capsules, Tablets, Intravenus & Oral Solution
Company:  Syntex (U.S.A.) LLC
Application No.:  50-722/S005, 50-723/S005, 50-728S004 & 50-759/S006
Approval Date: 7/28/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

• Medical Review(s)(PDF)  

• Statistical Review(s)(PDF)

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence(PDF)  

Date created: November 01, 2001

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