Drug Approval Package

Concerta (methylphenidate HCI) Extended-Release Tablets
Company:  Alza Corporation
Application No.:  21-121
Approval Date: 8/1/00

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

• Medical Review(s)(PDF)  

• Chemistry Review(s)(PDF)  

• Pharmacology Review(s)

• Statistical Review(s)(PDF)  

• Microbiology Review(s)(PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s) & Correspondence(PDF)  

Date created: June 18, 2001

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.