Drug Approval Package

Ritalin LA (Methylphenidate Hydrochloride) Extended-Release Capsules
Company:  Novartis Pharmaceuticals Corporation
Application No.:  21-284
Approval Date: 6/5/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review Part 1 (PDF)  

• Chemistry Review Part 2 (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: May 13, 2005

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