Drug Approval Package

 Metadate CD (Methylphenidate HCI) Extended-Release Capsules
Company:  Celltech Pharmaceuticals, Inc.
Application No.:  021259
Approval Date: 4/30/2001

• 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)
  Part 1 (PDF)  
  Part 2 (PDF)     

• Administrative Document(s) & Correspondence (PDF)

Date created: April 04, 2002

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