Drug Approval Package

 Risperdal Consta Long-Acting Injection
Company:  Johnson & Johnson Pharmaceutical Research
Application No.:  021346
Approval Date: 10/29/2003

• 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) (PDF)

• Correspondence (PDF)  

Date created: June 152005

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