Drug Approval Package

 Palladone (Hydromorphone HCI) ER Capsules
Company:  Purdue Pharma, L.P.
Application No.:  021044
Approval Date: 9/24/2004

• 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) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: November 302005

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