Drug Approval Package

 Fosrenol (Lanthanum Carbonate) Tablets
Company:  Shire Pharmaceutical Development Inc.
Application No.:  021468
Approval Date: 10/26/2004

• Approval Letter(s) (PDF)

• Approvable Letter (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF)

• Canine Toxicology & Pharmacokinetics Studies (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Studies (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: January 282005

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