Drug Approval Package

 Leucovorin Calcium Injection
Company:  Xanodyne Pharmacal, Inc.
Application No.:  008107
Approval Date: 2/12/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

Date created: July 132005

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