Drug Approval Package

Lupron Depot 3-month (Leuprolide Acetate)
Company:  Tap Holdings Inc.
Application No.:  20-708/S-005
Approval Date: 2/11/1999

• Approval Letter (PDF) (706 KB)

• Medical Review(s) (PDF) (2.6 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.9 MB)

• Administrative Document(s)
  Part 1 (PDF) ( MB)
  Part 2 (PDF) ( MB)

• Correspondence (PDF) (1.2 MB)

Date created: January 25, 2002; last update: July 5, 2004

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