Drug Approval Package

 Eligard (Leuprolide Acetate) Injectable Suspension
Company: Atrix Laboratories
Application No.:  021731
Approval Date: 12/14/2004

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 272006

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