Drug Approval Package

Zoladex (Goserelin Acetate Implant)
Company:  Zeneca Pharmaceuticals, Inc.
Application No.:  19-726/S-018
Approval Date: 6/27/1997

• Approval Letter(s) (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s)

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: January 18, 2006

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