Drug Approval Package

Antagon (Ganirelix Acetate)
Company:  Organon, Inc.
Application No.:  21-057
Approval Date: 7/29/1999

• 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) (PDF)  

• Correspondence (PDF)  

Date created: April 11, 2002

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