Visitor Monitoring Drug History: GANIRELIX ACETATE INJECTION
 
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Label and Approval History

Drug Name: GANIRELIX ACETATE INJECTION
FDA Application No: (NDA) 021057
Active Ingredient(s): GANIRELIX ACETATE
Company: ORGANON USA INC
 
Label History
 
View the label approved on July 29, 1999 for GANIRELIX ACETATE INJECTION, (NDA) 021057


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/20/2002 003Control Supplement  
5/15/2001 002Labeling Revision  
6/7/2001 001Control Supplement  
7/29/1999 000Approval Letter
Label
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