Visitor Monitoring Drug History: HALOTESTIN
 
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Label and Approval History

Drug Name: HALOTESTIN
FDA Application No: (NDA) 010611
Active Ingredient(s): FLUOXYMESTERONE
Company: PHARMACIA AND UPJOHN
 
Label History
 
Labels are not available on this site for HALOTESTIN, (NDA) 010611
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/20/1991 038Labeling Revision  
5/20/1991 037Labeling Revision  
11/2/1990 036Labeling Revision  
5/5/1989 035Expiration Date Change  
5/5/1989 034Formulation Revision  
3/5/1987 033Labeling Revision  
6/18/1984 032Labeling Revision  
6/14/1978 021Labeling Revision  
10/15/1956 000Approval  
 
Therapeutic Equivalents
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