Visitor Monitoring Drug History: ESTRACE
 
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Label and Approval History

Drug Name: ESTRACE
FDA Application No: (ANDA) 081295
Active Ingredient(s): ESTRADIOL
Company: BRISTOL MYERS SQUIBB
 
Label History
 
Labels are not available on this site for ESTRACE, (ANDA) 081295
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/25/2001 011Control Supplement  
10/5/1998 009Labeling  
7/28/1997 008Chemistry  
1/8/1997 007Labeling  
10/27/1995 006Chemistry  
6/6/1995 005Chemistry  
2/2/1995 004Chemistry  
1/7/1997 003Labeling  
1/7/1997 002Chemistry  
5/9/1994 001Labeling  
6/30/1993 000Approval  
 
Therapeutic Equivalents
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