Visitor Monitoring Drug History: ESTRACE
 
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Label and Approval History

Drug Name: ESTRACE
FDA Application No: (ANDA) 084499
Active Ingredient(s): ESTRADIOL
Company: BRISTOL MYERS SQUIBB
 
Label History
 
Labels are not available on this site for ESTRACE, (ANDA) 084499
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/25/2001 039Control Supplement  
10/5/1998 037Labeling  
7/28/1997 036Chemistry  
1/8/1997 035Labeling  
9/11/1995 034Chemistry  
1/19/1995 033Chemistry  
1/19/1995 032Chemistry  
1/19/1995 031Chemistry  
1/19/1995 030Chemistry  
5/9/1994 029Labeling  
1/12/1993 028Labeling in Effect  
8/10/1992 027Labeling  
6/30/1989 026Chemistry  
11/9/1992 024Chemistry  
11/9/1992 023Labeling  
11/9/1992 022Chemistry  
9/8/1992 021Labeling  
12/19/1985 019Chemistry  
3/10/1983 013Chemistry  
6/4/1982 012Chemistry  
7/28/1975 000Approval  
 
Therapeutic Equivalents
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