Visitor Monitoring Drug History: ESTRADIOL
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: ESTRADIOL
FDA Application No: (NDA) 020538
Active Ingredient(s): ESTRADIOL
Company: NOVARTIS
 
Label History
 
View the label approved on August 10, 2004 for ESTRADIOL, (NDA) 020538


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
8/6/2004 024Labeling Revision Letter
Label 
1/28/2004 019Labeling Revision Letter
Label 
3/28/2002 017Control Supplement  
2/22/2002 016Control Supplement  
5/3/2002 015New or Modified Indication Letter
Label
Review 
5/3/2002 014Efficacy Supplement with Clinical Data to Support Letter
Label 
7/9/2001 013Manufacturing Change or Addition  
5/3/2002 012Labeling Revision Letter
Label 
9/29/2000 010Control Supplement  
10/29/1999 009Control Supplement  
3/26/1999 008Labeling Revision  
7/30/1999 007Control Supplement  
1/8/1999 006Formulation Revision Letter
Label
Review 
9/26/1997 005Manufacturing Change or Addition  
9/25/1997 004Control Supplement  
9/23/1997 003Control Supplement  
9/15/1997 002Control Supplement  
9/15/1997 001Control Supplement  
7/31/1996 000Approval  
 
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