Visitor Monitoring Drug History: VIVELLE
 
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: VIVELLE
FDA Application No: (NDA) 020323
Active Ingredient(s): ESTRADIOL
Company: NOVARTIS
 
Label History
 
View the label approved on August 10, 2004 for VIVELLE, (NDA) 020323


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 033Labeling Revision Letter
Label 
1/22/2004 030Labeling Revision Letter
Label 
7/18/2002 029Control Supplement  
3/28/2002 028Control Supplement  
10/31/2001 027Control Supplement  
7/3/2001 026Manufacturing Change or Addition  
1/22/2004 025Labeling Revision Letter
Label 
2/1/2001 024Control Supplement  
8/16/2000 023Labeling Revision Letter
Label
Review 
10/29/1999 022Control Supplement  
2/25/2000 021Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
4/1/1999 020Control Supplement  
10/27/1998 019Manufacturing Change or Addition  
10/28/1998 018Manufacturing Change or Addition  
1/22/2004 017Labeling Revision Letter
Label 
7/23/1997 016Control Supplement  
7/22/1997 015Control Supplement  
5/29/1997 014Labeling Revision  
7/10/1996 013Control Supplement  
1/9/1997 012Control Supplement  
2/21/1996 011Manufacturing Change or Addition  
2/21/1996 010Control Supplement  
12/7/1995 009Labeling Revision  
12/11/1995 008Labeling Revision  
4/10/1996 006Manufacturing Change or Addition  
8/9/1995 005Control Supplement  
6/20/1995 004Manufacturing Change or Addition  
10/2/1995 003Labeling Revision  
6/9/1995 002Control Supplement  
3/21/1995 001Control Supplement  
10/28/1994 000Approval  
 
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