Visitor Monitoring Drug History: LESCOL
 
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: LESCOL
FDA Application No: (NDA) 020261
Active Ingredient(s): FLUVASTATIN SODIUM
Company: NOVARTIS
 
Label History
 
View the label approved on June 14, 2007 for LESCOL, (NDA) 020261


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
6/12/2007 039Labeling Revision Letter
Label 
3/22/2006 037Labeling Revision Letter
Label 
4/10/2006 036Patient Population Altered Letter
Label 
4/10/2006 035New Dosage Regimen Letter
Label 
1/5/2005 034Labeling Revision Letter
Label 
5/27/2003 033New or Modified Indication Letter
Label
Review 
9/6/2002 032Labeling Revision Letter
Label 
2/11/2002 031Manufacturing Change or Addition  
9/25/2001 030Labeling Revision Label 
5/23/2001 029Manufacturing Change or Addition  
10/6/2000 028Labeling Revision Letter
Label
Review 
7/26/2000 027Manufacturing Change or Addition  
12/18/2000 025New or Modified Indication Letter 
10/23/2000 024Efficacy Supplement with Clinical Data to Support Letter
Label 
10/14/1999 023Manufacturing Change or Addition  
3/8/1999 022Efficacy Supplement with Clinical Data to Support Letter
Review 
5/14/1999 021Control Supplement  
4/21/1999 020Package Change  
1/4/1999 019Labeling Revision  
3/8/1999 018New or Modified Indication Letter
Review 
8/5/1998 017Manufacturing Change or Addition  
4/23/1998 016Control Supplement  
11/20/1997 015Package Change  
4/21/1997 014Package Change Review 
6/16/1997 013Control Supplement Review 
10/1/1997 012New or Modified Indication  
10/8/1998 011Control Supplement  
4/30/1996 010Manufacturing Change or Addition Review 
2/8/1996 009Control Supplement  
12/22/1995 008Manufacturing Change or Addition  
10/17/1995 007Control Supplement  
3/20/1996 006New Dosage Regimen  
5/3/1995 005Labeling Revision  
11/10/1994 004Control Supplement Review 
11/28/1994 003Package Change Review 
3/21/1994 002Labeling Revision  
3/13/1995 001Control Supplement  
12/31/1993 000Approval  
 
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