Visitor Monitoring Drug History: LESCOL XL
 
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 XL
FDA Application No: (NDA) 021192
Active Ingredient(s): FLUVASTATIN SODIUM
Company: NOVARTIS
 
Label History
 
View the label approved on June 14, 2007 for LESCOL XL, (NDA) 021192


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 013Labeling Revision Letter
Label 
3/22/2006 012Labeling Revision Letter
Label 
4/10/2006 011Patient Population Altered Letter
Label 
4/10/2006 010New Dosage Regimen Letter
Label 
1/5/2005 008Labeling Revision Letter
Label 
5/27/2003 005New or Modified Indication Letter
Label 
9/6/2002 004Labeling Revision Letter
Label 
2/11/2002 003Manufacturing Change or Addition  
9/25/2001 002Labeling Revision Label 
9/24/2001 001Manufacturing Change or Addition  
10/6/2000 000Approval Letter
Label
Review 
 
There are no Therapeutic Equivalents
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