Visitor Monitoring Drug History: LEXAPRO
 
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Label and Approval History

Drug Name: LEXAPRO
FDA Application No: (NDA) 021323
Active Ingredient(s): ESCITALOPRAM OXALATE
Company: FOREST LABS
 
Label History
 
View the label approved on August 3, 2007 for LEXAPRO, (NDA) 021323


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
8/2/2007 025Labeling Revision Letter
Label 
2/18/2005 020Labeling Revision Letter 
5/20/2004 015Labeling Revision Letter 
1/11/2005 014Labeling Revision Letter 
4/8/2004 010Supplement  
12/18/2003 007Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
12/18/2003 003New or Modified Indication Letter
Label
Review 
12/13/2002 002Manufacturing Change or Addition  
8/29/2002 001Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
8/14/2002 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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