Visitor Monitoring Drug History: ALLEGRA
 
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: ALLEGRA
FDA Application No: (NDA) 020872
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on October 19, 2005 for ALLEGRA, (NDA) 020872


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
10/13/2005 015New Dosage Regimen Letter
Label 
5/12/2003 011Efficacy Supplement with Clinical Data to Support Letter
Label 
10/10/2002 010Manufacturing Change or Addition  
12/10/2002 009Manufacturing Change or Addition  
2/20/2002 008Control Supplement  
7/11/2001 007Labeling Revision Letter 
1/5/2001 005Manufacturing Change or Addition  
5/30/2001 004Control Supplement Letter
Review 
5/12/2003 003Efficacy Supplement with Clinical Data to Support Letter
Label 
3/21/2000 002Package Change Letter
Review 
4/14/2000 001Manufacturing Change or Addition Letter
Review 
2/25/2000 000Approval Letter
Label
Review 
 
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