Visitor Monitoring Drug History: ZYRTEC
 
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: ZYRTEC
FDA Application No: (NDA) 019835
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
Company: PFIZER
 
Label History
 
View the label approved on April 5, 2004 for ZYRTEC, (NDA) 019835


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
4/4/2006 020Formulation Revision Letter 
3/17/2004 016Labeling Revision Letter
Label 
10/21/2002 015Patient Population Altered Letter
Label 
9/19/2000 013Control Supplement  
2/1/2000 011Manufacturing Change or Addition  
2/25/2000 010Labeling Revision  
2/4/2000 009Package Change  
7/9/1999 008Manufacturing Change or Addition  
1/27/1999 007Manufacturing Change or Addition  
5/22/1998 006Control Supplement  
5/15/1998 005New or Modified Indication Letter
Review 
11/1/1996 004Labeling Revision  
11/14/1996 003Control Supplement  
9/23/1996 002Labeling Revision  
5/23/1996 001Control Supplement  
12/8/1995 000Approval  
 
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