Visitor Monitoring Drug History: ZYRTEC-D 12 HOUR
 
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Label and Approval History

Drug Name: ZYRTEC-D 12 HOUR
FDA Application No: (NDA) 021150
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Company: PFIZER
 
Label History
 
View the label approved on April 5, 2004 for ZYRTECD 12 HOUR, (NDA) 021150


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
3/17/2004 005Labeling Revision Letter
Label 
4/17/2003 002Efficacy Supplement with Clinical Data to Support Letter
Label 
2/14/2002 001Control Supplement  
8/10/2001 000Approval Letter
Label
Review 
 
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