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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  10/21/2002
 
Trade Name:  Zyrtec
 
Generic Name or Proper Name (*):  cetirizine
 
Indications Studied:  Perennial Allergic Rhinitis & Chronic Urticaria
 
Label Changes Summary:  Extended the age range from 2 years to 6 months Information on dose, PK parameters and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  03/13/2002
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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