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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:  12/04/2000
 
Trade Name:  Claritin
 
Generic Name or Proper Name (*):  loratadine
 
Indications Studied:  Allergic rhinitis/Urticaria
 
Label Changes Summary:  Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Schering
 
Pediatric Exclusivity Granted Date:  08/14/2000
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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