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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Schering
Pediatric Exclusivity Granted Date:
08/14/2000
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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