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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:
04/12/2007
Trade Name:
Altabax Ointment 1%
Generic Name or Proper Name (*):
retapamulin
Indications Studied:
Treatment of impetigo in patients 9 months of age and older
Label Changes Summary:
Safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age Studies waived in children 0-2 months of age and deferred in children 2-9 months of age New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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