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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:
09/30/2003
Trade Name:
Floxin Otic Solution
Generic Name or Proper Name (*):
ofloxacin
Indications Studied:
Treatment of otitis externa (outer ear infection) in children 6 months of age and older
Label Changes Summary:
Dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients New dosing regimen
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Daiichi
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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