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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Daiichi
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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