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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:  04/29/2016
 
Trade Name:  Otovel Otic Solution
 
Generic Name or Proper Name (*):  ciprofloxacin and fluocinolone acetonide
 
Indications Studied:  Treatment of acute otitis media with tympanostomy tubes in pediatric patients 6 months and older
 
Label Changes Summary:  * Approved for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients aged 6 months and older, * Information on dosing, and clinical trials. * New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Laboratorios SALVAT, S.A.
 
NNPS:  FALSE
 
Therapeutic Category:  antibiotic/anti-inflammatory
 
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