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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:
07/18/2003
Trade Name:
Ciprodex Sterile Otic Suspension
Generic Name or Proper Name (*):
ciprofloxacin; dexamethasone
Indications Studied:
Treatment of acute otitis media in patients with tympanostomy tubes (inner ear infection) in children 6 months of age and older treatment of acute otitis externa (outer ear infection) in children 6 months of age and older
Label Changes Summary:
Over 700 pediatric patients in safety and effectiveness studies to support both indications Pediatric dosing information added New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Alcon
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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