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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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