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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  05/01/2009
Trade Name:  Cetraxal
Generic or Proper Name (*):  ciprofloxacin otic solution
Indications Studied:  Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus
Therapeutic Category:  Antibiotic, topical
Ages Studied:  1 year and older
Study #:  1
Study Type:  Efficacy/Safety
Study Design:  Single-Blind/Active Control/Parallel Group
No Patients:  336
No Centers:  47
No Countries:  2