finafloxacin

FDA Drug Profile — XTORO

finafloxacin is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including XTORO. Available dosage form: suspension.

Drug Details

Generic Name
finafloxacin
Brand Names
XTORO
Application Number
NDA206307
Sponsor
Fonseca Biosciences, LLC
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
AURICULAR (OTIC)
Active Ingredients
FINAFLOXACIN

Indications and Usage

1 INDICATIONS AND USAGE XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus . ( 1 )