Ofloxacin

Product manufactured by Direct Rx

Application Nr Approved Date Route Status External Links
ANDA078222 2008-03-17 Auricular (otic) RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Section Ofloxacin Otic Solution, 0.3% Is Indicated For The Treatment Of Infections Caused By Susceptible Isolates Of The Designated Microorganisms In The Specific Conditions Listed Below: Otitis Externa In Adults And Pediatric Patients, 6 Months And Older, Due To Escherichia Coli, Pseudomonas Aeruginosa, And Staphylococcus Aureus. Chronic Suppurative Otitis Media In Patients 12 Years And Older With Perforated Tympanic Membranes Due To Proteus Mirabilis, Pseudomonas Aeruginosa, And Staphylococcus Aureus. Acute Otitis Media In Pediatric Patients One Year And Older With Tympanostomy Tubes Due To Haemophilus Influenzae, Moraxella Catarrhalis, Pseudomonas Aeruginosa, Staphylococcus Aureus, And Streptococcus Pneumoniae.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ofloxacin OFLOXACIN ZINC537891

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