Application Nr Approved Date Route Status External Links
ANDA076616 None Auricular (otic) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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 Aereus . 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)


Active Ingredients ( 1 Total)

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