Application Nr Approved Date Route Status External Links
ANDA076128 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 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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