Application Nr Approved Date Route Status External Links
ANDA205548 None Auricular (otic) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ciprofloxacin 0.3% And Dexamethasone 0.1% Otic Suspension Is Indicated For The Treatment Of Infections Caused By Susceptible Isolates Of The Designated Microorganisms In The Specific Conditions Listed Below: Acute Otitis Media (aom) In Pediatric Patients (age 6 Months And Older) With Tympanostomy Tubes Due To Staphylococcus Aureus, Streptococcus Pneumoniae, Haemophilus Influenzae, Moraxella Catarrhalis , And Pseudomonas Aeruginosa. Acute Otitis Externa (aoe) In Pediatric (age 6 Months And Older), Adult And Elderly Patients Due To Staphylococcus Aureus And Pseudomonas Aeruginosa. Ciprofloxacin 0.3% And Dexamethasone 0.1% Otic Suspension Is A Combination Of Ciprofloxacin, A Fluoroquinolone Antibacterial And Dexamethasone, A Corticosteroid, Indicated For The Treatment Of Infections Caused By Susceptible Isolates Of The Designated Microorganisms In The Specific Conditions Listed Below: • Acute Otitis Media (aom) In Pediatric Patients (age 6 Months And Older) With Tympanostomy Tubes Due To Staphylococcus Aureus, Streptococcus Pneumoniae, Haemophilus Influenzae, Moraxella Catarrhalis , And Pseudomonas Aeruginosa. ( 1 ) • Acute Otitis Externa (aoe) In Pediatric (age 6 Months And Older), Adult And Elderly Patients Due To Staphylococcus Aureus And Pseudomonas Aeruginosa . ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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