Application Nr Approved Date Route Status External Links
NDA208251 None Auricular (Otic) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ciprofloxacin And Fluocinolone Acetonide Otic Solution Is Indicated For The Treatment Of Acute Otitis Media With Tympanostomy Tubes (Aomt) In Pediatric Patients (Aged 6 Months And Older) Due To Staphylococcus Aureus , Streptococcus Pneumoniae , Haemophilus Influenzae , Moraxella Catarrhalis , And Pseudomonas Aeruginosa . Ciprofloxacin And Fluocinolone Acetonide Otic Solution Is A Combination Of Ciprofloxacin, A Fluoroquinolone Antibacterial, And Fluocinolone Acetonide, A Corticosteroid, Indicated For The Treatment Of Acute Otitis Media With Tympanostomy Tubes (Aomt) In Pediatric Patients (Aged 6 Months And Older) Due To Staphylococcus Aureus , Streptococcus Pneumoniae , Haemophilus Influenzae , Moraxella Catarrhalis , And Pseudomonas Aeruginosa ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ciprofloxacin CIPROFLOXACIN ZINC20220
2. Fluocinolone Acetonide

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