Application Nr Approved Date Route Status External Links
NDA050065 None Ophthalmic None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For Steroid-Responsive Inflammatory Ocular Conditions For Which A Corticosteroid Is Indicated And Where Bacterial Infection Or A Risk Of Bacterial Ocular Infection Exists. Ocular Steroids Are Indicated In Inflammatory Conditions Of The Palpebral And Bulbar Conjunctiva, Cornea, And Anterior Segment Of The Globe Where The Inherent Risk Of Steroid Use In Certain Infective Conjunctivitides Is Accepted To Obtain A Diminution In Edema And Inflammation. They Are Also Indicated In Chronic Anterior Uveitis And Corneal Injury From Chemical, Radiation Or Thermal Burns; Or Penetration Of Foreign Bodies. The Use Of A Combination Drug With An Anti-Infective Component Is Indicated Where The Risk Of Infection Is High Or Where There Is An Expectation That Potentially Dangerous Numbers Of Bacteria Will Be Present In The Eye. The Particular Anti-Infective Drug In This Product Is Active Against The Following Common Bacterial Eye Pathogens: Staphylococcus Aureus, Escherichia Coli, Haemophilus Influenzae, Klebsiella/enterobacter Species, Neisseria Species, And Pseudomonas Aeruginosa. This Product Does Not Provide Adequate Coverage Against: Serratia Marcescens And Streptococci , Including Streptococcus Pneumoniae.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 3 Total)

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