| Document Date: 2013-02-14 16:20:43
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City Irvine / Reference / / Company Allergan Inc. / / Country United States / / IndustryTerm long-term local corticosteroid applications / long-term applications / / MedicalCondition glaucoma / inflammatory response / Patients If inflammation / scar / craniorachischisis / Keratitis / corticosteroid-responsive inflammation / acute anterior uveitis / spina bifida / conjunctival hyperemia / secondary ocular infections / ocular irritation / Carcinogenesis / ocular diseases / herpes / posterior subcapsular cataract / Fungal and viral infections / erythema / mydriasis / viral infections / viral diseases / dendritic keratitis / eye pruritus / conjunctivitis / pain / epithelial herpes simplex keratitis / cleft palate / mycobacterial infection / encephalocele / allergic reactions / suspected hypersensitivity / eye pain / bleb formation / infection / Acute purulent infections / inflammation / vaccinia / rash / varicella / cataract / fungal infections / fungal diseases / secondary ocular infection / chronic conditions / / MedicalTreatment cataract surgery / / Position PRECAUTIONS General / physician / / Product FML / dexamethasone / edetate disodium / sodium chloride / / ProvinceOrState California / /
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NDA[removed]S-063 Page 3 FML® (fluorometholone ophthalmic suspension, USP) 0.1% sterile DESCRIPTION