| Document Date: 2010-09-07 12:18:06
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City Melville / / Company Nycomed US Inc. / Ames / / Country United States / / Currency pence / / Event FDA Phase / Product Recall / Product Issues / / Facility Laboratory Tests / / IndustryTerm treatment site / breakdown product / topical products / renal clearance accounting / mineral oil / / MedicalCondition intracranial hypertension / Cushing syndrome / inflammatory and pruritic manifestations / allergic contact dermatitis / rosacea and perioral dermatitis / hyperglycemia/ glycosuria / headaches / Atopic Dermatitis / rash Facial telangiectasia / severe psoriasis / caused depression / severe eczema / dermatitis / acneiform eruptions / secondary infection / Chronic corticosteroid therapy / numbness / transient urticaria / miliaria / erythematous rash / disorder / psoriasis / hypersensitivity / pruritus / sepsis / human hepatoma cells / Adverse Events Skin infection Infected eczema Viral warts Herpes / concomitant skin infections / telangiectasia / immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia / disease / free cortisol test Carcinogenesis / hyperglycemia / folliculitis / eczema / hypopigmentation / erythema / bilateral papilledema / pain / cleft palate / corticosteroid-responsive dermatoses / urticaria / perioral dermatitis / dusky erythema / hypertrichosis / irritation / infection / diaper dermatitis / inflammation / / MedicalTreatment immunosuppression / / Organization DOSAGE AND ADMINISTRATION / / Position investigator / physician / / Product fluticasone propionate / ACTH / cosyntropin / drug / CUTIVATE / CUTIVATE® Cream / S-017 / CUTIVATE® Ointment / / ProvinceOrState New York / / Technology Pharmacokinetics / /
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NDA[removed]S-017 Page 3 CUTIVATE - fluticasone propionate cream PHARMADERM., A division of Nycomed US Inc[removed]CUTIVATE®