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Glucocorticoids / GlaxoSmithKline / Organofluorides / Fluticasone propionate / Placebo / Rhinitis / Nasal spray / Allergic rhinitis / Corticosteroid / Medicine / Pharmacology / Allergology


BPCA CLINICAL SUMMARY OF NDA[removed], SE8-028 APPLICATION: APPLICANT: MEDICAL OFFICER: TEAM LEADER:
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Document Date: 2004-09-14 08:01:31


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File Size: 173,51 KB

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City

Triangle Park / /

Company

GlaxoSmithKline / BP / GM / ITT / Biometrics / /

Country

United States / Denmark / /

Event

FDA Phase / /

IndustryTerm

inhaled corticosteroid containing drug products / treatment / treatment for the symptoms / serous otitis media / otitis media / /

MedicalCondition

epistaxis / nosebleeds / cough bronchitis / upper respiratory infections / serous otitis media / perennial allergic rhinitis / allergic and non-allergic rhinitis / patient’s disease / streptococcal pharyngitis / pulmonary studies / pain / vomiting / Pulmonary / allergic rhinitis / diarrhea / tonsillitis / sinusitis / otitis media / cough / upper and lower respiratory infections / allergic rhinitis disease / wheezing / asthma / sore throats / /

Organization

FDA / Advisory Committee / /

Person

Elashoff / Eugene Sullivan / /

Position

investigator / TEAM LEADER / overnight BPCA Clinical Executive / Consultant / Division of Pulmonary and Allergy Drug Products BPCA Clinical Executive Summary NDA / investigator / and gender / raw BPCA Clinical Executive / Executive / Major / MEDICAL OFFICER / /

Product

Fluticasone propionate / Cutivate / Flonase / Glucocorticoid Intranasal Aqueous suspension / Allergy Drug / Flonase® Nasal Spray / /

ProvinceOrState

North Carolina / /

Technology

pdf / /

SocialTag