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Piperazines / Sun tanning / Skin physiology / Cyclopropanes / Moxifloxacin / Otologicals / Ofloxacin / Quinolone / Photosensitivity / Chemistry / Electromagnetic radiation / Organic chemistry


Document Date: 2009-04-02 11:03:00

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File Size: 41,84 KB

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City

Rockville / Haven / /

Company

S-031 Bayer Pharmaceuticals Corporation / Bayer Pharmaceuticals Corporation / /

Event

FDA Phase / /

Facility

National Library of Medicine / /

IndustryTerm

supplemental new drug applications / drug product / supplemental applications / fluoroquinolone products / /

MedicalCondition

exaggerated sunburn / relative photosensitivity/phototoxicity / photosensitivity/phototoxicity / phototoxicity / erythema / severe blistering sunburns / severe sunburn / pain / pseudomembranous colitis / severe photosensitivity/phototoxicity / /

MedicalTreatment

antibiotics / Drug therapy / /

Organization

Food and Drug Administration / Special Pathogen and Transplant Products Office / DEPARTMENT OF HEALTH / Division of Special Pathogen / Center for Drug Evaluation and Research Enclosure / /

Person

Renata Albrecht / Kristen Miller / Janet Herrington / /

/

Position

PRECAUTIONS/General / Deputy Director / Regulatory Affairs / Director / physician / Regulatory Project Manager / M.D. Director / /

Product

moxifloxacin hydrochloride / Avelox / NaCl injection / NDA / NDA Drug / Special / S-031 / S-038 / HFD-001 / /

ProvinceOrState

Maryland / Connecticut / /

URL

http /

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