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Medicine / Ciprofloxacin / Pefloxacin / Ofloxacin / Quinolone / New Drug Application / Food and Drug Administration / Package insert / Tendinosis / Piperazines / Chemistry / Organic chemistry


Document Date: 2009-04-02 10:43:37

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City

Haven / /

Company

S-018 Bayer Corporation Pharmaceutical / /

Event

FDA Phase / /

IndustryTerm

supplemental new drug applications / drug products / /

MedicalCondition

anosmia / hemolytic anemia / myoclonus / dysesthesias / marrow depression / torsades de pointes / vasculitis / myasthenia / myasthenia gravis / tendonitis / hyperesthesia / dysphagia / erythema multiforme / monoliasis moniliasis / toxic epidermal necrolysis / exfoliative dermatitis / hepatic necrosis / hypesthesia / Peripheral neuropathy / Stevens-Johnson syndrome / hypoesthesias / pain / numbness / serum sickness / hepatic failure / pancreatitis / delirium / peripheral neuropathies / albuminuria / anaphylactic reactions / inflammation / renal calculi / constipation / vaginal candidiasis / MS / pseudomembranous colitis / paresthesias / methemoglobinemia / agranulocytosis / pancytopenia / hypotension / axonal polyneuropathy affecting small / /

Organization

Special Pathogen and Immunologic Drug Products Office / FDA / Center for Drug Evaluation and Research / Division of Special Pathogen / /

Person

Renata Albrecht / Andrew S. Verderame / Robin Anderson / /

/

Position

Director / Regulatory Affairs / Director / R.N. / M.D. Director / /

Product

phenytoin / ciprofloxacin hydrochloride / Cipro / ciprofloxacin / Oral Suspension / PRECAUTIONS / S-053 / Drug Product Supplement / SLR-054 / HFD-410 / SLR-018 / S-054 / S-017 / /

ProvinceOrState

Maryland / Connecticut / /

Technology

pdf / /

SocialTag