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Medicine / Pefloxacin / Ofloxacin / Ciprofloxacin / Quinolone / Achilles tendon / Boxed warning / Tendinitis / New Drug Application / Piperazines / Chemistry / Organic chemistry


Document Date: 2009-04-02 11:01:55


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City

Rockville / Montville / /

Company

S-024 Bayer Pharmaceuticals Corporation / Bayer Pharmaceuticals Corporation / /

Event

FDA Phase / /

Facility

National Library of Medicine / /

IndustryTerm

supplemental new drug applications / shipped product / printing / supplemental applications / healthcare / drug products / /

MedicalCondition

Tendinopathy / severe tendon disorders / tendinitis / severe tendon disorder / tendonitis / rheumatoid arthritis / pain / tendon disorders / serious tendon disorders / renal failure / inflammation / /

MedicalTreatment

lung transplants / /

Movie

Page 3 3 / /

Organization

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

Person

Renata Albrecht / Janet Herrington / Kristen Miller / /

/

Position

Director / physician / Deputy Director / Regulatory Affairs P.O. Box / Safety Regulatory Project Manager / M.D. Director / /

Product

CIPRO XR / ciprofloxacin hydrochloride / Dextrose / CIPRO / ciprofloxacin / Oral Suspension / S-068 / NDA / S-049 / S068 / S-042 / S-026 / S-024 / date / HFD-001 / /

ProvinceOrState

New Jersey / Maryland / /

URL

http /

SocialTag