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Company GlaxoSmithKline / ACE / / Country United States / / Facility Clinical laboratory There / / MedicalCondition arrhythmia / congestive heart failure / pneumonia / chemotherapy-induced cardiomyopathy / congenital heart disease / hypertension / systemic ventricular systolic dysfunction / cardiomyopathy / chest pain / headache / left ventricular dysfunction / dyspnea / cardiac failure / congestive cardiomyopathy / dysfunction / chronic / Duchenne's muscular dystrophy / systemic left ventricular dysfunction / primary cardiomyopathy / cardiomegaly / tricuspid atresia / syncope / atrioventricular block / clinical congestive heart failure / heart failure / dilated cardiomyopathy / bradycardia / ventricular fibrillation / infection / cardiac arrest / dizziness / subject’s ventricular dysfunction / idiopathic dilated cardiomyopathy / chronic symptomatic CHF / symptomatic systemic ventricular systolic dysfunction / respiratory distress / hypotension / dehydration / / MedicalTreatment heart transplants / antibiotics / heart surgery / chemotherapy / / Organization NL V / / Person Maryann Gordon / / Position investigator / AM MEDICAL OFFICER / physician / forward / / Product digoxin / Coreg / carvedilol / / Technology chemotherapy / transplantation / /
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NDA #20297 Supplement amendment: 022 dated September 1, 2006 Sponsor: GlaxoSmithKline Name of Finished Product: Coreg® Name of Active Ingredient: carvedilol Proposed indication: pediatric patients with symptomatic syste