| Document Date: 2004-06-08 09:30:58
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City Princenton / / Company Children / BP / Bristol-Myers Squibb / / Event Product Recall / FDA Phase / Product Issues / / IndustryTerm fosinopril groups / treatment of hypertension / fosinopril solution / placebo / study protocol / / MedicalCondition bronchopulmonary dysplasia / diabetes mellitus / hypertension / heart failure / angioedema / renal disease / High Blood Pressure / diabetes / / MedicalTreatment adjunctive therapy / / Organization Division of Cardio-Renal Drug Products EXECUTIVE SUMMARY INTRODUCTION Monopril / / Person Juan Carlos Pelayo / / Position investigator / the reduction / / Product phase / fosinopril sodium / effect / Study medication / Monopril / CV118-027 / CV118-028 / / ProvinceOrState New Jersey / / Technology study protocol / Pharmacokinetics / SUMMARY/CONCLUSIONS The study Protocol / /
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Medical Review NDA No.: [removed]S-037) Drug Name: Monopril (fosinopril sodium) Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute