| Document Date: 2010-01-20 12:05:18
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Company ACE / / Event Product Issues / FDA Phase / / IndustryTerm food effects / sodium hydroxide solution / food / treatment of hypertension / food intake / therapy of hypertension / / MedicalCondition vascular disease / renal artery stenosis / head and neck angioedema / systemic lupus erythematosus / laryngeal edema / hyperparathyroidism / cerebrovascular accident / ischemic heart disease / nausea / cirrhosis / thrombocytopenia / chronic therapy / hyponatremia / gout / fatigue / hepatic coma / drowsiness / injury / renal disease / tachycardia / diarrhea / hypersensitivity / restlessness / bone resorption / alkalosis / liver disease / cramps / Agranulocytosis / Hypotension / abdominal pain / hyperkalemia / congestive heart failure / intrauterine growth retardation / necrosis / hypertension / bronchial asthma / airway obstruction / disease / collagen-vascular disease / scleroderma / patent ductus arteriosus / hypophosphatemia / neonatal jaundice / Neutropenia / oliguria / aortic stenosis / caused agranulocytosis / diabetes / Neutropenia/ Agranulocytosis / azotemia / allergy / lethargy / vomiting / renal insufficiency / myocardial infarction / diabetes mellitus / angioedema / hypercalcemia / Oligohydramnios / contractures / renal failure / anuria / depression / hypokalemia / apparent low-renin hypertension / acute renal failure / syndrome / / MedicalTreatment peritoneal dialysis / concomitant therapy / intravenous infusion / surgery / apheresis / major surgery / dialysis / / Organization I.V. administration / DOSAGE AND ADMINISTRATION / / Person Serum Electrolyte Imbalances / / Position General / Major / / Product polyethylene glycol / ACTH / cimetidine / moexipril hydrochloride and hydrochlorothiazide / digoxin / moexipril hydrochloride / epinephrine / Uniretic / S-021 Page / captopril / cholestyramine / hydrochlorothiazide / S-021 / renal function / / Technology ultrasound / Pharmacokinetics / Pharmacodynamics / dialysis / /
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NDA[removed]S-021 Page 3 Uniretic tablets (moexipril HCl / hydrochlorothiazide)