Enalapril

FDA Drug Profile — Enalapril Maleate

Drug Details

Generic Name
Enalapril
Brand Names
Enalapril Maleate
Application Number
NDA208686
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
2
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
ENALAPRIL MALEATE

Indications and Usage

1 INDICATIONS AND USAGE Enalapril is an angiotensin-converting enzyme inhibitor indicated for: treatment of symptomatic heart failure. ( 1.2 ) treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. ( 1.3 ) 1.2 Heart Failure Enalapril maleate oral solution is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In these patients, enalapril maleate oral solution increases survival and decreases the frequency of hospitalization. 1.3 Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate oral solution decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure.