Application Nr Approved Date Route Status External Links
ANDA040282 1999-12-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Digoxin Is A Cardiac Glycoside Indicated For: •treatment Of Mild To Moderate Heart Failure In Adults. (1.1) •increasing Myocardial Contractility In Pediatric Patients With Heart Failure. (1.2) •control Of Resting Ventricular Rate In Patients With Chronic Atrial Fibrillation In Adults. (1.3) 1.1 Heart Failure In Adults Digitek® (digoxin Tablets) Is Indicated For The Treatment Of Mild To Moderate Heart Failure In Adults. Digitek® (digoxin Tablets) Increases Left Ventricular Ejection Fraction And Improves Heart Failure Symptoms As Evidenced By Improved Exercise Capacity And Decreased Heart Failure-Related Hospitalizations And Emergency Care, While Having No Effect On Mortality. Where Possible, Digitek® (digoxin Tablets) Should Be Used In Combination With A Diuretic And An Angiotensin-Converting Enzyme (ace) Inhibitor. 1.2 Heart Failure In Pediatric Patients Digitek® (digoxin Tablets) Increases Myocardial Contractility In Pediatric Patients With Heart Failure. 1.3 Atrial Fibrillation In Adults Digitek® (digoxin Tablets) Is Indicated For The Control Of Ventricular Response Rate In Adult Patients With Chronic Atrial Fibrillation.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Digoxin

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