Application Nr Approved Date Route Status External Links
ANDA077614 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Carvedilol Tablets Are An Alpha/beta-Adrenergic Blocking Agent Indicated For The Treatment Of: • Mild To Severe Chronic Heart Failure ( 1.1 ) • Left Ventricular Dysfunction Following Myocardial Infarction In Clinically Stable Patients ( 1.2 ) • Hypertension ( 1.3) 1.1 Heart Failure Carvedilol Tablets Are Indicated For The Treatment Of Mild-To-Severe Chronic Heart Failure Of Ischemic Or Cardiomyopathic Origin, Usually In Addition To Diuretics, Ace Inhibitors, And Digitalis, To Increase Survival And, Also, To Reduce The Risk Of Hospitalization [ See Drug Interactions ( 7.4 ) And Clinical Studies ( 14.1 ) ]. 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablets Are Indicated To Reduce Cardiovascular Mortality In Clinically Stable Patients Who Have Survived The Acute Phase Of A Myocardial Infarction And Have A Left Ventricular Ejection Fraction Of Less Than Or Equal To 40% (With Or Without Symptomatic Heart Failure) [See Clinical Studies (14.2) ] 1.3 Hypertension Carvedilol Tablets Are Indicated For The Management Of Essential Hypertension [See Clinical Studies ( 14.3 , 14.4 ) ]. It Can Be Used Alone Or In Combination With Other Antihypertensive Agents, Especially Thiazide-Type Diuretics [See Drug Interactions (7.2)].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carvedilol CARVEDILOL ZINC1530579

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