Application Nr Approved Date Route Status External Links
ANDA077316 2007-09-05 Oral RX 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), 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 (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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