Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA077614 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, Usp Is An Alpha/beta-Adrenergic Blocking Agent Indicated For The Treatment Of: •left Ventricular Dysfunction Following Myocardial Infarction In Clinically Stable Patients(1.1) •hypertension(1.2) 1.1 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablets, Usp 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 ≤40% (with Or Without Symptomatic Heart Failure) [see Clinical Studies (14.1)]. 1.2 Hypertension Carvedilol Tablets, Usp Are Indicated For The Management Of Essential Hypertension [see Clinical Studies (14.2)] . It Can Be Used Alone Or In Combination With Other Antihypertensive Agents, Especially Thiazide-Type Diuretics [see Drug Interactions (7.2)].

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Povidones POVIDONES Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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