Carvedilol

Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78786, held by Mlv. Carvedilol.

As of Nov 15, 2026, ANDA 78786 (Carvedilol), held by Mlv, was first approved by FDA on Dec 22, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2009
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Carvedilol tablets, USP is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure left ventricular dysfunction following myocardial infarction in clinically stable patients hypertension 1.1 Heart Failure Carvedilol tablets, USP 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. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 22, 2009	Original application	Approved	None posted

Products

4 strengths and forms


Carvedilol3.125MG · tablet;oral	Carvedilol	Rx
Carvedilol6.25MG · tablet;oral	Carvedilol	Rx
Carvedilol12.5MG · tablet;oral	Carvedilol	Rx
Carvedilol25MG · tablet;oral	Carvedilol	Rx

All 3 submissions, including labeling and manufacturing supplements


Aug 27, 2026	Supplement 5Manufacturing	Approved	None posted
Oct 9, 2024	Supplement 2Manufacturing	Approved	None posted
Dec 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78786
Drugs@FDA: Overview at FDA
Company: MLV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters