Carvedilol

Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 76373, held by Teva. Carvedilol.

As of Nov 15, 2026, ANDA 76373 (Carvedilol), held by Teva, was first approved by FDA on Sep 5, 2007, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2007
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Carvedilol tablets are 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 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 12 submissions below

Date	Submission	Status	Documents
Sep 5, 2007	Original application	Approved	Letter

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 12 submissions, including labeling and manufacturing supplements


Aug 23, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Mar 2, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Jan 23, 2012	Supplement 10Labeling	Approved	None posted
Jan 23, 2012	Supplement 12Labeling	Approved	None posted
Jan 17, 2012	Supplement 5Labeling	Approved	None posted
Jan 17, 2012	Supplement 6Labeling	Approved	None posted
Apr 1, 2011	Supplement 8Labeling	Approved	None posted
Apr 1, 2011	Supplement 9Labeling	Approved	None posted
Mar 30, 2010	Supplement 7Labeling	Approved	None posted
Dec 22, 2008	Supplement 4Labeling	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 76373
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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