Carvedilol

Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78332, held by Aurobindo Pharma. Carvedilol.

As of Nov 15, 2026, ANDA 78332 (Carvedilol), held by Aurobindo Pharma, was first approved by FDA on Sep 5, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2007
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Carvedilol 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 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 10 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 10 submissions, including labeling and manufacturing supplements


Mar 3, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Apr 4, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Sep 22, 2014	Supplement 8Labeling	Approved	None posted
Sep 21, 2014	Supplement 5Labeling	Approved	None posted
Sep 21, 2014	Supplement 10Labeling	Approved	None posted
Sep 21, 2014	Supplement 12Labeling	Approved	None posted
Sep 21, 2014	Supplement 14Labeling	Approved	None posted
May 14, 2013	Supplement 4Labeling	Approved	None posted
Oct 19, 2007	Supplement 1Labeling	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 78332
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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