Carvedilol

Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78251, held by Glenmark Pharms Ltd. Carvedilol.

As of Nov 15, 2026, ANDA 78251 (Carvedilol), held by Glenmark Pharms Ltd, was first approved by FDA on Sep 5, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2007
Supplements approved: 10
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 11 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 11 submissions, including labeling and manufacturing supplements


Nov 1, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Mar 6, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Mar 21, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 9Manufacturing	Approved	None posted
Sep 26, 2014	Supplement 11Labeling · Standard review	Approved	None posted
May 7, 2013	Supplement 8Labeling	Approved	None posted
May 7, 2013	Supplement 10Labeling	Approved	None posted
Oct 21, 2011	Supplement 6Manufacturing	Approved	None posted
Oct 15, 2010	Supplement 5Labeling	Approved	None posted
Nov 13, 2007	Supplement 1Labeling	Approved	None posted
Sep 5, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 78251
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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