Coreg Cr

Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. NDA 22012, held by Waylis Therap. Carvedilol Phosphate.

As of Nov 13, 2026, NDA 22012 (Coreg Cr), held by Waylis Therap, was first approved by FDA on Dec 19, 2008, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2008
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

COREG CR 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 COREG CR is 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 15 submissions below

Date	Submission	Status	Documents
Dec 19, 2008	Original applicationTYPE 2/3 · Standard review	Approved	None posted
Oct 20, 2006	Original applicationTYPE 2/3 · Standard review	Approved	Review Label Letter

Products

4 strengths and forms

Product	Active ingredient	Marketing
Coreg Cr10MG · capsule, extended release;oral	Carvedilol Phosphate	RxReference drug
Coreg Cr20MG · capsule, extended release;oral	Carvedilol Phosphate	RxReference drug
Coreg Cr40MG · capsule, extended release;oral	Carvedilol Phosphate	RxReference drug
Coreg Cr80MG · capsule, extended release;oral	Carvedilol Phosphate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 26, 2023	Supplement 24Labeling · Standard review	Approved	Letter Label
Sep 14, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 2, 2015	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 6, 2011	Supplement 20Labeling	Approved	Letter Label
Jan 25, 2011	Supplement 16Labeling	Approved	Letter Label
Jan 6, 2011	Supplement 19Labeling	Approved	Letter Label
Jan 6, 2011	Supplement 17Labeling	Approved	Label Letter
Jun 23, 2009	Supplement 13Labeling · Standard review	Approved	Label Letter
Jun 23, 2009	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 19, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 19, 2008	Original applicationTYPE 2/3 · Standard review	Approved	None posted
Oct 19, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 3, 2007	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 16, 2007	Supplement 1Labeling · Standard review	Approved	Label Letter
Oct 20, 2006	Original applicationTYPE 2/3 · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22012
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

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