Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78165, held by Rubicon Research. Carvedilol.
As of Nov 15, 2026, ANDA 78165 (Carvedilol), held by Rubicon Research, was first approved by FDA on Sep 5, 2007, with 5 approved supplements and 0 published complete response letters.
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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2007 | Original application | Approved |
| Carvedilol3.125MG · tablet;oral | Carvedilol | Rx |
| Carvedilol6.25MG · tablet;oral | Carvedilol | Rx |
| Carvedilol12.5MG · tablet;oral | Carvedilol | Rx |
| Carvedilol25MG · tablet;oral | Carvedilol | Rx |
| Mar 11, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 26, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 16, 2010 | Supplement 5Labeling | Approved | None posted |
| Oct 16, 2007 | Supplement 1Labeling | Approved | None posted |
| Sep 5, 2007 | Original application | Approved |
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
