Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78384, held by Regcon Holdings. Carvedilol.
As of Nov 15, 2026, ANDA 78384 (Carvedilol), held by Regcon Holdings, was first approved by FDA on Sep 5, 2007, with 2 approved supplements and 0 published complete response letters.
Carvedilol Tablet 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 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 |
| Sep 17, 2014 | Supplement 2Manufacturing | Approved | None posted |
| Sep 30, 2008 | 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
