Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 77614, held by Zydus Pharms USA Inc. Carvedilol.
As of Nov 15, 2026, ANDA 77614 (Carvedilol), held by Zydus Pharms USA Inc, was first approved by FDA on Sep 5, 2007, with 7 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2007 | Original application | Approved |
| Carvedilol6.25MG · tablet;oral | Carvedilol | Rx |
| Carvedilol12.5MG · tablet;oral | Carvedilol | Rx |
| Carvedilol25MG · tablet;oral | Carvedilol | Rx |
| Carvedilol3.125MG · tablet;oral | Carvedilol | Rx |
| Mar 19, 2025 | Supplement 27Labeling · Standard review | Approved | None posted |
| Mar 3, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 25, 2016 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 19, 2014 | Supplement 6Labeling | Approved | None posted |
| Sep 19, 2014 | Supplement 9Labeling | Approved | None posted |
| Nov 18, 2008 | Supplement 3Labeling | Approved | None posted |
| Oct 25, 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
