Treats mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin…. ANDA 78227, held by Sandoz. Carvedilol.
As of Nov 15, 2026, ANDA 78227 (Carvedilol), held by Sandoz, was first approved by FDA on Sep 5, 2007, with 6 approved supplements and 0 published complete response letters.
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. 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure). 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 24, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 25, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 26, 2016 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 7, 2013 | Supplement 1Labeling | Approved | None posted |
| May 7, 2013 | Supplement 3Labeling | Approved | None posted |
| May 7, 2013 | Supplement 5Labeling | 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
