Manages essential hypertension. ANDA 76649, held by Rising. Carvedilol.
As of Nov 15, 2026, ANDA 76649 (Carvedilol), held by Rising, was first approved by FDA on Sep 5, 2007, with 7 approved supplements and 0 published complete response letters.
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: Left ventricular dysfunction following myocardial infarction in clinically stable patients Hypertension 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 ≤ 40% (with or without symptomatic heart failure). 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension.
| 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 |
| May 7, 2013 | Supplement 9Labeling | Approved | None posted |
| May 7, 2013 | Supplement 8Labeling | Approved | None posted |
| Oct 21, 2010 | Supplement 7Labeling | Approved | None posted |
| Feb 18, 2010 | Supplement 6Labeling | Approved | None posted |
| Jan 30, 2009 | Supplement 4Labeling | Approved | None posted |
| Aug 22, 2008 | Supplement 3Labeling | Approved | None posted |
| Oct 19, 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
