ANDA 77780, held by Taro. Carvedilol.
As of Nov 15, 2026, ANDA 77780 (Carvedilol), held by Taro, was first approved by FDA on Sep 5, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2007 | Original application | Approved |
| Carvedilol3.125MG · tablet;oral | Carvedilol | Discontinued |
| Carvedilol6.25MG · tablet;oral | Carvedilol | Discontinued |
| Carvedilol12.5MG · tablet;oral | Carvedilol | Discontinued |
| Carvedilol25MG · tablet;oral | Carvedilol | Discontinued |
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
