ANDA 78240, held by Pliva Hrvatska Doo. Carvedilol.
As of Nov 15, 2026, ANDA 78240 (Carvedilol), held by Pliva Hrvatska Doo, was first approved by FDA on Oct 30, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2007 | Original application | Approved | None posted |
| 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
