ANDA 76883, held by Teva. Sotalol Hydrochloride.
As of Nov 15, 2026, ANDA 76883 (Sotalol Hydrochloride), held by Teva, was first approved by FDA on Jul 26, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2004 | Original application | Approved | None posted |
| Sotalol Hydrochloride80MG · tablet;oral | Sotalol Hydrochloride | Discontinued |
| Sotalol Hydrochloride120MG · tablet;oral | Sotalol Hydrochloride | Discontinued |
| Sotalol Hydrochloride160MG · tablet;oral | Sotalol Hydrochloride | 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
