ANDA 76576, held by Sun Pharm Industries. Sotalol Hydrochloride.
As of Nov 15, 2026, ANDA 76576 (Sotalol Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Apr 8, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 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
