Sotalol Hydrochloride

ANDA 75725, held by Rising. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75725 (Sotalol Hydrochloride), held by Rising, was first approved by FDA on Dec 19, 2000, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2000
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 19, 2000	Original application	Approved	Review Letter

Products

4 strengths and forms


Sotalol Hydrochloride80MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride120MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride160MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride240MG · tablet;oral	Sotalol Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 7, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Feb 16, 2021	Supplement 8Labeling · Standard review	Approved	None posted
May 22, 2007	Supplement 4Manufacturing	Approved	None posted
Jun 4, 2003	Supplement 1Labeling	Approved	None posted
Dec 19, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75725
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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