Sotalol Hydrochloride

ANDA 75238, held by Watson Labs. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75238 (Sotalol Hydrochloride), held by Watson Labs, was first approved by FDA on Jul 13, 2000, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2000
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 13, 2000	Original application	Approved	Letter 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 7 submissions, including labeling and manufacturing supplements


Jan 31, 2003	Supplement 8Labeling	Approved	None posted
Nov 7, 2002	Supplement 7Manufacturing	Approved	None posted
Sep 16, 2002	Supplement 6Manufacturing	Approved	None posted
Jun 24, 2002	Supplement 4Manufacturing	Approved	None posted
Jun 24, 2002	Supplement 5Manufacturing	Approved	None posted
Dec 5, 2000	Supplement 1Labeling	Approved	None posted
Jul 13, 2000	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 75238
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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