Sotalol Hydrochloride

ANDA 75366, held by Upsher Smith Labs. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75366 (Sotalol Hydrochloride), held by Upsher Smith Labs, was first approved by FDA on May 1, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: May 1, 2000
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 1, 2000	Original application	Approved	Letter Label 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 8 submissions, including labeling and manufacturing supplements


Dec 18, 2015	Supplement 16Manufacturing	Approved	None posted
Dec 18, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Sep 18, 2002	Supplement 5Labeling	Approved	None posted
Apr 30, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 3Labeling	Approved	None posted
Sep 7, 2000	Supplement 1Manufacturing	Approved	None posted
Sep 7, 2000	Supplement 2Manufacturing	Approved	None posted
May 1, 2000	Original application	Approved	Letter Label Review Letter

Identifiers

Application: ANDA 75366
Drugs@FDA: Overview at FDA
Company: Upsher-Smith 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