Sotalol Hydrochloride

ANDA 75663, held by Impax Pharms. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75663 (Sotalol Hydrochloride), held by Impax Pharms, was first approved by FDA on Nov 7, 2000, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 7, 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
Nov 7, 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


Dec 6, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Feb 28, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Feb 16, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Oct 3, 2002	Supplement 1Labeling	Approved	None posted
Nov 7, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75663
Drugs@FDA: Overview at FDA
Company: Impax Pharms

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