APPLICATION
ANDA075725
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-19
LATEST ACTION
2026-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
Approval history
2026-07-07Labeling · Supplement 10 · standardAP
2021-02-16Labeling · Supplement 8 · standardAP
2007-05-22Manufacturing (CMC) · Supplement 4AP
2003-06-04Labeling · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.