APPLICATION
ANDA075366
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-01
LATEST ACTION
2015-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
Approval history
2015-12-18Labeling · Supplement 19 · standardAP
2015-12-18Manufacturing (CMC) · Supplement 16AP
2002-09-18Labeling · Supplement 5AP
2002-04-30Manufacturing (CMC) · Supplement 4AP
2000-10-25Labeling · Supplement 3AP
2000-09-07Manufacturing (CMC) · Supplement 2AP
2000-09-07Manufacturing (CMC) · 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.