← FDA DRUG APPROVALS

FDA NDA · NDA019865

BETAPACE

sotalol hydrochloride

Sponsor: LEGACY

APPLICATION
NDA019865
TYPE
NDA
ORIGINAL APPROVAL
1992-10-30
LATEST ACTION
2023-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

BETAPACE · ReferencePrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
BETAPACEDiscontinued
SOTALOL HYDROCHLORIDE 320MG · TABLET · ORAL
BETAPACE · ReferencePrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
BETAPACE · ReferencePrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
BETAPACE · ReferencePrescription
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL

Approval history

2023-06-15Labeling · Supplement 26 · standard — Label ↗AP
2021-06-03Labeling · Supplement 22 · standard — Letter ↗AP
2016-05-10Labeling · Supplement 21 · standard — Label ↗AP
2011-08-17Labeling · Supplement 20 · unknown — Letter ↗AP
2011-02-03Labeling · Supplement 19 · unknown — Letter ↗AP
2001-10-01Efficacy · Supplement 10 · standard — Review ↗AP
2001-07-26Manufacturing (CMC) · Supplement 14 · priorityAP
2000-11-22Manufacturing (CMC) · Supplement 12 · priorityAP
2000-07-07Labeling · Supplement 11 · standardAP
1999-08-23Labeling · Supplement 8 · standardAP
1999-04-09Manufacturing (CMC) · Supplement 9 · priorityAP
1995-12-04Manufacturing (CMC) · Supplement 6 · priorityAP
1995-07-26Labeling · Supplement 5 · standardAP
1994-09-06Manufacturing (CMC) · Supplement 3 · priorityAP
1994-04-20Labeling · Supplement 4 · standardAP
1994-04-20Manufacturing (CMC) · Supplement 2 · priorityAP
1993-04-13Manufacturing (CMC) · Supplement 1 · priorityAP
1992-10-30Type 1 - New Molecular Entity · Original · priorityAP
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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.

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