← FDA DRUG APPROVALS

FDA NDA · NDA020931

TIKOSYN

dofetilide

Sponsor: PFIZER

APPLICATION
NDA020931
TYPE
NDA
ORIGINAL APPROVAL
1999-10-01
LATEST ACTION
2019-08-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TIKOSYN · ReferencePrescription
DOFETILIDE 0.25MG · CAPSULE · ORAL
TIKOSYN · ReferencePrescription
DOFETILIDE 0.5MG · CAPSULE · ORAL
TIKOSYN · ReferencePrescription
DOFETILIDE 0.125MG · CAPSULE · ORAL

Approval history

2019-08-08Labeling · Supplement 17 · standard — Label ↗AP
2016-03-08REMS · Supplement 13 — Review ↗AP
2016-03-08Labeling · Supplement 12 · standard — Letter ↗AP
2015-11-25REMS · Supplement 10 — Letter ↗AP
2015-07-08REMS · Supplement 9 — Letter ↗AP
2013-12-06Labeling · Supplement 7 · standard — Letter ↗AP
2011-07-11REMS · Supplement 3 — Letter ↗AP
2007-10-18Manufacturing (CMC) · Supplement 2 · standardAP
2004-10-22Labeling · Supplement 1 · standard — Letter ↗AP
1999-10-01Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →