← FDA DRUG APPROVALS

FDA ANDA · ANDA212750

DOFETILIDE 0.125MG

Sponsor: GRANULES

APPLICATION
ANDA212750
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-14
LATEST ACTION
2024-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DOFETILIDEPrescription
DOFETILIDE 0.25MG · CAPSULE · ORAL
DOFETILIDEPrescription
DOFETILIDE 0.5MG · CAPSULE · ORAL
DOFETILIDEPrescription
DOFETILIDE 0.125MG · CAPSULE · ORAL

Approval history

2024-04-30Labeling · Supplement 2 · standardAP
2021-10-14UNKNOWN · Original · standardAP
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 →