APPLICATION
ANDA210740
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-22
LATEST ACTION
2020-11-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOFETILDEPrescription
DOFETILIDE 0.25MG · CAPSULE · ORAL
DOFETILDEPrescription
DOFETILIDE 0.5MG · CAPSULE · ORAL
DOFETILDEPrescription
DOFETILIDE 0.125MG · CAPSULE · ORAL
Approval history
2020-11-30Labeling · Supplement 1 · standardAP
2019-01-22UNKNOWN · Original · standardAP
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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