Application Nr Approved Date Route Status External Links
ANDA210466 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Maintenance Of Normal Sinus Rhythm (Delay In Af/afl Recurrence) Dofetilide Capsules Are Indicated For The Maintenance Of Normal Sinus Rhythm (Delay In Time To Recurrence Of Atrial Fibrillation/atrial Flutter [Af/afl]) In Patients With Atrial Fibrillation/atrial Flutter Of Greater Than One Week Duration Who Have Been Converted To Normal Sinus Rhythm. Because Dofetilide Can Cause Life Threatening Ventricular Arrhythmias, It Should Be Reserved For Patients In Whom Atrial Fibrillation/atrial Flutter Is Highly Symptomatic. In General, Antiarrhythmic Therapy For Atrial Fibrillation/atrial Flutter Aims To Prolong The Time In Normal Sinus Rhythm. Recurrence Is Expected In Some Patients (See Clinical Studies ). Conversion Of Atrial Fibrillation/flutter Dofetilide Capsules Are Indicated For The Conversion Of Atrial Fibrillation And Atrial Flutter To Normal Sinus Rhythm. Dofetilide Capsules Have Not Been Shown To Be Effective In Patients With Paroxysmal Atrial Fibrillation.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dofetilide DOFETILIDE ZINC596731

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