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Active ingredient

Dofetilide

38 finished FDA listings contain Dofetilide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DOFETILIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
13
Strengths listed
.125 mg/1 · .25 mg/1 · .5 mg/1 · 125 ug/1 · 250 ug/1 · 500 ug/1
Brand names in FDA listings
Tikosyn

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 49247

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020931PFIZER1999-10-013
ANDA 207058DR REDDYS LABS SA2016-06-066
ANDA 207746SIGMAPHARM LABS LLC2018-03-263
ANDA 208625BIONPHARMA2018-04-103
ANDA 210466SUN PHARM2018-10-096
ANDA 210740AUROBINDO PHARMA LTD2019-01-223
ANDA 213220MSN2020-01-295
ANDA 213338ACCORD HLTHCARE2020-06-193
ANDA 212750GRANULES2021-10-146

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.