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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 213220


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NDA 213220 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma Intl, Sun Pharm, and Teva Pharms Usa, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the DOFETILIDE profile page.

The generic ingredient in DOFETILIDE is dofetilide. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 213220
Tradename:DOFETILIDE
Applicant:Msn
Ingredient:dofetilide
Patents:0
Pharmacology for NDA: 213220
Suppliers and Packaging for NDA: 213220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 213220 ANDA Novadoz Pharmaceuticals LLC 72205-039 72205-039-37 4 BLISTER PACK in 1 CARTON (72205-039-37) / 10 CAPSULE in 1 BLISTER PACK (72205-039-11)
DOFETILIDE dofetilide CAPSULE;ORAL 213220 ANDA Novadoz Pharmaceuticals LLC 72205-039 72205-039-60 60 CAPSULE in 1 BOTTLE (72205-039-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Jan 29, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Jan 29, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Jan 29, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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