Last Updated: November 13, 2026

Details for New Drug Application (NDA): 208625

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NDA 208625 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Andas 5 Holding, Bionpharma, Dr Reddys Labs Sa, Granules, Ingenus Pharms Llc, MSN, Prinston Inc, Sigmapharm Labs Llc, Somerset Theraps Llc, Strides Pharma Intl, Sun Pharm, and Teva Pharms Usa, and is included in thirteen NDAs. It is available from eleven suppliers. Additional details are available on the DOFETILIDE profile page.

The generic ingredient in DOFETILIDE is dofetilide. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 208625
Tradename:DOFETILIDE
Applicant:Bionpharma
Ingredient:dofetilide
Patents:0
Pharmacology for NDA: 208625
Suppliers and Packaging for NDA: 208625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 208625 ANDA Bionpharma Inc. 69452-131 69452-131-17 60 CAPSULE in 1 BOTTLE (69452-131-17)
DOFETILIDE dofetilide CAPSULE;ORAL 208625 ANDA Bionpharma Inc. 69452-132 69452-132-17 60 CAPSULE in 1 BOTTLE (69452-132-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Apr 10, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Apr 10, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Apr 10, 2018TE:ABRLD:No

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Preferred Citation:

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