Last Updated: November 9, 2026

Details for New Drug Application (NDA): 212750

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NDA 212750 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 212750
Tradename:DOFETILIDE
Applicant:Granules
Ingredient:dofetilide
Patents:0
Pharmacology for NDA: 212750
Suppliers and Packaging for NDA: 212750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOFETILIDE dofetilide CAPSULE;ORAL 212750 ANDA Granules Pharmaceuticals Inc. 70010-024 70010-024-06 60 CAPSULE in 1 BOTTLE (70010-024-06)
DOFETILIDE dofetilide CAPSULE;ORAL 212750 ANDA Granules Pharmaceuticals Inc. 70010-025 70010-025-06 60 CAPSULE in 1 BOTTLE (70010-025-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Oct 14, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Oct 14, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Oct 14, 2021TE:ABRLD:No

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Preferred Citation:

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