Last Updated: May 10, 2026

Details for New Drug Application (NDA): 210018

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NDA 210018 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, Ingenus Pharms Llc, MSN, 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 eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 210018

Tradename:	DOFETILIDE
Applicant:	Teva Pharms Usa
Ingredient:	dofetilide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Apr 15, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Apr 15, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Apr 15, 2022	TE:		RLD:	No

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