Last Updated: November 13, 2026

Details for New Drug Application (NDA): 215323

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NDA 215323 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 215323

Tradename:	DOFETILIDE
Applicant:	Somerset Theraps Llc
Ingredient:	dofetilide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Apr 14, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Apr 14, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Apr 14, 2022	TE:		RLD:	No

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