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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 207746

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NDA 207746 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 207746

Tradename:	DOFETILIDE
Applicant:	Sigmapharm Labs Llc
Ingredient:	dofetilide
Patents:	0

Pharmacology for NDA: 207746

Suppliers and Packaging for NDA: 207746

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOFETILIDE	dofetilide	CAPSULE;ORAL	207746	ANDA	Sigmapharm Laboratories, LLC	42794-044	42794-044-10	60 CAPSULE in 1 BOTTLE, PLASTIC (42794-044-10)
DOFETILIDE	dofetilide	CAPSULE;ORAL	207746	ANDA	Sigmapharm Laboratories, LLC	42794-045	42794-045-10	60 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Mar 26, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Mar 26, 2018	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Mar 26, 2018	TE:	AB	RLD:	No

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