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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 213338

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NDA 213338 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 ten 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. Twelve suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 213338

Tradename:	DOFETILIDE
Applicant:	Accord Hlthcare
Ingredient:	dofetilide
Patents:	0

Pharmacology for NDA: 213338

Suppliers and Packaging for NDA: 213338

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOFETILIDE	dofetilide	CAPSULE;ORAL	213338	ANDA	Accord Healthcare, Inc.	16729-490	16729-490-12	60 CAPSULE in 1 BOTTLE (16729-490-12)
DOFETILIDE	dofetilide	CAPSULE;ORAL	213338	ANDA	Accord Healthcare, Inc.	16729-491	16729-491-12	60 CAPSULE in 1 BOTTLE (16729-491-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Jun 19, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Jun 19, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Jun 19, 2020	TE:	AB	RLD:	No

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