You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215323

✉ Email this page to a colleague

« Back to Dashboard

NDA 215323 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 215323

Tradename:	DOFETILIDE
Applicant:	Rk Pharma
Ingredient:	dofetilide
Patents:	0

Pharmacology for NDA: 215323

Suppliers and Packaging for NDA: 215323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOFETILIDE	dofetilide	CAPSULE;ORAL	215323	ANDA	VGYAAN Pharmaceuticals LLC	72664-229	72664-229-60	60 CAPSULE in 1 BOTTLE (72664-229-60)
DOFETILIDE	dofetilide	CAPSULE;ORAL	215323	ANDA	VGYAAN Pharmaceuticals LLC	72664-230	72664-230-60	60 CAPSULE in 1 BOTTLE (72664-230-60)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.