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Last Updated: November 16, 2024

Details for New Drug Application (NDA): 208519

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NDA 208519 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, Sun Pharm, and Teva Pharms Usa, and is included in twelve NDAs. It is available from sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 208519

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Oct 9, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Oct 9, 2018	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Oct 9, 2018	TE:	AB	RLD:	No

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