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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 090643

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NDA 090643 describes IBUTILIDE FUMARATE, which is a drug marketed by Avet Lifesciences, Luitpold, Mylan Institutional, and Pharmobedient, and is included in four NDAs. It is available from two suppliers. Additional details are available on the IBUTILIDE FUMARATE profile page.

The generic ingredient in IBUTILIDE FUMARATE is ibutilide fumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.

Summary for 090643

Tradename:	IBUTILIDE FUMARATE
Applicant:	Pharmobedient
Ingredient:	ibutilide fumarate
Patents:	0

Pharmacology for NDA: 090643

Suppliers and Packaging for NDA: 090643

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090643	ANDA	Mylan Institutional LLC	67457-366	67457-366-10	1 VIAL, GLASS in 1 CARTON (67457-366-10) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.1MG/ML
Approval Date:	Jan 11, 2010	TE:	AP	RLD:	No

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