Last Updated: November 8, 2026

Details for New Drug Application (NDA): 204146

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NDA 204146 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 one supplier. Additional details are available on the IBUTILIDE FUMARATE profile page.

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

Summary for 204146

Tradename:	IBUTILIDE FUMARATE
Applicant:	Avet Lifesciences
Ingredient:	ibutilide fumarate
Patents:	0

Pharmacology for NDA: 204146

Suppliers and Packaging for NDA: 204146

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	204146	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-326	23155-326-31	1 VIAL, GLASS in 1 CARTON (23155-326-31) / 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:	Apr 1, 2024	TE:	AP	RLD:	No

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