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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205904

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NDA 205904 describes DRONEDARONE HYDROCHLORIDE, which is a drug marketed by Lupin and is included in one NDA. Additional details are available on the DRONEDARONE HYDROCHLORIDE profile page.

The generic ingredient in DRONEDARONE HYDROCHLORIDE is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Summary for 205904

Tradename:	DRONEDARONE HYDROCHLORIDE
Applicant:	Lupin
Ingredient:	dronedarone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Jan 31, 2024	TE:	AB	RLD:	No

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