Last Updated: May 12, 2026

Generic Companies with Tentative Approvals for: dronedarone

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dronedarone Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Alkem Labs Ltd	dronedarone hydrochloride	205895	400MG	TABLET;ORAL
Glenmark Generics	dronedarone hydrochloride	205903	400MG	TABLET;ORAL
Sandoz Inc	dronedarone hydrochloride	205744	400MG	TABLET;ORAL
Aurobindo Pharma Ltd	dronedarone	210678	400MG	TABLET;ORAL
Watson Labs Inc	dronedarone hydrochloride	205682	400MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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