Last Updated: July 21, 2026

Generic Companies with Tentative Approvals for: enzalutamide

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enzalutamide 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
Zydus Pharms Usa Inc	enzalutamide	217322	80MG	TABLET;ORAL
Zydus Pharms Usa Inc	enzalutamide	217322	40MG	TABLET;ORAL
Haimen Pharma Inc	enzalutamide	219675	80MG	TABLET
Hikma Pharmaceuticals Usa Inc	enzalutamide	218731	40MG	TABLET
Hikma Pharmaceuticals Usa Inc	enzalutamide	218731	80MG	TABLET
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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