Last Updated: July 10, 2026

Generic Companies with Tentative Approvals for: Hikma

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Hikma 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
Hikma Pharms	rosiglitazone maleate	078658	2MG	TABLET; ORAL
Hikma Pharms	rosiglitazone maleate	078658	4MG	TABLET; ORAL
Hikma Pharmaceuticals Usa Inc	enzalutamide	218731	40MG	TABLET
Hikma Pharms	rosiglitazone maleate	078658	8MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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